BONJESTA EXTENDED-RELEASE TABLETS 20 MG20 MG

Land: Singapore

Språk: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv ingrediens:

Doxylamine Succinate; Pyridoxine HCl

Tilgjengelig fra:

UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED

ATC-kode:

R06AA59

Legemiddelform:

TABLET, FILM COATED, EXTENDED RELEASE

Sammensetning:

Doxylamine Succinate 20.0mg; Pyridoxine HCl 20.00mg

Administreringsrute:

ORAL

Resept typen:

Prescription Only

Produsert av:

Duchesnay Inc.

Autorisasjon status:

ACTIVE

Autorisasjon dato:

2023-09-18

Preparatomtale

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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BONJESTA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
BONJESTA.
BONJESTA
(DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE),
EXTENDED-RELEASE TABLETS, FOR ORAL USE. ---------------------------- INDICATIONS AND USAGE
--------------------------
BONJESTA
is a fixed dose combination drug product of 20 mg doxylamine
succinate, an antihistamine, and 20 mg pyridoxine hydrochloride, a
Vitamin
B
6
analog, indicated for the treatment of nausea and vomiting of
pregnancy in
women who do not respond to conservative management. (1) ----------------------- DOSAGE AND ADMINISTRATION
----------------------
On Day 1, take one tablet at bedtime. On Day 2, if symptoms are not
adequately controlled, the dose can be increased to one tablet in the
morning
and one tablet at bedtime. The maximum recommended dose is two tablets
daily, one in the morning and one at bedtime, as described in the full
prescribing information. (2) ---------------------- DOSAGE FORMS AND STRENGTHS -------------------
Extended-release tablets containing 20 mg doxylamine succinate and 20
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
---------------------
•
Somnolence: BONJESTA may cause somnolence. Avoid engaging in
activities requiring complete mental alertness, such as driving or
operating heavy machinery, while using BONJESTA until cleared to do
so by a healthcare provider (5.1)
•
Central nervous system (CNS) depressants: Concurrent use with alcohol
or other CNS depressants is not recommended (5.1)
•
Anticholinergic actions: Use with caution in patients with asthma,
increased intrao