TIZANIDINE HYDROCHLORIDE capsule

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

TIZANIDINE HYDROCHLORIDE (UNII: B53E3NMY5C) (TIZANIDINE - UNII:6AI06C00GW)

Tillgänglig från:

Par Pharmaceutical, Inc.

INN (International namn):

TIZANIDINE HYDROCHLORIDE

Sammansättning:

TIZANIDINE 2 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Tizanidine hydrochloride capsules are a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride capsules should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration (2.1)] . Tizanidine hydrochloride capsules are contraindicated in patients taking potent inhibitors of CYP1A2, such as fluvoxamine or ciprofloxacin [see Drug Interactions (7.1, 7.2)]. Pregnancy Category C   Tizanidine hydrochloride has not been studied in pregnant women. Tizanidine hydrochloride should be given to pregnant women only if the benefit outweighs the risk to the unborn fetus. Reproduction studies performed in rats at a dose of 3 mg/kg, equal to the maximum recommended human dose on a mg/m2  basis, and in rabbits at 30 mg/kg, 16 times the maximum recommended human dose on a mg/m2 basis, did not show evidence of teratogenicity. Tizanidine at doses that a

Produktsammanfattning:

Tizanidine hydrochloride capsules are available in three strengths as two-piece hard gelatin capsules containing tizanidine hydrochloride 2.29 mg, 4.58 mg and 6.87 mg, equivalent to 2 mg, 4 mg and 6 mg tizanidine base. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in containers with child resistant closure.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

TIZANIDINE HYDROCHLORIDE- TIZANIDINE HYDROCHLORIDE CAPSULE
PAR PHARMACEUTICAL, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TIZANIDINE HYDROCHLORIDE
CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
TIZANIDINE HYDROCHLORIDE
CAPSULES.
TIZANIDINE HYDROCHLORIDE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Tizanidine hydrochloride capsules are a central alpha-2-adrenergic
agonist indicated for the management of spasticity.
Because of the short duration of therapeutic effect, treatment with
tizanidine hydrochloride capsules should be reserved
for those daily activities and times when relief of spasticity is most
important. (1) (1)
DOSAGE AND ADMINISTRATION
Recommended starting dose: 2 mg; dose can be repeated at 6 to 8 hour
intervals, up to a maximum of 3 doses in 24
hours (2.1)
Dosage can be increased by 2 mg to 4 mg per dose, with 1 to 4 days
between increases; total daily dose should not
exceed 36 mg (2.1)
Tizanidine pharmacokinetics differs between tablets and capsules, and
when taken with or without food. These
differences could result in a change in tolerability and control of
symptoms (2.1, 12.3)
To discontinue tizanidine hydrochloride capsules, decrease dose slowly
to minimize the risk of withdrawal and rebound
hypertension, tachycardia, and hypertonia (2.2)
DOSAGE FORMS AND STRENGTHS
Capsules: 2 mg, 4 mg or 6 mg (3)
CONTRAINDICATIONS
Concomitant use with potent inhibitors of CYP1A2, such as fluvoxamine
or ciprofloxacin (4, 5.5, 7.1, 7.2)
WARNINGS AND PRECAUTIONS
Hypotension: monitor for signs and symptoms of hypotension, in
particular in patients receiving concurrent
antihypertensives; tizanidine hydrochloride should not be used with
other α -adrenergic agonists (5.1, 7.7)
Risk of liver injury: monitor ALTs; discontinue tizanidine
hydrochloride if liver injury occurs (5.2)
Sedation: Tizanidine hydrochloride may interfere with everyday
activities; sedative effects of tizanidine hydrochlor