Side Effects:
Side effects have seldom reported in patients treated with intravenous Metronidazole. Further studies are needed to determine the frequency and nature of adverse effects likely to be encountered with higher dosage and greater duration of Metronidazole treatment. Adverse effects which occur commonly with dosages of Metronidazole used to treat trichomonas and amoebiasis, have included anorexia, nausea, abdominal pain, vomiting, vertigo, tirednesss, and dark coloration of the urine. Less commonly reported side effects have include ataxia, headache, transient and reversible neutropenia, metallic taste, vaginal and urethral burning, gastric irritation, diarrhea, furred tongue. Peripheral neuropathy has also occurred in the patient treated with IV Metronidazole for anaerobic infection.
Drug Interactions:
Clinically significant interaction between Metronidazole and warfarin reported. Metronidazole has been found to increase prothrombin time. It is preferable to discontinue oral anticoagulants 24 hours prior to administration of Metronidazole IV.
Simultaneous administration of Metronidazole and disulfiram has been reported to cause acute psychosis and confusional state.
It is advisable to avoid mixing IV infusions of different drugs. In keeping with this rule, Metronidazole IV should not be mixed with any other drug. Add mixture 10% Dextrose, Penicillin G Potassium and Ringers Lactate Solution to Metronidazole infusion is contraindicated because of chemical incompatibility.
Directions for Use:
The over wrap is moisture barrier. The inner container maintains the sterility of the product.
After removing the over wrap, check for minute leaks by squeezing the container. Do not use if leaks are found.
Bring the injection bottle to room temperature just before used.
Clean the spout of injection bottle with surgical spirit.
Keep the bottle on a table or on a hand surface and insert the cannula at the sterile infusion set into the spout of the injection bottle (Please note that the cannula of the infusion set should be inserted fully and not half way into the spout of the Metronidazole IV bottle to avoid leakage)
For administration hang the bottle upside down.
Inject intravenously slowly at a rate of about 5mL/ minute.
To admit air, insert a sterile injection cannula on the top of the inverted bottle anywhere above the level of the liquid.
Warning:
Even invisible damage to bottle caused during storage or transit, may result in contamination. Do not use if leak found on squeezing, or contents not clear.
Indications:
Metronidazole IV is an isotonic formulation, composed of superior grade of injectable Metronidazole for intravenous administration in susceptible life threatening infections. It is particularly suited for patients who cannot retain oral medication and in patients in whom desired serum concentrations have to be attained, rapidly and reliably. Metronidazole IV is thus indicated for:
Treatment of infections cased by Bacteroides fragilis, other species of Bacteroides, Fusobacteria spp. Eubacteria spp. and other anaerobic cocci such as: (a) intra abdominal infections appendicitis, cholecystitis, peritonitis, liver abscess and post operative wound infection; (b) gynecological and obstetrical infections-purperal sepsis, pelvic cellulitis pelvic peritonitis; (c) respiratory infections-necrotising pneumonia, empyema, lung abscess; (d) miscellaneous infections-septicemia, gas gangrene, ostemylitis.
Prevention of post operative infections due to anaerobic bacteria.
Treatment of amoebic abscess of the liver and in moribund or toxic cases of fuminating intestinal amoebiasis.
Dosage and Administration:
Adult and children over 12 years of age:
500mg (100mL) infused at a rate of 5mL/minute repeated every 8 hours
Children below 12 years of age:
Depending upon clinical and bacteriological assessment, the physician may decide the duration of treatment, depending on the weight of the child. The volume of the fluid to be infused should be determined on the basis of 7.5mg/kg. The rate of infusion is at 5mL/min repeated every 8 hours. Oral medication should be substituted as soon as this becomes feasible. Initial dose of 800mg followed by 400mg every 8 hours.
Storage:
Store at a temperature not exceeding 25 degrees celcius.
Protect from light.
Availability: 100mL glass container
Caution: foods, drugs, devices and cosmetics act prohibits dispensing without prescription.
Manufactured by: Mount Mettur Pharmaceutials Ltd. C-2 Sipcot Industrial Estate, Gummidipoondi – 600 201, India.