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TIAGABINE HYDROCHLORIDE

Sun Pharmaceutical Industries Limited

Tiagabine Hydrochloride Tablets


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

TIAGABINE HYDROCHLORIDE DESCRIPTION


202522
TIAGABINE HYDROCHLORIDE
Inactive Ingredients





CLINICAL PHARMACOLOGY

Mechanism of Action


in vitro5085



in vitro1A23121A11B

Pharmacokinetics


PRECAUTIONS, General, Use in Non-Induced Patients

Absorption and Distribution:maxmax





Metabolism and Elimination:in vivoin vitro

in vitro



min

Special Populations


Renal Insufficiency:

Hepatic Insufficiency: PRECAUTIONS

Geriatric

Pediatric:

Gender, Race and Cigarette Smoking:

Interactions with other Antiepilepsy Drugs: PRECAUTIONS, Drug Interactions

Interactions with Other Drugs: See PRECAUTIONS, Drug Interactions.

CLINICAL STUDIES










Table 1 Median Reduction and Median Percent Reduction from Baseline in 4-Week Seizure Rates in Study 1
Placebo (N=91)
 Tiagabine Hydrochloride 16 mg/day
(N=61)		 Tiagabine Hydrochloride 32 mg/day
(N=87)
 Tiagabine Hydrochloride 56 mg/day
(N=56)
 Combined 32 + 56 mg/day (N=143)
Complex
Partial
 Median
Reduction
 0.6
 0.8
 2.2p <0.05
2.9p <0.05
2.6p <0.05
Median %
ReductionStatistical significance was not assessed for median % reduction.
9%
 13%
 25%
 32%
 29%
All
Partial
 Median
Reduction
 0.2
 1.2
 2.7p <0.05
3.5p <0.05
2.9p <0.05
Median %
ReductionStatistical significance was not assessed for 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
Placebo (N=107)
 Tiagabine Hydrochloride 16 mg BID
(N=106)		 Tiagabine Hydrochloride 8 mg QID
(N=104)
Complex
Partial
 Median Reduction
 0.3
 1.6
 1.3p <0.027, necessary for statistical significance due to multiple comparisons.
Median % ReductionStatistical significance was not assessed for median % reduction.
4%
 22%
 15%
All
Partial
 Median Reduction
 0.5
 1.6
 1.3
Median % ReductionStatistical significance was not assessed for median % reduction.
5%
 19%
 13%




Figure 1
Study 1
TIAGABINE HYDROCHLORIDE


Figure 2
Study 1
TIAGABINE HYDROCHLORIDE


Figure 3
Study 2
TIAGABINE HYDROCHLORIDE
Table 3 Median Reduction and Median Percent Reduction from Baseline in 4-Week Seizure Rates in Study 3
    Placebo (N=77)
 		 Tiagabine Hydrochloride 30 mg/day
(N=77)
Complex PartialN=72 and 75 for placebo and tiagabine hydrochloride, respectively.
Median Reduction
 -0.1
 1.3p <0.05
Median % ReductionStatistical significance was not assessed for median % reduction.
-1%
 14%
All Partial
 Median Reduction
 -0.5
 1.1p <0.05
Median % ReductionStatistical significance was not assessed for median % reduction.
-7%
 11%


Figure 4
Study 3
TIAGABINE HYDROCHLORIDE

TIAGABINE HYDROCHLORIDE INDICATIONS AND USAGE


TIAGABINE HYDROCHLORIDE CONTRAINDICATIONS


WARNINGS


Seizures in Patients Without Epilepsy: Postmarketing reports have shown that tiagabine hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride by inducing its metabolism. Use of tiagabine hydrochloride 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 tiagabine hydrochloride 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 hydrochloride treatment, tiagabine hydrochloride should be discontinued and patients should be evaluated for an underlying seizure disorder.

