Drug interactions - summary-

Probenecid + Doripenem

probenecid interferes with the active tubular secretion of doripenem resulting in increaed
plasma concentrations. Coadministration is not recommended.

Doripenem + valproic acid

doripenem may reduce serum valproic acid concentration resulting in loss of seizure control.
Monitor serum valproic acid levels frequently after initiating doripenem  therapy

Complicated intra-abdominal infections
Complicated urinary tract infections ( UTIs )
 

Cardiovascular  -      phlebitis  3%

CNS -                        headache 14%

Dermatologic -        pruritus     <1 %   rash 1%

GI                             diarrhea    5%       nausea  3%

Haematological /lymphatic    anemia  1%

Hepatic -               hepatic enzyme elevation  1%

Renal -                  renal function impairment  < 1%

Miscellaneous-    oral candidiasis   1%      vulvomycotic  infection 1% 

Known hypersensitivity  to dropenem or other drugs in the same category

Special Precautions/Warnings-

Drug resistent bacteria-  prescribing doripenem in the absence of a proven or strongly
suspected  bacterial infection is unlikely to provide benefit to the patient and increase the
risk of develoment of drug resistent bacteria.

Pneumonia with inhalational use - Not investigated. Do not administer by this route

Hypersensitivity reactions- serious  and occasionally fatal hypersensitivity reactions
( anaphylactic ) and serious skin reactions have been reported in patients receiving
beta-lactum antibitics.

Excercise caution if this product is give to a penicillin allergic or other
beta-lactum patient, because cross-hypersentivity among beta-latum antibiotics has not been clearly documented.

Pregnancy - there are no adequate and well documented and well controlled studies in pregnant women.

Lactation- excercise caution whendoripenem is administered to breast-feeding woman.

Children- safety and effectiveness in children have not been establshed

Elderly-  because elderly patients are more likely to have decreased renal function  function, take care in dose selection.

Monitoring-  monitor renal function in patients  with moderate to severe renal function impairment.  
 

Complicated Intra-abdominal infections and complicated urinary tract                     infections, including complicated and uncomplicated pyelonephritis                                        and cases with  concurrent bacteremia

Complicated intra-abdominal infections
Complicated urinary tract infections ( UTIs )

Dosage-

500mg every 8 hours by intrvenous IV infusion over 1 hour in patients 18 years of
age and older.

Complicated intra-abdominal infection -  500mg every 8 hours  1 hour infusion time
                                                                        for 5 to 14 days

Complicated UTIs including pyelonephritis  500mg  every 8 hours  1 hour infusion timr
                                                                           for 10 days

1. Advice patients that allergic reactions, sometimes, serious allergic reactions could occur and that  such  reactions require immediate treatment. Patients adviced to inform their doctor about any previous hypersensitivity reactions to other medicines or allergen.

2. Counsel patients that antibacterial drugs including doripenem should only be used to treat
bacterial agents.They  do not treat viral infections eg. common cold.

3. Tell patients that although it is common to feel better early in the course of therapy the
medications should be taken exactly as directed

3. Skipping doses or not completing the full course of therapy may decrease the effectiveness of immediate treatment and increase the likelihood that bacteria will develop resistence and will not be treatable by dorepenem or other antibacterial drugs in the future.

Pregnancy -
There are no adequate and well documented and well controlled studies in pregnant
women.

Lactation-
Excercise caution when doripenem is administered to breast-feeding woman.

Children-
Safety and effectiveness in children have not been establshed

Elderly- 
Because elderly patients are more likely to have decreased renal function  function,
take care in dose selection.