Drug Interaction:
Drug interactions -summary
HMG-CoA reductase inhibitors-
inhibitors of HMG CoA may cause myopathy that is manifested by muscle pain oe weaknening
associated with elevated levels of CPK .
Therefore consider tempororary suspension of of use of HMG-CoA reductase inhibitors in
patients receiving daptomycin
Warfarin-
Monitor anticoagulant activity in patients receiving daptomycin and warfarin for the first
several days after initiating therapy
Indication:
U.S FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
36. Daptomycin powder for concentrate 28-01-08
for solution for infusion (350mg/500mg per vial)
For the treatment of completely skin structure
infections and for staphylococcus aureus bloodstream
infections (bactermia)
Skin and skin structure infections
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Daptomycin Powder for 28-01-2008
Concentrate for Solution For
Infusion 350mg/500mg/ml
For the treatment of complicated skin and Skin structure infections
and for Staphylococcus Aureus Bloodstream Infections (Bacteremia)
Adverse Reaction:
Adverse reactions-
Cardiovascular - Hypertension, hypotension
CNS- Headache, insomnia
Dermatologic - Pruritus, rash
GI - Constipation, dyspepsia, nausea, vomiting
Lab test abnomalites- abnormal liver enzyme tests, elevated CPK
Musculoskeletal - arthalgia, limb pain
Miscellaneous- anemia ,dyspnea, fever, fungal infections, injection site reactions
urinary tract infections
Contra-Indications:
Hypersensitivity to the drug
Special Precautions/warnings-
Pseudiomembraneous colitis- has been reported with all antibactetial agents including
daptomycin. Consider diagnosis in patients who present diarrhea subsequent
to the administration of ant antibacterial agent.
Superinfection- use of antibiotcs may promote over growth of nonsuseptible organisms.
If superinfection occurs during therapy, take appropiate measures.
Pregnancy- use this drug during pregnancy only if clearly needed
Lactation- excercise caution when administering daptomycin to a breast feeding woman.
Children- safety for use in patients younger than 18 years of age have not been studied
Elderly - Treatment emergent adverse reactions more common in patients of 65 age of age and above.
Dosages/ Overdosage Etc:
Indication-
Skin and skin structure infections
Dosage-
Adults- 4mg/kg by IV infusion over 30 minutes once every 24 hours for 7 to 14 days
Patient Information:
1. Advice patients to report to their doctor,any signs of muscle pain r weakness , particularly
in the distal extremities
2. Advice patients to report severe diarrhea, stomach pain/cramps or bloody stools to their doctor.
Pregnancy and lactation:
Pregnancy-
Use this drug during pregnancy only if clearly needed
Lactation-
Excercise caution when administering daptomycin to a breast feeding woman.
Children-
Safety for use in patients younger than 18 years of age have not been studied
Elderly -
Treatment emergent adverse reactions more common in patients of 65 age of age and above.
Manufacturer Details