- Approval Id
- ac05e34c00568675
- Drug Name
- BONJESTA EXTENDED-RELEASE TABLETS 20 MG/20 MG
- Product Name
- BONJESTA EXTENDED-RELEASE TABLETS 20 MG/20 MG
- Approval Number
- SIN16865P
- Approval Date
- 2023-09-18
- Registrant
- UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
- Licence Holder
- UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED, EXTENDED RELEASE
- Dosage
- **2\. DOSAGE AND ADMINISTRATION**
**2.1 Dosage Information**
Initially, take one BONJESTA extended-release tablet orally at bedtime (Day 1). If this dose adequately controls symptoms the next day, continue taking one tablet daily at bedtime only. However, if symptoms persist on Day 2, increase the daily dose to one tablet in the morning and one tablet at bedtime. The maximum recommended dose is two tablets per day, one in the morning and one at bedtime.
Take on an empty stomach with a glass of water _\[see Clinical Pharmacology (11.2)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_. Swallow tablets whole. Do not crush, chew, or split BONJESTA tablets.
Take daily and not on an as needed basis. Reassess the woman for continued need for BONJESTA as her pregnancy progresses.
- Route Of Administration
- ORAL
- Indication Info
- **1\. INDICATIONS AND USAGE**
BONJESTA is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.
**Limitations of Use**
BONJESTA has not been studied in women with hyperemesis gravidarum.
- Contraindications
- **4\. CONTRAINDICATIONS**
BONJESTA is contraindicated in women with any of the following conditions:
- Known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any inactive ingredient in the formulation
- Monoamine oxidase (MAO) inhibitors intensify and prolong the adverse central nervous system effects of BONJESTA _\[see Drug Interactions (7.1)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_.
- Atc Code
- R06AA59
- Atc Item Name
- doxylamine, combinations
- Pharma Manufacturer Name
- UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
- Company Detail Path
- /organization/8d42910f3e682a33/united-italian-trading-corporation-private-limited
