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Tizanidine 4 Mg Caps 150 By Actavis Pharma

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Tizanidine 4 Mg Caps 150 By Actavis Pharma

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Tizanidine 4 Mg Caps 150 By Actavis Pharma. This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXB10102692/RXD4565909/RXA453035
Size : 150
Selling UoM : EA
NDC: 00591-2789-86
UPC Barcode : 305912789860
Supplier: 0050000679 ACTAVIS PHARMA INC/GENERIC
Supplier Material : 278986
Generic Code : 058905 TIZANIDINE HCL ORAL CAPSULE 4 MG
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : GRX Generic RX

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Product Description.:

4 mg
capsule , blue white , oblong oblong
OpaqueWhite ink

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).
DRUG 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. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiodiazole hydrochloride.

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.
Adverse Events Reported in Controlled Studies

The events cited reflect experience gained under closely monitored conditions of clinica studies in a highly selected patient population. In actual clinical practice or in other clinica studies, these frequency estimates may not apply, as the conditions of use, reporting behavior, and the kinds of patients treated may differ. Table 1 lists treatment emergent signs and symptoms that were reported in greater than 2% of patients in three multiple dose placebo-controlled studies who received tizanidine where the frequency in the tizanidine group was at least as common as in the placebo group. These events are not necessarily related to tizanidine treatment. For comparison purposes, the corresponding frequency of the event (per 100 patients) among placebo treated patients is also provided.