Topamac Tablets (Generic Topiramate Tablets)

Topamac Tablets (Generic Topiramate Tablets)
© The Swiss Pharmacy

Topamac (Generic Topiramate Tablets) is is a medicine used to treat
epilepsy. It used as monotherapy in adults, adolescents and
children over 6 years of age with partial seizures with or without
secondary generalised seizures, and primary generalised tonic-
clonic seizures.
It is also used as adjunctive therapy in children aged 2 years and
above, adolescents and adults with partial onset seizures with or
without secondary generalization or primary generalized tonic-
clonic seizures and for the treatment of seizures associated with
Lennox-Gastaut syndrome.
Topiramate tablets are also used in adults for the prophylaxis of
migraine headache after careful evaluation of possible alternative
treatment options. Topiramate is not intended for acute treatment.

Topamac Tablets are manufactured by Janssen Cilag
Pharmaceuticals (Johnson and Johnson Private Limited, India) in
the strength of 25 mg, 50 mg and 100 mg.

Chemical Structure

The active ingredient contained in Topamac tablets is
Topiramate.
Each film-coated Topamac tablet contains 25 mg, 50 mg or 100
mg of Topiramate.

Uses of Topamac 25 mg, 50 mg and 100 mg Tablets:
Topamac (Generic Topiramate Tablets) is used alone or together
with other medicines to help treat certain types of seizures (eg, partial
seizures, tonic-clonic seizures, or Lennox-Gastaut syndrome). This
medicine will not cure epilepsy and will only work to control seizures
for as long as you continue to take it. It is also used to help prevent
migraine headaches.
Monotherapy Epilepsy: Topamac (Generic Topiramate tablets) are
used as initial monotherapy in patients 2 years of age and older with
partial onset or primary generalized tonic-clonic seizures. Safety and
effectiveness in patients who were converted to monotherapy from a
previous regimen of other anticonvulsant drugs have not been
established in controlled trials.
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Uses of Topamac 25 mg, 50 mg and 100 mg Tablets:
Adjunctive Therapy Epilepsy: Topiramate tablets are used as
adjunctive therapy for adults and pediatric patients ages 2 to 16 years
with partial onset seizures or primary generalized tonic-clonic
seizures, and in patients 2 years of age and older with seizures
associated with Lennox-Gastaut syndrome.
Migraine: Topamac is used in adults for the prophylaxis of
migraine headache. The usefulness of Topamac in the acute
treatment of migraine headache has not been studied.

Recommended Adult Dosage
For most patients, the starting dose of Topamac Tablets
(Generic Topiramate Tablets) for the treatment of Epilepsy as
monotherapy for adults and pediatric patients 10 years and
above is 50 mg/day in two divided doses.
The dosage should be increased weekly by increments of 50
mg for the first 4 weeks then 100 mg for weeks 5 to 6. The
recommended dose 400 mg/day in two divided doses

The recommended dose for treatment of Epilepsy as adjunctive
therapy for adults with partial onset seizures or LGS is 25 to 50
mg/day. The dosage should be increased weekly to an effective
dose by increments of 25 to 50 mg. The recommended dose is 200
to 400 mg/day in two divided doses.
The recommended dose for treatment of Epilepsy as adjunctive
therapy for adults with primary generalized tonic
clonic seizures 25 to
50 mg/day. The dosage should be increased weekly to an effective
dose by increments of 25 to 50 mg. The recommended dose is 400
mg/day in two divided doses.

Migraine: The recommended Topamac tablets dose for
prophylaxis of Migraine in adults and adolescents 12 years of
age and older is 25 mg/day administered nightly for the first
week. The dosage should be increased weekly by increments
of 25 mg.
Dose and titration should be guided by clinical outcome. The
recommended dose is 100 mg/day administered in two divided
doses.

Contraindications
➔
Topamac is contraindicated in patients with a known
hypersensitivity to Topiramate or any component of the tablet.
➔
Migraine prophylaxis in pregnancy and in women of childbearing
potential if not using a highly effective method of contraception.

Storage Instructions
Topamac Tablets (Generic Topiramate Tablets) have to be stored at
controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with
excursions permitted between 15° to 30°C (59° to 86°F).
Keep this as well as all other medicines away from children and pets.

