Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
TIZANIDINE HYDROCHLORIDE (UNII: B53E3NMY5C) (TIZANIDINE - UNII:6AI06C00GW)
Acorda Therapeutics, Inc.
TIZANIDINE HYDROCHLORIDE
TIZANIDINE 4 mg
ORAL
PRESCRIPTION DRUG
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
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 .
New Drug Application
ZANAFLEX- TIZANIDINE HYDROCHLORIDE CAPSULE ZANAFLEX- TIZANIDINE HYDROCHLORIDE TABLET ACORDA THERAPEUTICS, INC. ---------- 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, Izlasiet visu dokumentu