Ornidazole - Nitroimidazole- (FDC- List )- (Jan 1997)
Drug Name:
Ornidazole - Nitroimidazole- (FDC- List )- (Jan 1997)
List Of Brands:
Indication Type Description:
Pharmacology/ Pharmacokinetics
Drug Interaction:
Possible disulfram-like reaction may exist between omidazole and alcohol.
Concomittant oral anticoagulants may increase the risk of haemorrhage due to their diminished metabolism.
Omidazole may decrease the clearance of 5-fluorouracil.
Indication:
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Ornidazole Anti-Protozoal 13-01-1997
2.Ornidazole IP 1%w/w 03-01-2012
+ Povidone Iodine IP
(0.5%w/w Avialble Iodine)
5% w/w Ointment
For the prevention and treatment of Surgical Wound infections in
Adult Patients undergoing surgery
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
Ornidazole IP 1%w/w + 03-01-2012
Povidone Iodine IP 0.5%
(available iodine) 5% w/w ointment
For the prevention and treatment of surgical wound
infections in adult patients undergoing surgery
Giardiasis
Adverse Reaction:
Headache, lassitude, dizziness and fatigue. Nausea, vomiting, diarrhorea, epigastric distress, anorexia, and dry mouth.
Bitter and metallic taste.
Contra-Indications:
Hypersensitivity to omidazole. Special precautions: Due caution to be exercised in neurological disorders.
Blood count monitoring during treatment.
Dosages/ Overdosage Etc:
Indication-
Giardiasis
Dosage-
500mg b.i.d orally for 5 to 10 days.
Children- 25mg/kg/day single dose 5-10 days.
Pharmacology/ Pharmacokinetics:
Pharmacology:
Antibacterial activity similar to metronidazole Pharmacokinetics: Omidazole is rapidly absorbed from the GIT. Peak plasma concentrations of about 30mcg/ml have been acheived within 2 hrs of a single dose of 1.5g.
The plasma half-life is 12- 14 hrs. The drug undergoes hepatic metabolism and is excreted in the urine.
Pregnancy and lactation:
Omidazole is advised only if the potential benefits decisively outweigh the potential risks to the fetus or neonates.