TOPIRAMATE tablet, film coated

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

DOH CENTRAL PHARMACY

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Topiramate tablets and topiramate capsules are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. Topiramate tablets  and topiramate capsules are indicated as adjunctive therapy for adults and pediatric patients 2 to 16 years of ages 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 and topiramate capsules 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

Resumen del producto:

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. 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. 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. 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. 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: 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: They are supplied by DOH CENTRAL PHARMACY as follows: Store at 20o to 25o C (68o to 77o F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container.

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

TOPIRAMATE - TOPIRAMATE TABLET, FILM COATED
DOH CENTRAL PHARMACY
----------
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
•
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 if you have any o

Fitxa tècnica

TOPIRAMATE - TOPIRAMATE TABLET, FILM COATED
DOH CENTRAL PHARMACY
----------
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
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)
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 ideation (5.5)
Cognitive/neuropsychiatric adverse reactions: use caution when
operatin