Pyridoxine Hydrochloride & Doxylamine Succinate: Uses,Side Effects

Generic Name
Pyridoxine Hydrochloride & Doxylamine Succinate
Therapeutic Class:
Anti-emetic drugs

Indications:
Pyridoxine Hydrochloride & Doxylamine Succinate tablet is indicated for the treatment of nausea and vomiting of pregnancy in women.

Presentation:
Pyridoxine Hydrochloride & Doxylamine Succinate tablet:
Each enteric-coated tablet contains Pyridoxine Hydrochloride BP 20 mg & Doxylamine Succinate BP 20 mg.

Description:
Doxylamine is an antihistamine that blocks Histamine (H1) receptor. It affects the vestibular system and decreases the stimulation of the vomiting center. Its muscarinic receptor inhibition may also play a role in antihistamine antiemetic activity. Pyridoxine (Vitamin B6) is a vitamin used to prevent nausea and vomiting due to its antiemetic properties.

Dosage & Administration:
Initially, take one Pyridox tablet orally at bedtime (Day 1). If this does 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 the tablets whole. Do not crush, chew, or split Pyridoxine Hydrochloride & Doxylamine Succinate tablets. Take daily and not on an as-needed basis.

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

Precautions:
Somnolence: Pyridox may cause somnolence due to the anticholinergic properties of doxylamine succinate, an antihistamine. Women should avoid engaging in activities requiring complete mental alertness, such as driving or operating heavy machinery.
Pyridoxine Hydrochloride & Doxylamine Succinate use is not recommended if a woman is concurrently using central nervous system (CNS) depressants. The combination may result in severe drowsiness leading to falls or accidents. Pyridoxine Hydrochloride & Doxylamine Succinate 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.

Use in Pregnancy & Lactation:
Pyridoxine Hydrochloride & Doxylamine Succinate is intended for use in pregnant women.

Interaction:
The use of Pyridox is contraindicated in women who are taking monoamine oxidase inhibitors (MAOIs), which prolong and intensify the adverse central nervous system effects (the anticholinergic effects) of antihistamines. Concurrent use of alcohol and other CNS depressants (such as hypnotic sedatives and tranquilizers) with Pyridox is not recommended.

Overdose:
Doxylamine Succinate & Pyridoxine Hydrochloride is an extended-release or Delayed Release formulation; therefore, signs and symptoms of intoxication may not be apparent immediately. Signs and symptoms of overdose may include restlessness, dryness of mouth, dilated pupils, sleepiness, vertigo, mental confusion, and tachycardia. At toxic doses, Doxylamine Succinate exhibits anticholinergic effects, including seizures, rhabdomyolysis, acute renal failure, and death. If treatment is needed, it consists of gastric lavage or activated charcoal, whole bowel irrigation, and symptomatic treatment.

Storage:
Store in a cool and dry place away from light.
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