METRONIDAZOLE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

METRONIDAZOLE (UNII: 140QMO216E) (METRONIDAZOLE - UNII:140QMO216E)

Available from:

Gland Pharma Limited

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Metronidazole Injection and other antibacterial drugs, Metronidazole Injection should be used only to treat or prevent 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. TREATMENT OF ANAEROBIC INFECTIONS Metronidazole Injection is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with Metronidazole Injection therapy. In a mixed aerobic and anaerobic infection, antibiotics appropriate for the treatment of the aerobic infection should be used in addition to Metronidazole Injection. Metronidazole Injection is effective in Bac

Product summary:

Metronidazole Injection USP, sterile, is clear almost colorless solution and is supplied in 100 mL fill bags, each containing an isotonic, buffered solution of 500 mg metronidazole USP; packaged 24 per case. Metronidazole injection USP is sterile premixed solution intended for single use only. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]; however, brief exposure up to 40°C does not adversely affect the product. Protect from light until use.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METRONIDAZOLE - METRONIDAZOLE INJECTION, SOLUTION
GLAND PHARMA LIMITED
----------
METRONIDAZOLE INJECTION USP
500 MG/100 ML (5 MG/ML)
STERILE
RX ONLY
FOR INTRAVENOUS INFUSION ONLY.
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
Metronidazole Injection and other antibacterial drugs, Metronidazole
Injection should be
used only to treat or prevent infections that are proven or strongly
suspected to be
caused by bacteria.
WARNING
Metronidazole has been shown to be carcinogenic in mice and rats (see
PRECAUTIONS). Its use, therefore, should be reserved for the
conditions
described in the INDICATIONS AND USAGE section below.
DESCRIPTION
Metronidazole Injection USP is a sterile, parenteral dosage form of
metronidazole in
water.
Each 100 mL of Metronidazole Injection USP contains a sterile,
nonpyrogenic, isotonic,
buffered solution of Metronidazole USP 500 mg, Sodium Chloride USP 740
mg, Dibasic
Sodium Phosphate•7H O USP 112 mg, and Citric Acid Anhydrous USP 40
mg in Water
for Injection USP. Metronidazole Injection USP has a calculated
osmolarity of 297
mOsmol/liter and a pH of 5.8 (4.5–7.0). Sodium content: 13.5
mEq/container.
Metronidazole USP is classified as a nitroimidazole antimicrobial and
is administered by
the intravenous route.
Metronidazole USP is chemically designated
2-methyl-5-nitroimidazole-1-ethanol
(C H N O ):
Not made with natural rubber latex, PVC, or DEHP.
The plastic container is polypropylene formulated and developed for
parenteral drugs.
The copolymer contains no plasticizers. The safety of the plastic
container has been
confirmed by biological evaluation procedures.
2
6
9
3
3
The material passes Class VI testing as specified in the U.S.
Pharmacopeia for Biological
Tests – Plastic Containers. The container/solution unit is a closed
system and is not
dependent upon entry of external air during administration.
CLINICAL PHARMACOLOGY
Metronidazole is a synthetic antibacterial compound. Disposition of
metronidazole in the
body is similar for both oral and int