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Monday, 9 July 2012

Gabitril

tiagabine hydrochloride

Dosage Form: tablet
Gabitril®

(tiagabine hydrochloride)

Tablets

Gabitril Description

Gabitril® (tiagabine HCl) is an antiepilepsy drug available as 2 mg, 4 mg, 12 mg, and 16 mg tablets for oral administration. Its chemical name is (-)-(R)-1-[4,4-Bis(3-methyl-2-thienyl)-3-butenyl]nipecotic acid hydrochloride, its molecular formula is C20H25NO2S2 HCl, and its molecular weight is 412.0. Tiagabine HCl is a white to off-white, odorless, crystalline powder. It is insoluble in heptane, sparingly soluble in water, and soluble in aqueous base. The structural formula is:

Inactive Ingredients

Gabitril tablets contain the following inactive ingredients: Ascorbic acid, colloidal silicon dioxide, crospovidone, hydrogenated vegetable oil wax, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, stearic acid, and titanium dioxide.

In addition, individual tablets contain:

2 mg tablets: FD&C Yellow No. 6.

4 mg tablets: D&C Yellow No. 10.

12 mg tablets: D&C Yellow No. 10 and FD&C Blue No. 1.

16 mg tablets: FD&C Blue No. 2.

Gabitril - Clinical Pharmacology

Mechanism of Action

The precise mechanism by which tiagabine exerts its antiseizure effect is unknown, although it is believed to be related to its ability, documented in in vitro experiments, to enhance the activity of gamma aminobutyric acid (GABA), the major inhibitory neurotransmitter in the central nervous system. These experiments have shown that tiagabine binds to recognition sites associated with the GABA uptake carrier. It is thought that, by this action, tiagabine blocks GABA uptake into presynaptic neurons, permitting more GABA to be available for receptor binding on the surfaces of post-synaptic cells. Inhibition of GABA uptake has been shown for synaptosomes, neuronal cell cultures, and glial cell cultures. In rat-derived hippocampal slices, tiagabine has been shown to prolong GABA-mediated inhibitory post-synaptic potentials. Tiagabine increases the amount of GABA available in the extracellular space of the globus pallidus, ventral palladum, and substantia nigra in rats at the ED50 and ED85 doses for inhibition of pentylenetetrazol (PTZ)-induced tonic seizures. This suggests that tiagabine prevents the propagation of neural impulses that contribute to seizures by a GABA-ergic action.

Tiagabine has shown efficacy in several animal models of seizures. It is effective against the tonic phase of subcutaneous PTZ-induced seizures in mice and rats, seizures induced by the proconvulsant DMCM in mice, audiogenic seizures in genetically epilepsy-prone rats (GEPR), and amygdala-kindled seizures in rats. Tiagabine has little efficacy against maximal electroshock seizures in rats and is only partially effective against subcutaneous PTZ-induced clonic seizures in mice, picrotoxin-induced tonic seizures in the mouse, bicuculline-induced seizures in the rat, and photic seizures in photosensitive baboons. Tiagabine produces a biphasic dose-response curve against PTZ- and DMCM-induced convulsions, with attenuated effectiveness at higher doses.

Based on in vitro binding studies, tiagabine does not significantly inhibit the uptake of dopamine, norepinephrine, serotonin, glutamate, or choline and shows little or no binding to dopamine D1 and D2, muscarinic, serotonin 5HT1A, 5HT2, and 5HT3, beta-1 and 2 adrenergic, alpha-1 and alpha-2 adrenergic, histamine H2 and H3, adenosine A1 and A2, opiate µ and K1, NMDA glutamate, and GABAA receptors at 100 µM. It also lacks significant affinity for sodium or calcium channels. Tiagabine binds to histamine H1, serotonin 5HT1B, benzodiazepine, and chloride channel receptors at concentrations 20 to 400 times those inhibiting the uptake of GABA.

Pharmacokinetics

Tiagabine is well absorbed, with food slowing absorption rate but not altering the extent of absorption. The elimination half-life of tiagabine is 7 to 9 hours in normal volunteers. In epilepsy clinical trials, most patients were receiving hepatic enzyme-inducing agents (e.g., carbamazepine, phenytoin, primidone, and phenobarbital). The pharmacokinetic profile in induced patients is significantly different from the non-induced population (see PRECAUTIONS, General, Use in Non-Induced Patients). The systemic clearance of tiagabine in induced patients is approximately 60% greater resulting in considerably lower plasma concentrations and an elimination half-life of 2 to 5 hours. Given this difference in clearance, the systemic exposure after a dose of 32 mg/day in an induced population is expected to be comparable to the systemic exposure after a dose of 12 mg/day in a non-induced population. Similarly, the systemic exposure after a dose of 56 mg/day in an induced population is expected to be comparable to the systemic exposure after a dose of 22 mg/day in a non-induced population.

Absorption and Distribution

Absorption of tiagabine is rapid, with peak plasma concentrations occurring at approximately 45 minutes following an oral dose in the fasting state. Tiagabine is nearly completely absorbed (>95%), with an absolute oral bioavailability of about 90%. A high fat meal decreases the rate (mean Tmax was prolonged to 2.5 hours, and mean Cmax was reduced by about 40%) but not the extent (AUC) of tiagabine absorption. In all clinical trials, tiagabine was given with meals.

The pharmacokinetics of tiagabine are linear over the single dose range of 2 to 24 mg. Following multiple dosing, steady state is achieved within 2 days.

Tiagabine is 96% bound to human plasma proteins, mainly to serum albumin and α1-acid glycoprotein over the concentration range of 10 ng/mL to 10,000 ng/mL. While the relationship between tiagabine plasma concentrations and clinical response is not currently understood, trough plasma concentrations observed in controlled clinical trials at doses from 30 to 56 mg/day ranged from <1 ng/mL to 234 ng/mL.

Metabolism and Elimination

Although the metabolism of tiagabine has not been fully elucidated, in vivo and in vitro studies suggest that at least two metabolic pathways for tiagabine have been identified in humans: 1) thiophene ring oxidation leading to the formation of 5-oxo-tiagabine; and 2) glucuronidation. The 5-oxo-tiagabine metabolite does not contribute to the pharmacologic activity of tiagabine.

Based on in vitro data, tiagabine is likely to be metabolized primarily by the 3A isoform subfamily of hepatic cytochrome P450 (CYP 3A), although contributions to the metabolism of tiagabine from CYP 1A2, CYP 2D6 or CYP 2C19 have not been excluded.

Approximately 2% of an oral dose of tiagabine is excreted unchanged, with 25% and 63% of the remaining dose excreted into the urine and feces, respectively, primarily as metabolites, at least 2 of which have not been identified. The mean systemic plasma clearance is 109 mL/min (CV = 23%) and the average elimination half-life for tiagabine in healthy subjects ranged from 7 to 9 hours. The elimination half-life decreased by 50 to 65% in hepatic enzyme-induced patients with epilepsy compared to uninduced patients with epilepsy.

A diurnal effect on the pharmacokinetics of tiagabine was observed. Mean steady-state Cminvalues were 40% lower in the evening than in the morning. Tiagabine steady-state AUC values were also found to be 15% lower following the evening tiagabine dose compared to the AUC following the morning dose.

Special Populations

Renal Insufficiency

The pharmacokinetics of total and unbound tiagabine were similar in subjects with normal renal function (creatinine clearance >80 mL/min) and in subjects with mild (creatinine clearance 40 to 80 mL/min), moderate (creatinine clearance 20 to 39 mL/min), or severe (creatinine clearance 5 to 19 mL/min) renal impairment. The pharmacokinetics of total and unbound tiagabine were also unaffected in subjects with renal failure requiring hemodialysis.

Hepatic Insufficiency

In patients with moderate hepatic impairment (Child-Pugh Class B), clearance of unbound tiagabine was reduced by about 60%. Patients with impaired liver function may require reduced initial and maintenance doses of tiagabine and/or longer dosing intervals compared to patients with normal hepatic function (see PRECAUTIONS).

