Drug Interaction:
Drug interactions- summary-
Carbamazepine/phenobarbital/ phenytoin/primidone + tiagabine -
tiagabine clearance greater in patients taking carbamazepine, phenytoin, phenobarbital
or primidone. Adjust dose
Highly protein bound drugs + tiagabine/ Tiagabine + highly protein bound drugs-
tiagabine is bound to plasma protein and has potential to interact with highly protein-bound
drugs
Valproate + tiagabine / tiagabine + valproate-
tiagbine decrease steady state concentration of valproate .
Indication:
LIST OF DRUGS DURING 2004
Sr.No- 201
Name of the Drug- Tiagabin HCL tablets 92/4/12/16mg)
Pharmacological Classification- Anti-Epiletic
Date of Approval- 14-05-2004
Approved by U.S.FDA on 30-12-2004 (Ref- FDA approved List- 2004)
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Tiagabine Hcl Tablet Anti-epileptic 14-05-2004
2/4/12/16mg
Partial seizures
Adverse Reaction:
Adverse reactions-
CNS - abnormal gait 4% asthenia 22% ataxia 8% depression 6%
difficulty in concentration 12% dizziness 26% hostility 4%
nervousness 12% somnolence 18% tremor 20%
GI - diarrhoea 2%
GU - urinary tract infection 4%
Musculoskeletal- myalgia 4%
Respiratory- pharyngitis 6%
Special senses- amblyopia 4%
Miscellaneous- abdominal pain 4% accidental injury 20% flu syndrome 8%
infection 18%
Contra-Indications:
Hypersensitivity to the drug
Special precautions-
Seizure in patients without epilepsy- in nonepileptic patients who develop epilepsy while
on tiagabine treatment, discontiue tiagamine and evaluate patients for an underlying seizure
disorder
Withdrawal seizures- withdraw tiagabine gradually to minimize the potential for increased
seizure frequency
Serious rash- drug associated rash can, if extensive and serious cause irreversible morbidity
even death
Hepatic function impairment- because the clearance of tiagabine reduced in patients with liver
disease, dose reduction may be necessary in these patients
Hazardous tasks- because of possible additive depressive effects, use caution when patients
are taking other CNS depressants in combination with tiagabine
Pregnancy- use tiagabine during pregnancy only if required
Lactation- use tiagabine in women who are breast feeding only if benefits clearly outweigh the risks
Children- safety and efficacy for use in children younger than 12 years have not been established
Dosages/ Overdosage Etc:
Indication-
Partial seizures
Dosage- Total daily
Week 1 - initiate at 4mg once daily 4mg/day
Week 2- increase total daily dose by 4mg 8mg/day in 2 divided doses
Week -3 - increase total daily dose by 4mg 12mg/day in 3 divided doses
Week 4- increase total daily dose by 4mg 16mg/day in 2 to 4 divided doses
Week 5- increase total daily dose by 4 to 8mg 20 to 24mg/ day in 2 to 4 divided doses
Week 6- increase total daily dose by 4 to 8mg 24 to 32mg /day in 2 to 4 divided doses
Usual adult maintenance dose 32 to 56mg in 2 to 4 divided doses
Children- 12 to 18 years - initiate 4mg once daily . Total daily dose can be increased by 4 to 8mg
at weekly intervals . Total daily dose given in 2 to 4 times daily
Dosages above 32mg have been tolerated in a small number of adolescent patients for a relative
short duration.
Patient Information:
1. Advice patients that tiagabine can cause dizziness, somnolence, and other symptoms
and signs of CNS depressants
2. Because of possible additive effects advice patients to use caution while taking other
CNS depressants in combination with tigabine
3. Advice patients to inform their doctor if they are pregnant or planning to become pregnant
4. Advice patients to inform their doctor if they are breast feeding or intend to breast feed.
5. Advice patients against carrying out any operations requiring mental alertnes or dexterity
like operating machinery, driving vehicles etc. while on treatment with tigabine unless they have
gained sufficient experience with the usage of the drug.
Pregnancy and lactation:
Pregnancy-
Use tiagabine during pregnancy only if required
Lactation-
Use tiagabine in women who are breast feeding only if benefits clearly outweigh the risks
Children-
Safety and efficacy for use in children younger than 12 years have not been established
