A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Gabitril Indications, Dosage, Storage, Stability - Tiagabine Hcl
Gabitril Indications, Dosage, Storage, Stability - Tiagabine Hcl
INDICATIONS AND USAGE
GABITRIL (tiagabine hydrochloride) is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.
DOSAGE AND ADMINISTRATION
GABITRIL (tiagabine HCl) is recommended as adjunctive therapy in patients 12 years and older.
GABITRIL is given orally and should be taken with food.
Adequate and controlled clinical studies with GABITRIL were conducted in patients taking enzyme- inducing AEDs (e.g., phenytoin, carbamazepine, and barbiturates). Patients taking only non-enzyme- inducing AEDs (e.g., valproate, gabapentin, and lamotrigine) may require lower doses or a slower titration of GABITRIL for clinical response.
Adults and Adolescents 12 Years or Older
In adolescents 12 to 18 years old, GABITRIL should be initiated at 4 mg once daily. Modification of concomitant antiepilepsy drugs is not necessary, unless clinically indicated. The total daily dose of GABITRIL 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, GABITRIL should be initiated at 4 mg once daily. Modification of concomitant antiepilepsy drugs is not necessary, unless clinically indicated. The total daily dose of GABITRIL 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 well-controlled 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 is provided in Table 6.
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Table 6 Typical Dosing Titration Regimen for Patients Taking Enzyme-Inducing AEDs
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Initiation and Titration Schedule
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Total Daily Dose
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Week 1
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Initiate at 4 mg once daily |
4 mg/day |
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Week 2
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Increase total daily dose by 4 mg |
8 mg/day (in two divided doses) |
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Week 3
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Increase total daily dose by 4 mg |
12 mg/day (in three divided doses) |
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Week 4
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Increase total daily dose by 4 mg |
16 mg/day (in two to four divided doses) |
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Week 5
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Increase total daily dose by 4 to 8 mg |
20 to 24 mg/day (in two to four divided doses) |
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Week 6
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Increase total daily dose by 4 to 8 mg |
24 to 32 mg/day (in two to four divided doses) |
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Usual Adult
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Maintenance 32 to 56 mg/day in two to four divided doses |
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Dose:
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HOW SUPPLIED
GABITRIL tablets are available in four dosage strengths.
2 mg orange-peach, round tablets, debossed with C on one side and 402 on the opposite side, are available in bottles of 100 (NDC 63459-402-01).
4 mg yellow, round tablets, debossed with C on one side and 404 on the opposite side, are available in bottles of 100 (NDC 63459-404-01).
12 mg green, ovaloid tablets, debossed with C on one side and 412 on the opposite side, are available in bottles of 100 (NDC 63459-412-01).
16 mg blue, ovaloid tablets, debossed with C on one side and 416 on the opposite side, are available in bottles of 100 (NDC 63459-416-01).
Recommended Storage: Store tablets at controlled room temperature, between 20-25°C (68-77°F). See USP. Protect from light and moisture.
ANIMAL TOXICOLOGY
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.
Manufactured for: Cephalon, Inc. West Chester, PA 19380, ©2000 Cephalon, Inc. All rights reserved. PRINTED IN U.S.A.
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