Geriatric

The pharmacokinetic profile of tiagabine was similar in healthy elderly and healthy young adults.

Pediatric

Tiagabine has not been investigated in adequate and well-controlled clinical trials in patients below the age of 12. The apparent clearance and volume of distribution of tiagabine per unit body surface area or per kg were fairly similar in 25 children (age: 3 to 10 years) and in adults taking enzyme-inducing antiepilepsy drugs ([AEDs] e.g., carbamazepine or phenytoin). In children who were taking a non-inducing AED (e.g., valproate), the clearance of tiagabine based upon body weight and body surface area was 2 and 1.5-fold higher, respectively, than in non-induced adults with epilepsy.

Gender, Race and Cigarette Smoking

No specific pharmacokinetic studies were conducted to investigate the effect of gender, race and cigarette smoking on the disposition of tiagabine. Retrospective pharmacokinetic analyses, however, suggest that there is no clinically important difference between the clearance of tiagabine in males and females, when adjusted for body weight. Population pharmacokinetic analyses indicated that tiagabine clearance values were not significantly different in Caucasian (N=463), Black (N=23), or Hispanic (N=17) patients with epilepsy, and that tiagabine clearance values were not significantly affected by tobacco use.

Interactions with other Antiepilepsy Drugs

The clearance of tiagabine is affected by the co-administration of hepatic enzyme-inducing antiepilepsy drugs. Tiagabine is eliminated more rapidly in patients who have been taking hepatic enzyme-inducing drugs, e.g., carbamazepine, phenytoin, primidone and phenobarbital than in patients not receiving such treatment (see PRECAUTIONS, Drug Interactions).

Interactions with Other Drugs

See PRECAUTIONS, Drug Interactions.

Clinical Studies

The effectiveness of Gabitril as adjunctive therapy (added to other antiepilepsy drugs) was examined in three multi-center, double-blind, placebo-controlled, parallel-group, clinical trials in 769 patients with refractory partial seizures who were taking at least one hepatic enzyme-inducing antiepilepsy drug (AED), and two placebo-controlled cross-over studies in 90 patients. In the parallel-group trials, patients had a history of at least six complex partial seizures (Study 1 and Study 2, U.S. studies), or six partial seizures of any type (Study 3, European study), occurring alone or in combination with any other seizure type within the 8-week period preceding the first study visit in spite of receiving one or more AEDs at therapeutic concentrations.

In the first two studies, the primary protocol-specified outcome measure was the median reduction from baseline in the 4-week complex partial seizure (CPS) rates during treatment. In the third study, the protocol-specified primary outcome measure was the proportion of patients achieving a 50% or greater reduction from baseline in the 4-week seizure rate of all partial seizures during treatment. The results given below include data for complex partial seizures and all partial seizures for the intent-to-treat population (all patients who received at least one dose of treatment and at least one seizure evaluation) in each study.

Study 1 was a double-blind, placebo-controlled, parallel-group trial comparing Gabitril 16 mg/day, Gabitril 32 mg/day, Gabitril 56 mg/day, and placebo. Study drug was given as a four times a day regimen. After a prospective Baseline Phase of 12 weeks, patients were randomized to one of the four treatment groups described above. The 16-week Treatment Phase consisted of a 4-week Titration Period, followed by a 12-week Fixed-Dose Period, during which concomitant AED doses were held constant. The primary outcome was assessed for the combined 32 and 56 mg/day groups compared to placebo.

Study 2 was a double-blind, placebo-controlled, parallel-group trial consisting of an 8-week Baseline Phase and a 12-week Treatment Phase, the first 4 weeks of which constituted a Titration Period and the last 8 weeks a Fixed-Dose Period. This study compared Gabitril 16 mg BID and 8 mg QID to placebo. The protocol-specified primary outcome measure was assessed separately for each group treated with Gabitril.

The following tables display the results of the analyses of these two trials.

Table 1: Median Reduction and Median Percent Reduction from Baseline in 4-Week Seizure Rates in Study 1
* p < 0.05
†Statistical significance was not assessed for median % reduction.
		Placebo (N=91)	Gabitril 16 mg/day (N=61)	Gabitril 32 mg/day (N=87)	Gabitril 56 mg/day (N=56)	Combined 32 and 56 mg/day (N=143)
Complex Partial	Median Reduction	0.6	0.8	2.2*	2.9*	2.6*
Complex Partial	Median % Reduction†	9%	13%	25%	32%	29%
All Partial	Median Reduction	0.2	1.2	2.7*	3.5*	2.9*
All Partial	Median % Reduction†	3%	12%	24%	36%	27%

Table 2: Median Reduction and Median Percent Reduction from Baseline in 4-Week Seizure Rates in Study 2
* p < 0.027, necessary for statistical significance due to multiple comparisons.
†Statistical significance was not assessed for median % reduction.
	Placebo (N=107)	Gabitril 16 mg BID (N=106)	Gabitril 8 mg QID (N=104)
Complex Partial	Median Reduction	0.3	1.6	1.3*
Complex Partial	Median % Reduction†	4%	22%	15%
All Partial	Median Reduction	0.5	1.6	1.3
All Partial	Median % Reduction†	5%	19%	13%

Figures 1 to 4 present the proportion of patients (X-axis) whose percent reduction from baseline in the all partial seizure rate was at least as great as that indicated on the Y axis in the three placebo-controlled adjunctive studies (Studies 1, 2, and 3). A positive value on the Y axis indicates an improvement from baseline (i.e., a decrease in seizure rate), while a negative value indicates a worsening from baseline (i.e., an increase in seizure rate). Thus, in a display of this type, the curve for an effective treatment is shifted to the left of the curve for placebo.

Figure 1 indicates that the proportion of patients achieving any particular level of reduction in seizure rate was consistently higher for the combined Gabitril 32 mg and 56 mg groups compared to the placebo group in Study 1. For example, Figure 1 indicates that approximately 24% of patients treated with Gabitril experienced a 50% or greater reduction, compared to 4% in the placebo group.

Figure 1, Study 1

Figure 2 also displays the results for Study 1, which was a dose-response study, by treatment group, without combining Gabitril dosage groups. Figure 2 indicates a dose-response relationship across the three Gabitril groups. The proportion of patients achieving any particular level of reduction in all partial seizure rates was consistently higher as the dose of Gabitril was increased. For example, Figure 2 indicates that approximately 4% of patients in the placebo group experienced a 50% or greater reduction in all partial seizure rate, compared to approximately 10% of the Gabitril 16 mg/day group, 21% of the Gabitril 32 mg/day group, and 30% of the Gabitril 56 mg/day group.

Figure 2, Study 1

Figure 3 indicates that the proportion of patients achieving any particular level of reduction in partial seizure rate was consistently greater in patients taking Gabitril than in those taking placebo in Study 2. (Study 2 compared placebo to Gabitril 32 mg/day; one of the Gabitril groups received 8 mg QID, while the other Gabitril group received 16 mg BID). For example, Figure 3 indicates that approximately 7% of patients in the placebo group experienced a 50% or greater reduction in their partial seizure rate, compared to approximately 23% of patients in the Gabitril 8 mg QID group and 28% of patients in the Gabitril 16 mg BID group.

