USA - engelsk - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - carisoprodol (unii: 21925k482h) (carisoprodol - unii:21925k482h) - carisoprodol 350 mg - carisoprodol tablets, usp are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. carisoprodol tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration. [see dosage and administration (2)]. carisoprodol tablets are contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate. there are no data on the use of carisoprodol tablets during human pregnancy.  animal studies indicate that carisoprodol crosses the placenta and results in adverse effects on fetal growth and postnatal survival.  the primary metabolite of carisoprodol, meprobamate, is an approved anxiolytic.  retrospective, post-marketing studies do not show a consistent association between maternal use of meprobamate and an incre

USA - engelsk - NLM (National Library of Medicine)

h.j. harkins company, inc. - carisoprodol (unii: 21925k482h) (carisoprodol - unii:21925k482h) - carisoprodol 350 mg - carisoprodol tablets, usp are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. carisoprodol tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration. [see dosage and administration (2)]. carisoprodol tablets are contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate. there are no data on the use of carisoprodol tablets during human pregnancy.  animal studies indicate that carisoprodol crosses the placenta and results in adverse effects on fetal growth and postnatal survival.  the primary metabolite of carisoprodol, meprobamate, is an approved anxiolytic.  retrospective, post-marketing studies do not show a consistent association between maternal use of meprobamate and an incre

USA - engelsk - NLM (National Library of Medicine)

aurobindo pharma limited - carisoprodol (unii: 21925k482h) (carisoprodol - unii:21925k482h) - carisoprodol 250 mg - carisoprodol tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. limitation of use carisoprodol tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [see dosage and administration (2) ]. carisoprodol tablets are contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate. risk summary data over many decades of carisoprodol use in pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. data on meprobamate, the primary metabolite of carisoprodol, also do not show a consistent association between maternal use of meprobamate and an increased risk of major birth defects (see data). in a published animal reproduction study, pregnant mice administered carisoprodol orally at 2.6-and 4.1-times the maximum recommended human dose ([mrhd] of 1400 mg per day [350 mg qid] based on body surface area [bsa] comparison) from gestation through weaning resulted in reduced fetal weights, postnatal weight gain, and postnatal survival (see data). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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. data   human data retrospective case-control and cohort studies of meprobamate use during the first trimester of pregnancy have not consistently identified an increased risk or pattern of major birth defects. for children exposed to meprobamate in-utero , one study found no adverse effect on mental or motor development or iq scores. animal data embryofetal development studies in animals have not been completed. in a published pre-and post-natal development animal study, pregnant mice administered carisoprodol orally at 300, 750, or 1200 mg/kg/day (approximately 1-, 2.6-, and 4.1-times the mrhd based on bsa comparison) from 7-days prior to gestation through birth and from lactation through weaning resulted in reduced fetal weights, postnatal weight gain, and postnatal survival at 2.6-and 4.1-times the mrhd. risk summary data from published literature report that carisoprodol and its metabolite, meprobamate, are present in breastmilk. there are no data on the effect of carisoprodol on milk production. there is one report of sedation in an infant who was breastfed by a mother taking carisoprodol (see clinical considerations). because there have been no consistent reports of adverse events in breastfed infants over decades of use, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for carisoprodol and any potential adverse effects on the breastfed infant from carisoprodol or from the underlying maternal condition. clinical considerations infants exposed to carisoprodol through breast milk should be monitored for sedation. the efficacy, safety, and pharmacokinetics of carisoprodol in pediatric patients less than 16 years of age have not been established.  the efficacy, safety, and pharmacokinetics of carisoprodol in patients over 65 years old have not been established.  the safety and pharmacokinetics of carisoprodol in patients with renal impairment have not been evaluated. since carisoprodol is excreted by the kidney, caution should be exercised if carisoprodol is administered to patients with impaired renal function. carisoprodol is dialyzable by hemodialysis and peritoneal dialysis.  the safety and pharmacokinetics of carisoprodol in patients with hepatic impairment have not been evaluated. since carisoprodol is metabolized in the liver, caution should be exercised if carisoprodol is administered to patients with impaired hepatic function.   patients with reduced cyp2c19 activity have higher exposure to carisoprodol. therefore, caution should be exercised in administration of carisoprodol to these patients [see clinical pharmacology (12.3) ] .  carisoprodol, a schedule iv controlled substance. carisoprodol has been subject to abuse, misuse, and criminal diversion for nontherapeutic use [see warnings and precautions (5.2)] . abuse of carisoprodol poses a risk of overdosage which may lead to death, cns and respiratory depression, hypotension, seizures and other disorders [see warnings and precautions (5.2) and overdosage (10)] . patients at high risk of carisoprodol abuse may include those with prolonged use of carisoprodol, with a history of drug abuse, or those who use carisoprodol in combination with other abused drugs. prescription drug abuse is the intentional non-therapeutic use of a drug, even once, for its rewarding psychological effects. drug addiction, which develops after repeated drug abuse, is characterized by a strong desire to take a drug despite harmful consequences, difficulty in controlling its use, giving a higher priority to drug use than to obligations, increased tolerance, and sometimes physical withdrawal. drug abuse and drug addiction are separate and distinct from physical dependence and tolerance (for example, abuse or addiction may not be accompanied by tolerance or physical dependence) [see drug abuse and dependence (9.3)]. tolerance is when a patient’s reaction to a specific dosage and concentration is progressively reduced in the absence of disease progression, requiring an increase in the dosage to maintain the same. physical dependence is characterized by withdrawal symptoms after abrupt discontinuation or a significant dose reduction of a drug. both tolerance and physical dependence have been reported with the prolonged use of carisoprodol. reported withdrawal symptoms with carisoprodol include insomnia, vomiting, abdominal cramps, headache, tremors, muscle twitching, anxiety, ataxia, hallucinations, and psychosis. instruct patients taking large doses of carisoprodol or those taking the drug for a prolonged time to not abruptly stop carisoprodol [see warnings and precautions (5.2)].

