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par pharmaceutical, inc. - doxylamine succinate (unii: v9bi9b5yi2) (doxylamine - unii:95qb77jkpl), pyridoxine hydrochloride (unii: 68y4cf58bv) (pyridoxine - unii:kv2jz1bi6z) - doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.   limitations of use doxylamine succinate and pyridoxine hydrochloride delayed-release tablet has not been studied in women with hyperemesis gravidarum.   doxylamine succinate and pyridoxine hydrochloride is contraindicated in women with any of the following conditions:   - known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any inactive ingredient in the formulation monoamine oxidase (mao) inhibitors intensify and prolong the adverse central nervous system effects of doxylamine succinate and pyridoxine hydrochloride [see drug interactions (7.1)].  risk summary doxylamine succinate and pyridoxine hydrochloride is intended for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. maternal risks a

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

bryant ranch prepack - doxylamine succinate (unii: v9bi9b5yi2) (doxylamine - unii:95qb77jkpl), pyridoxine hydrochloride (unii: 68y4cf58bv) (pyridoxine - unii:kv2jz1bi6z) - doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.   limitations of use doxylamine succinate and pyridoxine hydrochloride delayed-release tablet has not been studied in women with hyperemesis gravidarum.   doxylamine succinate and pyridoxine hydrochloride is contraindicated in women with any of the following conditions:   - known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any inactive ingredient in the formulation monoamine oxidase (mao) inhibitors intensify and prolong the adverse central nervous system effects of doxylamine succinate and pyridoxine hydrochloride [see drug interactions (7.1)].  risk summary doxylamine succinate and pyridoxine hydrochloride is intended for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. maternal risks are discussed throughout the labeling. no increased risk for congenital malformations has been reported in epidemiologic studies in pregnant women. in the u.s. general population, the estimated background risks for major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively. data human data the combination of doxylamine succinate and pyridoxine hydrochloride has been the subject of many epidemiological studies (cohort, case control and meta-analyses) designed to detect possible teratogenicity. a meta-analysis of 16 cohort and 11 case-control studies published between 1963 and 1991 reported no increased risk for malformations from first trimester exposures to doxylamine succinate and pyridoxine hydrochloride, with or without dicyclomine hydrochloride. a second meta-analysis of 12 cohort and 5 case-control studies published between 1963 and 1985 reported no statistically significant relationships between fetal abnormalities and the first trimester use of the combination doxylamine succinate and pyridoxine hydrochloride with or without dicyclomine hydrochloride. women should not breastfeed while using doxylamine succinate and pyridoxine hydrochloride.   the molecular weight of doxylamine succinate is low enough that passage into breast milk can be expected. excitement, irritability and sedation have been reported in nursing infants presumably exposed to doxylamine succinate through breast milk. infants with apnea or other respiratory syndromes may be particularly vulnerable to the sedative effects of doxylamine succinate and pyridoxine hydrochloride resulting in worsening of their apnea or respiratory conditions. pyridoxine hydrochloride is excreted into breast milk. there have been no reports of adverse events in infants presumably exposed to pyridoxine hydrochloride through breast milk. the safety and effectiveness of doxylamine succinate and pyridoxine hydrochloride in children under 18 years of age have not been established. fatalities have been reported from doxylamine overdose in children. the overdose cases have been characterized by coma, grand mal seizures and cardiorespiratory arrest. children appear to be at a high risk for cardiorespiratory arrest. a toxic dose for children of more than 1.8 mg/kg has been reported. a 3 year old child died 18 hours after ingesting 1,000 mg doxylamine succinate. however, there is no correlation between the amount of doxylamine ingested, the doxylamine plasma level and clinical symptomatology.

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analog pharma - doxylamine succinate (unii: v9bi9b5yi2) (doxylamine - unii:95qb77jkpl), pyridoxine hydrochloride (unii: 68y4cf58bv) (pyridoxine - unii:kv2jz1bi6z) - doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. limitations of use doxylamine succinate and pyridoxine hydrochloride delayed-release tablets have not been studied in women with hyperemesis gravidarum. doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are contraindicated in women with any of the following conditions: - known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any inactive ingredient in the formulation - monoamine oxidase (mao) inhibitors intensify and prolong the adverse central nervous system effects of doxylamine succinate and pyridoxine hydrochloride delayed-release tablets [see drug interactions (7.1)] . risk summary doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are intended for the treatment of nausea and vomiting of pregnancy