Figure 3, Study 2

Study 3 was a double-blind, placebo-controlled, parallel-group trial that compared Gabitril 10 mg TID (N=77) with placebo (N=77). In this trial, patients were followed prospectively during a 12-week Baseline Phase and then randomized to receive study drug during an 18-week Treatment Phase. During the first 6 weeks of treatment (Titration Period), patients were titrated to 30 mg/day, after which they were maintained on this dose during the 12-week Fixed-Dose Period. The protocol-specified primary outcome measure (proportion of patients who achieved at least a 50% reduction from baseline in partial seizure rate) did not reach statistical significance. However, analyses of the median reduction from baseline in 4-week partial seizure rate (the analyses presented above for Study 1 and Study 2) were performed and showed a statistically significant improvement compared to placebo in all partial and complex partial seizure rates (Table 3):

Table 3: Median Reduction and Median Percent Reduction from Baseline in 4-Week Seizure Rates in Study 3
* p < 0.05
†Statistical significance was not assessed for median % reduction.
‡N=72 and 75 for placebo and Gabitril, respectively.
		Placebo (N=77)	Gabitril 30 mg/day (N=77)
Complex Partial‡	Median Reduction	-0.1	1.3*
Complex Partial‡	Median % Reduction†	-1%	14%
All Partial	Median Reduction	-0.5	1.1*
All Partial	Median % Reduction†	-7%	11%

Figure 4 indicates that the proportion of patients achieving any particular level of reduction in seizure activity was consistently higher in those taking Gabitril than those taking placebo in Study 3. For example, Figure 4 indicates that approximately 5% of patients in the placebo group experienced a 50% or greater reduction in their partial seizure rate compared to approximately 10% of patients in the Gabitril group.

Figure 4, Study 3

The two other placebo-controlled trials that examined the effectiveness of Gabitril were small cross-over trials (N=46 and 44). Both trials included an open Screening Phase during which patients were titrated to an optimal dose and then treated with this dose for an additional 4 weeks. After this Open Phase, patients were randomized to one of two blinded treatment sequences (Gabitril followed by placebo or placebo followed by Gabitril). The Double-Blind Phase consisted of two Treatment Periods, each lasting 7 weeks (with a 3 week washout between periods). The outcome measures were median with-in patient differences between placebo and Gabitril Treatment Periods in 4-week complex partial and all partial seizure rates. The reductions in seizure rates were statistically significant in both studies.

Indications and Usage for Gabitril

Gabitril (tiagabine hydrochloride) is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.

Contraindications

Gabitril is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.

Warnings

Seizures in Patients Without Epilepsy: Post-marketing reports have shown that Gabitril use has been associated with new onset seizures and status epilepticus in patients without epilepsy. Dose may be an important predisposing factor in the development of seizures, although seizures have been reported in patients taking daily doses of Gabitril as low as 4 mg/day. In most cases, patients were using concomitant medications (antidepressants, antipsychotics, stimulants, narcotics) that are thought to lower the seizure threshold. Some seizures occurred near the time of a dose increase, even after periods of prior stable dosing.

The Gabitril dosing recommendations in current labeling for treatment of epilepsy were based on use in patients with partial seizures 12 years of age and older, most of whom were taking enzyme-inducing antiepileptic drugs (AEDs; e.g., carbamazepine, phenytoin, primidone and phenobarbital) which lower plasma levels of Gabitril by inducing its metabolism. Use of Gabitril without enzyme-inducing antiepileptic drugs results in blood levels about twice those attained in the studies on which current dosing recommendations are based (see DOSAGE AND ADMINISTRATION).

Safety and effectiveness of Gabitril have not been established for any indication other than as adjunctive therapy for partial seizures in adults and children 12 years and older.

In nonepileptic patients who develop seizures while on Gabitril treatment, Gabitril should be discontinued and patients should be evaluated for an underlying seizure disorder.

Seizures and status epilepticus are known to occur with Gabitril overdosage (see OVERDOSAGE).

Suicidal Behavior and Ideation

Antiepileptic drugs (AEDs), including Gabitril, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide.

The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.

The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5-100 years) in the clinical trials analyzed.

Table 4 shows absolute and relative risk by indication for all evaluated AEDs.

Table 4: Risk by Indication for Antiepileptic Drugs in the Pooled Analysis
Indication	Placebo Patients with Events per 1000 Patients	Drug Patients with Events per 1000 Patients	Relative Risk: Incidence of Events in Drug Patients/Incidence in Placebo Patients	Risk Difference: Additional Drug Patients with Events per 1000 Patients
Epilepsy	1.0	3.4	3.5	2.4
Psychiatric	5.7	8.5	1.5	2.9
Other	1.0	1.8	1.9	0.9
Total	2.4	4.3	1.8	1.9

The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications.

Anyone considering prescribing Gabitril or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.

Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.

Withdrawal Seizures

As a rule, antiepilepsy drugs should not be abruptly discontinued because of the possibility of increasing seizure frequency. In a placebo-controlled, double-blind, dose-response study (Study 1 described in CLINICAL STUDIES) designed, in part, to investigate the capacity of Gabitril to induce withdrawal seizures, study drug was tapered over a 4-week period after 16 weeks of treatment. Patients’ seizure frequency during this 4-week withdrawal period was compared to their baseline seizure frequency (before study drug). For each partial seizure type, for all partial seizure types combined, and for secondarily generalized tonic-clonic seizures, more patients experienced increases in their seizure frequencies during the withdrawal period in the three Gabitril groups than in the placebo group. The increase in seizure frequency was not affected by dose. Gabitril should be withdrawn gradually to minimize the potential of increased seizure frequency, unless safety concerns require a more rapid withdrawal.

Cognitive/Neuropsychiatric Adverse Events

Adverse events most often associated with the use of Gabitril were related to the central nervous system. The most significant of these can be classified into 2 general categories: 1) impaired concentration, speech or language problems, and confusion (effects on thought processes); and 2) somnolence and fatigue (effects on level of consciousness). The majority of these events were mild to moderate. In controlled clinical trials, these events led to discontinuation of treatment with Gabitril in 6% (31 of 494) of patients compared to 2% (5 of 275) of the placebo-treated patients. A total of 1.6% (8 of 494) of the Gabitril treated patients in the controlled trials were hospitalized secondary to the occurrence of these events compared to 0% of the placebo treated patients. Some of these events were dose related and usually began during initial titration.

Patients with a history of spike and wave discharges on EEG have been reported to have exacerbations of their EEG abnormalities associated with these cognitive/neuropsychiatric events. This raises the possibility that these clinical events may, in some cases, be a manifestation of underlying seizure activity (see PRECAUTIONS, Laboratory Tests, EEG). In the documented cases of spike and wave discharges on EEG with cognitive/neuropsychiatric events, patients usually continued tiagabine, but required dosage adjustment.

Additionally, there have been postmarketing reports of patients who have experienced cognitive/neuropsychiatric symptoms, some accompanied by EEG abnormalities such as generalized spike and wave activity, that have been reported as nonconvulsant status epilepticus. Some reports describe recovery following reduction of dose or discontinuation of Gabitril.

Status Epilepticus

In the three double-blind, placebo-controlled, parallel-group studies (Studies 1, 2, and 3), the incidence of any type of status epilepticus (simple, complex, or generalized tonic-clonic) in patients receiving Gabitril was 0.8% (4 of 494 patients) versus 0.7% (2 of 275 patients) receiving placebo. Among the patients treated with Gabitril across all epilepsy studies (controlled and uncontrolled), 5% had some form of status epilepticus. Of the 5%, 57% of patients experienced complex partial status epilepticus. A critical risk factor for status epilepticus was the presence of a previous history; 33% of patients with a history of status epilepticus had recurrence during Gabitril treatment. Because adequate information about the incidence of status epilepticus in a similar population of patients with epilepsy who have not received treatment with Gabitril is not available, it is impossible to state whether or not treatment with Gabitril is associated with a higher or lower rate of status epilepticus than would be expected to occur in a similar population not treated with Gabitril.

Sudden Unexpected Death In Epilepsy (SUDEP)

There have been as many as 10 cases of sudden unexpected deaths during the clinical development of tiagabine among 2531 patients with epilepsy (3831 patient-years of exposure).

