Indications

This combination is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.

Composition

Pharmacology

Doxylamine Succinate is an antihistamine that blocks Histamine (H1) receptor. It can cross the blood brain barrier and has a high affinity for H1 receptors in the brain that blocks H1 receptors. It also decreases the action of histamine at the H1 receptor by inhibiting both vestibular system & Muscarinic receptor. It affects the vestibular system & decreases the stimulation of the vomiting center. Its muscarinic receptor inhibition may also play a role in antihistamine antiemetic activity. Pyridoxine Hydrochloride is a vitamin B6 analog. It is used to prevent nausea and vomiting due to its antiemetic properties.

Dosage & Administration

Initially, take one tablet orally at bedtime (Day 1). If this dose adequately controls symptoms the next day, continue taking one tablet daily at bedtime only. However, if symptoms persist on Day 2, increase the daily dose to one tablet in the morning and one tablet at bedtime. The maximum recommended dose is two tablets per day, one in the morning and one at bedtime. Take on an empty stomach with a glass of water. Swallow tablets whole. Do not crush, chew, or split this tablets. Take daily and not on an as needed basis.

Contraindications

Doxylamine Succinate & 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 & Pyridoxine Hydrochloride

Side Effects

Somnolence or other accidents resulting from the effect of the combined use of Doxylamine Succinate & Pyridoxine Hydrochloride with CNS depressants.

Pregnancy & Lactation

Pregnancy category A. This is intended for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Both Doxylamine Succinate & Pyridoxine Hydrochloride are excreted into breast milk. Therefore, caution should be exercised while breastfeeding.

Precautions & Warnings

Doxylamine Succinate & Pyridoxine Hydrochloride may cause somnolence due to the anticholinergic properties of Doxylamine Succinate, an antihistamine. Women should avoid engaging in activities, such as driving or operating heavy machinery, while using Doxylamine Succinate & Pyridoxine Hydrochloride. Doxylamine Succinate & Pyridoxine Hydrochloride use is not recommended if a woman is concurrently using central nervous system (CNS) depressants including alcohol. Doxylamine Succinate & Pyridoxine Hydrochloride has anticholinergic properties and, therefore, should be used with caution in women with asthma, increased intraocular pressure, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction or urinary bladder-neck obstruction.

Therapeutic Class

Anti-emetic drugs

Storage Conditions

Store at below 30°C in a dry place protected from light. Keep out of reach of children.