METRONIDAZOLE injection, solution

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Sun Pharmaceutical Industries, Inc.

Njia ya uendeshaji:

INTRAVENOUS

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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 Bacteroides fragilis infections resistant to clindamycin, chloramphenicol, and penicillin. Intra-Abdominal Infections , including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus) , Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species. Skin and Skin Structure Infections  caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. Gynec ologic Infections , including endometritis, endomyometritis, tubo-ovarian abscess, and post-surgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, and Peptostreptococcus species. Bacterial Septicemia caused by Bacteroides species including the B. fragilis group and Clostridium species. Bone and Joint Infections , as adjunctive therapy, caused by Bacteroides species including the B. fragilis group. Central Nervous System (CNS) Infections , including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group.  Lower Respiratory Tract Infections , including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group.  Endocarditis caused by Bacteroides species including the B. fragilis group. PROPHYLAXIS The prophylactic administration of Metronidazole Injection preoperatively, intraoperatively, and postoperatively may reduce the incidence of postoperative infection in patients undergoing elective colorectal surgery which is classified as contaminated or potentially contaminated. Prophylactic use of Metronidazole Injection should be discontinued within 12 hours after surgery. If there are signs of infection, specimens for cultures should be obtained for the identification of the causative organism(s) so that appropriate therapy may be given (see DOSAGE AND ADMINISTRATION ). To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole and other antibacterial drugs, metronidazole 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 antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Metronidazole Injection is contraindicated in patients with a prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives. Psychotic Reaction with Disulfiram Use of oral metronidazole is associated with psychotic reactions in alcoholic patients who were using disulfiram concurrently. Do not administer metronidazole to patients who have taken disulfiram within the last two weeks (see PRECAUTIONS-Drug Interactions ). Interaction with Alcohol Use of oral metronidazole is associated with a disulfiram-like reaction to alcohol, including abdominal cramps, nausea, vomiting, headaches, and flushing. Discontinue consumption of alcohol or products containing propylene glycol during and for at least three days after therapy with metronidazole (see PRECAUTIONS-Drug Interactions ). Cockayne Syndrome Metronidazole Injection is contraindicated in patients with Cockayne syndrome. Severe irreversible hepatotoxicity/acute liver failure with fatal outcomes have been reported after initiation of metronidazole in patients with Cockayne syndrome (see ADVERSE REACTIONS ).

Bidhaa muhtasari:

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.

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

METRONIDAZOLE - METRONIDAZOLE INJECTION, SOLUTION
SUN PHARMACEUTICAL INDUSTRIES, INC.
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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•7H2O 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 ):
6
9
3
3
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.
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 or