Librazol IV

Pneumonia, Giardiasis, Peptic ulcer disease, Peritonitis, H. pylori infection, Rosacea, Septicemia, Endometritis, Aspiration pneumonia, Lung abscess, Empyema, Bone and Joint Infections, Surgical Prophylaxis, Amoebiasis, Bacterial vaginosis, Balantidiasis, Blastocystis hominis infection, Trichomoniasis, Acute dental infections, Acute necrotising ulcerative gingivitis, Anaerobic bacterial infections, Antibiotic-associated colitis, Fungating tumours, Leg ulcers and pressure sores, Diverticulitis, Diabetic foot ulcer, Meningitis and brain abscesses, endocarditis

Susp: Should be taken on an empty stomach. Take at least 1 hr before meals. Tab: Should be taken with food. Reconstitution: Add 4.4 mL of sterile or bacteriostatic water for inj, NaCl 0.9% inj, or bacteriostatic NaCl inj to a vial labeled as containing metronidazole 500 mg. The resultant soln contains approx 100 mg/mL and must be further diluted w/ NaCl 0.9% inj, dextrose 5% inj, or lactated Ringer's inj to a concentration of 8 mg/mL or less. The reconstituted and diluted soln must then be neutralised by adding approx 5 mEq of Na bicarbonate inj for each 500 mg.

Oral Child: PO 30–50 mg/kg/day q8h Amoebiasis Adult: 800 mg tid for 5 days (intestinal infection); 5-10 days (extra-intestinal infection). Max: 2.4 g/day. Trichomoniasis Adult: 2 g as a single dose, 200 mg tid for 7 days or 400 mg bid for 5-7 days. Sexual partners should also be treated. Repeat treatment 4-6 wk between courses as necessary. Giardiasis Adult: 2 g once daily for 3 days, 400 mg tid for 5 days or 500 mg bid for 7-10 days. Bacterial vaginosis Adult: 2 g as a single dose or 400 mg bid for 5-7 days. Acute necrotising ulcerative gingivitis Adult: 200 mg tid for 3 days. Anaerobic bacterial infections Adult: Initially, 800 mg followed by 400 mg 8 hrly. Alternatively, 7.5 mg/kg 6-8 hrly. Max: 4 g/day. Duration of treatment is usually for 7 days depending on the severity of infection. Prophylaxis of postoperative anaerobic bacterial infections Adult: 400 mg 8 hrly 24 hr prior to surgery followed by post-op IV or rectal admin until oral therapy is possible. Eradication of H. pylori associated with peptic ulcer disease Adult: 400 mg bid in combination w/ another antibacterial and a PPI or 400 mg tid, if given w/ omeprazole and amoxicillin. Initial treatment is given for 1 wk. Leg ulcers and pressure sores Adult: 400 mg tid for 7 days. Acute dental infections Adult: 200 mg tid for 3-7 days. Intravenous Children: IV 22.5–40 mg/kg/day q8h Anaerobic bacterial infections Adult: 500 mg infused as 100 mL of a 5 mg/mL soln at 5 mL/min 8 hrly. Alternatively, 15 mg/kg infused over 1 hr, followed by 7.5 mg/kg infused over 1 hr 6 hrly. Max: 4 g/day. Substitute oral therapy as soon as possible. Prophylaxis of postoperative anaerobic bacterial infections Adult: 500 mg shortly before operation and repeated 8 hrly. Alternatively, 15 mg/kg infused over 30-60 min and completed approx 1 hr before surgery, followed by 7.5 mg/kg infused over 30-60 min at 6 and 12 hr after the initial dose. Hepatic impairment: Severe: 1/3 of usual dose once daily.

Oral Amoebiasis Child: 1-3 yr 100-200 mg tid; >3-7 yr 100-200 mg 4 times daily; >7-10 yr 200-400 mg tid. Doses are given for 5-10 days. Trichomoniasis Child: 1-10 yr 40 mg/kg as a single dose or 15-30 mg/kg daily in 2-3 divided doses for 7 days. Max: 2 g/dose. Giardiasis Child: 1-3 yr 500 mg once daily; >3-7 yr 600-800 mg once daily; >7-10 yr 1 g once daily. Doses are given for 3 days. Acute necrotising ulcerative gingivitis Child: 1-3 yr 50 mg tid; >3-7 yr 100 mg bid; >7-10 yr 100 mg tid. Doses are given for 3 days. Anaerobic bacterial infections Child: <8 wk 7.5 mg/kg 12 hrly or 15 mg/kg once daily. 8 wk to 12 yr 7.5 mg/kg 8 hrly or 20-30 mg/kg once daily. Duration of treatment is usually for 7 days depending on the severity of infection. Prophylaxis of postoperative anaerobic bacterial infections Child: <40 wk 10 mg/kg as a single dose before surgery; <12 yr 20-30 mg/kg as a single dose 1-2 hr before surgery. Intravenous Anaerobic bacterial infections Child: 7.5 mg/kg 8 hrly.

History of hypersensitivity to metronidazole or other nitroimidazole derivatives. Pregnancy (1st trimester) and lactation.

Metronidazole is converted to reduction products that interact w/ DNA to cause destruction of helical DNA structure and strand leading to a protein synthesis inhibition and cell death in susceptible organisms. It is active against most anaerobic protozoa, some gm+ve, gm-ve and facultative anaerobes.

Patients with CNS diseases; discontinue IV therapy if abnormal neurologic symptoms occur. History of seizure disorder. Evidence or a history of blood dyscrasias; perform total and differential leukocyte counts before and after treatment. Severe hepatic impairment; monitor plasma levels. Predisposition to oedema (inj contains sodium). Prolonged use may result in fungal or bacterial superinfection. Excreted in human milk; not recommended

GI disturbances e.g. nausea, unpleasant metallic taste, vomiting, diarrhoea or constipation. Furred tongue, glossitis, and stomatitis due to overgrowth of Candida. Rarely, antibiotic-associated colitis. Weakness, dizziness, ataxia, headache, drowsiness, insomnia, changes in mood or mental state. Numbness or tingling in the extremities, epileptiform seizures (high doses or prolonged treatment). Transient leucopenia and thrombocytopenia. Hypersensitivity reactions. Urethral discomfort and darkening of urine. Raised liver enzyme values, cholestatic hepatitis, jaundice. Thrombophlebitis (IV). Potentially Fatal: Anaphylaxis.

Concurrent use w/ disulfiram may produce psychotic reactions. May potentiate the effect of oral anticoagulants. May increase risk of lithium toxicity. May reduce the renal clearance resulting to increased toxicity of 5-fluorouracil. May increase serum levels of ciclosporin. May increase plasma levels of busulfan resulting to severe busulfan toxicity. Enhanced metabolism w/ phenobarbital and phenytoin resulting to decreased serum concentrations.