Pyridoxine Hydrochloride + Doxylamine Succinate

Indications
This tablet is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. This tablet has not been studied in women with hyperemesis gravidarum.

Therapeutic Class
Anti-emetic drugs

Pharmacology
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.

Dosage & Administration
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.

Interaction
This tablet is contraindicated in women who are taking monoamine oxidase inhibitors (MAOIs), which prolong and intensify the anticholinergic (drying) effects of antihistamines. Concurrent use of alcohol and other CNS depressants (such as hypnotic sedatives and tranquilizers) with this tablet is not recommended. A food-effect study demonstrated that the delay in the onset of action of this tablet may be further delayed, and a reduction in absorption may occur when tablets are taken with food. Therefore, this tablet should be taken on an empty stomach with a glass of water.

Contraindications
This tablet is contraindicated in women with any of the following conditions:
known hypersensitivity to doxylamine succinate or any of the ingredients;
have any of the following conditions: risk of asthmatic attack, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, bladder-neck obstruction;
taking monoamine oxidase inhibitors (MAOIs) [e.g., certain antidepressants, linezolid (an antibiotic), methylene blue (a diagnostic dye)], CNS depressants with alcohol.

Side Effects
Side effects associated with this tablet are: somnolence, dizziness, nervousness, stomach pain, headache, diarrhea, irritability, or insomnia. If anyone experience an allergic reaction (including skin rash, hives, swelling, trouble breathing) or any severe or unusual side effects, should seek immediate emergency medical assistance.

Pregnancy & Lactation
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.

Precautions & Warnings
This tablet 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, while using this tablet until cleared to do so by their healthcare provider. This tablet use is not recommended if a woman is concurrently using central nervous system (CNS) depressants including alcohol. The combination may result in severe drowsiness leading to falls or accidents.

Use in Special Populations
Pediatric Use: The safety and effectiveness of this tablet in children under 18 years of age have not been established.

Overdose Effects
This is a 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 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.
If one forget to take a dose of this tablet, should take it as soon as possible. However, if it is almost time for the next dose, must skip the missed dose and continue with the regular dosing schedule. It should not try to make up for a missed dose by taking a double dose.

Storage Conditions
Keep in a cool & dry place. Protect from light. Keep out of the reach of children.