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Flagyl/Flagyl Forte

Flagyl/Flagyl Forte

metronidazole

Manufacturer:

Kalventis Sinergi Farma
Concise Prescribing Info Bahasa Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Warnings Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing
Concise Prescribing Info
Contents
Metronidazole
Indications/Uses
Tab/Oral Susp/Supp Prevention of post-op anaerobic infection. Tab/Oral susp Urethritis & vaginitis; amoebiasis; giardiasis. Supp Identified anaerobic bacteria infection: Septicaemia, bacteremia, peritonitis, brain abscess, necrotising pneumonia, osteomyelitis, puerperal sepsis, pelvic cellulitis.
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Dosage/Direction for Use
Tab/Oral susp Hepatic & intestinal amoebiasis Adult 500-750 mg 3 times daily for 5-10 days. Childn 35-50 mg/kg/day in 3 divided doses for 10 days. Trichomoniasis Adult 2 g either as a single once daily dose or 500 mg 2 times daily or 250 mg 3 times daily for 7 consecutive days. Childn 15 mg/kg/day in 3 divided doses for 7-10 days. Giardiasis Adult 250-500 mg 3 times daily for 5-7 days or 2 g daily as a single dose for 3 days. Childn 5 mg/kg 3 times daily for 5-7 days. Anaerobic bacterial infections Adult 7.5 mg/kg every 6 hr for 7-10 days. Max: 4 g daily. Supp Treatment of infection in which anaerobic bacteria have been identified Adult 1 g into vag at 8 hrly intervals. Use ≥3 days, reduce the further doses into 1 g at 12 hrly intervals. Childn 7.5 mg/kg into vag at 8 hrly intervals. Prevention of post-op infections due to anaerobic bacteria Adult 1 g 2-4 hr before surgery, then at 8 hrly intervals until oral medication become possible. Childn ½ or ¼ of 500 mg at 8 hrly intervals.
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Overdosage
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Administration
Tab: Should be taken with food: Swallow whole, do not chew/crush. Oral susp: Should be taken on an empty stomach: Take at least 1 hr before meals.
Contraindications
Tab/Oral susp/Supp Hypersensitivity to imidazoles. 1st trimester of pregnancy. Oral susp/Supp History of bone marrow depression.
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Warnings
For additional cautionary notes to warn of the potential risk of using the medicine... Click to view Flagyl/Flagyl Forte detailed prescribing information
Special Precautions
Tab/Oral Susp/Supp CNS disease; hepatic dysfunction. Alcoholism. Perform hematological tests during prolonged administration. May impair ability to drive or operate machinery. Pregnancy & lactation. Childn except in amoebiasis. Tab/Oral Susp Darken urine (due to metronidazole metabolite). Discontinue in case of ataxia, vertigo, hallucinations or mental confusion. Patients w/ active or chronic severe peripheral & CNS diseases.
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Use In Pregnancy & Lactation
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Adverse Reactions
Epigastric pain, nausea, vomiting, diarrhea; oral mucositis, taste disorders, anorexia; reversible pancreatitis; tongue discoloration/furry tongue. Angioedema, anaphylactic shock. Peripheral sensory neuropathy; headache, convulsions, dizziness; encephalopathy (eg, confusion) & subacute cerebellar syndrome (eg, ataxia, dysarthria, gait impairment, nystagmus & tremor); aseptic meningitis. Psychotic disorders including confusion, hallucinations; depressed mood. Transient vision disorders eg, diplopia, myopia, blurred vision, decreased visual acuity, changes in color vision; optic neuropathy/neuritis. Agranulocytosis, neutropenia & thrombocytopenia. Increase in liver enzymes (AST, ALT, alkaline phosphatase), cholestatic or mixed hepatitis & hepatocellular liver injury; liver failure. Rash, pruritus, flushing, urticaria; pustular eruptions; erythema multiforme. Fever.
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Drug Interactions
Tab/Oral Susp/Supp Potentiates the effects of oral anticoagulants. Reduces clearance of 5-fluorouracil. Plasma levels of busulfan may be increased. Tab/Supp Cimetidine may prolong the plasma clearance of metronidazole. Tab/Oral susp Alcohol may cause disulfiram-like reactions. Disulfiram may cause psychotic reactions. Potentiates the action of vecuronium. Plasma levels of lithium may be increased. Risk of elevation of ciclosporin serum levels. Phenytoin or phenobarb may increase elimination of metronidazole resulting in reduced plasma level.
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Storage
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Description
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Action
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MIMS Class
Other Antibiotics / Antiamoebics / Preparations for Vaginal Conditions
ATC Classification
G01AF01 - metronidazole ; Belongs to the class of imidazole derivative antiinfectives. Used in the treatment of gynecological infections.
P01AB01 - metronidazole ; Belongs to the class of nitroimidazole derivatives antiprotozoals. Used in the treatment amoebiasis and other protozoal diseases.
Regulatory Classification
K
Presentation/Packing
Form
Flagyl oral susp 125 mg/5 mL
Packing/Price
60 mL x 1's (Rp66,333/botol)
Form
Flagyl supp 0.5 g
Packing/Price
2 × 5's (Rp161,189/boks)
Form
Flagyl supp 1 g
Packing/Price
2 × 5's (Rp323,885/boks)
Form
Flagyl Forte tab 500 mg
Packing/Price
10 × 10's (Rp571,010/boks)
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