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

Suicidal Behavior and Ideation:







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
 3.4
 3.5
 2.4
Psychiatric
 5.7
 8.5
 1.5
 2.9
Other
 1
 1.8
 1.9
 0.9
Total
 2.4
 4.3
 1.8
 1.9






Withdrawal Seizures: CLINICAL STUDIES

Cognitive/Neuropsychiatric Adverse Events:

PRECAUTIONS, Laboratory Tests, EEG



Status Epilepticus:

Sudden Unexpected Death In Epilepsy (SUDEP):

PRECAUTIONS

General


Use in Non-Induced Patients: DOSAGE AND ADMINISTRATION

Generalized Weakness:

Binding in the Eye and Other Melanin-Containing Tissues:

Use in Hepatically-Impaired Patients:

Serious Rash:

Information for Patients




Suicidal Thinking and Behavior







PRECAUTIONS, Pregnancy

Laboratory Tests




Clinical Chemistry and Hematology:

WARNINGS, Cognitive/Neuropsychiatric Adverse Events

Drug Interactions


PRECAUTIONS, General, Use in Non-Induced Patients



Effects of Tiagabine Hydrochloride on other Antiepilepsy Drugs (AEDs):

Phenytoin

Carbamazepine

Valproate

Phenobarbital or Primidone:

Effects of other Antiepilepsy Drugs (AEDs) on Tiagabine Hydrochloride:

Carbamazepine

Phenytoin

Valproatein vitroin vitro

Interaction of Tiagabine Hydrochloride with Other Drugs:

Cimetidine

Theophylline

Warfarin

Digoxin

Ethanol or Triazolam:

Oral Contraceptives:

Antipyrine

Interaction of Tiagabine Hydrochloride with Highly Protein Bound Drugs:

In vitro

Carcinogenesis, Mutagenesis, Impairment of Fertility


Carcinogenesis:2

Mutagenesisin vitroin vitroin vitroin vivo

Impairment of Fertility:22

Pregnancy




22

22



To provide additional information regarding the effects of in utero exposure to tiagabine hydrochloride, physicians are advised to recommend that pregnant patients taking tiagabine hydrochloride enroll in the NAAED Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/.

Use in Nursing Mothers


Pediatric Use


CLINICAL PHARMACOLOGY, Special Populations, Pediatric

Geriatric Use


TIAGABINE HYDROCHLORIDE ADVERSE REACTIONS








Adverse Event Incidence in Controlled Clinical Trials:

Table 5: Treatment-Emergent Adverse EventPatients in these add-on studies were receiving one to three concomitant enzyme-inducing antiepilepsy drugs in addition to tiagabine hydrochloride or placebo. Patients may have reported multiple adverse experiences; thus, patients may be included in more than one category. Incidence in Parallel-Group, Placebo-Controlled, Add-On Trials (events in at least 1% of patients treated with Tiagabine Hydrochloride and numerically more frequent than in the placebo group)
Body System/
COSTART		 Tiagabine Hydrochloride
N=494
%		 Placebo
N=275
%
Body as a Whole
Abdominal Pain
 7
 3
Pain (unspecified)
 5
 3
Cardiovascular
Vasodilation
 2
 1
Digestive
Nausea
 11
 9
Diarrhea
 7
 3
Vomiting
 7
 4
Increased Appetite
 2
 0
Mouth Ulceration
 1
 0
Musculoskeletal
Myasthenia
 1
 0
Nervous System
Dizziness
 27
 15
Asthenia
 20
 14
Somnolence
 18
 15
Nervousness
 10
 3
Tremor
 9
3
Difficulty with Concentration/AttentionCOSTART term substituted with a more clinically descriptive term.
6
 2
Insomnia
 6
 4
Ataxia
 5
 3
Confusion
 5
 3
Speech Disorder
 4
 2
Difficulty with MemoryCOSTART term substituted with a more clinically descriptive term.
4
 3
Paresthesia
 4
 2
Depression
 3
 1
Emotional Lability
 3
 2
Abnormal Gait
 3
 2
Hostility
 2
 1
Nystagmus
 2
 1
Language ProblemsCOSTART term substituted with a more clinically descriptive term.
2
 0
Agitation
 1
 0
Respiratory System
Pharyngitis
 7
 4
Cough Increased
 4
 3
Skin and Appendages
Rash
 5
4
Pruritus
 2
 0


