Dirozyl 60 ml Suspension

Dirozyl 200 mg/5 ml Suspension,60 ml bottle

DESCRIPTION

Dirozyl (Metronidazole) is a synthetic heterocyclic nitro derivative of simple structure (nitroimidazole). Dirozyl (Metronidazole) has an extremely broad spectrum of anti protozoal and antimicrobial activity with high activity against anaerobic bacteria and protozoa. It breaks subsequent DNA strands and causes a loss of the helical structure of DNA and inhibits DNA synthesis.

Dirozyl (Metronidazole) does not inhibit DNA synthesis in normal human cells.

COMPOSITION

Tablet 200: Each film-coated tablet contains Metronidazole BP 200 mg.

Tablet 400: Each film-coated tablet contains Metronidazole BP 400 mg.

Suspension: Each 5 ml suspension contains Benzoyl Metronidazole BP

equivalent to Metronidazole 200 mg.

Suppository: Each suppository contains Metronidazole BP 500 mg.

IV Infusion: Each 100 ml contains Metronidazole BP 500 mg (5 mg/ml)

INDICATIONS

Amebiasis, urogenital trichomoniasis (both symptomatic and asymptomatic), giardiasis, anaerobic infections, acute ulcerative gingivitis, intra-abdominal infections (peritonitis, intra-abdominal abscess and liver abscess), skin infections, gynaecological infections (endometritis, endomyometritis, tuboovarian abscess and post-surgical vaginal cuff infection), bacterial septicaemia,

bone and joint infections, CNS infections (meningitis and brain abscess), lower respiratory tract infections (pneumonia, empyema and lung abscess), endocarditis, leg ulcer and pressure sores, prophylaxis of colorectal and pelvic surgery and eradication of Helicobacter pylori in triple therapy with Amoxycillin and Ranitidine.

Triple therapy against H. pylori infection (gastritis, peptic ulcers and gastric cancer):

Two weeks regimen: Dirozyl (Metro-nidazole) 500 mg thrice daily plus Moxilin (Amoxycillin) 750 mg thrice daily plus Ranidin (Ranitidine) 300 mg at night or 150 mg twice daily.

For suppository :

Anaerobic Infections

Adults :1 g every 8 hours for 3 days, then 1 g every 12 hours.

Children : 5-10 years : 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose. Surgical Prophylaxis

Adults : 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.

Children : 5-10 years : 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures. For IV Infusion:

Dirozyl intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.

Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours. Children under 12 years: 7.5mg/kg body weight/day every 8 hours at a rate of 5ml/minute.

OR AS DIRECTED BY THE PHYSICIAN.

SIDE EFFECTS

Nausea, vomiting, unpleasant taste, furred tongue and gastrointestinal disturbance, rarely drowsiness, headache, dizziness, ataxia, darkening of urine, on prolonged and intensive therapy peripheral neuropathy, transient epileptiform seizures and leucopenia.

CONTRAINDICATIONS

Metronidazole is contraindicated in patients with a prior history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.

PRECAUTIONS

Metronidazole should be administered with caution to patients with central nervous system disease. Patients with severe hepatic disease doses below those usually recommended should be administered cautiously. Patients with candidiasis require treatment with a candidial agent with Metronidazole.

Alcoholic beverage should be avoided while taking Metronidazole and for at least one day afterward. Caution should be taken in case of children, pregnant women, elderly and patients with known neurological disease. It is recommended that Metronidazole should not be given during the first trimester of pregnancy and should be avoided during the last trimester if possible.

USE IN PREGNANCY AND LACTATION

There is inadequate evidence of safety of Metronidazole in pregnancy. Dirozyl should not therefore be given during pregnancy or during lactation unless the physician considers it essential. In this circumstance the high dosage regimens are not recommended.

DRUG INTERACTIONS

Metronidazole interacts with warfarin and increases the blood level of warfarin, causing a hypothrombinomic effect. It is postulated that Metronidazole inhibits ring oxidation of warfarin and therefore impairs total body clearance of warfarin.

Cimetidine prolongs the half-life of Metronidazole through the reduction of its total plasma clearance.

SUPPLY

Tablet 200: Each box contains 10 x 10 film-coated tablets in blisters.

Tablet 400: Each box contains 10 x 10 film-coated tablets in blisters.

Suspension: Each bottle contains 60 ml suspension with a measuring spoon.

Suppository: Each box contains 2 x 5 suppositories in blister pack.

IV Infusion: 100 ml sterile solution in clear glass bottle.* Further information is available on request.