This represents an estimated incidence of 0.0026 deaths per patient-year. This rate is within the range of estimates for the incidence of sudden and unexpected deaths in patients with epilepsy not receiving Gabitril (ranging from 0.0005 for the general population with epilepsy, 0.003 to 0.004 for clinical trial populations similar to that in the clinical development program for Gabitril, to 0.005 for patients with refractory epilepsy). The estimated SUDEP rates in patients receiving Gabitril are also similar to those observed in patients receiving other antiepilepsy drugs, chemically unrelated to Gabitril, that underwent clinical testing in similar populations at about the same time. This evidence suggests that the SUDEP rates reflect population rates, not a drug effect.

Precautions

General

Use in Non-Induced Patients

Virtually all experience with Gabitril has been obtained in patients with epilepsy receiving at least one concomitant enzyme-inducing antiepilepsy drug (AED), which lowers the plasma levels of tiagabine. Use in non-induced patients requires lower doses of Gabitril. These patients may also require a slower titration of Gabitril compared to that of induced patients (see DOSAGE AND ADMINISTRATION). Patients taking a combination of inducing and non-inducing agents (e.g., carbamazepine and valproate) should be considered to be induced. Patients not receiving hepatic enzyme-inducing agents are referred to as non-induced patients.

Generalized Weakness

Moderately severe to incapacitating generalized weakness has been reported following administration of Gabitril in 28 of 2531 (approximately 1%) patients with epilepsy. The weakness resolved in all cases after a reduction in dose or discontinuation of Gabitril.

Binding in the Eye and Other Melanin-Containing Tissues

When dogs received a single dose of radiolabeled tiagabine, there was evidence of residual binding in the retina and uvea after 3 weeks (the latest time point measured). Although not directly measured, melanin binding is suggested. The ability of available tests to detect potentially adverse consequences, if any, of the binding of tiagabine to melanin-containing tissue is unknown and there was no systematic monitoring for relevant ophthalmological changes during the clinical development of Gabitril. However, long term (up to one year) toxicological studies of tiagabine in dogs showed no treatment-related ophthalmoscopic changes and macro- and microscopic examinations of the eye were unremarkable. Accordingly, although there are no specific recommendations for periodic ophthalmologic monitoring, prescribers should be aware of the possibility of long-term ophthalmologic effects.

Use in Hepatically-Impaired Patients

Because the clearance of tiagabine is reduced in patients with liver disease, dosage reduction may be necessary in these patients.

Serious Rash

Four patients treated with tiagabine during the product’s premarketing clinical testing developed what were considered to be serious rashes. In two patients, the rash was described as maculopapular; in one it was described as vesiculobullous; and in the 4th case, a diagnosis of Stevens Johnson Syndrome was made. In none of the 4 cases is it certain that tiagabine was the primary, or even a contributory, cause of the rash. Nevertheless, drug associated rash can, if extensive and serious, cause irreversible morbidity, even death.

Information for Patients

Patients should be informed of the availability of a Medication Guide, and they should be instructed to read it prior to taking Gabitril. The complete text of the Medication Guide is provided at the end of this labeling.

Suicidal Thinking and Behavior

Patients, their caregivers, and families should be counseled that AEDs, including Gabitril, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.

Patients should be advised that Gabitril may cause dizziness, somnolence, and other symptoms and signs of CNS depression. Accordingly, patients should be advised neither to drive nor to operate other complex machinery until they have gained sufficient experience on Gabitril to gauge whether or not it affects their mental and/or motor performance adversely. Because of the possible additive depressive effects, caution should also be used when patients are taking other CNS depressants in combination with Gabitril.

Because teratogenic effects were seen in the offspring of rats exposed to maternally toxic doses of tiagabine and because experience in humans is limited, patients should be advised to notify their physicians if they become pregnant or intend to become pregnant during therapy.

Because of the possibility that tiagabine may be excreted in breast milk, patients should be advised to notify those providing care to themselves and their children if they intend to breast-feed or are breast-feeding an infant.

Patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334 (see PRECAUTIONS,Pregnancy).

Laboratory Tests

Therapeutic Monitoring of Plasma Concentrations of Tiagabine

A therapeutic range for tiagabine plasma concentrations has not been established. In controlled trials, trough plasma concentrations observed among patients randomized to doses of tiagabine that were statistically significantly more effective than placebo ranged from <1 ng/mL to 234 ng/mL (median, 10th and 90th percentiles are 23.7 ng/mL, 5.4 ng/mL, and 69.8 ng/mL, respectively). Because of the potential for pharmacokinetic interactions between Gabitril and drugs that induce or inhibit hepatic metabolizing enzymes, it may be useful to obtain plasma levels of tiagabine before and after changes are made in the therapeutic regimen.

Clinical Chemistry and Hematology

During the development of Gabitril, no systematic abnormalities on routine laboratory testing were noted. Therefore, no specific guidance is offered regarding routine monitoring; the practitioner retains responsibility for determining how best to monitor the patient in his/her care.

EEG

Patients with a history of spike and wave discharges on EEG have been reported to have exacerbations of their EEG abnormalities associated with cognitive/neuropsychiatric events. This raises the possibility that these clinical events may, in some cases, be a manifestation of underlying seizure activity (see WARNINGS, Cognitive/Neuropsychiatric Adverse Events). In the documented cases of spike and wave discharges on EEG with cognitive/neuropsychiatric events, patients usually continued tiagabine, but required dosage adjustment.

Drug Interactions

In evaluating the potential for interactions among co-administered antiepilepsy drugs (AEDs), whether or not an AED induces or does not induce metabolic enzymes is an important consideration. Carbamazepine, phenytoin, primidone, and phenobarbital are generally classified as enzyme inducers; valproate and gabapentin are not. Gabitril is considered to be a non-enzyme inducing AED (see PRECAUTIONS, General, Use in Non-Induced Patients).

The drug interaction data described in this section were obtained from studies involving either healthy subjects or patients with epilepsy.

Effects of Gabitril on other Antiepilepsy Drugs (AEDs):

Phenytoin: Tiagabine had no effect on the steady-state plasma concentrations of phenytoin in patients with epilepsy.

Carbamazepine: Tiagabine had no effect on the steady-state plasma concentrations of carbamazepine or its epoxide metabolite in patients with epilepsy.

Valproate: Tiagabine causes a slight decrease (about 10%) in steady-state valproate concentrations.

Phenobarbital or Primidone: No formal pharmacokinetic studies have been performed examining the addition of tiagabine to regimens containing phenobarbital or primidone. The addition of tiagabine in a limited number of patients in three well-controlled studies caused no systematic changes in phenobarbital or primidone concentrations when compared to placebo.

Effects of other Antiepilepsy Drugs (AEDs) on Gabitril:

Carbamazepine: Population pharmacokinetic analyses indicate that tiagabine clearance is 60% greater in patients taking carbamazepine with or without other enzyme-inducing AEDs.

Phenytoin: Population pharmacokinetic analyses indicate that tiagabine clearance is 60% greater in patients taking phenytoin with or without other enzyme-inducing AEDs.

Phenobarbital (Primidone): Population pharmacokinetic analyses indicate that tiagabine clearance is 60% greater in patients taking phenobarbital (primidone) with or without other enzyme-inducing AEDs.