Table 6: Treatment-Emergent Adverse Event Incidence in Study 1Patients in this study were receiving one to three concomitant enzyme-inducing antiepilepsy drugs in addition to tiagabine hydrochloride or placebo. Patients may have reported multiple adverse experiences; thus, patients may be included in more than one category. (events in at least 5% of patients treated with Tiagabine Hydrochloride 32 or 56 mg and numerically more frequent than in the placebo group)
Body System/
COSTART Term		 Tiagabine Hydrochloride 56 mg
(N=57)
%		 Tiagabine Hydrochloride 32 mg
(N=88)
%		 Placebo
(N=91)
%
Body as a Whole
Accidental Injury
 21
 15
 20
Infection
 19
 10
 12
Flu Syndrome
 9
 6
 3
Pain
 3
 7
 2
Abdominal Pain
 5
 7
 4
Digestive System
Diarrhea
 2
 10
 6
Hemic and Lymphatic System
Ecchymosis
 0
 6
 1
Musculoskeletal System
Myalgia
 5
 2
 3
Nervous System
Dizziness
 28
 31
 12
Asthenia
 23
 18
 15
Tremor
 21
 14
 1
Somnolence
 19
 21
 17
Nervousness
 14
 11
 6
Difficulty with Concentration/AttentionCOSTART term substituted with a more clinically descriptive term.
14
 7
 3
Ataxia
 9
 6
 6
Depression
 7
 1
 0
Insomnia
 5
 6
 3
Abnormal Gait
 5
 5
 3
Hostility
 5
 5
 2
Respiratory System
Pharyngitis
 7
 8
 6
Special Senses
Amblyopia
 4
 9
 8
Urogenital System
Urinary Tract Infection
5
 0
 2


Other Adverse Events Observed During All Clinical Trials:



Body as a Whole: FrequentInfrequent
Cardiovascular System: FrequentInfrequent

Digestive SystemFrequent Infrequent:

Endocrine SystemInfrequent

Hemic and Lymphatic System: FrequentInfrequent:

Metabolic and Nutritional: FrequentInfrequent:

Musculoskeletal System: FrequentInfrequent:

Nervous System: FrequentInfrequent

Respiratory System: FrequentInfrequent

Skin and Appendages: FrequentInfrequent

Special Senses: FrequentInfrequent

Urogenital System: FrequentInfrequent

DRUG ABUSE AND DEPENDENCE


OVERDOSAGE


Human Overdose Experience:



Management of Overdose:

TIAGABINE HYDROCHLORIDE DOSAGE AND ADMINISTRATION


General:





  • Tiagabine hydrochloride tablets are given orally and should be taken with food.
  • Do not use a loading dose of tiagabine hydrochloride tablets
  • Dose titration: Rapid escalation and/or large dose increments of tiagabine hydrochloride tablets should not be used.
  • Missed dose(s): If the patient forgets to take the prescribed dose of tiagabine hydrochloride tablets at the scheduled time, the patient should not attempt to make up for the missed dose by increasing the next dose. If a patient has missed multiple doses, patient should refer back to his or her physician for possible re-titration as clinically indicated.
  • Dosage adjustment of tiagabine hydrochloride tablets should be considered whenever a change in patient's enzyme-inducing status occurs as a result of the addition, discontinuation, or dose change of the enzyme-inducing agent.
Induced Adults and Adolescents 12 Years or Older:





