TOPIRAMATE tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Cipla USA Inc.

INN（国际名称）:

TOPIRAMATE

组成:

TOPIRAMATE 25 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Topiramate tablets 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 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 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-free number 1-888-233-2334. Information about the North American Drug Pregnancy

產品總結:

Topiramate tablets ,USP Topiramate tablets, USP are available in the following strengths and colors:                                                                    25 mg, White colored, circular, biconvex film-coated tablets, debossed with "122" on one side and "C" on the other side and are available in Bottles of 60's (NDC 69097-122-03) Bottles of 500's (NDC 69097-122-12) Bottles of 1000's (NDC 69097-122-15) 50 mg, Light orange colored, circular, biconvex, film-coated tablets, debossed with "123" on one side and "C" on the other side and are available in Bottles of 60's (NDC 69097-123-03) Bottles of 500's (NDC 69097-123-12) Bottles of 1000's (NDC 69097-123-15) 100 mg, Orange colored, circular, biconvex, film-coated tablets, debossed with "124" on one side and "Cipla" on the other side and are available in Bottles of 60's (NDC 69097-124-03) Bottles of 500's (NDC 69097-124-12) Bottles of 1000's (NDC 69097-124-15) 200 mg, Pink colored, capsule shaped, biconvex, film-coated tablets, debossed with "125" on one side and "Cipla" on other side and are available in Bottles of 60's (NDC 69097-125-03) Bottles of 500's (NDC 69097-125-12) Bottles of 1000's (NDC 69097-125-15) PHARMACIST: Dispense in a tight container as defined in the USP. Use child-resistant closure (as required). Store at 20°C to 25°C (68°F to 77°F) [See USP controlled room temperature]. Protect from moisture.

授权状态:

Abbreviated New Drug Application

资料单张

TOPIRAMATE - TOPIRAMATE TABLET
Cipla USA Inc.
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SPL MEDGUIDE
Topiramate (toe pir'a mate) Tablets USP
What is the most important information I should know about topiramate
tablets?
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 tablets 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 tablets 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 tablets 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 have any of these
symptoms, espe

产品特点

TOPIRAMATE - TOPIRAMATE TABLET
CIPLA USA 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
RECENT MAJOR CHANGES
Warnings and Precautions (5.1, 5.4, 5.7, 5.10, 5.13) 11/2022
INDICATIONS AND USAGE
Topiramate tablets are indicated for:
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)
DOSAGE AND ADMINISTRATION
Topiramate tablets 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
Tablets: 25 mg, 50 mg, 100 mg, and 200 mg (3)
CONTRAINDICATIONS
None (4).
WARNINGS AND PRECAUTIONS
Acute myopia and secondary angle closure glaucoma: can lead to
permanent visual loss; discontinue
topiramate tablets as soon as possible (5.1)
Visual field defects: consider discontinuation of topiramate tablets
(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 tablets if
clinically appropriate (5.4)
Suicidal behavior and ideation: antiepileptic drugs increase the risk
of suicidal behavior or ideation (5.5)
Cognitive/neuropsychiatric adverse