Tiagabine Hydrochloride (Tiagabine Hydrochloride)

Trade Name : Tiagabine Hydrochloride

Teva Pharmaceuticals USA, Inc.

TABLET, FILM COATED

Strength 2 mg/1

TIAGABINE HYDROCHLORIDE Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Tiagabine Hydrochloride (Tiagabine Hydrochloride) which is also known as Tiagabine Hydrochloride and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 2 mg/1 per ml. Read more

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Tiagabine hydrochloride 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 CHNOS 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:

No data

Tiagabine HCl is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.

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

Seizures in Patients Without Epilepsy: Post-marketing reports have shown that tiagabine HCl 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 tiagabine HCl 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 tiagabine HCl 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 tiagabine HCl by inducing its metabolism. Use of tiagabine HCl without enzyme-inducing antiepileptic drugs results in blood levels about twice those attained in the studies on which current dosing recommendations are based (see ).
Safety and effectiveness of tiagabine HCl 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 tiagabine HCl treatment, tiagabine HCl should be discontinued and patients should be evaluated for an underlying seizure disorder.
Seizures and status epilepticus are known to occur with tiagabine HCl overdosage (see ).
Suicidal Behavior and Ideation:
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.
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 tiagabine HCl 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:n- Array
Cognitive/Neuropsychiatric Adverse Events:
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 ). 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 tiagabine HCl.
Status Epilepticus:
Sudden Unexpected Death In Epilepsy (SUDEP):
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 tiagabine HCl (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 tiagabine HCl, to 0.005 for patients with refractory epilepsy). The estimated SUDEP rates in patients receiving tiagabine HCl are also similar to those observed in patients receiving other antiepilepsy drugs, chemically unrelated to tiagabine HCl, 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.

No data

The most commonly observed adverse events in placebo-controlled, parallel-group, add-on epilepsy trials associated with the use of tiagabine HCl in combination with other antiepilepsy drugs not seen at an equivalent frequency among placebo-treated patients were dizziness/light-headedness, asthenia/lack of energy, somnolence, nausea, nervousness/irritability, tremor, abdominal pain, and thinking abnormal/difficulty with concentration or attention.
Approximately 21% of the 2531 patients who received tiagabine HCl in clinical trials of epilepsy discontinued treatment because of an adverse event. The adverse events most commonly associated with discontinuation were dizziness (1.7%), somnolence (1.6%), depression (1.3%), confusion (1.1%), and asthenia (1.1%).
In Studies 1 and 2 (U.S. studies), the double-blind, placebo-controlled, parallel-group, add-on studies, the proportion of patients who discontinued treatment because of adverse events was 11% for the group treated with tiagabine HCl and 6% for the placebo group. The most common adverse events considered the primary reason for discontinuation were confusion (1.2%), somnolence (1.0%), and ataxia (1.0%).
Adverse Event Incidence in Controlled Clinical Trials:
The prescriber should be aware that these figures, obtained when tiagabine HCl was added to concurrent antiepilepsy drug therapy, cannot be used to predict the frequency of adverse events in the course of usual medical practice when patient characteristics and other factors may differ from those prevailing during clinical studies. Similarly, the cited frequencies cannot be directly compared with figures obtained from other clinical investigations involving different treatments, uses, or investigators. An inspection of these frequencies, however, does provide the prescribing physician with one basis to estimate the relative contribution of drug and non-drug factors to the adverse event incidences in the population studied.
1 Patients in these add-on studies were receiving one to three concomitant enzyme-inducing antiepilepsy drugs in addition to tiagabine HCl or placebo. Patients may have reported multiple adverse experiences; thus, patients may be included in more than one category.* COSTART term substituted with a more clinically descriptive term.
Other events reported by 1% or more of patients treated with tiagabine HCl but equally or more frequent in the placebo group were: accidental injury, chest pain, constipation, flu syndrome, rhinitis, anorexia, back pain, dry mouth, flatulence, ecchymosis, twitching, fever, amblyopia, conjunctivitis, urinary tract infection, urinary frequency, infection, dyspepsia, gastroenteritis, nausea and vomiting, myalgia, diplopia, headache, anxiety, acne, sinusitis, and incoordination.
Study 1 was a dose-response study including doses of 32 mg and 56 mg. Table 6 shows adverse events reported at a rate of u2265 5% in at least one tiagabine HCl group and more frequent than in the placebo group. Among these events, depression, tremor, nervousness, difficulty with concentration/attention, and perhaps asthenia exhibited a positive relationship to dose.
u2020 Patients in this study were receiving one to three concomitant enzyme-inducing antiepilepsy drugs in addition to tiagabine HCl or placebo. Patients may have reported multiple adverse experiences; thus, patients may be included in more than one category.* COSTART term substituted with a more clinically descriptive term.
The effects of tiagabine HCl in relation to those of placebo on the incidence of adverse events and the types of adverse events reported were independent of age, weight, and gender. Because only 10% of patients were non-Caucasian in parallel-group, placebo-controlled trials, there is insufficient data to support a statement regarding the distribution of adverse experience reports by race.
Other Adverse Events Observed During All Clinical Trials:
Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring in at least 1/100 patients; infrequent adverse events are those occurring in 1/100 to 1/1000 patients; rare events are those occurring in fewer than 1/1000 patients.
Body as a Whole:u00a0n- Frequent:n- Infrequent:
Cardiovascular System:n- Frequent:n- Infrequent:
Digestive System:u00a0n- Frequent:n- Infrequent:
Endocrine System:u00a0n- Infrequent:
Hemic and Lymphatic System:u00a0n- Frequent:n- Infrequent:
Metabolic and Nutritional:u00a0n- Frequent:n- Infrequent:
Musculoskeletal System:u00a0n- Frequent:n- Infrequent:
Nervous System: n- Frequent:n- Infrequent:
Respiratory System:u00a0n- Frequent:n- Infrequent:
Skin and Appendages:u00a0n- Frequent:n- Infrequent:
Special Senses:u00a0n- Frequent:n- Infrequent:
Urogenital System:u00a0n- Frequent:n- Infrequent:
The following adverse reactions have been identified during postapproval use of tiagabine HCl. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Skin and subcutaneous tissue disorders:
Eye disorders:

