TIZANIDINE HYDROCHLORIDE capsule, gelatin coated

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Lake Erie Medical DBA Quality Care Products LLC

INN (Rahvusvaheline Nimetus):

TIZANIDINE HYDROCHLORIDE

Koostis:

TIZANIDINE 6 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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 is 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 are

Toote kokkuvõte:

Tizanidine hydrochloride capsules are available in three strengths as two-piece hard gelatin capsules containing tizanidine hydrochloride 2 mg, 4 mg, or 6 mg. The 2 mg capsules have a light blue opaque body with a light blue opaque cap with “2 MG” printed on the cap. The 4 mg capsules have a white opaque body with a blue opaque cap with “4 MG” printed on the cap. The 6 mg capsules have a blue opaque body with a white stripe and blue opaque cap with “6 MG” printed on the cap. The capsules are provided as follows: 55700-295-30 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.

Volitamisolek:

New Drug Application

Toote omadused

TIZANIDINE HYDROCHLORIDE- TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN
COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TIZANIDINE HYDROCHLORIDECAPSULES SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TIZANIDINE
HYDROCHLORIDECAPSULES.
TIZANIDINE HYDROCHLORIDE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2002
INDICATIONS AND USAGE
Tizanidine hydrochloride is a central alpha-2-adrenergic agonist
indicated for the management of spasticity. Because of the
short duration of therapeutic effect, treatment with tizanidine
hydrochloride 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 tizanidine hydrochloride, 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 hydro