Metronidazole


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult: PO Anaerobic bacterial infections Initial: 800 mg followed by 400 mg 8 hourly usually for about 7 days. Max: 4,000 mg/day. Prophylaxis of postoperative anaerobic bacterial infections 400 mg 8 hourly in the 24 hours before surgery followed by IV or rectal dosage post-operatively until oral therapy is possible. Max: 4,000 mg/day. Amoebiasis 800 mg tid 5 days (intestinal infection); 400-800 mg for 5-10 days (extra-intestinal infection). Alternatively, 35-50 mg /kg daily in 3 divided doses for 5-10 days. Max: 2,400 mg/day Trichomoniasis 2,000 mg as a single dose or 200 mg tid for 7 days. Alternatively, 400 mg bid for 5-7 days. Sexual partners should also be treated. Bacterial vaginosis 400 mg bid for 5-7 days. Alternatively, 2,000 mg as single dose. Giardiasis 2,000 mg once daily for 3 days or 400 mg tid for 5 days or 500 mg bid for 7-10 days. Alternatively, 15-40 mg/kg/day in 2-3 divided doses. H. pylori eradication associated with peptic ulcer disease Combined with another antibacterial and PPI: 400 mg bid for 7-14 days. Combined with omeprazole and amoxicillin: 400 mg tid. Consult official guidelines before initiating therapy. Acute ulcerative gingivitis 200-400 mg tid for 3 days. Acute dental infections 200 mg tid for 3-7 days. Leg ulcers and pressure sores 400 mg tid for 7 days. IV Anaerobic bacterial infections 1,000-1,500 mg once daily as single dose. Alternatively, 500 mg 8 hourly via infusion at a rate of 5 mL/min over 20-60 minutes usually for about 7 days. Max: 4,000 mg/day. Substitute oral therapy as soon as possible Prophylaxis of post-op anaerobic bacterial infections 1,000-1,500 mg once daily for 30-60 minutes preoperatively. Alternatively, 500 mg immediately prior, during or after operation, then 500 mg 8 hourly for 24 hours. Rectal Anaerobic infections As supp: 1 g 8 hourly for 3 days, then reduce to 12 hourly if needs to continue for more than 3 days. Substitute oral therapy as soon as possible. Prophylaxis of post-op anaerobic bacterial infections As supp: 1 g 2 hours before surgery, repeated 8 hourly for 3 days, then 12 hourly until oral doses can be given to complete the 7-day treatment course. Intravaginal Bacterial vaginosis Each applicator delivers approx 5 gm gel containing 37.5 mg metronidazole: 1 applicator-full once daily at bedtime for 5 days. Topical/Cutaneous Rosacea As 0.75% gel/cream/lotion: Apply thinly to the affected area twice daily. Average treatment period: 3-4 months, may be continued for further 3-4 months may be necessary depending on the severity of the infection.
Administration
Susp: Should be taken on an empty stomach. Take at least 1 hr before meals.
Tab: Should be taken with food.
Contraindications
Hypersensitivity to metronidazole and other nitroimidazoles. Concomitant use with disulfiram within the last 14 days. Coadministration with alcohol or propylene glycol containing products during or 3 days after therapy discontinuation. Pregnancy during the 1st trimester in the treatment of trichomoniasis.
Special Precautions
Patient with or history seizure disorder, blood dyscrasias (e.g. agranulocytosis, leukopenia, neutropenia); Cockayne syndrome. Hepatic impairment and severe renal impairment or ESRD. Pregnancy and lactation. Patient Counselling This drug may cause drowsiness, if affected do not drive or operate machinery. Monitoring Parameters Monitor CBC with differential at baseline, during, and after repeated or prolonged treatment. Monitor LFT in patients with Cockayne syndrome. Monitor neurologic symptoms.
Adverse Reactions
Significant: Severe neurological disturbances, encephalopathy, convulsive seizures, aseptic meningitis, peripheral and optic neuropathy, paraesthesia; superinfection (e.g. fungal or bacterial superinfection, C. difficile-associated diarrhoea. Blood and lymphatic system disorders: Leucopenia, neutropenia. Cardiac disorders: Chest pain, tachycardia. Ear and labyrinth disorders: Tinnitus. Eye disorders: Light sensitivity, nystagmus. Gastrointestinal disorders: Nausea, dry mouth, vomiting, constipation, abdominal pain diarrhoea, sharp unpleasant metallic taste. Investigations: Flattening of T wave on ECG. Metabolism and nutrition disorders: Anorexia. Musculoskeletal and connective tissue disorders: Myalgia. Nervous system disorders:Insomnia, headache, ataxia, vertigo, incoordination, dizziness. Psychiatric disorders: Confusion, hallucination. Reproductive system and breast disorders: Genital pruritus. Respiratory, thoracic and mediastinal disorders: Pharyngitis, sinusitis. Skin and subcutaneous tissue disorders: Erythematous rash, urticaria, dry skin. Vascular disorders: Syncope.
Potentially Fatal: Stevens-Johnson syndrome, toxic epidermal necrolysis; severe hepatotoxicity/acute hepatic failure in patients with Cockayne syndrome.
Drug Interactions
Confusional state or acute psychosis with disulfiram. May potentiate anticoagulant effect of warfarin. May retain lithium serum levels increasing the risk to renal damage. Decreased serum concentration with phenobarbital or phenytoin. May increase serum concentrations of ciclosporin and busulfan. May reduce the renal clearance of 5-fluorouracil.
ATC Classification
A01AB17 - metronidazole ; Belongs to the class of local antiinfective and antiseptic preparations. Used in the treatment of diseases of the mouth.
P01AB01 - metronidazole ; Belongs to the class of nitroimidazole derivatives antiprotozoals. Used in the treatment amoebiasis and other protozoal diseases.
J01XD01 - metronidazole ; Belongs to the class of imidazole derivative antibacterials. Used in the systemic treatment of infections.
D06BX01 - metronidazole ; Belongs to the class of other topical chemotherapeutics used in the treatment of dermatological diseases.
G01AF01 - metronidazole ; Belongs to the class of imidazole derivative antiinfectives. Used in the treatment of gynecological infections.
Disclaimer: This information is independently developed by CIMS based on metronidazole from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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