The abuse and dependence potential of tiagabine HCl have not been evaluated in human studies.

Human Overdose Experience:
From post-marketing experience, reports of overdose involving tiagabine HCl alone have included cases in which patients required intubation and ventilatory support as part of the management of their status epilepticus. Overdoses involving multiple drugs, including tiagabine HCl, have resulted in fatal outcomes. Symptoms most often accompanying tiagabine HCl overdose, alone or in combination with other drugs, have included: seizures including status epilepticus in patients with and without underlying seizure disorders, nonconvulsive status epilepticus, respiratory arrest, coma, loss of consciousness, ataxia, dizziness, confusion, somnolence, drowsiness, impaired speech, aggression, agitation, lethargy, myoclonus, spike wave stupor, encephalopathy, amnesia, dyskinesia, tremors, disorientation, psychotic disorder, vomiting, hostility, and temporary paralysis. Respiratory depression was seen in a number of patients, including children, in the context of seizures.
Management of Overdose:

The blood level of tiagabine obtained after a given dose depends on whether the patient also is receiving a drug that induces the metabolism of tiagabine. The presence of an inducer means that the attained blood level will be substantially reduced. Dosing should take the presence of concomitant medications into account.
Tiagabine HCl is recommended as adjunctive therapy for the treatment of partial seizures in patients 12 years and older.
The following dosing recommendations apply to all patients taking tiagabine HCl:
Induced Adults and Adolescents 12 Years or Older:
In adolescents 12 to 18 years old, tiagabine HCl should be initiated at 4 mg once daily. Modification of concomitant antiepilepsy drugs is not necessary, unless clinically indicated. The total daily dose of tiagabine HCl may be increased by 4 mg at the beginning of Week 2. Thereafter, the total daily dose may be increased by 4 to 8 mg at weekly intervals until clinical response is achieved or up to 32 mg/day. The total daily dose should be given in divided doses two to four times daily. Doses above 32 mg/day have been tolerated in a small number of adolescent patients for a relatively short duration.
In adults, tiagabine HCl should be initiated at 4 mg once daily. Modification of concomitant antiepilepsy drugs is not necessary, unless clinically indicated. The total daily dose of tiagabine HCl may be increased by 4 to 8 mg at weekly intervals until clinical response is achieved or, up to 56 mg/day. The total daily dose should be given in divided doses two to four times daily. Doses above 56 mg/day have not been systematically evaluated in adequate and well-controlled clinical trials.
Experience is limited in patients taking total daily doses above 32 mg/day using twice daily dosing. A typical dosing titration regimen for patients taking enzyme-inducing AEDs (induced patients) is provided in Table 7.
Non-Induced Adults and Adolescents 12 Years or Older:
Following a given dose of tiagabine HCl, the estimated plasma concentration in the non-induced patients is more than twice that in patients receiving enzyme-inducing agents. Use in non-induced patients requires lower doses of tiagabine HCl. These patients may also require a slower titration of tiagabine HCl compared to that of induced patients (see ).

