European Union - English - EMA (European Medicines Agency)

acorda therapeutics ireland limited - levodopa - parkinson disease - anti-parkinson drugs - inbrija is indicated for the intermittent treatment of episodic motor fluctuations (off episodes) in adult patients with parkinson’s disease (pd) treated with a levodopa/dopa-decarboxylase inhibitor.

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

acorda therapeutics, inc. - capsaicin (unii: s07o44r1zm) (capsaicin - unii:s07o44r1zm) - capsaicin 640 ug in 1 cm2 - qutenza is indicated for the management of neuropathic pain associated with postherpetic neuralgia. none. teratogenic effects: pregnancy category b there are no adequate and well-controlled studies evaluating qutenza in pregnant women. there was no evidence of fetal teratogenicity in embryofetal developmental toxicological studies conducted in pregnant rats and rabbits in which qutenza patches (rats) or liquid (rabbits) were applied once daily for a 3 hour duration during the period of fetal organogenesis up to doses corresponding to an 11-fold (rat, 32 mg capsaicin patch/day) and 37-fold (rabbit, 260 mg capsaicin/day) margin over the maximum recommended human dose [mrhd] based on a c max exposure comparison. in a peri- and post-natal reproduction toxicology study, pregnant female rats were treated with qutenza patches at doses up to 32 mg capsaicin patch/rat/day applied once daily for a 3 hours duration during gestation and lactation (from gestation day 7 through day 28 postpartum). analyses of milk samples

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)

acorda therapeutics, inc. - levodopa (unii: 46627o600j) (levodopa - unii:46627o600j) - inbrija is indicated for the intermittent treatment of off episodes in patients with parkinson's disease treated with carbidopa/levodopa. inbrija is contraindicated in patients currently taking a nonselective monoamine oxidase (mao) inhibitor (e.g., phenelzine and tranylcypromine) or who have recently (within 2 weeks) taken a nonselective mao inhibitor. hypertension can occur if these drugs are used concurrently [see drug interactions (7.1)]. risk summary there are no adequate data on the developmental risk associated with the use of inbrija in pregnant women. in animal studies, carbidopa/levodopa has been shown to be developmentally toxic (including teratogenic effects) [see 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 defects and miscarriage for the indicated

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

acorda therapeutics, inc. - dalfampridine (unii: bh3b64okl9) (dalfampridine - unii:bh3b64okl9) - dalfampridine 10 mg - ampyra is indicated as a treatment to improve walking in adult patients with multiple sclerosis (ms). this was demonstrated by an increase in walking speed [see clinical studies (14)]. the use of ampyra is contraindicated in the following conditions: - history of seizure [ see warnings and precautions (5.1)] - moderate or severe renal impairment (crcl≤50 ml/min) [see warnings and precautions (5.2) ] - history of hypersensitivity to ampyra or 4-aminopyridine; reactions have included anaphylaxis [see warnings and precautions (5.4) ] risk summary there are no adequate data on the developmental risk associated with use of ampyra in pregnant women. administration of dalfampridine to animals during pregnancy and lactation resulted in decreased offspring viability and growth at clinically relevant doses [see data ]. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data oral administration of dalfampridine to pregnant rats and rabbits throughout organogenesis resulted in no evidence of developmental toxicity in either species. the highest doses tested (10 mg/kg/day in rats, 5 mg/kg/day in rabbits), which were associated with maternal toxicity, are approximately 5 times the mrhd on a body surface area (mg/m 2 ) basis. oral administration of dalfampridine (0, 1, 3, and 9 to 6 mg/kg/day; high dose reduced during the second week of dosing) to female rats throughout pregnancy and lactation resulted in decreased offspring viability at the highest dose tested and decreased body weight in offspring at the mid and high doses. the no-effect dose for pre- and postnatal developmental toxicity in rats (1 mg/kg/day) is less than the mrhd on a mg/m 2 basis. risk summary there are no data on the presence of dalfampridine in human milk, the effects of dalfampridine on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ampyra and any potential adverse effects on the breastfed infant from ampyra or from the underlying maternal condition. safety and effectiveness in patients younger than 18 years of age have not been established. clinical studies of ampyra did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. a population pk analysis showed that dalfampridine clearance modestly decreased with increasing age, but not sufficiently to necessitate a modification of dose with age. other reported clinical experience has identified no differences in responses between the elderly and younger patients. ampyra is known to be substantially excreted by the kidneys and the risk of adverse reactions, including seizures, is greater with increasing exposure of dalfampridine. because elderly patients are more likely to have decreased renal function, it is particularly important to know the estimated creatinine clearance (crcl) in these patients [see warnings and precautions (5.2)]. clearance of dalfampridine is decreased in patients with renal impairment and is significantly correlated with creatinine clearance (crcl) [see clinical pharmacology (12.3)] . ampyra is contraindicated in patients with moderate or severe renal impairment (crcl ≤50 ml/min) [see contraindications (4)]. the risk of seizures in patients with mild renal impairment (crcl 51–80 ml/min) is unknown, but dalfampridine plasma levels in these patients may approach those seen at a dose of 15 mg twice daily, a dose that may be associated with an increased risk of seizures. if unknown, estimated creatinine clearance should be calculated prior to initiating treatment with ampyra [see dosage and administration (2.3) and warnings and precautions (5.2)] .

Canada - English - Health Canada

biogen canada inc - fampridine - tablet (extended-release) - 10mg - fampridine 10mg - other miscellaneous therapeutic agents

Australia - English - Department of Health (Therapeutic Goods Administration)

biogen idec australia pty ltd - fampridine -

Australia - English - Department of Health (Therapeutic Goods Administration)

biogen australia pty ltd - fampridine, quantity: 10 mg - tablet, modified release - excipient ingredients: colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose; hypromellose; titanium dioxide; macrogol 400 - fampyra modified release tablets are indicated for the symptomatic improvement of walking ability in adult patients with multiple sclerosis who have shown improvement after 8 weeks of treatment

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

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

lake erie medical & surgical supply dba quality care products llc - tizanidine hydrochloride (unii: b53e3nmy5c) (tizanidine - unii:6ai06c00gw) - tizanidine 2 mg