AMPICILLIN SODIUM FOR INJECTION BP POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

AMPICILLIN (AMPICILLIN SODIUM)

Available from:

AURO PHARMA INC

ATC code:

J01CA01

INN (International Name):

AMPICILLIN

Dosage:

250MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

AMPICILLIN (AMPICILLIN SODIUM) 250MG

Administration route:

INTRAMUSCULAR

Units in package:

10ML

Prescription type:

Prescription

Therapeutic area:

AMINOPENICILLINS

Product summary:

Active ingredient group (AIG) number: 0105872002; AHFS:

Authorization status:

APPROVED

Authorization date:

2017-03-09

Summary of Product characteristics

Page 1 of 12
PRESCRIBING INFORMATION
INCLUDING PATIENT MEDICATION INFORMATION
PR
AMPICILLIN SODIUM FOR INJECTION BP
Powder for solution
250 mg, 500 mg, 1 g and 2 g ampicillin (as ampicillin sodium) per vial
For intramuscular or Intravenous Use
STERILE
ANTIBIOTIC
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8
CANADA
Date of Revision:
December 22, 2021
Submission Control No: 254972
Page 2 of 12
PRESCRIBING INFORMATION
PR AMPICILLIN SODIUM FOR INJECTION BP
Powder for solution
Sterile
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 Sodium for Injection BP and other antibacterial drugs,
Ampicillin Sodium for
Injection BP 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 allergic reactions to penicillin or cephalosporins.
WARNINGS
Before therapy, inquiry as to past penicillin or other allergies is
essential as reactions occur more
frequently in hypersensitive persons. During therapy, if allergic or
anaphylactic reactions occur,
discontinue
tre