AZITHROMYCIN TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE)

から入手可能:

SANIS HEALTH INC

ATCコード:

J01FA10

INN（国際名）:

AZITHROMYCIN

投薬量:

600MG

医薬品形態:

TABLET

構図:

AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) 600MG

投与経路:

ORAL

パッケージ内のユニット:

6/30/100

処方タイプ:

Prescription

治療領域:

OTHER MACROLIDES

製品概要:

Active ingredient group (AIG) number: 0126072005; AHFS:

認証ステータス:

CANCELLED POST MARKET

承認日:

2014-08-01

製品の特徴

_ _
_Page 1 of 66 _
PRODUCT MONOGRAPH
Pr
_AZITHROMYCIN_
Azithromycin Monohydrate
Tablets 250 mg and 600 mg
Antibiotic
Sanis Health Inc.
333 Champlain Street, Suite 102
Dieppe, NB E1A 1P2
Date of Revision:
August 19, 2014
Control No: 176512
_ _
_Page 2 of 66 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
3
SUMMARY PRODUCT INFORMATION
3
INDICATIONS AND CLINICAL USE
3
CONTRAINDICATIONS
5
WARNINGS AND PRECAUTIONS
5
ADVERSE REACTIONS
7
DRUG INTERACTIONS
14
DOSAGE AND ADMINISTRATION
18
OVERDOSAGE
19
ACTION AND CLINICAL PHARMACOLOGY
20
STORAGE AND STABILITY
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
22
PART II: SCIENTIFIC INFORMATION
23
PHARMACEUTICAL INFORMATION
23
CLINICAL TRIALS
24
DETAILED PHARMACOLOGY
28
MICROBIOLOGY
32
TOXICOLOGY
42
REFERENCES
59
PART III: CONSUMER INFORMATION
64
_ _
_Page 3 of 66 _
_AZITHROMYCIN_
Azithromycin Monohydrate
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
ROUTE OF
ADMINISTRATION
DOSAGE FORM /
STRENGTH
ALL NONMEDICINAL INGREDIENTS
Oral
tablet /
250 mg, 600 mg
dibasic
calcium
phosphate
anhydrous,
pregelatinized
starch,
sodium
croscarmellose,
sodium
lauryl
sulphate,
magnesium stearate, Titanium dioxide, Talc,
Lecithin (Soya), Polyvinyl alcohol (Partially
Hydrolyzed) and Xanthum gum.
The 250 mg tablets also contain: Ponceau
4R
Aluminum
Lake,
Carmoisine
(Azorubine) Aluminum Lake, and Quinoline
Yellow Lake.
INDICATIONS AND CLINICAL USE
_AZITHROMYCIN_ (Azithromycin Monohydrate) is indicated for treatment
of mild to moderate
infections caused by susceptible strains of the designated
microorganisms in the following
diseases and specific conditions. As recommended dosages, durations of
therapy and applicable
patient populations vary among these infections, see DOSAGE AND
ADMINISTRATION for
specific dosing recommendations.
Because some strains are resistant to azithromycin, when applicable,
appropriate culture and
susceptibility tests should be initiated before treatment to determine
the causative organism and
its susceptibility to azithromycin. Therapy with _AZ