Valproate: The addition of tiagabine to patients taking valproate chronically had no effect on tiagabine pharmacokinetics, but valproa

Sunday, 8 July 2012

Y-Cof DM Sustained-Release Tablets

Pronunciation: dex-brome-fen-IR-a-meen/dex-troe-meth-OR-fan/fen-ill-EF-rin
Generic Name: Dexbrompheniramine/Dextromethorphan/Phenylephrine
Brand Name: Tussal-ER and Y-Cof DM

Y-Cof DM Sustained-Release Tablets are used for:

Relieving symptoms of sinus congestion, runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Y-Cof DM Sustained-Release Tablets are a decongestant, antihistamine, and cough suppressant combination. It works by constricting blood vessels and reducing swelling in the nasal passages, The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing while the cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Y-Cof DM Sustained-Release Tablets if:

you are allergic to any ingredient in Y-Cof DM Sustained-Release Tablets

you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems

you are unable to urinate or are having an asthma attack

you take sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Y-Cof DM Sustained-Release Tablets:

Some medical conditions may interact with Y-Cof DM Sustained-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have a fast, slow, or irregular heartbeat

if you have a history of adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; heart blood vessel problems; stroke; glaucoma; a blockage of your bladder, stomach, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; or an overactive thyroid

if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus

Some MEDICINES MAY INTERACT with Y-Cof DM Sustained-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAO inhibitors (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects of Y-Cof DM Sustained-Release Tablets may be increased

Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased

Bromocriptine or hydantoins (eg, phenytoin) because side effects may be increased by Y-Cof DM Sustained-Release Tablets

Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased by Y-Cof DM Sustained-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Y-Cof DM Sustained-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Y-Cof DM Sustained-Release Tablets:

Use Y-Cof DM Sustained-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Y-Cof DM Sustained-Release Tablets may be taken with or without food.

Swallow Y-Cof DM Sustained-Release Tablets whole. Do not break, crush, or chew before swallowing.

If you miss a dose of Y-Cof DM Sustained-Release Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Y-Cof DM Sustained-Release Tablets.

Important safety information:

Y-Cof DM Sustained-Release Tablets may cause dizziness, drowsiness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Y-Cof DM Sustained-Release Tablets. Using Y-Cof DM Sustained-Release Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.

Do not take diet or appetite control medicines while you are taking Y-Cof DM Sustained-Release Tablets without checking with your doctor.

Y-Cof DM Sustained-Release Tablets contains dexbrompheniramine, dextromethorphan, and phenylephrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains dexbrompheniramine, dextromethorphan, or phenylephrine. If it does or if you are uncertain, contact your doctor or pharmacist.

Do NOT exceed the recommended dose or take Y-Cof DM Sustained-Release Tablets for longer than prescribed without checking with your doctor.

If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.

Y-Cof DM Sustained-Release Tablets may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Y-Cof DM Sustained-Release Tablets. Use a sunscreen or protective clothing if you must be outside for a prolonged period.

If you are scheduled for allergy skin testing, do not take Y-Cof DM Sustained-Release Tablets for several days before the test because it may decrease your response to the skin tests.

Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Y-Cof DM Sustained-Release Tablets.

Use Y-Cof DM Sustained-Release Tablets with caution in the ELDERLY because they may be more sensitive to its effects.

Caution is advised when using Y-Cof DM Sustained-Release Tablets in CHILDREN because they may be more sensitive to its effects.

PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Y-Cof DM Sustained-Release Tablets, discuss with your doctor the benefits and risks of using Y-Cof DM Sustained-Release Tablets during pregnancy. It is unknown if Y-Cof DM Sustained-Release Tablets are excreted in breast milk. Do not breast-feed while taking Y-Cof DM Sustained-Release Tablets.

Possible side effects of Y-Cof DM Sustained-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor; trouble sleeping; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Y-Cof DM side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Y-Cof DM Sustained-Release Tablets:

Store Y-Cof DM Sustained-Release Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Y-Cof DM Sustained-Release Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Y-Cof DM Sustained-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.

Y-Cof DM Sustained-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Y-Cof DM Sustained-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Y-Cof DM resources

Y-Cof DM Side Effects (in more detail)
Y-Cof DM Use in Pregnancy & Breastfeeding
Y-Cof DM Drug Interactions
Y-Cof DM Support Group
0 Reviews for Y-Cof DM - Add your own review/rating

Compare Y-Cof DM with other medications

Cough and Nasal Congestion

Zorbtive

Pronunciation: SOE-ma-TROE-pin
Generic Name: Somatropin (rDNA origin - Nonrefrigerated)
Brand Name: Zorbtive

Zorbtive is used for:

Treating short bowel syndrome (SBS). It is used along with a specialized diet. It may also be used for other conditions as determined by your doctor.

Zorbtive is a growth hormone. It works by increasing the flow of water, electrolytes, and nutrients into the bowels.

Do NOT use Zorbtive if:

you are allergic to any ingredient in Zorbtive or in the diluent

you have active or recurring cancer or a brain tumor

you have severe breathing problems (eg, respiratory failure) or a serious illness caused by complications from a surgery or injury

Contact your doctor or health care provider right away if any of these apply to you.

Before using Zorbtive:

Some medical conditions may interact with Zorbtive. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances (including benzyl alcohol)

if you have a history of lung or breathing problems (eg, airway blockage, respiratory infection, sleep apnea), an underactive thyroid, heart problems, high blood pressure, pancreas problems, liver or kidney problems, ear or hearing problems (eg, repeated ear infections), or endocrine problems (eg, pituitary or adrenal gland problems)

if you have a history of diabetes, high blood sugar levels, a certain type of eye problem caused by diabetes (diabetic retinopathy), or if a member of your family has had diabetes

if you have a history of leukemia, other types of cancer (eg, skin cancer), or any unusual growths or tumors (especially in the brain)

if you have curvature of the spine (scoliosis), carpal tunnel syndrome, or Prader-Willi syndrome

if you are very overweight or have had a recent major surgery or injury

Some MEDICINES MAY INTERACT with Zorbtive. Tell your health care provider if you are taking any other medicines, especially any of the following:

Estrogens because they may decrease Zorbtive's effectiveness

Anticonvulsants (eg, carbamazepine) or cyclosporine because the risk of their side effects may be increased by Zorbtive

Corticosteroids (eg, cortisone, prednisone), or insulin or other medicines for diabetes because their effectiveness may be decreased by Zorbtive

This may not be a complete list of all interactions that may occur. Ask your health care provider if Zorbtive may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Zorbtive:

Use Zorbtive as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Zorbtive. Talk to your pharmacist if you have questions about this information.

Zorbtive is given as an injection under the skin. A health care provider will teach you how to use it. Be sure you understand how to use Zorbtive. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.

Gently swirl Zorbtive to mix it. Do not shake Zorbtive.

Zorbtive should be clear and colorless. Do not use Zorbtive if it contains particles, is cloudy or discolored, or if the container is cracked or damaged.

Be sure to rotate your injection site as directed to help avoid thickening or hardening of the skin. Do not inject Zorbtive into skin that is sore, red, infected, or damaged.

Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.

If you miss a dose of Zorbtive, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once. Do not use more than 1 dose in a day. Contact your doctor if you miss more than 3 doses.

Ask your health care provider any questions you may have about how to use Zorbtive.

Important safety information:

Follow the diet plan given to you by your health care provider.

Do not drink alcohol while you are using Zorbtive.

If you experience nausea, vomiting, stomach pain, or gas, check with your doctor for ways to lessen these effects.

Pancreas inflammation (pancreatitis) has been reported rarely in patients who take Zorbtive. The risk may be greater in children, especially in girls who have Turner syndrome. Contact your doctor right away if you develop stomach or back pain.

Rarely, children using Zorbtive have experienced a slipped growth plate in the hip. Contact the doctor right away if the patient develops hip or knee pain or a limp.

Zorbtive may cause mild swelling (particularly in the hands or feet) or muscle pain or stiffness. These effects may go away on their own. If they persist or become bothersome, check with your doctor for ways to lessen these effects.

Zorbtive may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.

Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

Lab tests, including blood tests and eye exams, may be performed while you use Zorbtive. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use Zorbtive with caution in the ELDERLY; they may be more sensitive to its effects.

Zorbtive may have benzyl alcohol in it. Do not use it in NEWBORNS or INFANTS. It may cause serious and sometimes fatal nervous system problems and other side effects.