Table 7
Table 7: Typical Dosing Titration Regimen for Patients Already Taking Enzyme-Inducing AEDs
  Initiation and Titration Schedule Total Daily Dose
Week 1
Initiate at 4 mg once daily
 4 mg/day
Week 2
Increase total daily dose by 4 mg
 8 mg/day
(in two divided doses)
Week 3
Increase total daily dose by 4 mg
 12 mg/day
(in three divided doses)
Week 4
Increase total daily dose by 4 mg
 16 mg/day
(in two to four divided doses)
Week 5
Increase total daily dose by 4 to 8 mg
 20 to 24 mg/day
(in two to four divided doses)
Week 6
Increase total daily dose by 4 to 8 mg
 24 to 32 mg/day
(in two to four divided doses)
Usual Adult Maintenance Dose in Induced Patients:
32 to 56 mg/day in two to four divided doses
Non-Induced Adults and Adolescents 12 Years or Older:

CLINICAL PHARMACOLOGY, Pharmacokinetics and PRECAUTIONS, General, Use in Non-Induced Patients

HOW SUPPLIED
















ANIMAL TOXICOLOGY


Medication Guide


Tiagabine Hydrochloride Tablets


 
What is the most important information I should know about tiagabine hydrochloride tablets?

Do not stop taking tiagabine hydrochloride tablets without first talking to your healthcare provider.



Tiagabine hydrochloride tablets can cause serious side effects, including:
  • Tiagabine hydrochloride tablets may cause seizures in people who do not have epilepsy. If you do not have a seizure disorder and you take tiagabine hydrochloride tablets, you may have a seizure or seizures that do not stop (status epilepticus). Call your healthcare provider right away if you have a seizure and you are not taking tiagabine hydrochloride tablets for epilepsy.
  • Like other antiepileptic drugs, tiagabine hydrochloride tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:









How can I watch for early symptoms of suicidal thoughts and actions?
  • Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
  • Keep all follow-up visits with your healthcare provider as scheduled.
  • Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop tiagabine hydrochloride tablets without first talking to a healthcare provider.

  • Stopping tiagabine hydrochloride tablets suddenly can cause serious problems. If you have epilepsy and stop a seizure medicine suddenly, you may have more frequent seizures or seizures that will not stop (status epilepticus).
What are tiagabine hydrochloride tablets?



Who should not take tiagabine hydrochloride tablets?


 
What should I tell my healthcare provider before taking tiagabine hydrochloride tablets?

Before taking tiagabine hydrochloride tablets, tell your healthcare provider if you:
  • have or have had depression, mood problems, or suicidal thoughts or behavior
  • have liver problems
  • have a history of seizures that do not stop (status epilepticus)
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if tiagabine hydrochloride tablets can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking tiagabine hydrochloride tablets. You and your healthcare provider will decide if you should take tiagabine hydrochloride tablets while you are pregnant.
    • If you become pregnant while taking tiagabine hydrochloride tablets, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicines during pregnancy. You can enroll in this registry by calling 1-888-233-2334.
  • are breastfeeding or plan to breastfeed. It is not known if tiagabine passes into breast milk or if it can harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take tiagabine hydrochloride tablets.
Tell your healthcare provider about all the medicines you take



How should I take tiagabine hydrochloride tablets?
  • Take tiagabine hydrochloride tablets exactly as your healthcare provider tells you.
  • Your healthcare provider may change your dose.
  • Tiagabine hydrochloride tablets should be taken with food.
  • Do not stop taking tiagabine hydrochloride tablets without talking to your healthcare provider. Stopping tiagabine hydrochloride tablets suddenly can increase your chances of having a seizure or cause seizures that will not stop.
  • If you miss a dose of tiagabine hydrochloride tablets, do not take 2 doses of tiagabine hydrochloride tablets at the same time. Contact your healthcare provider if you miss more than one dose.


What should I avoid while taking tiagabine hydrochloride tablets?
  • Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking tiagabine hydrochloride tablets without first talking to your healthcare provider. Taking tiagabine hydrochloride tablets with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
  • Do not drive, operate heavy machinery, or do other dangerous activities until you know how tiagabine hydrochloride tablets affect you. Tiagabine hydrochloride tablets can slow your thinking and motor skills.
What are possible side effects of tiagabine hydrochloride tablets?