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

actavis pharma, inc. - doxylamine succinate (unii: v9bi9b5yi2) (doxylamine - unii:95qb77jkpl), pyridoxine hydrochloride (unii: 68y4cf58bv) (pyridoxine - unii:kv2jz1bi6z) - doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. limitations of use doxylamine succinate and pyridoxine hydrochloride delayed-release tablets have not been studied in women with hyperemesis gravidarum. doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are contraindicated in women with any of the following conditions: - known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any inactive ingredient in the formulation - monoamine oxidase (mao) inhibitors intensify and prolong the adverse central nervous system effects of doxylamine succinate and pyridoxine hydrochloride delayed-release tablets [see drug interactions (7.1) ] . risk summary doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are intended for the treatment of nausea and vomiting of pregnanc

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

mylan pharmaceuticals inc. - doxylamine succinate (unii: v9bi9b5yi2) (doxylamine - unii:95qb77jkpl), pyridoxine hydrochloride (unii: 68y4cf58bv) (pyridoxine - unii:kv2jz1bi6z) - doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. limitations of use: doxylamine succinate and pyridoxine hydrochloride delayed-release tablets have not been studied in women with hyperemesis gravidarum. doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are contraindicated in women with any of the following conditions: doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are intended for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. maternal risks are discussed throughout the labeling. no increased risk for congenital malformations has been reported in epidemiologic studies in pregnant women. in the u.s. general population, the estimated background risks for major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectiv

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

hf acquisition co llc, dba healthfirst - pyridoxine hydrochloride (unii: 68y4cf58bv) (pyridoxine - unii:kv2jz1bi6z) - pyridoxine hydrochloride injection is effective for the treatment of pyridoxine deficiency as seen in the following: inadequate dietary intake. drug-induced deficiency, as from isoniazid (inh) or oral contraceptives. inborn errors of metabolism, e.g., vitamin b6 dependent convulsions or vitamin b6 responsive anemia. the parenteral route is indicated when oral administration is not feasible as in anorexia, nausea and vomiting, and preoperative and postoperative conditions. it is also indicated when gastrointestinal absorption is impaired. a history of sensitivity to pyridoxine or to any of the ingredients in pyridoxine hydrochloride injection, usp is a contraindication. symptoms of dependence have been noted in adults given only 200 mg daily, followed by withdrawal.

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mission pharmacal company - pyridoxine hydrochloride (unii: 68y4cf58bv) (pyridoxine - unii:kv2jz1bi6z), folic acid (unii: 935e97boy8) (folic acid - unii:935e97boy8), ascorbic acid (unii: pq6ck8pd0r) (ascorbic acid - unii:pq6ck8pd0r), calcium citrate (unii: mlm29u2x85) (calcium cation - unii:2m83c4r6zb), iron (unii: e1uol152h7) (iron - unii:e1uol152h7), cholecalciferol (unii: 1c6v77qf41) (cholecalciferol - unii:1c6v77qf41) - pyridoxine hydrochloride 25 mg - citranatal b-calm ® is a multivitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers. citranatal b-calm ® may be used in conjunction with a physician prescribed regimen to help minimize pregnancy related nausea and vomiting. this product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

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avkare, inc. - pyridoxine hydrochloride (unii: 68y4cf58bv) (pyridoxine - unii:kv2jz1bi6z), folic acid (unii: 935e97boy8) (folic acid - unii:935e97boy8), cyanocobalamin (unii: p6yc3eg204) (cyanocobalamin - unii:p6yc3eg204) - pyridoxine hydrochloride 25 mg

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virtus pharmaceuticals - pyridoxine hydrochloride (unii: 68y4cf58bv) (pyridoxine - unii:kv2jz1bi6z), folic acid (unii: 935e97boy8) (folic acid - unii:935e97boy8), cyanocobalamin (unii: p6yc3eg204) (cyanocobalamin - unii:p6yc3eg204) - pyridoxine hydrochloride 25 mg - this product is contraindicated in patients with a known hypersensitivity to any of the components contained in this product. this product is contraindicated for individuals with conditions for which any of the ingredients are contraindicated. virt-vite forte tablets is indicated for patients in need of dietary supplementation as determined by a licensed medical practitioner. virt-vite forte tablets should be administered under the supervision of a licensed medical practitioner

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

avion pharmaceuticals, llc - pyridoxine hydrochloride (unii: 68y4cf58bv) (pyridoxine - unii:kv2jz1bi6z), cyanocobalamin (unii: p6yc3eg204) (cyanocobalamin - unii:p6yc3eg204), calcium carbonate (unii: h0g9379fgk) (calcium cation - unii:2m83c4r6zb), folic acid (unii: 935e97boy8) (folic acid - unii:935e97boy8) - pyridoxine hydrochloride 75 mg - description: prenate ® am is a yellow, oval, oil- and water-soluble, multivitamin/multimineral, film-coated tablet debossed with "prenate" on one side and "am" on the other.