Metrolex

Metrolex

metronidazole

Manufacturer:

Siam Bheasach

Distributor:

Siam Pharmaceutical
Concise Prescribing Info
Contents
Metronidazole
Indications/Uses
Prophylaxis & treatment of susceptible anaerobic bacterial infection eg, urogenital or sexually transmitted infections in male or female; bacterial vaginosis & vag infection including non-specific vaginitis, anaerobic vaginosis or Gardnerella vaginitis; intestinal & extraintestinal amoebiasis; diarrhea; septicemia & bacteremia; intra-abdominal infections including peritonitis, intra-abdominal & liver abscess; CNS infections including brain abscess & meningitis; lower resp tract infections including, pneumonia, empyema & lung abscess; skin & skin structure including bone & joint infections; acute necrotizing ulcerative gingivitis. Prevention of post-op infections particularly caused by Bacteroides sp. Tab: Acute dental infections eg, acute pericoronitis & acute apical infections. Inj: Severe infection. To reduce infection in intra- & post-op surgical prophylaxis. Bacteroides fragilis infection which failed to respond to clindamycin, chloramphenicol & penicillin.
Dosage/Direction for Use
Tab Prophylaxis against anaerobic bacterial infections in abdominal & gynaecological surgery Adult 400 mg every 8 hr for 3-4 days followed by post-op IV. May administer shorter pre-op course & higher oral dose (up to 1 g). Childn 7.5 mg/kg every 8 hr. Treatment of established anaerobic bacterial infection Adult Initially 800 mg, followed by 400 mg every 8 hr. Childn 7.5 mg/kg every 8 hr. Duration: Approx 7-10 days based on symptom & disease severity. Urogenital trichomoniasis Adult & childn >10 yr 200 mg tid for 7 days or 400 mg bid for 7 days or 800 mg in the morning & 1,200 mg in the evening for 2 days or 2 g as single dose for 1 day. Childn 7-10 yr 100 mg tid for 7 days, 3-7 yr 100 mg bid for 7 days, 1-3 yr 50 mg tid for 5-10 days. Bacterial vaginosis Adult & childn >10 yr 400 mg bid for 7 days or 2 g as single dose for 1 day. Amoebiasis Invasive intestinal disease in susceptible patient: Adult & childn >10 yr 800 mg tid for 5 days. Childn 7-10 yr 400 mg tid for 5 days, 3-7 yr 200 mg qid for 5 days, 1-3 yr 200 mg tid for 5 days. Intestinal disease in less susceptible patients & chronic amoebic hepatitis: Adult & childn >10 yr 400 mg tid for 5-10 days. Childn 7-10 yr 200 mg tid for 5-10 days, 3-7 yr 100 mg qid for 5-10 days, 1-3 yr 100 mg tid for 5-10 days. Symptomless cyst passer: Adult & childn >10 yr 400-800 mg tid for 5-10 days. Childn 7-10 yr 200-400 mg tid for 5-10 days, 3-7 yr 100-200 mg qid for 5-10 days, 1-3 yr 100-200 mg tid for 5-10 days. Giardiasis Adult & childn >10 yr 2 g once daily for 3 days. Childn 7-10 yr 1 g once daily for 3 days, 3-7 yr 600-800 mg once daily for 3 days, 1-3 yr 500 mg once daily for 3 days. Acute ulcerative gingivitis Adult & childn >10 yr 200 mg tid for 3 days. Childn 7-10 yr 100 mg tid for 3 days, 3-7 yr 100 mg bid for 3 days, 1-3 yr 50 mg tid for 3 days. Acute dental infections Adult & childn >10 yr 200 mg tid for 3-7 days. Leg ulcers & pressure sores Adult & childn >10 yr 400 mg tid for 7 days. Childn & infants weighing <10 kg Administer proportionately smaller dosages. Hepatic impairment 1/3 of usual dose once daily. Inj Administer by continuous or intermittent IV infusion. Adult Severe anaerobic bacterial infection Initial loading dose: 15 mg/kg (approx 1 g for 70 kg adult) over 1 hr, followed by maintenance dose of 7.5 mg/kg every 6 hr (approx 500 mg for 70 kg adult) after 6 hr of 1st infusion. Max: 4 g w/in 24 hr. Perioperative & post-op prophylaxis 15 mg/kg over 30-60 min 1 hr prior to procedure, followed by 7.5 mg/kg over 30-60 min at 6 & 12 hr after initial dose. Hepatic impairment 1/3 of usual dose once daily.
Administration
Should be taken with food.
Contraindications
Hypersensitivity to metronidazole or nitroimidazole derivatives. Pregnancy (1st trimester).
Special Precautions
Peripheral neuropathy w/ chronic use. Candidiasis. May increase symptoms of encephalopathy. Patients w/ restricted Na; predisposition to edema; CNS disease; history of blood dyscrasias. Perform leukocyte counts before & after treatment. Monitor plasma conc regularly. Concomitant use w/ steroids. Disulfiram-like reactions w/ alcohol. Not recommended in patients w/ renal impairment undergoing peritoneal dialysis. Reduce dose in patients w/ hepatic impairment. Not to be used in pregnancy especially during 1st trimester. Avoid breastfeeding in lactating women requiring treatment. Elderly.
Adverse Reactions
Taste disorders (unpleasant metallic taste), furred tongue, nausea, vomiting, GI disturbance, diarrhea, epigastric distress, abdominal pain, constipation, stomatitis, gastritis, vulvovag candidiasis, drowsiness, dizziness, headache, urticaria, angioedema, pruritus, erythema multiforme, flattening of T-wave in ECG tracings, dry mouth, flushing, fever, transient leukopenia & thrombocytopenia, dysuria, cystitis, polyuria, incontinence, dark or reddish brown urine, ataxia, confusion, depression, insomnia, weakness, anaphylaxis, convulsion & peripheral neuropathy (weakness & numbness), encephalopathy (confusion, ataxia, dysarthria, gait impairment, nystagmus, tremor), transient epileptiform seizures.
Drug Interactions
May increase serum conc of warfarin, lithium & phenytoin. Increased metabolism rate w/ phenobarb. Acute pyschoses & confusion w/ disulfiram. Disulfiram-like reactions including, flushing, nausea, vomiting, palpitation, tachycardia w/ alcohol. Increased plasma t½ & decreased total plasma clearance w/ cimetidine. May interfere w/ AST, ALT, LDH, triglycerides & hexokinase glucose testing.
MIMS Class
Antiamoebics / Other Antibiotics / Preparations for Vaginal Conditions
ATC Classification
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.
Presentation/Packing
Form
Metrolex inj 0.5 %
Packing/Price
100 mL x 1's
Form
Metrolex tab 200 mg
Packing/Price
10 × 10's;50 × 10's
Form
Metrolex tab 400 mg
Packing/Price
10 × 10's;50 × 10's
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