TIZANIDINE HYDROCHLORIDE capsule, gelatin coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Actavis Pharma, Inc.

INN (International Name):

TIZANIDINE HYDROCHLORIDE

Composition:

TIZANIDINE 2 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Tizanidine hydrochloride capsules are 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 )]. Risk Summary There are no adequate data on the developmental risk associated with use of tizanidine hydrochloride 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

Product summary:

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. •  The 2 mg capsules have a light blue opaque body with a light blue opaque cap with “2 MG” printed on the cap: bottles of 150 capsules (NDC 0591-2788-86) •  The 4 mg capsules have a white opaque body with a blue opaque cap with “4 MG” printed on the cap: bottles of 150 capsules (NDC 0591-2789-86) •  The 6 mg capsules have a blue opaque body with a white stripe and blue opaque cap with “6 MG” printed on the capsules: bottles of 150 capsules (NDC  0591-2790-86) 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.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

TIZANIDINE HYDROCHLORIDE- TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN
COATED
ACTAVIS PHARMA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TIZANIDINE
HYDROCHLORIDE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
TIZANIDINE HYDROCHLORIDE CAPSULES.
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
hydrochloride, alcohol, and ot