To reduce the development of drug-resistant bacteria and maintain the effectiveness of Doripenem and other antibacterial drugs, Doripenem should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting and modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Complicated Intra-Abdominal Infections: Doripenem injection is indicated as a single agent for the treatment of complicated intra-abdominal infections caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides caccae, Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Streptococcus intermedius, Streptococcus constellatus and Peptostreptococcus micros.

Complicated Urinary Tract Infections, Including Pyelonephritis: Doripenem injection is indicated as a single agent for the treatment of complicated urinary tract infections, including pyelonephritis caused by Escherichia coli including cases with concurrent bacteremia, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa and Acinetobacter baumannii.

Intravenous-

• Complicated intra-abdominal infections: 500 mg 8 hrly infused over 1 hr for 5-14 days. May switch to an appropriate oral therapy, after at least 3 days of parenteral therapy.
• Complicated UTI, Pyelonephritis: 500 mg 8 hrly infused over 1 hr for 10 days. May switch to an appropriate oral therapy, after at least 3 days of parenteral therapy.
• Patient with concurrent bacteraemia: Duration can be extended up to 14 days.

Renal impairment-

• CrCI (30-50 ml/min): 250 mg every 8 hr by IV infusion over 1 hr
• CrCI (11 -29 ml/min): 250 mg every 12 hr by IV infusion over 1 hr

Hypersensitivity to doripenem, other carbapenem antibacterial agents; history of anaphylactic reaction to β-lactams (e.g. penicillins, cephalosporins).

Headache, nausea, diarrhoea, rash, pruritus, phlebitis, elevated hepatic enzymes, oral candidiasis, anaemia, vulvomycotic infection, thrombocytopenia, neutropenia.

Patient with known or suspected CNS disorders (e.g. brain lesions, history of seizures). Not intended for treatment of any type of pneumonia. Renal impairment. Pregnancy and lactation. Monitoring Parameters Monitor renal function and for signs of anaphylaxis during 1st dose. Consider haematologic assessment during prolonged therapy.

Pregnancy & Lactation

Pregnancy Category B. Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).