TOPIRAMATE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391)

Available from:

Cardinal Health 107, LLC

INN (International Name):

TOPIRAMATE

Composition:

TOPIRAMATE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Topiramate tablets and topiramate capsules are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. Topiramate tablets and topiramate capsules are indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older. Topiramate tablets and topiramate capsules are indicated for the preventive treatment of migraine in patients 12 years of age and older. None. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to topiramate during pregnancy. Patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll-fr

Product summary:

Topiramate Tablets, USP Topiramate Tablets USP, 25 mg are white to off-white, round-shaped, biconvex, beveled-edge, film-coated tablets debossed with "ZD 16" on one side and plain on the other side and are supplied as follows: Overbagged with 10 tablets per bag, NDC 55154-7146-0 Topiramate Tablets USP, 100 mg are white to off-white, round-shaped, biconvex, beveled-edge, film-coated tablets debossed with "ZD 14" on one side and plain on the other side and are supplied as follows: Overbagged with 10 tablets per bag, NDC 55154-7142-0 Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature]. Protect from moisture. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TOPIRAMATE- TOPIRAMATE TABLET, FILM COATED
Cardinal Health 107, LLC
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MEDICATION GUIDE
8234201/1020
Topiramate (toe-pir’-a-mate) Tablets, USP
Topiramate (toe-pir’-a-mate) Capsules, USP
What is the most important information I should know about topiramate?
Topiramate may cause eye problems. Serious eye problems include:
•
any sudden decrease in vision with or without eye pain and redness,
•
a blockage of fluid in the eye causing increased pressure in the eye
(secondary angle closure
glaucoma).
•
These eye problems can lead to permanent loss of vision if not
treated.
•
You should call your healthcare provider right away if you have any
new eye symptoms, including any
new problems with your vision.
Topiramate may cause decreased sweating and increased body temperature
(fever). People, especially
children, should be watched for signs of decreased sweating and fever,
especially in hot temperatures. Some
people may need to be hospitalized for this condition. If a high
fever, a fever that does not go away, or
decreased sweating develops, call your healthcare provider right away.
Topiramate can increase the level of acid in your blood (metabolic
acidosis). If left untreated, metabolic
acidosis can cause brittle or soft bones (osteoporosis, osteomalacia,
osteopenia), kidney stones, can slow the
rate of growth in children, and may possibly harm your baby if you are
pregnant. Metabolic acidosis can
happen with or without symptoms. Sometimes people with metabolic
acidosis will:
•
feel tired
•
not feel hungry (loss of appetite)
•
feel changes in heartbeat
•
have trouble thinking clearly
Your healthcare provider should do a blood test to measure the level
of acid in your blood before and during
your treatment with topiramate. If you are pregnant, you should talk
to your healthcare provider about
whether you have metabolic acidosis.
Like other antiepileptic drugs, topiramate may cause suicidal thoughts
or actions in a very small number of
people, about 1 in 500.
Call a healthcare provider right away

Summary of Product characteristics

TOPIRAMATE- TOPIRAMATE TABLET, FILM COATED
CARDINAL HEALTH 107, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TOPIRAMATE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TOPIRAMATE.
TOPIRAMATE TABLETS, FOR ORAL USE
TOPIRAMATE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
RECENT MAJOR CHANGES
Warnings and Precautions, Serious Skin Reactions ( 5.9)
           6/2020
INDICATIONS AND USAGE
Topiramate is indicated for:
•
•
DOSAGE AND ADMINISTRATION
Topiramate initial dose, titration, and recommended maintenance dose
varies by indication and age
group. See Full Prescribing Information for recommended dosage, and
dosing considerations in patients
with renal impairment, geriatric patients, and patients undergoing
hemodialysis ( 2.1, 2.2, 2.3, 2.4, 2.5,
2.6)
DOSAGE FORMS AND STRENGTHS
•
•
CONTRAINDICATIONS
None ( 4).
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
•
•
•
•
•
ADVERSE REACTIONS
EPILEPSY: Most common (≥ 10% more frequent than placebo or low-dose
topiramate) adverse reactions
in adult and pediatric patients were: paresthesia, anorexia, weight
loss, speech disorders/related speech
problems, fatigue, dizziness, somnolence, nervousness, psychomotor
slowing, abnormal vision and fever. (
Epilepsy: initial monotherapy for the treatment of partial-onset or
primary generalized tonic-clonic
seizures in patients 2 years of age and older ( 1.1); adjunctive
therapy for the treatment of partial-
onset seizures, primary generalized tonic-clonic seizures, or seizures
associated with Lennox-Gastaut
syndrome in patients 2 years of age and older ( 1.2)
Preventive treatment of migraine in patients 12 years of age and older
( 1.3)
Tablets: 25 mg, 50, mg, 100 mg, and 200 mg ( 3)
Sprinkle Capsules: 15 mg and 25 mg ( 3)
Acute myopia and secondary angle closure glaucoma: can lead to
permanent visual loss: discontinue
topiramate as soon as possible ( 5.1)
Visual field defects: consider discontinuation