Zorbtive should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Zorbtive while you are pregnant. It is not known if Zorbtive is found in breast milk. If you are or will be breast-feeding while you use Zorbtive, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Zorbtive:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Gas; mild swelling (eg, of the hands or feet); muscle or joint pain; pain, swelling, redness, itching, or bruising at the injection site.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast enlargement in males; burning, tingling, itching, or numbness in the palm of the hand, fingers, or wrist; change in appearance or size of a mole; confusion; ear pain, discharge, or discomfort; fever; hearing problems; hip or knee pain; limp; new growth on the skin; one-sided weakness; persistent or severe cough or sore throat; severe or persistent muscle or joint pain; severe or persistent swelling of the hands, ankles, or feet; shortness of breath; slurred speech; snoring or irregular breathing during sleep; sudden, severe, or persistent headache, dizziness, nausea, or vomiting; symptoms of dehydration (eg, very dry mouth or skin); symptoms of high blood sugar (eg, increased thirst, hunger, or urination; unusual weakness); symptoms of pancreas inflammation (eg, severe or persistent stomach or back pain, yellowing of the skin or eyes, fast heartbeat, unusual sweating); thickened or hardened skin at the injection site; trouble breathing; unusual bruising; vision changes.

See also: Zorbtive side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include excessive thirst or hunger; frequent urination; headache; nausea or vomiting; swelling of the ankles, feet, or hands.

Proper storage of Zorbtive:

Store new (unopened) vials at room temperature between 59 and 86 degrees F (15 and 30 degrees C). Do not freeze. Protect from heat, moisture, and light. Do not use Zorbtive past the expiration date on the product label.

If you mix Zorbtive with bacteriostatic water for injection, the mixed medicine may be stored in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Throw away mixed vials after 14 days, even if they still contain medicine.

If you mix Zorbtive with sterile water for injection, use it right away. Throw away any medicine left in the vial. Do not save medicine mixed with sterile water for injection for use at a later time.

Contact your pharmacist if you have any questions about how to properly store Zorbtive. Keep Zorbtive out of the reach of children and away from pets.

General information:

If you have any questions about Zorbtive, please talk with your doctor, pharmacist, or other health care provider.

Zorbtive is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Zorbtive. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Zorbtive resources

Zorbtive Side Effects (in more detail)
Zorbtive Use in Pregnancy & Breastfeeding
Zorbtive Drug Interactions
Zorbtive Support Group
0 Reviews for Zorbtive - Add your own review/rating

Zorbtive Prescribing Information (FDA)

Zorbtive Advanced Consumer (Micromedex) - Includes Dosage Information

Zorbtive Consumer Overview

Somatropin Professional Patient Advice (Wolters Kluwer)

Genotropin Advanced Consumer (Micromedex) - Includes Dosage Information

Genotropin Prescribing Information (FDA)

Humatrope Prescribing Information (FDA)

Norditropin Prescribing Information (FDA)

Nutropin Prescribing Information (FDA)

Nutropin AQ Prescribing Information (FDA)

Nutropin Depot Prescribing Information (FDA)

Omnitrope Consumer Overview

Omnitrope Prescribing Information (FDA)

Saizen Prescribing Information (FDA)

Serostim Prescribing Information (FDA)

Tev-Tropin Prescribing Information (FDA)

Compare Zorbtive with other medications

Short Bowel Syndrome
Short Stature for Age

Thursday, 5 July 2012

Mydfrin Ophthalmic

Generic Name: phenylephrine (Ophthalmic route)

fen-il-EF-rin

Commonly used brand name(s)

In the U.S.

AK-Dilate

Altafrin

Eye Cool

Mydfrin

Neofrin

Neo-Synephrine

Ocu-Phrin

Prefrin Liquifilm

Available Dosage Forms:

Solution

Therapeutic Class: Mydriatic-Cycloplegic

Pharmacologic Class: Sympathomimetic

Chemical Class: Alkylarylamine

Uses For Mydfrin

Ophthalmic phenylephrine in strengths of 2.5 and 10% is used to dilate (enlarge) the pupil. It is used before eye examinations, before and after eye surgery, and to treat certain eye conditions. In the U.S., these preparations are available only with your doctor's prescription.

Before Using Mydfrin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Children may be especially sensitive to the effects of phenylephrine. This may increase the chance of side effects during treatment. In addition, the 10% strength is not recommended for use in infants. Also, the 2.5 and 10% strengths are not recommended for use in low birth weight infants.

Geriatric

Repeated use of 2.5 or 10% phenylephrine may increase the chance of problems during treatment with this medicine. In addition, heart and blood vessel problems have occurred more often in elderly patients than in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Clorgyline

Iproniazid

Isocarboxazid

Nialamide

Phenelzine

Procarbazine

Rasagiline

Selegiline

Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Amitriptyline

Amoxapine

Clomipramine

Desipramine

Dothiepin

Doxepin

Furazolidone

Imipramine

Lofepramine

Midodrine

Nortriptyline

Opipramol

Pargyline

Protriptyline

Trimipramine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Guanethidine

Propranolol

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of phenylephrine

This section provides information on the proper use of a number of products that contain phenylephrine. It may not be specific to Mydfrin. Please read with care.

Do not use if the solution turns brown or becomes cloudy.

To use:

First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 2 or 3 minutes to allow the medicine to be absorbed by the eye.

Immediately after using the eye drops, wash your hands to remove any medicine that may be on them.

To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

For patients using the 2.5 or 10% eye drops:

It is very important that you use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of too much medicine being absorbed into the body and the chance of side effects. This is especially important when this medicine is used in children or in patients with heart disease or high blood pressure, since high doses of this medicine may cause an irregular heartbeat and an increase in blood pressure.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For ophthalmic solution (eye drops) dosage form:
- For eye redness:
  - Adults and children—Use one drop of 0.12% solution every three or four hours as needed.
- For eye exams:
  - Adults and children—Use one drop of 2.5% solution. Depending on the eye test to be done, it will take from fifteen minutes to one or two hours for the medicine to work before you can have the eye test.
- For use before eye surgery:
  - Adults and teenagers—Use one drop of 2.5 or 10% solution thirty to sixty minutes before the start of eye surgery.
  - Children—Use one drop of 2.5% solution thirty to sixty minutes before the start of eye surgery.
- For certain eye conditions:
  - Adults and teenagers—Depending on the eye condition being treated, your doctor may tell you to use one drop of 2.5 or 10% solution in the eye from once a day to three times a day.
  - Children—Depending on the eye condition being treated, your doctor may tell you to use one drop of 2.5% solution in the eye from once a day to three times a day.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

For non-prescription strength eye drops, follow the package directions.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Mydfrin

If eye pain or change in vision occurs or if redness or irritation of the eye continues, gets worse, or lasts for more than 72 hours, stop using the medicine and check with your doctor.

For patients using the 2.5 or 10% eye drops:

After you apply this medicine to your eyes, your pupils will become unusually large. This will cause your eyes to become more sensitive to light than they are normally. When you go out during the daylight hours, even on cloudy days, wear sunglasses that block ultraviolet (UV) light to protect your eyes from sunlight and other bright lights. Ordinary sunglasses may not protect your eyes. If you have any questions about the kind of sunglasses to wear, check with your doctor. Also, if this effect continues for longer than 12 hours after you have stopped using this medicine, check with your doctor.

Mydfrin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Symptoms of too much medicine being absorbed into the body - Less common with 10% solution; rare with 2.5% or weaker solution

Dizziness

fast, irregular, or pounding heartbeat

increased sweating

increase in blood pressure

paleness

trembling

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common with 2.5 or 10% solution

Burning or stinging of eyes

headache or browache

sensitivity of eyes to light

watering of eyes

Less common

Eye irritation not present before use of this medicine

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Mydfrin Ophthalmic resources

Mydfrin Ophthalmic Use in Pregnancy & Breastfeeding
Mydfrin Ophthalmic Drug Interactions
Mydfrin Ophthalmic Support Group
0 Reviews for Mydfrin Ophthalmic - Add your own review/rating

Compare Mydfrin Ophthalmic with other medications

Eye Dryness/Redness
Eye Redness/Itching
Pupillary Dilation

Tuesday, 3 July 2012

Ventavis

Generic Name: iloprost (ill O prost)

Brand Names: Ventavis

What is iloprost inhalation?

