BONJESTA EXTENDED-RELEASE TABLETS 20 MG20 MG

国家: 新加坡

语言: 英文

来源: HSA (Health Sciences Authority)

有效成分:

Doxylamine Succinate; Pyridoxine HCl

可用日期:

UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED

ATC代码:

R06AA59

药物剂型:

TABLET, FILM COATED, EXTENDED RELEASE

组成:

Doxylamine Succinate 20.0mg; Pyridoxine HCl 20.00mg

给药途径:

ORAL

处方类型:

Prescription Only

厂商:

Duchesnay Inc.

授权状态:

ACTIVE

授权日期:

2023-09-18

产品特点

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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