TOPIRAMATE capsule, extended release

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Zydus Pharmaceuticals USA Inc.

INN (Internationale Bezeichnung):

TOPIRAMATE

Zusammensetzung:

TOPIRAMATE 25 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Topiramate extended-release capsules are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older [see Clinical Studies (14.2)] . Topiramate extended-release 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 6 years of age and older [see Clinical Studies (14.3)] . Topiramate extended-release capsules are indicated for the preventive treatment of in patients 12 years of age and older [see Clinical Studies (14.4)].   Topiramate extended-release capsules are contraindicated in patients: -   With recent alcohol use (i.e., within 6 hours prior to and 6 hours after topiramate extended-release capsules use) [see Warnings and Precautions (5.5)] Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drug

Produktbesonderheiten:

Topiramate Extended-Release Capsules Topiramate Extended-Release Capsules are available in the following strengths: 25 mg capsules : Off white pellets filled in size '2' hard gelatin capsules with white opaque cap printed with '863' in black ink and a white opaque body and are supplied as follows: NDC 68382-863-06 in bottle of 30 capsules with child-resistant closure NDC 68382-863-16 in bottle of 90 capsules with child-resistant closure NDC 68382-863-01 in bottle of 100 capsules with child-resistant closure NDC 68382-863-05 in bottle of 500 capsules NDC 68382-863-77 in cartons of 100 (10 x 10) unit-dose capsules 50 mg capsules : Off white pellets filled in size '0' hard gelatin capsules with white opaque cap printed with '864' in black ink and a white opaque body and are supplied as follows: NDC 68382-864-06 in bottle of 30 capsules with child-resistant closure NDC 68382-864-16 in bottle of 90 capsules with child-resistant closure NDC 68382-864-01 in bottle of 100 capsules with child-resistant closure NDC 68382-864-05 in bottle of 500 capsules NDC 68382-864-77 in cartons of 100 (10 x 10) unit-dose capsules 100 mg capsules : Off white pellets filled in size '0el' hard gelatin capsules with white opaque cap printed with '769' in black ink and a white opaque body and are supplied as follows: NDC 68382-769-06 in bottle of 30 capsules with child-resistant closure NDC 68382-769-16 in bottle of 90 capsules with child-resistant closure NDC 68382-769-01 in bottle of 100 capsules with child-resistant closure NDC 68382-769-05 in bottle of 500 capsules NDC 68382-769-77 in cartons of 100 (10 x 10) unit-dose capsules 200 mg capsules: White to off-white pellets filled in size '00' hard gelatin capsules with white opaque cap printed with '358' in black ink and a white opaque body and are supplied as follows: NDC 68382-358-06 in bottle of 30 capsules with child-resistant closure NDC 68382-358-01 in bottle of 100 capsules with child-resistant closure NDC 68382-358-05 in bottle of 500 capsules NDC 68382-358-78 in cartons of 30 capsules (3 x 10 unit-dose) (Unit-dose blisters are child-resistant) Topiramate extended-release capsules should be stored in well-closed containers at 20° to 25°C (68° to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and light.

Berechtigungsstatus:

Abbreviated New Drug Application

Gebrauchsinformation

Zydus Pharmaceuticals USA Inc.
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SPL MEDGUIDE
MEDICATION GUIDE
Topiramate (toe pir' a mate) Extended-Release Capsules
What is the most important information I should know about topiramate
extended-release capsules?
Take topiramate extended-release capsules whole. Do not sprinkle
topiramate extended-release capsules
on food or break, crush, dissolve or chew topiramate extended-release
capsules before swallowing. If
you cannot swallow topiramate extended-release capsules whole, tell
your healthcare provider. You
may need a different medicine.
Do not drink alcohol within 6 hours prior to and 6 hours after
topiramate extended-release capsules
administration.
Topiramate extended-release capsules 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 extended-release capsules 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 extended-release capsules 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
h

Fachinformation

TOPIRAMATE- TOPIRAMATE CAPSULE, EXTENDED RELEASE
ZYDUS PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TOPIRAMATE EXTENDED-
RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR TOPIRAMATE
EXTENDED-RELEASE CAPSULES.
TOPIRAMATE EXTENDED-RELEASE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
RECENT MAJOR CHANGES
Warnings and Precautions (5.1, 5.4, 5.10, 5.11, 5.14)
10/2022
INDICATIONS AND USAGE
Topiramate extended-release capsules are indicated for:
Epilepsy: initial monotherapy for the treatment of partial-onset or
primary generalized tonic-clonic
seizures in patients 6 years of age and older (1.1); adjunctive
therapy for the treatment of partial-
onset, primary generalized tonic-clonic seizures, or seizures
associated with Lennox-Gastaut syndrome
(LGS) in patients 6 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 extended-release capsulesinitial 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)
Swallow capsule whole and intact. Do not sprinkle on food, chew, or
crush (2.7)
DOSAGE FORMS AND STRENGTHS
Extended-release capsules: 25 mg, 50 mg, 100 mg and 200 mg (3)
CONTRAINDICATIONS
With recent alcohol use, i.e., within 6 hours prior to and 6 hours
after topiramate extended-release
capsules use (4, 5.5)
WARNINGS AND PRECAUTIONS
ACUTE MYOPIA AND SECONDARY ANGLE CLOSURE GLAUCOMA:can lead to
permanent visual loss;
discontinue topiramate extended-release capsules as soon as possible
(5.1)
VISUAL FIELD DEFECTS:consider discontinuation of topiramate
extended-release capsules (5.2)
OLIGOHYDROSIS AND HYPERTHERMIA:monitor decreased sweating and
increased body temperature,
espec