USA - engelsk - NLM (National Library of Medicine)

lake erie medical & surgical supply dba quality care products llc - carisoprodol (unii: 21925k482h) (carisoprodol - unii:21925k482h) - carisoprodol 350 mg - carisoprodol is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. carisoprodol tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration. [see dosage and administration (2)]. carisoprodol tablets are contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate. there are no data on the use of carisoprodol during human pregnancy. animal studies indicate that carisoprodol crosses the placenta and results in adverse effects on fetal growth and postnatal survival. the primary metabolite of carisoprodol, meprobamate, is an approved anxiolytic. retrospective, post-marketing studies do not show a consistent association between maternal use of meprobamate and an increased risk for particular c

USA - engelsk - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - carisoprodol (unii: 21925k482h) (carisoprodol - unii:21925k482h) - carisoprodol 350 mg - carisoprodol tablets, usp are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. carisoprodol tablets, usp should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [ see dosage and administration (2) ]. carisoprodol tablets are contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate. there are no data on the use of carisoprodol during human pregnancy. animal studies indicate that carisoprodol crosses the placenta and results in adverse effects on fetal growth and postnatal survival. the primary metabolite of carisoprodol, meprobamate, is an approved anxiolytic. retrospective, postmarketing studies do not show a consistent association between maternal use of meprobamate and an increased r

USA - engelsk - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - carisoprodol (unii: 21925k482h) (carisoprodol - unii:21925k482h) - carisoprodol 350 mg - carisoprodol tablets usp are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. carisoprodol tablets usp should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [see dosage and administration (2) ]. carisoprodol tablets are contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate. pregnancy category c.  there are no data on the use of carisoprodol during human pregnancy. animal studies indicate that carisoprodol crosses the placenta and results in adverse effects on fetal growth and postnatal survival. the primary metabolite of carisoprodol, meprobamate, is an approved anxiolytic. retrospective, post-marketing studies do not show a consistent association between maternal use of meprobamat

USA - engelsk - NLM (National Library of Medicine)

par pharmaceutical - carisoprodol (unii: 21925k482h) (carisoprodol - unii:21925k482h) - carisoprodol 350 mg - carisoprodol tablets usp are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. carisoprodol tablets usp should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [see dosage and administration (2) ]. carisoprodol tablets are contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate. pregnancy category c.  there are no data on the use of carisoprodol during human pregnancy. animal studies indicate that carisoprodol crosses the placenta and results in adverse effects on fetal growth and postnatal survival. the primary metabolite of carisoprodol, meprobamate, is an approved anxiolytic. retrospective, post-marketing studies do not show a consistent association between maternal use of meprobama

USA - engelsk - NLM (National Library of Medicine)

remedyrepack inc. - carisoprodol (unii: 21925k482h) (carisoprodol - unii:21925k482h) - carisoprodol 350 mg - carisoprodol tablets usp are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. carisoprodol tablets usp should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [ see dosage and administration (2) ]. carisoprodol tablets are contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate. pregnancy category c.  there are no data on the use of carisoprodol during human pregnancy. animal studies indicate that carisoprodol crosses the placenta and results in adverse effects on fetal growth and postnatal survival. the primary metabolite of carisoprodol, meprobamate, is an approved anxiolytic. retrospective, post-marketing studies do not show a consistent association between maternal use of meprobam

USA - engelsk - NLM (National Library of Medicine)

apotheca inc. - carisoprodol (unii: 21925k482h) (carisoprodol - unii:21925k482h) - carisoprodol 350 mg - carisoprodol tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. carisoprodol tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [ see dosage and administration (2) ]. carisoprodol tablets usp are contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate. there are no data on the use of carisoprodol during human pregnancy. animal studies indicate that carisoprodol crosses the placenta and results in adverse effects on fetal growth and postnatal survival. the primary metabolite of carisoprodol, meprobamate, is an approved anxiolytic. retrospective, post-marketing studies do not show a consistent association between maternal use of meprobam

USA - engelsk - NLM (National Library of Medicine)

orient pharma co., ltd. - carisoprodol (unii: 21925k482h) (carisoprodol - unii:21925k482h) - carisoprodol 350 mg - carisoprodol tablets usp is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. limitation of use carisoprodol tablets usp should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration. [see dosage and administration (2) ]. carisoprodol is contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate. risk summary data over many decades of carisoprodol use in pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. data on meprobamate, the primary metabolite of carisoprodol, also do not show a consistent association between maternal use of meprobamate and an increased risk of major birth defects (see data). in a publish