This is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.
Anti-emetic drugs
Doxylamine is an antihistamine that blocks Histamine (H1) receptor. It affects the vestibular system and decreases the stimulation of the vomiting center. Its mascarinic 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.
Day 1: Take 2 tablets, by mouth at bedtime.
Day 2: Take 2 tablets at bedtime. If your nausea and vomiting is better or controlled on Day 2, continue to take 2 tablets every night at bedtime. This will be your usual dose unless your healthcare provider tells you otherwise.
Day 3: If you still had nausea and vomiting on Day 2, take 3 tablets on Day 3 (1 tablet in the morning and 2 tablets at bedtime).
Day 4: If your nausea and vomiting was better or controlled on Day 3, continue to take 3 tablets each day (1 tablet in the morning and 2 tablets at bedtime). If you still had nausea and vomiting on day 3, start taking 4 tablets each day (1 tablet in the morning, 1 tablet in the afternoon and 2 tablets at bedtime).
Do not take more than 4 tablets (1 in the morning, 1 in the mid-afternoon, and 2 at bedtime) in 1 day. This drug should be taken on an empty stomach.
Use of Doxylamine Succinate & Pyridoxine Hydrochloride 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 Doxylamine Succinate & Pyridoxine Hydrochloride is not recommended.
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
Somnolence or other accidents resulting from the effect of the combined use of Doxylamine Succinate & Pyridoxine Hydrochloride with CNS depressants.
Pregnancy category A. This tablet is intended for use in pregnant women. This may pass into breast milk and unusual excitement, irritability or sedation (sleepiness) may occur in the infant. Women should not breastfeed while using this tablet.
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.
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.
Store at below 30°C in a dry place protected from light. Keep out of reach of children.
Anti-emetic drugs
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.
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.
