Estados Unidos - inglés - NLM (National Library of Medicine)

bionpharma 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 havenot 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 [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% to 4% and 15% to 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.

Canadá - inglés - Health Canada

teva canada limited - doxylamine succinate; pyridoxine hydrochloride - tablet (delayed-release) - 10mg; 10mg - doxylamine succinate 10mg; pyridoxine hydrochloride 10mg - antihistamines

Canadá - inglés - Health Canada

apotex inc - doxylamine succinate; pyridoxine hydrochloride - tablet (delayed-release) - 10mg; 10mg - doxylamine succinate 10mg; pyridoxine hydrochloride 10mg - miscellaneous antiemetics

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

noumed pharmaceuticals pty ltd - doxylamine succinate, quantity: 25 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; calcium hydrogen phosphate dihydrate; pregelatinised maize starch; purified talc; povidone; magnesium stearate; croscarmellose sodium - temporary relief of sleeplessness.

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

noumed pharmaceuticals pty ltd - doxylamine succinate, quantity: 25 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; calcium hydrogen phosphate dihydrate; croscarmellose sodium; pregelatinised maize starch; povidone; magnesium stearate; purified talc - temporary relief of sleeplessness.

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

medreich australia pty ltd - doxylamine succinate, quantity: 25 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; lactose; magnesium stearate; maize starch - temporary relief sleeplessness

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

symbion pty ltd - doxylamine succinate -

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

inova pharmaceuticals (australia) pty ltd - doxylamine succinate, quantity: 25 mg - tablet, uncoated - excipient ingredients: purified talc; microcrystalline cellulose; croscarmellose sodium; povidone; calcium hydrogen phosphate dihydrate; magnesium stearate; pregelatinised maize starch - temporary relief of sleeplessness.

Irlanda - inglés - HPRA (Health Products Regulatory Authority)

inibsa ginecología, s.a. - doxylamine succinate; pyridoxine hydrochloride - modified-release capsule, hard - 10/10 milligram(s) - doxylamine, combinations

Irlanda - inglés - HPRA (Health Products Regulatory Authority)

italfarmaco s.p.a. - doxylamine succinate; pyridoxine hydrochloride - modified-release capsule, hard - doxylamine, combinations