Novea® Tablet 10 mg: Each delayed-release tablet contains Doxylamine Succinate USP 10 mg and Pyridoxine Hydrochloride BP 10 mg.
Novea® Tablet 20 mg: Each extended-release tablet contains Doxylamine Succinate USP 20 mg and Pyridoxine Hydrochloride BP 20 mg.
Nausea and Vomiting in Pregnancy.
Novea® Tablet 10 mg:
Day 1: Take 2 tablets at bedtime.
Day 2: Take 2 tablets at bedtime. If nausea and vomiting improve or are controlled on Day 2, continue to take 2 tablets every night at bedtime. This will be the usual dose unless advised otherwise by a healthcare provider.
Day 3: If nausea and vomiting persist on Day 2, take 3 tablets on Day 3 (1 tablet in the morning and 2 tablets at bedtime).
Day 4: If nausea and vomiting improve or are controlled on Day 3, continue to take 3 tablets each day (1 tablet in the morning and 2 tablets at bedtime). If nausea and vomiting persist on Day 3, take 4 tablets each day (1 tablet in the morning, 1 tablet in the afternoon, and 2 tablets at bedtime). Do not exceed 4 tablets in one day.
Novea® Tablet 20 mg:
Take one tablet daily at night. If this dose adequately controls symptoms, continue taking one tablet daily at night from Day 2 onward.
If symptoms persist on Day 2, take two tablets starting on Day 3 (one tablet in the morning and one at night).
The maximum recommended dose is two tablets per day, one in the morning and one at night.
Take on an empty stomach with a glass of water. Swallow tablets whole. Do not crush, chew, or split the tablet. Take daily, not on an as-needed basis.
Use in pregnancy: Both Doxylamine and Pyridoxine are pregnancy category A drugs. Therefore, Novea® can be safely given to pregnant women.
Use in nursing mothers: Both Doxylamine and Pyridoxine are excreted into breast milk. Caution should be exercised during breastfeeding.
Novea® is contraindicated in women with:
Known hypersensitivity to Doxylamine Succinate, other ethanolamine derivative antihistamines, Pyridoxine Hydrochloride, Monoamine Oxidase Inhibitors (MAOIs), or any inactive ingredient in the formulation.
Doxylamine Succinate and Pyridoxine Hydrochloride may cause somnolence due to the anticholinergic properties of Doxylamine Succinate. Women should avoid activities requiring complete mental alertness, such as driving or operating heavy machinery.
Use is not recommended if the patient is concurrently using Central Nervous System (CNS) depressants, including alcohol.
The most common side effect is somnolence.
Women taking Novea® should avoid Monoamine Oxidase Inhibitors (MAOIs).
Concurrent use of alcohol and other CNS depressants with Novea® is not recommended.
Store at a temperature not exceeding 25°C in a dry place.
Protect from light and moisture.
Medicine: Keep out of reach of children.
