TOPIRAMATE- 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:

Preferred Pharmaceuticals, Inc.

INN (International Name):

TOPIRAMATE

Composition:

TOPIRAMATE 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Topiramate tablets are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. Topiramate tablets are indicated as adjunctive therapy for adults and pediatric patients 2 to 16 years of age 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. Topiramate tablets are indicated for patients 12 years of age and older for the prophylaxis of migraine headache. None. Pregnancy Category D [see Warnings and Precautions (5.7)] Topiramate 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) and for being small for gestational age. When multiple species of pregnant animals received topiramate at clinically relevant doses, structural malformations, including craniofaci

Product summary:

Topiramate tablets, USP are available as debossed, film-coated, circular tablets in the following strengths and colors: 200 mg brown (coded “S” on one side; “712” on the other) 200 mg tablets; Bottles of 15’s with Child Resistant Cap…...............NDC 68788-6824-5 Bottles of 30’s with Child Resistant Cap…...............NDC 68788-6824-3 Bottles of 60’s with Child Resistant Cap…...............NDC 68788-6824-6 Bottles of 90’s with Child Resistant Cap…...............NDC 68788-6824-9 Store topiramate tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TOPIRAMATE- TOPIRAMATE TABLET, FILM COATED
Preferred Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
Topiramate Tablets, USP
(toe-PEER-uh-mate)
What is the most important information I should know about topiramate
tablet?
Topiramate tablets 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 tablet 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 tablet 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 tablets. If you are pregnant,
you should talk to your healthcare
provider about whether you have metabolic acidosis.
Like other antiepileptic drugs, topiramate tablet may cause suicidal
thoughts or actions in a very small
number of people, about 1 in 500.
Call a healthcare provider right away if you

Summary of Product characteristics

TOPIRAMATE- TOPIRAMATE TABLET, FILM COATED
PREFERRED PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TOPIRAMATE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TOPIRAMATE TABLETS.
TOPIRAMATE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Topiramate is indicated for:
• Epilepsy: initial monotherapy in patients ≥2 years of age with
partial onset or primary generalized tonic-clonic seizures
(1.1); adjunctive therapy for adults and pediatric patients (2 to 16
years of age) with partial onset seizures or primary
generalized tonic-clonic seizures, and for patients ≥2 years of age
with seizures associated with Lennox-Gastaut syndrome
(1.2)
• Prophylaxis of migraine in patients 12 years of age and older
(1.3) (1)
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) (2)
DOSAGE FORMS AND STRENGTHS
• Tablets: 25 mg, 50 mg, 100 mg, and 200 mg (3) (3)
CONTRAINDICATIONS
None (4) (4)
WARNINGS AND PRECAUTIONS
• 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 of topiramate (5.2)
• Oligohidrosis and hyperthermia: monitor decreased sweating and
increased body temperature, especially in pediatric
patients (5.3)
• Metabolic acidosis: baseline and periodic measurement of serum
bicarbonate is recommended; consider dose reduction
or discontinuation of topiramate if clinically appropriate (5.4)
• Suicidal behavior and ideation: antiepileptic drugs increase the
risk of suicidal behavior or ideation (5.5)
• Cognitive/neuropsychiatric adverse reactions: use caution when
oper