United States - English - NLM (National Library of Medicine)

acorda therapeutics, inc. - tizanidine hydrochloride (unii: b53e3nmy5c) (tizanidine - unii:6ai06c00gw) - tizanidine 4 mg - zanaflex is a central alpha-2-adrenergic agonist indicated for the management of spasticity. because of the short duration of therapeutic effect, treatment with zanaflex should be reserved for those daily activities and times when relief of spasticity is most important [ see dosage and administration(2.1) ]. zanaflex is contraindicated in patientstaking potent inhibitors of cyp1a2, such as fluvoxamine or ciprofloxacin [ see drug interactions (7.1, 7.2) ]. pregnancy category c zanaflex has not been studied in pregnant women. zanaflex 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/m 2 basis, and in rabbits at 30 mg/kg, 16 times the maximum recommended human dose on a mg/m 2 basis, did not show evidence of teratogenicity. tizanidine at doses that are equal to and up to 8 times the maximum recommended human dose on a mg/m 2 basis increased gestation du

United States - English - NLM (National Library of Medicine)

covis pharma us, inc - tizanidine hydrochloride (unii: b53e3nmy5c) (tizanidine - unii:6ai06c00gw) - zanaflex is indicated for the management of spasticity. because of the short duration of therapeutic effect, treatment with zanaflex should be reserved for those daily activities and times when relief of spasticity is most important [see dosage and administration (2.1)] . zanaflex is contraindicated in patients taking potent inhibitors of cyp1a2, such as fluvoxamine or ciprofloxacin [see drug interactions (7.1, 7.2)] . there are no adequate data on the developmental risk associated with use of zanaflex 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 recognized pregnancies is 2% - 4% and 15% - 20%, respectively. the background risk of major birth defec

United States - English - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - tizanidine hydrochloride (unii: b53e3nmy5c) (tizanidine - unii:6ai06c00gw) - tizanidine 4 mg - zanaflex is a central alpha-2-adrenergic agonist indicated for the management of spasticity. because of the short duration of therapeutic effect, treatment with zanaflex should be reserved for those daily activities and times when relief of spasticity is most important [ see dosage and administration(2.1) ]. zanaflex is contraindicated in patientstaking potent inhibitors of cyp1a2, such as fluvoxamine or ciprofloxacin [ see drug interactions (7.1, 7.2) ]. pregnancy category c zanaflex has not been studied in pregnant women. zanaflex 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/m 2 basis, and in rabbits at 30 mg/kg, 16 times the maximum recommende

United States - English - NLM (National Library of Medicine)

rebel distributors corp - tizanidine hydrochloride (unii: b53e3nmy5c) (tizanidine - unii:6ai06c00gw) - tizanidine hydrochloride 4 mg - 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. abuse potential was not evaluated in human studies. rats were able to distinguish tizanidine from saline in a standard discrimination pa

United States - English - NLM (National Library of Medicine)

stat rx usa llc - tizanidine hydrochloride (unii: b53e3nmy5c) (tizanidine - unii:6ai06c00gw) - tizanidine hydrochloride 4 mg - 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

Ireland - English - HPRA (Health Products Regulatory Authority)

teva pharma b.v. - tizanidine - tablet - 2 milligram(s) - other centrally acting agents; tizanidine

Ireland - English - HPRA (Health Products Regulatory Authority)

teva pharma b.v. - tizanidine - tablet - 4 milligram(s) - other centrally acting agents; tizanidine

Ireland - English - HPRA (Health Products Regulatory Authority)

pco manufacturing ltd. - tizanidine - tablet - 2 milligram(s) - other centrally acting agents; tizanidine

Ireland - English - HPRA (Health Products Regulatory Authority)

pco manufacturing ltd. - tizanidine - tablet - 4 milligram(s) - other centrally acting agents; tizanidine

Ireland - English - HPRA (Health Products Regulatory Authority)

pco manufacturing ltd. - tizanidine hydrochloride - tablet - 4 base milligrams - other centrally acting agents; tizanidine