TOPIRAMATE tablet, film coated

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Zydus Pharmaceuticals USA Inc.

INN (Tên quốc tế):

TOPIRAMATE

Thành phần:

TOPIRAMATE 25 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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-free n

Tóm tắt sản phẩm:

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: NDC 68382-138-14 in bottle of 60 tablets with child-resistant closure NDC 68382-138-16 in bottle of 90 tablets with child-resistant closure NDC 68382-138-01 in bottle of 100 tablets NDC 68382-138-05 in bottle of 500 tablets Topiramate Tablets USP, 50 mg are white to off-white, round-shaped, biconvex, beveled-edge, film-coated tablets debossed with "ZD 15" on one side and plain on the other side and are supplied as follows: NDC 68382-139-14 in bottle of 60 tablets with child-resistant closure NDC 68382-139-16 in bottle of 90 tablets with child-resistant closure NDC 68382-139-01 in bottle of 100 tablets NDC 68382-139-05 in bottle of 500 tablets 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: NDC 68382-140-14 in bottle of 60 tablets with child-resistant closure NDC 68382-140-16 in bottle of 90 tablets with child-resistant closure NDC 68382-140-01 in bottle of 100 tablets NDC 68382-140-05 in bottle of 500 tablets Topiramate Tablets USP, 200 mg are white to off-white, round-shaped, biconvex, beveled-edge, film-coated tablets debossed with "ZD 13" on one side and plain on the other side and are supplied as follows: NDC 68382-141-14 in bottle of 60 tablets with child-resistant closure NDC 68382-141-16 in bottle of 90 tablets with child-resistant closure NDC 68382-141-01 in bottle of 100 tablets NDC 68382-141-05 in bottle of 500 tablets Topiramate Capsules, USP Topiramate Capsules USP, 15 mg are white to off-white pellets filled in size '2' empty hard gelatin capsules with white opaque cap imprinted with "ZA63" and white opaque body imprinted with "15 mg" in black ink and are supplied as follows: NDC 68382-004-14 in bottle of 60 capsules with child-resistant closure NDC 68382-004-16 in bottle of 90 capsules with child-resistant closure NDC 68382-004-01 in bottle of 100 capsules with child-resistant closure NDC 68382-004-05 in bottle of 500 capsules NDC 68382-004-10 in bottle of 1,000 capsules Topiramate Capsules USP, 25 mg are white to off-white pellets filled in size '1' empty hard gelatin capsules with white opaque cap imprinted with "ZA64" and white opaque body imprinted with "25 mg" in black ink and are supplied as follows: NDC 68382-005-17 in bottle of 28 capsules with child-resistant closure NDC 68382-005-14 in bottle of 60 capsules with child-resistant closure NDC 68382-005-16 in bottle of 90 capsules with child-resistant closure NDC 68382-005-01 in bottle of 100 capsules with child-resistant closure NDC 68382-005-05 in bottle of 500 capsules NDC 68382-005-10 in bottle of 1,000 capsules Store at 20o C to 25o C (68o F to 77o F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Tờ rơi thông tin

Zydus Pharmaceuticals USA Inc.
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MEDICATION GUIDE
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
•
feel changes in heartbeat
•
not feel hungry (loss of appetite)
•
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 if you have any of these
symptoms, especially if th

Đặc tính sản phẩm

TOPIRAMATE- TOPIRAMATE TABLET, FILM COATED
ZYDUS PHARMACEUTICALS USA INC.
----------
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 (5.1, 5.4, 5.7, 5.9, 5.10, 5.13)10/2022
INDICATIONS AND USAGE
Topiramate is 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 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)
Sprinkle Capsules: 15 mg and 25 mg (3)
CONTRAINDICATIONS
None (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 idea