AMPICILLIN FOR INJECTION, USP POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

AMPICILLIN (AMPICILLIN SODIUM)

Available from:

FRESENIUS KABI CANADA LTD

ATC code:

J01CA01

INN (International Name):

AMPICILLIN

Dosage:

500MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

AMPICILLIN (AMPICILLIN SODIUM) 500MG

Administration route:

INTRAMUSCULAR

Units in package:

10 ML

Prescription type:

Prescription

Therapeutic area:

AMINOPENICILLINS

Product summary:

Active ingredient group (AIG) number: 0105872001; AHFS:

Authorization status:

APPROVED

Authorization date:

1998-01-06

Summary of Product characteristics

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Ampicillin for Injection, USP_ _– Prescribing Information
Page 1 of 10
PRESCRIBING INFORMATION
INCLUDING PATIENT MEDICATION INFORMATION
PR
AMPICILLIN FOR INJECTION, USP
Powder for solution
250 mg, 500 mg, 1 g and 2 g per vial
For Intramuscular or Intravenous Use
STERILE
ANTIBIOTIC
FRESENIUS KABI CANADA LTD.
Date of Preparation:
165 Galaxy Blvd, Suite 100 August 16, 2019
Toronto, ON M9W 0C8
CONTROL NUMBER: 223388
_____________________________________________________________________________________________
Ampicillin for Injection, USP_ _– Prescribing Information
Page 2 of 10
PRESCRIBING INFORMATION
PR
AMPICILLIN FOR INJECTION, USP
Powder for solution
Sterile
PHARMACOLOGICAL CLASSIFICATION
Antibiotic
ACTIONS AND CLINICAL PHARMACOLOGY
Ampicillin
has a broad spectrum of bactericidal activity against many
gram-positive
and gram-
negative aerobic and anaerobic bacteria. It acts through the
inhibition
of cell wall mucopeptide
biosynthesis during the stage of active multiplication.
INDICATIONS AND CLINICAL USE
The treatment of infections
due to susceptible
gram-negative
organisms
(including
strains of
_Shigellae_, _ S. typhosa_ and other
_salmonellae, E. coli_, _ H. influenzae_, and _ P. mirabilis_) and
susceptible
gram-positive
organisms
[including
streptococci,
pneumococci,
and
non-beta-
lactamase (penicillinase) producing staphylococci].
To reduce the development of drug
‐
resistant bacteria and maintain the effectiveness of Ampicillin
for Injection,
USP and other antibacterial
drugs, Ampicillin
for Injection,
USP should
be used
only to treat infections that are proven or strongly suspected to be
caused by susceptible bacteria.
When culture and susceptibility
information
are available, they should be considered in selecting
or
modifying
antibacterial
therapy.
In
the
absence of
such
data,
local
epidemiology
and
susceptibility
patterns may contribute to the empiric selection of therapy.
CONTRAINDICATIONS
A history of alle