ZANAFLEX- tizanidine hydrochloride capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

STAT RX USA LLC

INN (International Name):

TIZANIDINE HYDROCHLORIDE

Composition:

TIZANIDINE HYDROCHLORIDE 4 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Tizanidine is a short-acting drug for the management of spasticity. Because of the short duration of effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important (see DOSAGE AND ADMINISTRATION). Concomitant use of tizanidine with fluvoxamine or with ciprofloxacin, potent inhibitors of CYP1A2, is contraindicated. Significant alterations of pharmacokinetic parameters of tizanidine including increased AUC, t1/2, Cmax, increased oral bioavailability and decreased plasma clearance have been observed with concomitant administration of either fluvoxamine or ciprofloxacin. This pharmacokinetic interaction can result in potentially serious adverse events (See WARNINGS and CLINICAL PHARMACOLOGY: Drug Interactions). Zanaflex is contraindicated in patients with known hypersensitivity to Zanaflex or its ingredients. Tizanidine should be used with caution in elderly patients because clearance is decreased four-fold. There are no adequate an

Product summary:

Zanaflex Capsules® (tizanidine hydrochloride) 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 standard blue opaque body with a standard blue opaque cap with "2 MG" printed on the cap. The 4 mg capsules have a white opaque body with a standard blue opaque cap with "4 MG" printed on the cap. The 6 mg capsules have a light blue opaque body with a white stripe and light blue opaque cap with "6 MG" printed on the capsules. The capsules are provided as follows: Zanaflex Capsules® (tizanidine hydrochloride), 2 mg, bottles of 150 capsules (NDC 10144-602-15) Zanaflex Capsules® (tizanidine hydrochloride), 4 mg, bottles of 150 capsules (NDC 10144-604-15) Zanaflex Capsules® (tizanidine hydrochloride), 6 mg, bottles of 150 capsules (NDC 10144-606-15) 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 Zanaflex® (tizanidine hydrochloride) tablets are available in one strength as white, uncoated tablets containing tizanidine hydrochloride 4 mg. The 4 mg tablets have a quadrisecting score on one side and are debossed with "A594" on the other side. Tablets are provided as follows: Zanaflex® (tizanidine hydrochloride) tablets, 4 mg, 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 Rx Only Zanaflex® is the registered trademark of Acorda Therapeutics, Inc. Zanaflex Capsules® is the trademark of Acorda Therapeutics, Inc. Marketed and Distributed by: Acorda Therapeutics, Inc. Hawthorne, NY 10532 ©2008, Acorda Therapeutics, Inc., All rights reserved. Rev. 04/08

Authorization status:

New Drug Application

Summary of Product characteristics

ZANAFLEX - TIZANIDINE HYDROCHLORIDE CAPSULE
STAT RX USA LLC
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PHARMACOKINETIC DIFFERENCES BETWEEN ZANAFLEX CAPSULES AND
ZANAFLEX TABLETS:
ZANAFLEX CAPSULES ARE NOT BIOEQUIVALENT TO ZANAFLEX TABLETS IN
THE FED STATE. THE PRESCRIBER SHOULD BE THOROUGHLY FAMILIAR WITH
THE COMPLEX EFFECTS OF FOOD ON TIZANIDINE PHARMACOKINETICS (SEE
PHARMACOKINETICS AND DOSAGE AND ADMINISTRATION).
DESCRIPTION
Zanaflex
(tizanidine hydrochloride) is a centrally acting α -adrenergic
agonist. Tizanidine HCl
(tizanidine) is a white to off-white, fine crystalline powder, which
is odorless or with a faint
characteristic odor. Tizanidine is slightly soluble in water and
methanol; solubility in water decreases
as the pH increases. Its chemical name is
5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiodiazole
hydrochloride. Tizanidine's molecular formula is C H ClN S-HCl, its
molecular weight is 290.2 and
its structural formula is:
Zanaflex Capsules
are supplied as 2, 4, and 6 mg capsules and Zanaflex
tablets are supplied as 4 mg
tablets for oral administration. Zanaflex Capsules
are composed of the active ingredient, tizanidine
hydrochloride (2.29 mg equivalent to 2 mg tizanidine base, 4.58 mg
equivalent to 4 mg tizanidine base,
and 6.87 mg equivalent to 6 mg tizanidine base), and the inactive
ingredients, hydroxypropyl methyl
cellulose, silicon dioxide, sugar spheres, titanium dioxide, gelatin,
and colorants.
Zanaflex
tablets are composed of the active ingredient, tizanidine
hydrochloride (4.58 mg equivalent
to 4 mg tizanidine base), and the inactive ingredients, silicon
dioxide colloidal, stearic acid,
microcrystalline cellulose and anhydrous lactose.
CLINICAL PHARMACOLOGY
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MECHANISM OF ACTION
Tizanidine is an agonist at α -adrenergic receptor sites and
presumably reduces spasticity by increasing
presynaptic inhibition of motor neurons. In animal models, tizanidine
has no direct effect on skeletal
muscle fibers or the neuromuscular junction, and no major effect on
monosynaptic spinal reflexes. Th