|Flancogyl 250 Coated tablets: each tablet contains 250 mg Metronidazole.
Trichomonas vaginalis, Entamoeba histolytica
Metronidazole possesses direct trichomonacidal and amebacidal activity against T. vaginalis and E. histolytica.
Metronidazole is active in vitro against most obligate anaerobes. Against susceptible organisms, metronidazole is generally bactericidal at concentrations equal to or slightly higher than the minimum inhibitory concentrations. Metronidazole has been shown to have in vitro and clinical activity against the following organisms:
· Anaerobic gram-negative bacilli, including:
Bacteroides species including the Bacteroides fragilis group (B. fragilis, B.distasonis,
B. ovatus, B. thetaiotaomicron, B. vulgatus).
· Fusobacterium species.
· Anaerobic gram-positive bacilli, including:
Clostridium species and susceptible strains of Eubacterium.
· Anaerobic gram-positive cocci, including:
|· Symptomatic Trichomoniasis
Metronidazole is indicated for the treatment of symptomatic trichomoniasis in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures).
· Asymptomatic Trichomoniasis
Metronidazole is indicated in the treatment of asymptomatic females when the organism is associated with endocervicitis, cervicitis, or cervical erosion.
· Treatment of Asymptomatic Consorts
T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner.
Metronidazole is indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess.
· Anaerobic Bacterial Infections
Metronidazole is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with Metronidazole therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole.
· 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 niger, and Peptostreptococcus species.
· SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B. fragilis group,
· GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical caused by Bacteroides species including the B. fragilis group.
· 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, emphysema, and lung abscess, caused by Bacteroides species including the B. fragilis group.
· ENDOCARDITIS caused by Bacteroides species including the B. fragilis group.
|Metronidazole is contraindicated in patients with a prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives.
In patients with trichomoniasis, Metronidazole is contraindicated during the first trimester of pregnancy.
|WARNINGS & PRECAUTIONS|
Central and Peripheral Nervous System Effects
Convulsion seizures, neuropathy.
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.
The suspension contains methyl hydroxy benzoate and propyl hydroxy benzoate which may induce allergic reactions (may be later).
|The most adverse reactions convulsive seizures, encephalopathy, aseptic meningitis, peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity. Since persistent peripheral neuropathy has been reported in some patients receiving prolonged administration of metronidazole, patients should be specifically warned about these reactions and should be told to stop the drug and report immediately to their physicians if any neurologic symptoms occur.
The most common adverse reactions reported have been referable to the gastrointestinal tract, particularly nausea reported by about 12% of patients, sometimes accompanied by headache, anorexia, vomiting; diarrhea; epigastric distress; and abdominal cramping. Constipation has also been reported.
The following reactions have also been reported during treatment with metronidazole:
Mouth: A sharp, unpleasant metallic taste is not unusual, glossitis, and stomatitis have occurred; these may be associated with a sudden overgrowth of Candida which may occur during therapy.
Hematopoietic: Reversible neutropenia; rarely, reversible thrombocytopenia.
Cardiovascular: Flattening of the T-wave may be seen in electrocardiography.
Central Nervous System: Encephalopathy, aseptic meningitis, convulsive seizures, peripheral neuropathy, dizziness, vertigo, ataxia, confusion, irritability, depression, weakness, and insomnia.
Hypersensitivity: Urticaria, erythematous rash, Stevens-Johnson Syndrome, toxic epidermal necrolysis, flushing, nasal congestion, dryness of the (mouth or vagina or vulva), and fever.
Renal: Dysuria, cystitis, polyuria, incontinence, and a sense of pelvic pressure.
|Metronidazole has been reported to potentiate the anticoagulant effect of warfarin and other oral coumarin anticoagulants, resulting in a prolongation of prothrombin time.
The simultaneous administration of drugs that induce microsomal liver enzymes, such as phenytoin or phenobarbital, may accelerate the elimination of metronidazole, resulting in reduced plasma levels; impaired clearance of phenytoin has also been reported.
|PREGNANCY AND LACTATION|
Pregnancy Category B
Metronidazole crosses the placental barrier and enters the fetal circulation rapidly.
There are, however, no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed.
A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Metronidazole is secreted in human milk in concentrations similar to those found in plasma.
|DOSAGE & ADMINISTRATION|
In the Female: One-day treatment _ two grams of Metronidazole, given either as a single dose or in two divided doses.
Seven-day course of treatment _ 250 mg three times daily for seven consecutive days.
In the Male: Treatment should be individualized as it is for the female.
For acute intestinal amebiasis (acute amebic dysentery): 750 mg orally three times daily for 5 to 10 days.
For amebic liver abscess: 500 mg or 750 mg orally three times daily for 5 to 10 days.
Children over 10 years - 400 mg orally three times daily.
Children and infants - Children > 8 weeks to 12 years of age: The usual daily dose is 20-30 mg/kg/day as a single dose or divided into 7.5 mg/kg every 8 hours. The daily dose may be increased to 40 mg/kg, depending on the severity of the infection. Duration of treatment is usually 7 days.
Children < 8 weeks of age: 15 mg/kg as a single dose daily or divided into 7.5 mg/kg every 12 hours.
Prophylaxis against postoperative infections caused by anaerobic bacteria:
Children < 12 years: 20-30 mg/kg as a single dose given 1-2 hours before surgery
Eradication of Helicobacter pylori in pediatric patients:
As a part of a combination therapy, 20mg/kg/day not to exceed 500mg twice daily for 7-14 days.
Anaerobic Bacterial Infections
The usual adult oral dosage is 7.5 mg/kg every six hours (approx. 500 mg for a 70 kg adult). A maximum of 4 g should not be exceeded during a 24 hours period.
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.
|Single oral doses of metronidazole, up to 15 grams. Symptoms reported include nausea, vomiting, and ataxia. Oral metronidazole has been studied as a radiation sensitizer in the treatment of malignant tumors.
Neurotoxic effects, including seizures and peripheral neuropathy, have been reported after 5 to 7 days of doses of 6 to 10.4 g every other day.
Treatment: There is no specific antidote for Metronidazole overdose; therefore, management of the patient should consist of symptomatic and supportive therapy.
|Flancogyl 250 Coated tablets: 2 or 1000 X 10 tablets packed in PVC/Aluminum blister inside a carton box with a leaflet.
|Store below 25 ⁰C, Protect from light, Keep away from children.