Product Description.:
2 mg
capsule , blue , oblong oblong
White inkOpaque
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
DESCRIPTION
Zanaflex? (tizanidine hydrochloride) is a centrally acting ⓬-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.
Zanaflex Capsules? are supplied as 2, 4, and 6 mg capsules and Zanaflex? tablets are supplied as 2 and 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 (2.29 mg equivalent to 2 mg tizanidine base and 4.58 mg equivalent to 4 mg tizanidine base), and the inactive ingredients, silicon dioxide colloidal, stearic acid, microcrystalline cellulose and anhydrous lactose.
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
SIDE EFFECTS
In multiple dose, placebo-controlled clinical studies, 264 patients were treated with tizanidine and 261 with placebo. Adverse events, including severe adverse events, were more frequently reported with tizanidine than with placebo.
Common Adverse Events Leading to Discontinuation
Forty-five of 264 (17%) patients receiving tizanidine and 13 of 261 (5%) of patients receiving placebo in three multiple dose, placebo-controlled clinical studies, discontinued treatment fo adverse events. When patients withdrew from the study, they frequently had more than one reason for discontinuing. The adverse events most frequently leading to withdrawal o tizanidine treated patients in the controlled clinical studies were asthenia (weakness, fatigue and/or tiredness) (3%), somnolence (3%), dry mouth (3%), increased spasm or tone (2%) and dizziness (2%).
Most Frequent Adverse Clinical Events Seen in Association with Use of Tizanidine
In multiple dose, placebo-controlled clinical studies involving 264 patients with spasticity, the most frequent adverse effects were dry mouth, somnolence/sedation, asthenia (weakness fatigue and/or tiredness) and dizziness. Three-quarters of the patients rated the events as mild to moderate and one-quarter of the patients rated the events as being severe. These events appeared to be dose related.
