Doxylamine + Pyridoxine

Doxylamine + Pyridoxine is a combination of doxylamine succinate (an ethanolamine derivative antihistamine) and pyridoxine hydrochloride (vitamin B6 analog). Doxylamine blocks histamine H1 receptors and affects the vestibular system to reduce stimulation of the vomiting center. Pyridoxine is a vitamin with antiemetic properties. This combination is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. It is Pregnancy Category A and is considered safe during pregnancy. Take on an empty stomach with a glass of water. May cause somnolence; avoid driving or operating machinery. Avoid alcohol and other CNS depressants.

• Nausea and vomiting of pregnancy

Doxylamine Succinate is an antihistamine that blocks Histamine (H1) receptor. It can cross the blood brain barrier and has high affinity for H1 receptors in the brain. It affects the vestibular system and decreases stimulation of the vomiting center. Pyridoxine Hydrochloride is a vitamin B6 analog with antiemetic properties.

Doxylamine is an antihistamine that blocks Histamine (H1) receptor. It affects the vestibular system and decreases stimulation of the vomiting center. Pyridoxine (Vitamin B6) is a vitamin used to prevent nausea and vomiting due to its antiemetic properties.

Adult Dose (Nausea & Vomiting of Pregnancy):

• Delayed-release Tablet: 2 tablets at bedtime on Day 1. If symptoms not controlled, increase to 4 tablets daily (1 in AM, 1 mid-afternoon, 2 at bedtime).
• Conventional Tablet: 1 tablet at bedtime on Day 1. If adequately controlled, continue 1 tablet daily at bedtime. If symptoms persist, increase to 1 tablet in morning and 1 at bedtime. Maximum: 2 tablets daily.

Oral tablet. Take in the dose and duration as advised by your doctor. Swallow whole. Do not chew, crush or break. Take on an empty stomach with a glass of water. Take at a fixed time daily. Take daily, not on an as needed basis.

If you miss a dose of Doxylamine + Pyridoxine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular schedule.

Common Side Effects:

• Dryness in mouth
• Constipation
• Lightheadedness
• Drowsiness

• Doxylamine + Pyridoxine helps treat nausea and vomiting in pregnant women.
• Take on an empty stomach with a glass of water.
• May cause dizziness; do not drive or do anything requiring concentration.
• Do not take with other sedating medications (cough and cold medicines) as it may worsen dizziness and lead to falls.
• Contraindicated with MAO inhibitors (intensify anticholinergic and CNS effects).
• Use with caution in asthma, increased intraocular pressure, narrow angle glaucoma, peptic ulcer, pyloroduodenal or bladder obstruction.

• Hypersensitivity
• MAO inhibitors (intensify and prolong adverse anticholinergic and CNS effects)

MAO inhibitors intensify and prolong the adverse CNS effects (anticholinergic effects) of doxylamine. Concurrent use of alcohol and other CNS depressants (e.g., hypnotic sedatives and tranquilizers) is not recommended.

Caution is advised when consuming alcohol with Doxylamine + Pyridoxine. Please consult your doctor.

Pregnancy Category A. Safe during pregnancy for nausea and vomiting. Most studies have shown low or no risk to the developing baby.

Probably safe during breastfeeding. Limited human data suggests no significant risk to the baby. Larger doses or prolonged use may cause sleepiness and other effects in the baby.

Under 18 years: Safety and efficacy not established.

Limited information available regarding dose adjustment for elderly patients.

Renal impairment: Probably safe in kidney disease. Dose adjustment may not be needed.

Hepatic impairment: Probably safe in liver disease. Dose adjustment may not be needed.

Overdose may cause restlessness, dryness of mouth, dilated pupils, sleepiness, vertigo, mental confusion and tachycardia. Toxic doses may cause seizures, rhabdomyolysis, acute renal failure and death. Treatment includes gastric lavage, activated charcoal, whole bowel irrigation and symptomatic treatment.

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

Doxylamine + Pyridoxine