Warnings
Acute myopia and secondary angle closure glaucoma: Untreated elevated
intraocular pressure can lead to permanent visual loss. The primary
treatment to reverse symptoms is discontinuation of Topamac as rapidly as
possible.
Visual field defects: These have been reported independent of elevated
intraocular pressure. Consider discontinuation of Topamac.
Oligohidrosis and hyperthermia: Monitor decreased sweating and increased
body temperature, especially in pediatric patients.
Metabolic acidosis: Baseline and periodic measurement of serum
bicarbonate is recommended. Consider dose reduction or discontinuation
of Topamac if clinically appropriate.
Suicidal behavior and ideation: Antiepileptic drugs increase the risk of
suicidal behavior or ideation.

Warnings
Cognitive/neuropsychiatric: Topamac may cause cognitive dysfunction.
Patients should use caution when operating machinery including
automobiles. Depression and mood problems may occur in epilepsy and
migraine populations
Fetal Toxicity: Topamac use during pregnancy can cause cleft lip and/or
palate.
Withdrawal of AEDs: Withdrawal of Topamac should be done gradually
Hyperammonemia and encephalopathy associated with or without
concomitant valproic acid use: Patients with inborn errors of metabolism
or reduced mitochondrial activity may have an increased risk of hyper
ammonemia. Measure ammonia if encephalopathic symptoms occur.

Warnings
Kidney stones: Use with other carbonic anhydrase inhibitors, other
drugs causing metabolic acidosis, or in patients on a ketogenic diet
should be avoided.
Hypothermia has been reported with and without hyperammonemia
during Topiramate tablets treatment with concomitant valproic acid
use.

Possible Side Effects
Most common Topiramate (Topamac Tablets) side effects with an
incidence rate of greater than or equal to 10% and more frequent
than placebo at recommended dosing in adult and pediatric
controlled, epilepsy clinical trials were paresthesia, anorexia, weight
decrease, speech disorder related speech problem, fatigue, dizziness,
somnolence, nervousness, psychomotor slowing, abnormal vision,
and fever.

Possible Side Effects
The following Topiramate (Topamac Tablets) side effects occurred
in 5% or more frequent than placebo at recommended dosing in
adult and adolescent controlled, migraine clinical trials were
paresthesia, anorexia, weight decrease, difficulty with memory, taste
perversion, upper respiratory tract infection, abdominal pain,
diarrhea, hypoesthesia, and nausea

Topamac Tablets Overdosage
Overdoses of Topiramate (Topamac tablets) have been reported.
Signs and symptoms included convulsions, drowsiness, speech
disturbance, blurred vision, diplopia, mentation impaired, lethargy,
abnormal coordination, stupor, hypotension, abdominal pain,
agitation, dizziness and depression.
The clinical consequences were not severe in most cases, but
deaths have been reported after poly-drug overdoses involving
Topiramate (Topamac tablets).
Topiramate overdose has resulted in severe metabolic
acidosis.

Treatment of Topamac Tablets Overdosage
In acute Topiramate (Topamac tablets) overdose, if the ingestion is
recent, the stomach should be emptied immediately by lavage or
by induction of emesis. Activated charcoal has been shown to adsorb
Topiramate in vitro. Treatment should be appropriately supportive.
Hemodialysis is an effective means of removing Topiramate from the
body.
A patient who ingested a dose between 96 and 110g Topiramate was
admitted to a hospital with a coma lasting 20 to 24 hours followed by
full recovery after 3 to 4 days.

Topamac Tablets During Pregnancy
Topiramate (Topamac tablets) has been classified by the US FDA as
Pregnancy Category D.
Topiramate (Topamac tablets) can cause fetal harm when administered to
a pregnant woman. Data from pregnancy registries indicate that infants
exposed to topiramate in utero have an increased risk for cleft lip and/or
cleft palate (oral clefts). When multiple species of pregnant animals
were administered Topiramate at clinically relevant doses, structural
malformations, including craniofacial defects, and reduced fetal weights
occurred in offspring.
Topiramate (Topamac tablets) should be used during pregnancy only if the
potential benefit outweighs the potential risk. If this medication is used during
pregnancy, or if the patient becomes pregnant while taking this medicine, the
patient should be apprised of the potential hazard to a fetus.

Topamac Tablets (Generic Topiramate Tablets) are
manufactured by Janssen Cilag Pharmaceuticals
(Johnson and Johnson Private Limited, India).

Topamac Tablets (Generic Topiramate Tablets)

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