Vertina-DX

Indications

This medication is prescribed to alleviate nausea and vomiting during pregnancy for women who have not found relief through traditional management methods.

Pharmacology

Doxylamine Succinate functions as an antihistamine by obstructing the Histamine (H1) receptor. It traverses the blood-brain barrier and demonstrates a strong affinity for H1 receptors within the brain, effectively blocking their activation. Additionally, it reduces histamine activity at the H1 receptor by inhibiting both the vestibular system and Muscarinic receptor. By modulating the vestibular system, it decreases stimulation to the vomiting center. Its inhibition of the Muscarinic receptor may contribute to its antiemetic effects as well. Pyridoxine Hydrochloride, a vitamin B6 analog, complements this action by preventing nausea and vomiting through its antiemetic properties.

Dosage & Administration:

Begin by orally taking one tablet at bedtime on Day 1. If this effectively manages symptoms the following day, maintain a daily intake of one tablet at bedtime. However, if symptoms persist on Day 2, escalate the daily dosage to one tablet in the morning and one tablet at bedtime. The maximum recommended dosage is two tablets per day, to be taken once in the morning and once at bedtime. Administer on an empty stomach with a glass of water, swallowing the tablets whole. It is important not to crush, chew, or split the tablets. Ensure daily consumption rather than on an as-needed basis.

Interaction:

The utilization of Doxylamine Succinate & Pyridoxine Hydrochloride is not advised for women taking monoamine oxidase inhibitors (MAOIs), as they can extend and amplify the adverse central nervous system effects, including anticholinergic effects, of antihistamines. Simultaneous consumption of alcohol and other central nervous system depressants (such as hypnotic sedatives and tranquilizers) alongside Doxylamine Succinate & Pyridoxine Hydrochloride is also not recommended.

Contraindications:

Doxylamine Succinate & Pyridoxine Hydrochloride should not be administered to 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, as they can heighten and prolong the adverse central nervous system effects of Doxylamine Succinate & Pyridoxine Hydrochloride.

Side Effects:

Potential side effects of Doxylamine Succinate & Pyridoxine Hydrochloride include somnolence or other accidents that may occur due to the combined use of the medication with central nervous system depressants.

Pregnancy & Lactation:

This medication falls under pregnancy category A and is specifically designed for managing nausea and vomiting during pregnancy in women who do not respond to conventional treatments. Both Doxylamine Succinate & Pyridoxine Hydrochloride are excreted into breast milk, hence caution should be exercised while breastfeeding.

Precautions & Warnings:

Due to the anticholinergic properties of Doxylamine Succinate, somnolence may occur, thereby impairing activities such as driving or operating heavy machinery. It is advised for women not to engage in such activities while using Doxylamine Succinate & Pyridoxine Hydrochloride. Concurrent use with central nervous system (CNS) depressants, including alcohol, is not recommended.

Given its anticholinergic properties, Doxylamine Succinate & Pyridoxine Hydrochloride should be used cautiously in women with conditions such as asthma, increased intraocular pressure, narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, or urinary bladder-neck obstruction.

Overdose Effects:

As Doxylamine Succinate & Pyridoxine Hydrochloride is an extended-release or Delayed Release formulation, signs and symptoms of intoxication may not manifest immediately. Symptoms of overdose may include restlessness, dry mouth, dilated pupils, sleepiness, vertigo, mental confusion, and tachycardia. In cases of toxic doses, Doxylamine Succinate may induce anticholinergic effects such as seizures, rhabdomyolysis, acute renal failure, and even death. If necessary, treatment may involve gastric lavage or activated charcoal, whole bowel irrigation, and symptomatic management.

Therapeutic Class:

This medication belongs to the class of anti-emetic drugs.

Storage Conditions:

Store below 30°C in a dry place shielded from light. Ensure it is kept out of the reach of children.