Iloprost is an synthetic prostacyclin. It works by opening blood vessels in the lungs.

Iloprost is used as an inhalant to treat pulmonary arterial hypertension.

Iloprost inhalation may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about iloprost inhalation?

Use iloprost inhalation exactly as directed by your doctor. Iloprost inhalation should only be used with the Prodose AAD system. Do not use iloprost inhalation with other types of nebulizers. If you do not understand your instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Iloprost inhalation may lower blood pressure which can lead to dizziness or fainting. Stand up slowly when getting out of a chair or bed. If you experience fainting or if your dizziness gets worse contact your doctor.

What should I discuss with my healthcare provider before taking iloprost inhalation?

Before taking this medication, tell your doctor if you have.

liver disease;

heart disease;

kidney disease;

low blood pressure;

chronic obstructive pulmonary disease (COPD);

asthma; or

a chest cold or cough.

You may need a lower dose or special monitoring during therapy with iloprost inhalation.

Iloprost is in the FDA pregnancy category C. This means that it is not known whether iloprost will be harmful to an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment. Iloprost passes into breast milk in small amounts and may affect a nursing baby. Do not take iloprost without first talking to your doctor if you are breast-feeding a baby.

How should I use iloprost inhalation?

Use iloprost inhalation exactly as directed by your doctor. Iloprost inhalation should only be used with the Prodose AAD system. Do not use it with other types of nebulizers. If you do not understand the instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Iloprost inhalation may cause a lowering of blood pressure which can lead to dizziness or fainting. Stand up slowly when getting out of a chair or bed. If you experience fainting or if your dizziness gets worse contact your doctor.

Store iloprost inhalation at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and use the next one as directed. Do not use a double dose of this medication.

What happens if I overdose?

An overdose of this medication is not likely to occur. If you do suspect an overdose, call an emergency room or poison control center.

What should I avoid while taking iloprost inhalation?

Avoid items or activities that you know are allergens for you if they make your symptoms worse. Clean areas where dust or pet fur may aggravate your condition.

Do not stop taking iloprost inhalation until your doctor approves. It may be some time before you begin to notice effects from this medication.

Iloprost inhalation side effects

Serious side effects from iloprost inhalation are not likely to occur. Seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat, swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may also occur. Continue to use iloprost inhalation and talk to your doctor if you experience

dry mouth, nose, or throat after use;

coughing or throat irritation;

hoarseness or deepening of the voice;

headache, dizziness, or lightheadedness;

nausea;

flushing; or

jaw tightness or pain.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect iloprost inhalation?

Before using this medication, tell your doctor and pharmacist about any other drugs you are taking including vitamins, minerals, and herbal products.

More Ventavis resources

Ventavis Side Effects (in more detail)
Ventavis Use in Pregnancy & Breastfeeding
Ventavis Drug Interactions
Ventavis Support Group
0 Reviews for Ventavis - Add your own review/rating

Ventavis Prescribing Information (FDA)

Ventavis Monograph (AHFS DI)

Ventavis Advanced Consumer (Micromedex) - Includes Dosage Information

Ventavis Consumer Overview

Ventavis MedFacts Consumer Leaflet (Wolters Kluwer)

Iloprost Professional Patient Advice (Wolters Kluwer)

Compare Ventavis with other medications

Pulmonary Arterial Hypertension

Where can I get more information?

Your pharmacist has additional information about iloprost inhalation written for health professionals that you may read.

See also: Ventavis side effects (in more detail)

Monday, 2 July 2012

Temovate Scalp Application

Dosage Form: scalp application
TEMOVATE®

(clobetasol propionate scalp application)

Scalp Application, 0.05%

Rx only

FOR TOPICAL DERMATOLOGIC USE ONLY—NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE

DESCRIPTION

TEMOVATE® (clobetasol propionate scalp application) Scalp Application, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity.

Chemically, clobetasol propionate is (11β,16β)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)pregna-1, 4-diene-3,20-dione, and it has the following structural formula:

Clobetasol propionate has the molecular formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water.

TEMOVATE® Scalp Application contains clobetasol propionate 0.5 mg/g in a base of purified water, isopropyl alcohol (39.3%), carbomer 934R and sodium hydroxide.

CLINICAL PHARMACOLOGY

The corticosteroids are a class of compounds comprising steroid hormones secreted by the adrenal cortex and their synthetic analogs. In pharmacologic doses, corticosteroids are used primarily for their anti-inflammatory and/or immunosuppressive effects. Topical corticosteroids such as clobetasol propionate are effective in the treatment of corticosteroid-responsive dermatoses primarily because of their anti-inflammatory, antipruritic, and vasoconstrictive actions. However, while the physiologic, pharmacologic, and clinical effects of the corticosteroids are well known, the exact mechanisms of their actions in each disease are uncertain.

Clobetasol propionate, a corticosteroid, has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteristic of this class of drugs.

Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids, including clobetasol propionate, is determined by many factors, including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings (see DOSAGE AND ADMINISTRATION).

As with all topical corticosteroids, clobetasol propionate can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids (see DOSAGE AND ADMINISTRATION).

Once absorbed through the skin, topical corticosteroids enter pharmacokinetic pathways similarly to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids, including clobetasol propionate and its metabolites, are also excreted into the bile.

Following repeated nonocclusive application in the treatment of scalp psoriasis, there is some evidence that TEMOVATE® Scalp Application has the potential to depress plasma cortisol levels in some patients. However, hypothalamic-pituitary-adrenal (HPA) axis effects produced by systemically absorbed clobetasol propionate have been shown to be transient and reversible upon completion of a 2-week course of treatment.

INDICATIONS AND USAGE

TEMOVATE® Scalp Application is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/week because of the potential for the drug to suppress the HPA axis.

This product is not recommended for use in pediatric patients under 12 years of age.

CONTRAINDICATIONS

TEMOVATE® Scalp Application is contraindicated in patients with primary infections of the scalp, or in patients who are hypersensitive to clobetasol propionate, other corticosteroids, or any ingredient in this preparation.

PRECAUTIONS

General: Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at doses as low as 2 g (of ointment) per day. Systemic absorption of topical corticosteroids has resulted in reversible HPA axis suppression, manifestations of Cushing syndrome, hyperglycemia, and glucosuria in some patients.

Conditions that augment systemic absorption include the application of the more potent corticosteroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.

Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see PRECAUTIONS: Pediatric Use).

If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. Irritation is possible if TEMOVATE® Scalp Application contacts the eye. If that should occur, immediate flushing of the eye with a large volume of water is recommended.

If the inflammatory lesion becomes infected, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Although TEMOVATE® Scalp Application is intended for the treatment of inflammatory conditions of the scalp, it should be noted that certain areas of the body, such as the face, groin, and axillae, are more prone to atrophic changes than other areas of the body following treatment with corticosteroids. Frequent observation of the patient is important if these areas are to be treated.

As with other potent topical corticosteroids, TEMOVATE® Scalp Application should rot be used in the treatment of rosacea and perioral dermatitis. Topical corticosteroids in general should not be used in the treatment of acne or as sole therapy in widespread plaque psoriasis.

Information for Patients: Patients using TEMOVATE® Scalp Application should receive the following information and instructions:

This medication is to be used as directed by the physician and should not be used longer than the prescribed time period. It is for external use only. Avoid contact with the eyes.

This medication should not be used for any disorder other than that for which it was prescribed.

The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive.

Patients should report any signs of local adverse reactions to the physician.

Laboratory Tests: The following tests may be helpful in evaluating patients for HPA axis suppression:

: Urinary free cortisol test
: ACTH stimulation test

Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential of clobetasol propionate.

