Uppr/lower respratorytract infections Gynaecological ifctions ENT infection Genito-urinary tract infections
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Faropenam Sodium Extended 08-03-2010
Release Tablet 225/300/450mg
For the treatment of Respiratory Tract Infections, urinary Tract
Infection, skin and Skin Structure Infections, and Gyanecological
Infections
Adverse Reaction:
Faropenam is generally well tolerated. The most frequently reported adverse reactions are diarrhea, abdominal pain, loose bowel movment nausea, and rash
Contra-Indications:
In patients with hypersensitivity to any of the components of the products or other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactones
Warnings and Precautions-
Associated with the occurance of anaphlactic shock , diarrhoa and loose bowel movements.
Patients with past history of hypersensitivity to penicillin,cephem or carbapenem drugs.
Patients with family history of atopy Patients with renal insufficiency
Geriatric patients Patients with poor oral intake or general intake
Dosages/ Overdosage Etc:
Upper/lower respratorytract infections
Gynaecological ifctions
ENT infection
Genito-urinary tract infections
Pharmacology/ Pharmacokinetics:
Pharmacology-
Faropenem is bactericidal and acts by inhibiting cell wall synthesis. It has a strong affinity for the high molecular penicilln binding proteins (PSBPs) of the cell wall that is essential for multiplication of bacilli. Faropenem shows broad antibacterial activity against both aerobic and anaerobic gram-positive and gram negative bacteria
Pharmacokinetics-
From clinical trials maximum conc Cmax of fanopenem was found to be approx 13mg/L (300mg dose) Half life was 0.9 to 1.3 hrs. Urinary accumulation accounted for 14-20% of the dose and renal clearance was 1.6 - 2.9L/hour depeding on patients age and sex at oral dosages of 300, 600, and 1200 mg twice a day. It was found that protein binding was approx 95%.