PHENYTOIN SODIUM capsule extended release

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

PHENYTOIN SODIUM (UNII: 4182431BJH) (PHENYTOIN - UNII:6158TKW0C5)

Disponível em:

REMEDYREPACK INC.

DCI (Denominação Comum Internacional):

PHENYTOIN SODIUM

Composição:

PHENYTOIN SODIUM 100 mg

Tipo de prescrição:

PRESCRIPTION DRUG

Status de autorização:

Abbreviated New Drug Application

Características técnicas

PHENYTOIN SODIUM- PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE
REMEDYREPACK INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EXTENDED PHENYTOIN SODIUM
CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
EXTENDED PHENYTOIN SODIUM
CAPSULES.
EXTENDED PHENYTOIN SODIUM CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1953
RECENT MAJOR CHANGES
Contraindications ( 4)
12/2016
Warnings and Precautions ( 5.11)
12/2016
INDICATIONS AND USAGE
Extended phenytoin sodium capsules are indicated for the treatment of
tonic-clonic (grand mal) and psychomotor
(temporal lobe) seizures and prevention and treatment of seizures
occurring during or following neurosurgery. ( 1)
DOSAGE AND ADMINISTRATION
Adult starting dose in patients who have received no previous
treatment is one 100 mg extended phenytoin sodium
capsule three times a day, with dose adjustments as necessary. For
most adults, the satisfactory maintenance dose will
be one capsule three to four times a day. An increase, up to two
capsules three times a day may be made, if necessary.
( 2.1)
Adult once-a-day dose: If seizure control is established with divided
doses of three 100 mg extended phenytoin sodium
capsules extended capsules daily, once-a-day dosage with 300 mg
extended phenytoin sodium capsules may be
considered. ( 2.1)
Adult loading dose: reserved for patients in a clinic or hospital
setting who require rapid steady-state serum levels and
where intravenous administration is not desired. Refer to full
prescribing information. ( 2.1)
Pediatric starting dose is 5 mg/kg/day in two to three equally divided
doses, with dosage adjustments as necessary, up
to a maximum of 300 mg daily. Maintenance dosage is 4 mg/kg/day to 8
mg/kg/day. ( 2.2)
Serum blood level determinations may be necessary for optimal dosage
adjustments—the clinically effective serum
total concentration is 10 mcg/mL to 20 mcg/mL (unbound phenytoin
concentration is 1 mcg/mL to 2 mcg/mL). ( 2.3)
DOSAGE FORMS AND STRENGTHS
Ex