DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE tablet, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL), PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)

Available from:

Bionpharma Inc.,

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are supplied in a high‑density polyethylene bottle with a polypropylene child-resistant cap and a silica gel desiccant. Each white, round, film-coated, delayed-release tablet contains 10 mg doxylamine succinate, USP and 10 mg pyridoxine hydrochloride, USP and is imprinted on one side with “DP 1” in black ink and plain on other side. Doxylamine succinate and pyridoxine hydrochloride tablets are provided as follows: NDC 69452-206-20 Bottles of 100 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Keep bottle tightly closed and protect from moisture and light. Do not remove desiccant from bottle. Dispense in original container or equivalent air tight, light-resistant container.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE- DOXYLAMINE
SUCCINATE AND PYRIDOXINE HYDROCHLORIDE TABLET, DELAYED RELEASE
BIONPHARMA INC.,
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DOXYLAMINE SUCCINATE
AND PYRIDOXINE HYDROCHLORIDE DELAYED-RELEASE TABLETS SAFELY AND
EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR DOXYLAMINE SUCCINATE AND PYRIDOXINE
HYDROCHLORIDE
DELAYED-RELEASE TABLETS.
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE DELAYED-RELEASE
TABLETS, FOR
ORAL USE
INITIAL U.S. APPROVAL: 1976
INDICATIONS AND USAGE
Doxylamine succinate and pyridoxine hydrochloride delayed-release
tablets are a fixed dose combination
drug product of doxylamine succinate, an antihistamine, and pyridoxine
hydrochloride, a Vitamin B
analog, indicated for the treatment of nausea and vomiting of
pregnancy in women who do not respond
to conservative management. ( 1)
DOSAGE AND ADMINISTRATION
Take two tablets daily at bedtime. If symptoms are not adequately
controlled, the dose can be increased
to a maximum recommended dose of four tablets daily (one in the
morning, one mid-afternoon and two at
bedtime) as described in the full prescribing information. ( 2)
DOSAGE FORMS AND STRENGTHS
Delayed-release tablets containing 10 mg doxylamine succinate and 10
mg pyridoxine hydrochloride. ( 3)
CONTRAINDICATIONS
Known hypersensitivity to doxylamine succinate, other ethanolamine
derivative antihistamines,
pyridoxine hydrochloride or any inactive ingredient in the
formulation. ( 4)
Monoamine oxidase (MAO) inhibitors. ( 4, 7)
WARNINGS AND PRECAUTIONS
Activities requiring mental alertness: Avoid engaging in activities
requiring complete mental alertness,
such as driving or operating heavy machinery, while using doxylamine
succinate and pyridoxine
hydrochloride until cleared to do so by a healthcare provider. ( 5.1)
Central nervous system (CNS) depressants: Concurrent use with alcohol
or other CNS depressants is
not recommended. ( 5.1)
Anticholinergic actions: Use with