ZANAFLEX- tizanidine hydrochloride capsule ZANAFLEX- tizanidine hydrochloride tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Acorda Therapeutics, Inc.

INN (الاسم الدولي):

TIZANIDINE HYDROCHLORIDE

تركيب:

TIZANIDINE 4 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Zanaflex is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with Zanaflex should be reserved for those daily activities and times when relief of spasticity is most important [ see Dosage and Administration(2.1) ]. Zanaflex is contraindicated in patientstaking potent inhibitors of CYP1A2, such as fluvoxamine or ciprofloxacin [ see Drug Interactions (7.1, 7.2) ]. Pregnancy Category C Zanaflex has not been studied in pregnant women. Zanaflex 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/m 2 basis, and in rabbits at 30 mg/kg, 16 times the maximum recommended human dose on a mg/m 2 basis, did not show evidence of teratogenicity. Tizanidine at doses that are equal to and up to 8 times the maximum recommended human dose on a mg/m 2 basis increased gestation du

ملخص المنتج:

Zanaflex Capsules ® (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 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Dispense in containers with child resistant closure. Zanaflex ® (tizanidine hydrochloride) tablets are available as 4 mg white, uncoated tablets containing tizanidine hydrochloride 4.58 mg, equivalent to 4 mg tizanidine base. The tablets have a quadrisecting score on one side and are debossed with "A594" on the other side. Tablets are provided as follows: bottles of 150 tablets (NDC 10144-594-15). Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Dispense in containers with child resistant closure .

الوضع إذن:

New Drug Application

خصائص المنتج

ZANAFLEX- TIZANIDINE HYDROCHLORIDE CAPSULE
ZANAFLEX- TIZANIDINE HYDROCHLORIDE TABLET
ACORDA THERAPEUTICS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZANAFLEX SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ZANAFLEX.
ZANAFLEX CAPSULES (TIZANIDINE HYDROCHLORIDE) CAPSULES, FOR ORAL USE
ZANAFLEX (TIZANIDINE HYDROCHLORIDE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Zanaflex is a central alpha-2-adrenergic agonist indicated for the
management of spasticity. Because of the short duration of
therapeutic effect, treatment with Zanaflex should be reserved for
those daily activities and times when relief of spasticity
is most important. ( 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 Zanaflex, 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)
Tablets 4 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; Zanaflex should not be used with other α
-adrenergic agonists ( 5.1, 7.7)
Risk of liver injury: monitor ALTs; discontinue Zanaflex if liver
injury occurs ( 5.2)
Sedation: Zanaflex may interfere with everyday activities; sedative
effects of Zanaflex, alcohol, and other CNS
depressants are additive ( 5.3, 7.5,