Indications, posology and method of administration
THERAPEUTIC INDICATIONS
Pregnause is indicated for the treatment of nausea and vomiting of pregnancy in pregnant women who do not respond to conservative management.
The safety and efficacy have not been established in children under 18 years of age.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
The recommended starting dose is two tablets at bedtime. If this dose adequately controls symptoms the next day, the patient can continue taking two tablets at bedtime. However, if symptoms persist into the afternoon of day 2, the patient should continue the usual dose of two tablets at bedtime (day 2) and on day 3 take three tablets (one tablet in the morning and two tablets at bedtime). If 3 tablets control the symptoms well, continue with a dose of 3 tablets on the day 4. If not, the patient can take four tablets starting on day 4 (one tablet in the morning, one tablet mid-afternoon and two tablets at bedtime).
The maximum recommended daily dose is four tablets.
Method of administration:
Pregnause should be administered on an empty stomach with a glass of water. Enteric-coated tablet should be swallowed whole and should not be crushed, split or chewed.
CONTRAINDICATIONS
- Hypersensitivity to doxylamine succinate, other ethanolamine-derivative antihistamines, pyridoxine hydrochloride or any of the excipients.
- Concomitant use with monoamine oxidase inhibitors (MAOIs), as they may enhance and prolong the central nervous system effects of Pregnause.
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