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eon labs, inc. - carisoprodol (unii: 21925k482h) (carisoprodol - unii:21925k482h), aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - carisoprodol 200 mg - carisoprodol, aspirin and codeine phosphate tablets, usp are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. limitations of use carisoprodol, aspirin and codeine phosphate 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 ). carisoprodol, aspirin and codeine phosphate tablets are contraindicated for: • all children younger than 12 years of age (see warnings) • post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy (see warnings ). carisoprodol, aspirin and codeine phosphate tablets are also contraindicated in patients with: carisoprodol, aspirin, and codeine phosphate tablets contains codeine. codeine in combination with carisoprodol and aspirin is a schedule iii

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

eon labs, inc. - carisoprodol (unii: 21925k482h) (carisoprodol - unii:21925k482h), aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e) - carisoprodol 200 mg - carisoprodol and aspirin tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. carisoprodol and aspirin 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). carisoprodol and aspirin tablets are contraindicated in patients with a history of: controlled substance carisoprodol, a schedule iv controlled substance. carisoprodol has been subject to abuse, misuse, and criminal diversion for nontherapeutic use (see warnings ). abuse abuse of carisoprodol poses a risk of overdosage which may lead to death, cns and respiratory depression, hypotension, seizures and other disorders (see warnings ). patients at high risk of carisoprodol abuse may include those with prolonged use of carisoprodol, with a history of drug abuse, or tho

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rising pharmaceuticals, inc. - carisoprodol (unii: 21925k482h) (carisoprodol - unii:21925k482h), aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e) - carisoprodol 200 mg - carisoprodol and aspirin is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. carisoprodol and aspirin 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 ). carisoprodol and aspirin is contraindicated in patients with a history of: - a serious gi complication (i.e., bleeding, perforations, obstruction) due to aspirin use - aspirin induced asthma (a symptom complex which occurs in patients who have asthma, rhinosinusitis, and nasal polyps who develop a severe, potentially fatal bronchospasm shortly after taking aspirin or other nsaids) - hypersensitivity reaction to carbamate such as meprobamate - acute intermittent prophyria the efficacy, safety, and pharmacokinetics of carisoprodol and aspirin in pediatric patients less than 16 years

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

rising pharmaceuticals, inc. - carisoprodol (unii: 21925k482h) (carisoprodol - unii:21925k482h), aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - carisoprodol 200 mg - carisoprodol, aspirin and codeine phosphate tablets, usp are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. limitations of use because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses (seewarnings ), reserve carisoprodol, aspirin and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): - have not been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia carisoprodol, aspirin and codeine phosphate 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 ). carisoprodol, aspirin and codeine phosphate tablets are contraindicated for: - all children

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direct_rx - carisoprodol (unii: 21925k482h) (carisoprodol - unii:21925k482h) - carisoprodol tablets, usp is 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, usp is contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate. 8.1 pregnancy: 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 meprobamate and an increased risk for particular congenital malformations. teratogenic effects: animal studies have not adequately evaluated the teratogenic effects of carisoprodol. there was no increase in the incidence of congenital malformations noted in reproductive studies in rats, rabbits, and mice treated with meprobamate. retrospective, post-marketing studies of meprobamate during human pregnancy were equivocal for demonstrating an increased risk of congenital malformations following first trimester exposure. across studies that indicated an increased risk, the types of malformations were inconsistent. nonteratogenic effects: in animal studies, carisoprodol reduced fetal weights, postnatal weight gain, and postnatal survival at maternal doses equivalent to 1 to 1.5 times the human dose (based on a body surface area comparison). rats exposed to meprobamate in-utero showed behavioral alterations that persisted into adulthood. for children exposed to meprobamate in-utero, one study found no adverse effects on mental or motor development or iq scores. carisoprodol should be used during pregnancy only if the potential benefit justifies the risk to the fetus. 8.2 labor and delivery there is no information about the effects of carisoprodol on the mother and the fetus during labor and delivery. 8.3 nursing mothers very limited data in humans show that carisoprodol is present in breast milk and may reach concentrations two to four times the maternal plasma concentrations. in one case report, a breast-fed infant received about 4 to 6% of the maternal daily dose through breast milk and experienced no adverse effects. however, milk production was inadequate and the baby was supplemented with formula. in lactation studies in mice, female pup survival and pup weight at weaning were decreased. this information suggests that maternal use of carisoprodol may lead to reduced or less effective infant feeding (due to sedation) and/or decreased milk production. caution should be exercised when carisoprodol is administered to a nursing woman. 8.4 pediatric use the efficacy, safety, and pharmacokinetics of carisoprodol in pediatric patients less than 16 years of age have not been established. 8.5 geriatric use the efficacy, safety, and pharmacokinetics of carisoprodol in patients over 65 years old have not been established. 8.6 renal impairment 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. 8.7 hepatic impairment 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. 8.8 patients with reduced cyp2c19 activity 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)]. 9.1 controlled substance carisoprodol tablets, usp contains carisoprodol, usp a schedule iv controlled substance. carisoprodol has been subject to abuse, misuse, and criminal diversion for nontherapeutic use [see warnings and precautions (5.2)]. 9.2 abuse abuse of carisoprodol poses a risk of overdosage which may lead to death, cns and respiratory depression, hypotension, seizures and other disorders .[seewarnings and precautions (5.2) and over dosage(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 dependance(9.3)] 9.3 dependence 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)].

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avet pharmaceuticals inc. - carisoprodol (unii: 21925k482h) (carisoprodol - unii:21925k482h), aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e) - carisoprodol 200 mg - carisoprodol and aspirin tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. carisoprodol and aspirin 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 ). carisoprodol and aspirin tablets are contraindicated in patients with a history of: - a serious gi complication (i.e., bleeding, perforations, obstruction) due to aspirin use - aspirin induced asthma (a symptom complex which occurs in patients who have asthma, rhinosinusitis, and nasal polyps who develop a severe, potentially fatal bronchospasm shortly after taking aspirin or other nsaids) - hypersensitivity reaction to a carbamate such as meprobamate - acute intermittent porphyria controlled substance carisoprodol and aspirin tablets contain carisoprodol, a sche

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

strides pharma inc. - carisoprodol (unii: 21925k482h) (carisoprodol - unii:21925k482h) - carisoprodol 250 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 tablets usp 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 p

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rebel distributors corp - carisoprodol (unii: 21925k482h) (carisoprodol - unii:21925k482h), aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e) - carisoprodol 200 mg - carisoprodol and aspirin tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of pain, muscle spasm, and limited mobility associated with acute, painful musculoskeletal conditions. acute intermittent porphyria; bleeding disorders; allergic or idiosyncratic reactions to carisoprodol, aspirin, or related compounds. abuse: in clinical use, abuse has been rare. dependence: in clinical use, dependence with carisoprodol and aspirin tablets have been rare and there have been no reports of significant abstinence signs, nevertheless, the following information on the individual ingredients should be kept in mind. carisoprodol: in dogs, no withdrawal symptoms occurred after abrupt cessation of carisoprodol from dosages as high as 1 gm/kg/day. in a study in man, abrupt cessation of 100 mg/kg/day (about five times the recommended daily adult dosage) was followed in some subjects by mild withdrawal symptoms such as abdominal cramps, insomnia, chills, headache and nausea. delir

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west-ward pharmaceutical corp - 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 are contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reactions 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 increase

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

altura pharmaceuticals, 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 are contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reactions 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 increase