Tiagabine HCl tablets are available in four dosage strengths.
2 mg orange-peach, round tablets, debossed with on one side and 402 on the opposite side, are available in bottles of 30 ( 0093-5030-56).
4 mg yellow, round tablets, debossed with on one side and 404 on the opposite side, are available in bottles of 30 ( 0093-5031-56).
12 mg green, ovaloid tablets, debossed with on one side and 412 on the opposite side, are available in bottles of 30 ( 0093-8072-56).
16 mg blue, ovaloid tablets, debossed with on one side and 416 on the opposite side, are available in bottles of 30 ( 0093-8076-56).
Recommended Storage: Store tablets at controlled room temperature, between 20-25u00b0C (68-77u00b0F). See USP. Protect from light and moisture.

In repeat dose toxicology studies, dogs receiving daily oral doses of 5 mg/kg/day or greater experienced unexpected CNS effects throughout the study. These effects occurred acutely and included marked sedation and apparent visual impairment which was characterized by a lack of awareness of objects, failure to fix on and follow moving objects, and absence of a blink reaction. Plasma exposures (AUCs) at 5 mg/kg/day were equal to those in humans receiving the maximum recommended daily human dose of 56 mg/day. The effects were reversible upon cessation of treatment and were not associated with any observed structural abnormality. The implications of these findings for humans are unknown.
TIA-006
Revised: May 2018
Distributed by:n n- Teva Pharmaceuticals USA, Inc.n n- North Wales, PA 19454

Read this Medication Guide before you start taking tiagabine hydrochloride tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
What is the most important information I should know about tiagabine hydrochloride?
Do not stop taking tiagabine hydrochloride without first talking to your healthcare provider.
Stopping tiagabine hydrochloride suddenly can cause serious problems.
Tiagabine hydrochloride can cause serious side effects, including:
Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.
How can I watch for early symptoms of suicidal thoughts and actions?
Do not stop tiagabine hydrochloride without first talking to a healthcare provider.
What is tiagabine hydrochloride?
Tiagabine hydrochloride is a prescription medicine used with other medicines to treat partial seizures in adults and children age 12 and older.
Who should not take tiagabine hydrochloride?
Do not take tiagabine hydrochloride if you are allergic to tiagabine hydrochloride or any of the other ingredients in tiagabine hydrochloride. See the end of this Medication Guide for a complete list of ingredients in tiagabine hydrochloride.
What should I tell my healthcare provider before taking tiagabine hydrochloride?
Before taking tiagabine hydrochloride, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take,
Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine. Always tell your healthcare provider if there are any changes in any other medicines that you take.
How should I take tiagabine hydrochloride?
If you take too much tiagabine hydrochloride, call your healthcare provider or local Poison Control Center right away.
What should I avoid while taking tiagabine hydrochloride?
What are possible side effects of tiagabine hydrochloride?
See u201cWhat is the most important information I should know about tiagabine hydrochloride?u201d
Tiagabine hydrochloride may cause other serious side effects including:
Call your healthcare provider right away if you have any of the serious side effects listed above.
The most common side effects of tiagabine hydrochloride include:
These are not all the possible side effects of tiagabine hydrochloride. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store tiagabine hydrochloride?
Keep tiagabine hydrochloride and all medicines out of the reach of children.
General Information about tiagabine hydrochloride
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use tiagabine hydrochloride for a condition for which it was not prescribed. Do not give tiagabine hydrochloride to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about tiagabine hydrochloride. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about tiagabine hydrochloride that is written for health professionals.
What are the ingredients in tiagabine hydrochloride?
Active Ingredient:
Inactive Ingredients:
In addition:
This Medication Guide has been approved by the U.S. Food and Drug Administration.
TIAMG-006
May 2018
Rx only
Distributed by:n
Teva Pharmaceuticals USA, Inc.n
North Wales, PA 19454

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Tiagabine Hydrochloride (Tiagabine Hydrochloride)

Trade Name : Tiagabine Hydrochloride

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Tiagabine Hydrochloride (Tiagabine Hydrochloride)

Trade Name : Tiagabine Hydrochloride

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

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