Dosage/Direction for Use
Oral Pregnancy-associated nausea and vomiting Adult: Each tab contains doxylamine 10 mg and pyridoxine 10 mg: 2 tab at bedtime. In severe cases or in cases with nausea/vomiting during the day: increase dosage by 1 tab in morning and/or afternoon. |
Contraindications
Severe liver disease; avoid alcohol; premature infants or full-term neonates.
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Special Precautions
May impair ability to drive and operate machinery. Angle-closure glaucoma, urinary retention, prostatic hypertrophy or pyloroduodenal obstruction; epilepsy; hepatic impairment, elderly. Lactation.
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Adverse Reactions
Acute dystonic reactions and long-lasting impaired consciousness in child. CNS depression including slight drowsiness to deep sleep, lassitude, dizziness, incoordination. Headache, psychomotor impairment and antimuscarinic effects. Rarely rashes and hypersensitivity reactions, blood disorders, convulsions, sweating, myalgia, extrapyramidal effects, tremor, confusion, tinnitus, hypotension, hair loss. Severe peripheral neuropathies with long-term admin of large doses of pyridoxine.
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Drug Interactions
Doxylamine enhances effects of CNS depressants eg alcohol, barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives and antipsychotics. Atropine, tricyclic antidepressants (TCAs), MAOIs. It can mask signs of ototoxicity caused by aminoglycosides. INH, penicillamine and OC require greater pyridoxine dose. Pyridoxine reduces the effects of levodopa, phenobarb and phenytoin.
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Action
Doxylamine is an antihistamine derived from monoethanolamine possessing antimuscarinic and pronounced sedative effects.
Pyridoxine is a precursor of pyridoxal, which functions in the metabolism of carbohydrates, proteins and fats. It is essential in Hb formation and GABA synthesis within the CNS. It also aids in the release of glycogen stored in the liver and muscles.
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CIMS Class
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ATC Classification
R06AA09 - doxylamine ; Belongs to the class of aminoalkyl ethers used as systemic antihistamines.
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