Topirol (Topiramate Tablets)

Topirol (Topiramate Tablets) is used for the treatment of various types of seizures (antiepilepsy) in adults and children, aged 2 years and greater. It can also be used for the prevention of migraines in adults.

1. Topiramate Tablets
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Topirol (Topiramate Tablets) is used alone or
with other medicines to prevent and control
seizures (epilepsy). This medication is also used
to prevent migraine headaches and decrease
how often you get them. Topiramate tablets will
not treat a migraine headache once it has
occurred.

2. Topirol Tablets
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Topirol Tablets are manufactured by
Sun Pharmaceutical Industries Ltd.
(Website: www.sunpharma.com)

3. Topiramate Tablets – Brand Names
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Topiramate tablets are available as
Topirol, Topamac, Topamate,
Topaz , Topex, Toprisun, Topiram,
Nextop and Topirain.

4. Active Ingredient
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The active ingredient contained in Topirol
tablets is Topiramate. Each tablet of
Topirol contains 25 mg, 50 mg or 100 mg of
Topiramate.

5. Chemical Structure
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The structure of Topiramate is given below:

6. Uses of Topiramate Tablets
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Topirol (Topiramate Tablets) is used for
the treatment of various types of
seizures (antiepilepsy) in adults and
children, aged 2 years and over.
It can also be used for the prevention of
migraines in adults.
Topirol tablets are not used to treat
severe migraines that come on
suddenly (acute).

7. Storage Instructions

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Topirol (Topiramate Tablets) should be
stored in a dry place below 25ºC. Protect
Topirol tablets from light and moisture
and store in the original package. Do not
store in the bathroom.
Keep this as well as all other medicines
away from children and pets.

8. Warnings

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Acute myopia and secondary angle closure
glaucoma: Untreated elevated intraocular pressure
can lead to permanent visual loss. The main
treatment to reverse symptoms is discontinuation of
Topirol as quickly as possible.
This medicine can make you sweat less, making
you more likely to get heat stroke. Do not perform
activities that may cause you to overheat, such as
hard work or exercise in hot weather, or using hot
tubs.
In case of hot weather, drink a lot of fluids and
dress lightly. If you overheat, quickly look for a place
to cool down and rest. Get medical help right away if
you have a fever that does not go away,
mental/mood changes, headache, or dizziness.

9. Warnings

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Topirol may make you dizzy or drowsy or impair your
judgment. Do not drive, use machinery, or do any
activity that requires alertness until you are certain you
can carry out such activities safely. Avoid alcoholic
beverages when undergoing therapy with this
medicine.
Metabolic acidosis: Baseline and periodic
measurement of serum bicarbonate is recommended.
Consider dose reduction or stopping of this
medication if clinically appropriate.
Suicidal behavior and ideation: Antiepileptic drugs
increase the risk of suicidal behavior or ideation
Fetal Toxicity: Topirol use during pregnancy may
cause cleft lip and/or palate.

10. Warnings

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Withdrawal of AEDs:Withdrawal of Topirol
(Topiramate Tablets) must be done gradually.
Hyperammonemia and encephalopathy associated
with or without concomitant valproic acid use: Patients
with inborn errors of metabolism or decreased
mitochondrial activity can have an increased risk of
hyperammonemia. Measure ammonia in case
encephalopathic symptoms occur.
Kidney stones: Use with other carbonic anhydrase
inhibitors, other medicines causing metabolic acidosis,
or in patients on a ketogenic diet must be avoided.

11. Topirol (Topiramate Tablets) Dosage

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➢Epilepsy Monotherapy: Adults and Pediatric
patients more than 10 years: The initial dosage 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 dosage is 400 mg/day in
two divided doses
➢Epilepsy Adjunctive Therapy: Adults with partial
onset seizures or LGS. The initial dosage 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 dosage is 200 mg to
400 mg/day in two divided doses.
The dosage of Topirol tablets (Topiramate) is
given below:

12. Topirol (Topiramate Tablets) Dosage

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➢Epilepsy Adjunctive Therapy: Adults with primary
generalized tonic-clonic seizures. The initial dosage is
25 to 50 mg/day. The dosage should be increased
weekly to an effective dose by increments of 25 mg to
50 mg. The recommended dosage is 400 mg/day in
two divided doses.
➢Prophylaxis of Migraine: The initial dosage 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 dosage is 100 mg/day
administered in two divided doses
The dosage of Topirol Tablets (Topiramate) is
given below:

13. Topirol Tablets
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Contraindications
Topirol is contraindicated in patients with a
hypersensitivity to Topiramate or any other
component of this medication.

14. Topiramate Side Effects
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➢The most common Topiramate side effects with an
incidence rate of 10% 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.
➢The most common Topiramate side effects with an
incidence rate of 5% 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.

15. Topiramate Overdose
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Overdoses of Topiramate tablets have
been reported. The overdose 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 tablets.

16. Topirol Overdose
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In cases of acute Topirol (Topiramate Tablets)
overdose, in case the ingestion is recent, the
stomach should be emptied immediately by
lavage or by induction of emesis. Activated
charcoal has been observed to adsorb
Topiramate in vitro .
Treatment should be appropriately supportive.
Hemodialysis is an effective means of removing
topiramate from the body.
Laboratory and/or medical tests (such as eye
exams, bicarbonate blood level) must be
performed to monitor the patient's progress and
check for side effects.

17. Topiramate During Pregnancy
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Topirol (Topiramate Tablets) has been
classified by the US FDA as Pregnancy
Category D.
Topirol (Topiramate Tablets) can cause
fetal harm when administered to a pregnant
woman.
Data from pregnancy registries prove that
infants exposed to Topiramate tablets in
utero have an increased risk for cleft lip
and/or cleft palate (oral clefts).
Topirol should be used during pregnancy
only if the potential benefit outweighs the
potential risk.

18. Topirol Tablets
For more details on
Topirol Tablets click here
© Clearsky Pharmacy
Topirol (Topiramate tablets) by Sun
Pharmaceutical Industries Limited, India.