Product Name: Metronidazole Injection,Metronidazole Infusion
Product Description :A clear, colourless or almost colourless liquid.
Strength: (1)250ml: 1.25g,(2)250ml: 0.5g,(3)100ml: 0.5g
INN or Generic Name: Metronidazole Injection
Pharmaceutical Dosage Form: injection
Packing:butyl rubber stopper and aluminium cap,polypropylene bottle
(1)500ml: 30PCS/CTN,713 CTNS/20'FT,1532CTNS /40'FT,1796CTNS /40'HQ
(2)250ml: 30PCS/CTN,1082 CTNS/20'FT,2324 CTNS /40'FT,2725 CTNS /40'HQ
(3)100ml: 80PCS/CTN,726 CTNS/20'FT,1559 CTNS/40'FT,1828 CTNS/40'HQ
Port: Any port (depends on requests) Certificate:GMP
Exporting Region: Areas which GMP is applicable
Requested indication :
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Metronidazole Injection USP and other antibacterial drugs, Metronidazole Injection USP 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.
Recommended posology :
In elderly patients the pharmacokinetics of metronidazole may be altered and therefore monitoring of serum levels may be necessary to adjust the metronidazole dosage accordingly.
Treatment Of Anaerobic Infections
The recommended dosage schedule for adults is:
15 mg/kg infused over one hour (approximately 1 g for a 70-kg adult).
7.5 mg/kg infused over one hour every six hours (approximately 500 mg for a 70-kg adult). The first maintenance dose should be instituted six hours following the initiation of the loading dose.
Parenteral therapy may be changed to oral metronidazole when conditions warrant, based upon the severity of the disease and the response of the patient to Metronidazole Injection USP treatment. The usual adult oral dosage is 7.5 mg/kg every six hours.
A maximum of 4 g should not be exceeded during a 24-hour period.
Patients with severe hepatic disease metabolize metronidazole slowly, with resultant accumulation of metronidazole and its metabolites in the plasma. Accordingly, for such patients, doses below those usually recommended should be administered cautiously. Close monitoring of plasma metronidazole levels2 and toxicity is recommended.
In patients receiving metronidazole injection in whom gastric secretions are continuously removed by nasogastric aspiration, sufficient metronidazole may be removed in the aspirate to cause a reduction in serum levels.
The dose of Metronidazole Injection USP should not be specifically reduced in anuric patients since accumulated metabolites may be rapidly removed by dialysis.
The usual duration of therapy is 7 to 10 days; however, infections of the bone and joint, lower respiratory tract, and endocardium may require longer treatment.
For surgical prophylactic use, to prevent postoperative infection in contaminated or potentially contaminated colorectal surgery, the recommended dosage schedule for adults is:
- 15 mg/kg infused over 30 to 60 minutes and completed approximately one hour before surgery, followed by:
- 7.5 mg/kg infused over 30 to 60 minutes at 6 and 12 hours after the initial dose.
It is important that (1) administration of the initial preoperative dose be completed approximately one hour before surgery so that adequate drug levels are present in the serum and tissues at the time of initial incision, and (2) Metronidazole Injection USP be administered, if necessary, at 6-hour intervals to maintain effective drug levels. Prophylactic use of Metronidazole Injection USP should be limited to the day of surgery only, following the above guidelines.
Recommended route of administration :
Metronidazole Injection USP is to be administered by slow intravenous drip infusion only, either as a continuous or intermittent infusion. IV admixtures containing metronidazole and other drugs should be avoided. Additives should not be introduced into the Metronidazole Injection USP solution. If used with a primary intravenous fluid system, the primary solution should be discontinued during metronidazole infusion. DO NOT USE EQUIPMENT CONTAINING ALUMINUM (E.G., NEEDLES, CANNULAE, ETC.) THAT MAY CONTACT THE DRUG SOLUTION.
Metronidazole Injection USP is a ready-to-use isotonic solution. NO DILUTION OR BUFFERING IS REQUIRED.
Do not refrigerate. Each container of Metronidazole Injection USP contains 13.5 mEq of sodium.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if cloudy or precipitated or if the seals are not intact.
Use sterile equipment. It is recommended that the intravenous administration apparatus be replaced at least once every 24 hours.
Store at 20° to 25°CDispense in a tight, light resistant container with a child resistant closure