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

hospira, inc. - sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698) - sodium chloride 234 mg in 1 ml

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

nucare pharmaceuticals, inc. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium 75 mg - carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings: gastrointestinal bleeding, ulceration, and perforation ). diclofenac sodium delayed-release tablets are indicated: - for relief of the signs and symptoms of osteoarthritis - for relief of the signs and symptoms of rheumatoid arthritis - for acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis diclofenac sodium delayed-release tablets are contraindicated in the following patients. - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product (see warnings: anaphylactic reactions , serious skin reactions ). - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other

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

preferred pharmaceuticals inc. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium 75 mg - carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings: gastrointestinal bleeding, ulceration, and perforation ). diclofenac sodium delayed-release tablets are indicated: diclofenac sodium delayed-release tablets are contraindicated in the following patients.

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

sandoz inc - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium 25 mg - carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings: gastrointestinal bleeding, ulceration, and perforation ). diclofenac sodium delayed-release tablets are indicated: diclofenac sodium delayed-release tablets are contraindicated in the following patients.

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

preferred pharmaceuticals inc. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium 16.05 mg in 1 ml - diclofenac sodium topical solution is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1). diclofenac sodium topical solution is contraindicated in the following patients: pregnancy category c prior to 30 weeks gestation; category d starting 30 weeks gestation. risk summary use of nsaids, including diclofenac, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. avoid use of nsaids, including diclofenac, in pregnant women starting at 30 weeks of gestation (third trimester). there are no adequate and well-controlled studies of diclofenac sodium topical solution in pregnant women. data from observational studies regarding potential embryofetal risks of nsaid use in women in the first or second trimesters of pregnancy are inconclusive. in the general u.s. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2 to 4% for major malformations, and 15 to 20% for pregna

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

hikma pharmaceuticals usa inc. - sodium oxybate (unii: 7g33012534) (4-hydroxybutanoic acid - unii:30iw36w5b2) - sodium oxybate oral solution is indicated for the treatment of cataplexy or excessive daytime sleepiness (eds) in patients 7 years of age and older with narcolepsy. sodium oxybate oral solution is contraindicated for use in: risk summary there are no adequate data on the developmental risk associated with the use of sodium oxybate in pregnant women. oral administration of sodium oxybate to pregnant rats (150, 350, or 1,000 mg/kg/day) or rabbits (300, 600, or 1,200 mg/kg/day) throughout organogenesis produced no clear evidence of developmental toxicity; however, oral administration to rats throughout pregnancy and lactation resulted in increased stillbirths and decreased offspring postnatal viability and growth, at a clinically relevant dose [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 population

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

amneal pharmaceuticals ny llc - sodium oxybate (unii: 7g33012534) (4-hydroxybutanoic acid - unii:30iw36w5b2) - sodium oxybate oral solution is indicated for the treatment of cataplexy or excessive daytime sleepiness (eds) in patients 7 years of age and older with narcolepsy. sodium oxybate oral solution is contraindicated for use in: risk summary there are no adequate data on the developmental risk associated with the use of sodium oxybate in pregnant women. oral administration of sodium oxybate to pregnant rats (150, 350, or 1,000 mg/kg/day) or rabbits (300, 600, or 1,200 mg/kg/day) throughout organogenesis produced no clear evidence of developmental toxicity; however, oral administration to rats throughout pregnancy and lactation resulted in increased stillbirths and decreased offspring postnatal viability and growth, at a clinically relevant dose [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 population

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

preferred pharmaceuticals, inc. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium 100 mg - carefully consider the potential benefits and risks of diclofenac sodium extended-release tablets, usp and other treatment options before deciding to use diclofenac sodium extended-release tablets, usp. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings). diclofenac sodium extended-release tablets, usp are indicated: diclofenac sodium extended-release tablets, usp is contraindicated in patients with known hypersensitivity to diclofenac. diclofenac sodium extended-release tablets, usp should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic-like reactions to nsaids have been reported in such patients (see warnings, anaphylactic reactions, and precautions, preexisting asthma). diclofenac sodium extended-release tablets, usp are contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft

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

proficient rx lp - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium 100 mg - carefully consider the potential benefits and risks of diclofenac sodium extended-release tablets, usp and other treatment options before deciding to use diclofenac sodium extended-release tablets, usp. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings). diclofenac sodium extended-release tablets, usp are indicated: diclofenac sodium extended-release tablets, usp is contraindicated in patients with known hypersensitivity to diclofenac. diclofenac sodium extended-release tablets, usp should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic-like reactions to nsaids have been reported in such patients (see warnings, anaphylactic reactions, and precautions, preexisting asthma). diclofenac sodium extended-release tablets, usp are contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft

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

preferred pharmaceuticals inc. - phenytoin sodium (unii: 4182431bjh) (phenytoin - unii:6158tkw0c5) - phenytoin sodium 100 mg - extended phenytoin sodium capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. extended phenytoin sodium capsules are contraindicated in patients with: pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as extended phenytoin sodium capsules, during pregnancy. physicians are advised to recommend that pregnant patients taking extended phenytoin sodium capsules enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. information on the registry can also be found at the website http://www.aedpregnancyregistry.org/ risk summary in humans, prenatal exposure to phenytoin may increase the risks for congenital malformations and other adverse