CIMETIDINE TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

CIMETIDINE

Tersedia dari:

AA PHARMA INC

Kode ATC:

A02BA01

INN (Nama Internasional):

CIMETIDINE

Dosis:

600MG

Bentuk farmasi:

TABLET

Komposisi:

CIMETIDINE 600MG

Rute administrasi :

ORAL

Unit dalam paket:

100/500

Jenis Resep:

Prescription

Area terapi:

HISTAMINE H2-ANTAGONISTS

Ringkasan produk:

Active ingredient group (AIG) number: 0111925004; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2019-01-22

Karakteristik produk

_CIMETIDINE (Cimetidine) _
_ _
_Page 1 of 28_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR CIMETIDINE
Cimetidine
Tablet, 200, 300, 400, 600 and 800 mg, oral
USP
ATC Code: A02BA01
Histamine H
2
- Antagonist
AA PHARMA INC
Vaughan, Ontario
L4K 4N7
www.aapharma.ca
Date of Initial Authorization:
DEC 31, 1982
Date of Revision:
FEB 10, 2022
Submission Control Number: 256184
_CIMETIDINE (Cimetidine) _
_Page 2 of 28_
RECENT MAJOR LABEL CHANGES
1 Indications, 1.2 Geriatrics
02/2022
4 Dosage and Administration, 4.2 Recommended Dose and
Dosage Adjustment
02/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
TABLE OF CONTENTS
................................................................................................................2
1
INDICATIONS
................................................................................................................4
1.1
Pediatrics
............................................................................................................4
1.2
Geriatrics.............................................................................................................4
2
CONTRAINDICATIONS
...................................................................................................4
4
DOSAGE AND
ADMINISTRATION...................................................................................4
4.1
Dosing considerations
..........................................................................................4
4.2
Recommended Dose and Dosage
Adjustment.......................................................5
4.5
Missed Dose
........................................................................................................6
5
OVERDOSAGE
...............................................................................................................6
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
...................................7
7
WARNINGS AND PRECAUTIONS
......................................