Studies in the rat following subcutaneous administration at dosage levels up to 50 mcg/kg/day revealed that the females exhibited an increase in the number of resorbed embryos and a decrease in the number of living fetuses at the highest dose

Clobetasol propionate was nonmutagenic in 3 different test systems: the Ames test, the Saccharomyces cerevisiae gene conversion assay and the E. coli B WP2 fluctuation test.

Pregnancy: Teratogenic Effects: Pregnancy Category C.

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals.

Clobetasol propionate has not been tested for teratogenicity when applied topically; however, it is absorbed percutaneously, and when administered subcutaneously it was a significant teratogen in both the rabbit and mouse. Clobetasol propionate has greater teratogenic potential than steroids that are less potent.

Teratogenicity studies in mice using the subcutaneous route resulted in fetotoxicity at the highest dose tested (1 mg/kg) and teratogenicity at all dose levels tested down to 0.03 mg/kg. These doses are approximately 1.4 and 0.04 times, respectively, the human topical dose of TEMOVATE® Scalp Application. Abnormalities seen included cleft palate and skeletal abnormalities.

In rabbits, clobetasol propionate was teratogenic at doses of 3 and 10 mcg/kg. These doses are approximately 0.02 and 0.05 times, respectively, the human topical dose of TEMOVATE® Scalp Application. Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities.

There are no adequate and well-controlled studies of the teratogenic potential of clobetasol propionate in pregnant women. TEMOVATE® Scalp Application should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when TEMOVATE® Scalp Application is administered to a nursing woman.

Pediatric Use: Use of TEMOVATE® Scalp Application in pediatric patients under 12 years of age is not recommended.

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing syndrome than mature patients because of a larger skin surface area to body weight ratio.

HPA axis suppression, Cushing syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Geriatric Use: A limited number of patients at or above 65 years of age (n = 65) have been treated with TEMOVATE® Scalp Application in US and non-US clinical trials. While the number of patients is too small to permit separate analysis of efficacy and safety, the adverse reactions reported in this population were similar to those reported by younger patients. Based on available data, no adjustment of dosage of TEMOVATE® Scalp Application in geriatric patients is warranted.

Adverse Reactions

TEMOVATE® Scalp Application is generally well tolerated when used for 2-week treatment periods.

The most frequent adverse events reported for TEMOVATE® Scalp Application have been local and have included burning and/or stinging sensation, which occurred in 29 of 294 patients; scalp pustules, which occurred in 3 of 294 patients; and tingling and folliculitis, each of which occurred in 2 of 294 patients. Less frequent adverse events were itching and tightness of the scalp, dermatitis, tenderness, headache, hair loss, and eye irritation, each of which occurred in 1 of 294 patients.

The following local adverse reactions are reported infrequently when topical corticosteroids are used as recommended. These reactions are listed in an approximately decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing syndrome, hyperglycemia, and glucosuria in some patients. In rare instances, treatment (or withdrawal of treatment) of psoriasis with corticosteroids is thought to have exacerbated the disease or provoked the pustular form of the disease, so careful patient supervision is recommended.

OVERDOSAGE

Topically applied TEMOVATE® Scalp Application can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

DOSAGE AND ADMINISTRATION

TEMOVATE® Scalp Application should be applied to the affected scalp areas twice daily, once in the morning and once at night.

TEMOVATE® Scalp Application is potent; therefore, treatment must be limited to 2 consecutive weeks and amounts greater than 50 mL/week should not be used.

TEMOVATE® Scalp Application is not to be used with occlusive dressings.

Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with TEMOVATE® Scalp Application, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

HOW SUPPLIED

: TEMOVATE® (clobetasol propionate scalp application)
: Scalp Application, 0.05% is supplied in plastic squeeze bottles,
: 50 mL (NDC 0462-0269-50).
: Store between 4° and 25°C (39° and 77°F).
: Do not use near an open flame.

PharmaDerm®

A division of Nycomed US Inc.

Melville, NY 11747 USA

www.pharmaderm.com

I8269A

R10/08

#153

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 50 mL BOTTLE LABEL

NDC 0462-0269-50

PharmaDerm®

Temovate®

(clobetasol propionate

scalp application)

Scalp Application,

0.05%

For dermatologic use only-

Not for ophthalmic use.

Rx only

50 mL

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 50 mL CARTON

NDC 0462-0269-50

PharmaDerm®

Temovate®

(clobetasol propionate

scalp application)

Scalp Application,

0.05%

For dermatologic use only-

Not for ophthalmic use.

Rx only

50 mL

TEMOVATE SCALP APPLICATION
clobetasol propionate solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0462-0269
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
clobetasol propionate (clobetasol)	clobetasol propionate	0.5 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
isopropyl alcohol
sodium hydroxide
water

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0462-0269-50	50 mL In 1 BOTTLE, PLASTIC	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075391	02/08/1999

Labeler - PharmaDerm®, A division of Nycomed US Inc. (043838424)

Registrant - Nycomed US Inc. (043838424)

Establishment
Name	Address	ID/FEI	Operations
Nycomed US Inc.		043838424	ANALYSIS

Establishment
Name	Address	ID/FEI	Operations
Nycomed US Inc.		174491316	MANUFACTURE

Revised: 09/2009PharmaDerm®, A division of Nycomed US Inc.

More Temovate Scalp Application resources

Temovate Scalp Application Side Effects (in more detail)
Temovate Scalp Application Use in Pregnancy & Breastfeeding
Temovate Scalp Application Drug Interactions
Temovate Scalp Application Support Group
48 Reviews for Temovate Scalp Application - Add your own review/rating

Compare Temovate Scalp Application with other medications

Anal Itching
Atopic Dermatitis
Cutaneous T-cell Lymphoma
Dermatitis
Lichen Planus
Lichen Sclerosus
Necrobiosis Lipoidica Diabeticorum
Psoriasis
Seborrheic Dermatitis

Monday, 9 July 2012

Gabitril

Gabitril Description

Inactive Ingredients

Gabitril - Clinical Pharmacology

Mechanism of Action

Pharmacokinetics

Special Populations

Clinical Studies

Indications and Usage for Gabitril

Contraindications

Warnings

Suicidal Behavior and Ideation

Withdrawal Seizures

Cognitive/Neuropsychiatric Adverse Events

Status Epilepticus

Sudden Unexpected Death In Epilepsy (SUDEP)

Precautions

General

Laboratory Tests

Drug Interactions

Sunday, 8 July 2012

Y-Cof DM Sustained-Release Tablets

Y-Cof DM Sustained-Release Tablets are used for:

Do NOT use Y-Cof DM Sustained-Release Tablets if:

Before using Y-Cof DM Sustained-Release Tablets:

How to use Y-Cof DM Sustained-Release Tablets:

Important safety information:

Possible side effects of Y-Cof DM Sustained-Release Tablets:

If OVERDOSE is suspected:

General information:

More Y-Cof DM resources

Compare Y-Cof DM with other medications

Zorbtive

Zorbtive is used for:

Do NOT use Zorbtive if:

Before using Zorbtive:

How to use Zorbtive:

Important safety information:

Possible side effects of Zorbtive:

If OVERDOSE is suspected:

General information:

More Zorbtive resources

Compare Zorbtive with other medications

Thursday, 5 July 2012

Mydfrin Ophthalmic

Commonly used brand name(s)

Uses For Mydfrin

Before Using Mydfrin

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of phenylephrine

Dosing

Missed Dose

Storage

Precautions While Using Mydfrin

Mydfrin Side Effects

More Mydfrin Ophthalmic resources

Compare Mydfrin Ophthalmic with other medications

Tuesday, 3 July 2012

Ventavis

What is iloprost inhalation?

What is the most important information I should know about iloprost inhalation?

What should I discuss with my healthcare provider before taking iloprost inhalation?

How should I use iloprost inhalation?

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while taking iloprost inhalation?

Iloprost inhalation side effects

What other drugs will affect iloprost inhalation?

More Ventavis resources

Compare Ventavis with other medications

Where can I get more information?

Monday, 2 July 2012