Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

american health packaging - tizanidine hydrochloride (unii: b53e3nmy5c) (tizanidine - unii:6ai06c00gw) - tizanidine 2 mg - tizanidine tablet is a central alpha-2-adrenergic agonist indicated for the management of spasticity. because of the short duration of therapeutic effect, treatment with tizanidine tablets 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)]. pregnancy category c tizanidine hydrochloride has not been studied in pregnant women. tizanidine hydrochloride 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 duration in rats. prenatal and postnatal pup loss was increased and developmental retardation occurred. post-implantation loss was increased in rabbits at doses of 1 mg/kg or greater, equal to or greater than 0.5 times the maximum recommended human dose on a mg/m 2 basis. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when tizanidine hydrochloride is administered to a nursing woman. safety and effectiveness in pediatric patients have not been established. tizanidine hydrochloride is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. clinical studies of tizanidine hydrochloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. cross-study comparison of pharmacokinetic data following single dose administration of 6 mg tizanidine hydrochloride showed that younger subjects cleared the drug four times faster than the elderly subjects. in elderly patients with renal insufficiency (creatinine clearance <25 ml/min), tizanidine clearance is reduced by more than 50% compared to healthy elderly subjects; this would be expected to lead to a longer duration of clinical effect. during titration, the individual doses should be reduced. if higher doses are required, individual doses rather than dosing frequency should be increased. monitor elderly patients because they may have an increased risk for adverse reactions associated with tizanidine hydrochloride. tizanidine hydrochloride is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. in patients with renal insufficiency (creatinine clearance < 25 ml/min) clearance was reduced by more than 50%. in these patients, during titration, the individual doses should be reduced. if higher doses are required, individual doses rather than dosing frequency should be increased. these patients should be monitored closely for the onset or increase in severity of the common adverse events (dry mouth, somnolence, asthenia and dizziness) as indicators of potential overdose. [see dosage and administration (2.2), warnings and precautions (5.7) and clinical pharmacology (12.3)] the influence of hepatic impairment on the pharmacokinetics of tizanidine has not been evaluated. because tizanidine is extensively metabolized in the liver, hepatic impairment would be expected to have significant effects on pharmacokinetics of tizanidine. [see dosing and administration (2.3), warnings and precautions (5.2), and clinical pharmacology (12.3)]. abuse potential was not evaluated in human studies. rats were able to distinguish tizanidine from saline in a standard discrimination paradigm, after training, but failed to generalize the effects of morphine, cocaine, diazepam, or phenobarbital to tizanidine. tizanidine is closely related to clonidine, which is often abused in combination with narcotics and is known to cause symptoms of rebound upon abrupt withdrawal. three cases of rebound symptoms on sudden withdrawal of tizanidine have been reported. the case reports suggest that these patients were also misusing narcotics. withdrawal symptoms included hypertension, tachycardia, hypertonia, tremor, and anxiety. withdrawal symptoms are more likely to occur in cases where high doses are used, especially for prolonged periods, or with concomitant use of narcotics. if therapy needs to be discontinued, the dose should be decreased slowly to minimize the risk of withdrawal symptoms [see dosage and administration (2.2)]. monkeys were shown to self-administer tizanidine in a dose-dependent manner, and abrupt cessation of tizanidine produced transient signs of withdrawal at doses > 35 times the maximum recommended human dose on a mg/m 2 basis. these transient withdrawal signs (increased locomotion, body twitching, and aversive behavior toward the observer) were not reversed by naloxone administration.

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

avpak - tizanidine hydrochloride (unii: b53e3nmy5c) (tizanidine - unii:6ai06c00gw) - tizanidine 2 mg - tizanidine tablet is a central alpha-2-adrenergic agonist indicated for the management of spasticity. because of the short duration of therapeutic effect, treatment with tizanidine tablets 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 ) ]. pregnancy category c tizanidine hydrochloride has not been studied in pregnant women. tizanidine hydrochloride 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 duration in rats. prenatal and postnatal pup loss was increased and developmental retardation occurred. post-implantation loss was increased in rabbits at doses of 1 mg/kg or greater, equal to or greater than 0.5 times the maximum recommended human dose on a mg/m 2 basis. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when tizanidine hydrochloride is administered to a nursing woman. safety and effectiveness in pediatric patients have not been established. tizanidine hydrochloride is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. clinical studies of tizanidine hydrochloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. cross-study comparison of pharmacokinetic data following single dose administration of 6 mg tizanidine hydrochloride showed that younger subjects cleared the drug four times faster than the elderly subjects. in elderly patients with renal insufficiency (creatinine clearance <25 ml/min), tizanidine clearance is reduced by more than 50% compared to healthy elderly subjects; this would be expected to lead to a longer duration of clinical effect. during titration, the individual doses should be reduced. if higher doses are required, individual doses rather than dosing frequency should be increased. monitor elderly patients because they may have an increased risk for adverse reactions associated with tizanidine hydrochloride. tizanidine hydrochloride is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. in patients with renal insufficiency (creatinine clearance < 25 ml/min) clearance was reduced by more than 50%. in these patients, during titration, the individual doses should be reduced. if higher doses are required, individual doses rather than dosing frequency should be increased. these patients should be monitored closely for the onset or increase in severity of the common adverse events (dry mouth, somnolence, asthenia and dizziness) as indicators of potential overdose. [see dosage and administration ( 2.2), warnings and precautions (5.7) and clinical pharmacology ( 12.3 )] the influence of hepatic impairment on the pharmacokinetics of tizanidine has not been evaluated. because tizanidine is extensively metabolized in the liver, hepatic impairment would be expected to have significant effects on pharmacokinetics of tizanidine. [see dosing and administration (2.3), warnings and precautions ( 5.2), and clinical pharmacology ( 12.3) ]. abuse potential was not evaluated in human studies. rats were able to distinguish tizanidine from saline in a standard discrimination paradigm, after training, but failed to generalize the effects of morphine, cocaine, diazepam, or phenobarbital to tizanidine. tizanidine is closely related to clonidine, which is often abused in combination with narcotics and is known to cause symptoms of rebound upon abrupt withdrawal. three cases of rebound symptoms on sudden withdrawal of tizanidine have been reported. the case reports suggest that these patients were also misusing narcotics. withdrawal symptoms included hypertension, tachycardia, hypertonia, tremor, and anxiety. withdrawal symptoms are more likely to occur in cases where high doses are used, especially for prolonged periods, or with concomitant use of narcotics. if therapy needs to be discontinued, the dose should be decreased slowly to minimizethe risk of withdrawal symptoms [see dosage and administration ( 2.2) ]. monkeys were shown to self-administer tizanidine in a dose-dependent manner, and abrupt cessation of tizanidine produced transient signs of withdrawal at doses > 35 times the maximum recommended human dose on a mg/m 2 basis. these transient withdrawal signs (increased locomotion, body twitching, and aversive behavior toward the observer) were not reversed by naloxone administration.

