Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
TIZANIDINE HYDROCHLORIDE (UNII: B53E3NMY5C) (TIZANIDINE - UNII:6AI06C00GW)
Covis Pharma US, Inc
ORAL
PRESCRIPTION DRUG
Zanaflex is 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 patients taking potent inhibitors of CYP1A2, such as fluvoxamine or ciprofloxacin [see Drug Interactions (7.1, 7.2)] . There are no adequate data on the developmental risk associated with use of Zanaflex in pregnant women. In animal studies, administration of tizanidine during pregnancy resulted in developmental toxicity (embryofetal and postnatal offspring mortality and growth deficits) at doses less than those used clinically, which were not associated with maternal toxicity (see Animal Data ). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% - 4% and 15% - 20%, respectively. The background risk of major birth defec
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°C to 30°C (59°F to 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 70515-594-15). Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 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 COVIS PHARMA US, 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 (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 • • • • DOSAGE FORMS AND STRENGTHS • • CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS • • • • • • ADVERSE REACTIONS The most common adverse reactions (greater than 2% of 264 patients taking tizanidine and greater than in placebo-treated patients in three multiple dose, placebo-controlled studies) were dry mouth, somnolence, asthenia, dizziness, urinary tract infection, constipation, liver function tests abnormal, vomiting, speech disorder, amblyopia, urinary frequency, flu syndrome, SGPT/ALT increased, dyskinesia, nervousness, pharyngitis, and rhinitis (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT COVIS PHARMA AT 1-866-488-4423 OR ® ® ® 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) Cap Läs hela dokumentet