See “What is the most important information I should know about tiagabine hydrochloride tablets?”
 
Tiagabine hydrochloride tablets may cause other serious side effects including:
  • seizures that can happen more often or become worse
  • trouble concentrating, problems with speech and language, feeling confused, feeling sleepy and tired, and problems thinking
  • weakness all over your body
  • eye and vision problems
  • serious rash


The most common side effects of tiagabine hydrochloride tablets include:
  • dizziness
  • lack of energy
  • drowsiness
  • nausea
  • nervousness
  • tremor
  • stomach pain
  • abnormal thinking
  • difficulty with concentration or attention


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 tablets?
  • Store tiagabine hydrochloride tablets at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F).
  • Keep tiagabine hydrochloride tablets out of light
  • Keep tiagabine hydrochloride tablets dry
Keep tiagabine hydrochloride tablets and all medicines out of the reach of children.
General Information about Tiagabine Hydrochloride Tablets



.



What are the ingredients in tiagabine hydrochloride tablets?

Active Ingredient:

Inactive Ingredients:

  • 2 mg tablets: FD&C Yellow No. 6 and polysorbate 80.
  • 4 mg tablets: Lactose monohydrate and D&C Yellow No. 10.





Caraco Pharmaceutical Laboratories, Ltd.



Sun Pharmaceutical Industries Ltd.




PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL 2MG


NDC 62756-200-83
Tiagabine Hydrochloride Tablets
2 mg
Rx only
30 TABLETS
SUN PHARMACEUTICAL INDUSTRIES LTD.
PHARMACIST: Dispense the Medication Guide provided separately to each patient.
TIAGABINE HYDROCHLORIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL 4MG


NDC 62756-224-83
Tiagabine Hydrochloride Tablets
4 mg
Rx only
30 TABLETS
SUN PHARMACEUTICAL INDUSTRIES LTD.
PHARMACIST: Dispense the Medication Guide provided separately to each patient.
TIAGABINE HYDROCHLORIDE

TIAGABINE HYDROCHLORIDE

TIAGABINE HYDROCHLORIDE TABLET, FILM COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:62756-200
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
TIAGABINE HYDROCHLORIDE tiagabine 2 mg

Inactive Ingredients

Ingredient Name Strength
BUTYLATED HYDROXYANISOLE
ANHYDROUS LACTOSE
SILICON DIOXIDE
STARCH, CORN
talc
CROSPOVIDONE
HYPROMELLOSES
titanium dioxide
POLYETHYLENE GLYCOLS
polysorbate 80
FD&C YELLOW NO. 6

Product Characteristics

Color Size Imprint Code Shape
ORANGE 5 mm 200 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62756-200-83 30 in 1 BOTTLE
2 NDC:62756-200-18 1000 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077555 2011-11-04


TIAGABINE HYDROCHLORIDE

TIAGABINE HYDROCHLORIDE TABLET, FILM COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:62756-224
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
TIAGABINE HYDROCHLORIDE tiagabine 4 mg

Inactive Ingredients

Ingredient Name Strength
BUTYLATED HYDROXYANISOLE
ANHYDROUS LACTOSE
SILICON DIOXIDE
STARCH, CORN
talc
CROSPOVIDONE
HYPROMELLOSES
titanium dioxide
POLYETHYLENE GLYCOLS
lactose monohydrate
D&C YELLOW NO. 10

Product Characteristics

Color Size Imprint Code Shape
YELLOW 6 mm 224 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62756-224-83 30 in 1 BOTTLE
2 NDC:62756-224-88 100 in 1 BOTTLE
3 NDC:62756-224-08 100 in 1 BOTTLE
4 NDC:62756-224-18 1000 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077555 2011-11-04


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