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

altura pharmaceuticals, inc. - tizanidine hydrochloride (unii: b53e3nmy5c) (tizanidine - unii:6ai06c00gw) - tizanidine hydrochloride 2 mg - tizanidine tablets are 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 ). tizanidine tablets are contraindicated in patients with known hypersensitivity to tizanidine or its ingredients.

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

aphena pharma solutions - tennessee, llc - tizanidine hydrochloride (unii: b53e3nmy5c) (tizanidine - unii:6ai06c00gw) - tizanidine tablets are a central alpha-2-adrenergic agonist indicated for the management of spasticity. because of the short duration of therapeutic effect, treatment with tizanidine tablets should be reserved for those daily activities and times when relief of spasticity is most important [see dosage and administration (2.1)] . tizanidine is contraindicated in patients taking potent inhibitors of cyp1a2, such as fluvoxamine or ciprofloxacin [see drug interactions (7.1, 7.2)]. pregnancy category c tizanidine has not been studied in pregnant women. tizanidine 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/m2 basis, and in rabbits at 30 mg/kg, 16 times the maximum recommended human dose on a mg/m2 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/m2 basis

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

major pharmaceuticals - tizanidine hydrochloride (unii: b53e3nmy5c) (tizanidine - unii:6ai06c00gw) - tizanidine 4 mg

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

unichem pharmaceuticals (usa), inc. - tizanidine hydrochloride (unii: b53e3nmy5c) (tizanidine - unii:6ai06c00gw) - tizanidine 2 mg - tizanidine is a central alpha-2-adrenergic agonist indicated for the management of spasticity. because of the short duration of therapeutic effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important [see dosage and administration (2.1)] . tizanidine is contraindicated in patients taking potent inhibitors of cyp1a2, such as fluvoxamine or ciprofloxacin [see drug interactions (7.1, 7.2)]. pregnancy category c tizanidine has not been studied in pregnant women. tizanidine 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/m2 basis, and in rabbits at 30 mg/kg, 16 times the maximum recommended human dose on a mg/m2 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/m2 basis increased gestati

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

proficient rx lp - tizanidine hydrochloride (unii: b53e3nmy5c) (tizanidine - unii:6ai06c00gw) - tizanidine 4 mg - tizanidinetablets, usp is a central alpha-2-adrenergic agonist indicated for themanagement of spasticity. because of the short duration of therapeutic effect,treatment with tizanidine tablets, usp should be reserved for those dailyactivities and times when relief of spasticity is most important [see dosage andadministration(2.1) ]. tizanidine tablets, usp is contraindicated in patientstaking potent inhibitors of cyp1a2, such as fluvoxamine or ciprofloxacin [see drug interactions ( error! hyperlink reference not valid. , error! hyperlink reference not valid. ) ]. pregnancy category c tizanidine tablets, usp has not been studied in pregnant women. tizanidine tablets, usp 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/m2 basis, and in rabbits at 30 mg/kg, 16 times the maximum recommended human dose on a mg/m2 basis, did not show evidence of teratogenic

Ameerika Ühendriigid - inglise - 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

Ameerika Ühendriigid - inglise - 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

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

direct rx - tizanidine hydrochloride (unii: b53e3nmy5c) (tizanidine - unii:6ai06c00gw) - tizanidine 4 mg - tizanidine is a central alpha-2-adrenergic agonist indicated for the management of spasticity. because of the short duration of therapeutic effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important [see dosage and administration (2.1)]. tizanidine is contraindicated in patients taking potent inhibitors of cyp1a2, such as fluvoxamine or ciprofloxacin [see drug interactions (7.1, 7.2)]. 8.1 pregnancy pregnancy category c tizanidine has not been studied in pregnant women. tizanidine 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/m2 basis, and in rabbits at 30 mg/kg, 16 times the maximum recommended human dose on a mg/m2 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/m2 basis increas