Brand Name: Zetadidox Tablet.
Composition:
Each Zetadedox 10/10 Tablet contains:
Delayed-release tablets containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride.
Therapeutic Indications:
- Is a fixed-dose combination drug product of doxylamine succinate, an antihistamine, and pyridoxine hydrochloride, a Vitamin B6 analog, indicated for the treatment of nausea and vomiting during pregnancy in women who do not respond to conservative management.
Dosage and Administration:
- Take two tablets daily at bedtime. If symptoms are not adequately controlled the dose can be increased to a maximum recommended dose of four tablets daily (one in the morning, one mid-afternoon, and two at bedtime) as described in the full prescribing information.
Contraindications:
- Known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride, or any inactive ingredient in the formulation
- Monoamine oxidase (MAO) inhibitors
Warnings and precautions
- Activities requiring mental alertness: Avoid engaging in activities requiring complete mental alertness, such as driving or operating heavy machinery, while using Zetadidox until cleared to do so by a healthcare Provider.
- Central nervous system (CNS) depressants: Concurrent use with alcohol or other CNS depressants is not recommended
- Anticholinergic actions: Use with caution in patients with asthma, increased intraocular pressure, narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, and urinary bladder-neck obstruction.
Undesirable Effects:
- The most common adverse reaction with zetadidox (≥5 percent and exceeding the rate in placebo) is somnolence.
Pharmacological Properties:
Zetadedox contains Doxylamine is an antihistamine that is thought to work by affecting certain natural substances (acetylcholine, serotonin) in your body or by acting directly on certain parts of the brain. Pyridoxine is a B vitamin that is important for good health. Most people get enough pyridoxine in their diet, but certain health conditions (such as pregnancy, poor diet, and alcoholism) can result in a lack of this vitamin.
Packaging:
Zetadedox 10/10 Tablet contains: Box containing 3 blisters of 10 tablets each.
