ZANAFLEX- tizanidine hydrochloride capsule ZANAFLEX- tizanidine hydrochloride tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Covis Pharma US, Inc

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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

Produktu pārskats:

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.

Autorizācija statuss:

New Drug Application

Produkta apraksts

ZANAFLEX- TIZANIDINE HYDROCHLORIDE CAPSULE
ZANAFLEX- TIZANIDINE HYDROCHLORIDE TABLET
COVIS PHARMA US, 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 (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
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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