TOPIRAMATE tablet, film coated

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Lake Erie Medical DBA Quality Care Products LLC

INN:

TOPIRAMATE

composition:

TOPIRAMATE 25 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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

leaflet_short:

Topiramate tablets, USP are available as debossed, film-coated, circular tablets in the following strengths and colors: 25 mg white (coded “S” on one side; “707” on the other) 50 mg yellow (coded “S” on one side; “710” on the other) 100 mg yellow (coded “S” on one side; “711” on the other) 200 mg brown (coded “S” on one side; “712” on the other) They are supplied as follows: 25 mg tablets  55700-596-30 55700-596-60 55700-596-90 55700-596-27 50 mg tablets  100 mg tablets 200 mg tablets 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

PIL

TOPIRAMATE- topiramate tablet, film coated
Lake Erie Medical DBA Quality Care Products LLC
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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. Call your
healthcare provider right away if you have a
high fever, a fever that does not go away, or decreased sweating.
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 rig

SPC

TOPIRAMATE- TOPIRAMATE TABLET, FILM COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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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