Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
Doxylamine Succinate; Pyridoxine Hydrochloride
UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
R06AA59
TABLET, DELAYED RELEASE
Doxylamine Succinate 10mg; Pyridoxine Hydrochloride 10mg
ORAL
Prescription Only
Duchesnay Inc.
ACTIVE
2017-07-20
HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DICLECTIN SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DICLECTIN. DICLECTIN (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE, 10MG/10MG) DELAYED-RELEASE TABLETS, FOR ORAL USE. --------------------------- RECENT MAJOR CHANGES ------------------------- Warnings and Precautions, Interference with Urine Screen for Methadone, Opiates and Phencyclidine Phosphate (PCP) (5.3) 07/2018 ---------------------------- INDICATIONS AND USAGE -------------------------- DICLECTIN 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 of pregnancy in women who do not respond to conservative management. (1) ----------------------- 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. (2) ---------------------- DOSAGE FORMS AND STRENGTHS ------------------- Delayed-release tablets containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. (3) ------------------------------- CONTRAINDICATIONS ----------------------------- • Known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any inactive ingredient in the formulation (4) • Monoamine oxidase (MAO) inhibitors (4, 7) ------------------------ WARNINGS AND PRECAUTIONS --------------------- • Activities requiring mental alertness: Avoid engaging in activities requiring complete mental alertness, such as driving or operating heavy machinery, while using DICLECTIN until cleared to do so by a healthcare provider (5.1) • Central nervous system (CNS) depressants: Concurrent use with alcohol or other C Read the complete document