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10 X 1g
DO NOT MIX OR CO-INFUSE INVANZ WITH OTHER MEDICATIONS. DO NOT USE DILUENTS CONTAINING DEXTROSE (α-D-GLUCOSE).
INVANZ may be administered by intravenous infusion for up to 14 days or intramuscular injection for up to 7 days. When administered intravenously, INVANZ should be infused over a period of 30 minutes.
Intramuscular administration of INVANZ may be used as an alternative to intravenous administration in the treatment of those infections for which intramuscular therapy is appropriate.
13 years of age and older: The dose of INVANZ in patients 13 years of age and older is 1 gram (g) given once a day .
3 months to 12 years of age: The dose of INVANZ in patients 3 months to 12 years of age is 15 mg/kg twice daily (not to exceed 1 g/day).
See prescribing information for treatment guidelines.
Patients with Renal Impairment: INVANZ may be used for the treatment of infections in adult patients with renal impairment. In patients whose creatinine clearance is >30 mL/min/1.73 m², no dosage adjustment is necessary. Adult patients with severe renal impairment (creatinine clearance ≤30 mL/min/1.73 m²) and end-stage renal disease (creatinine clearance ≤10 mL/min/1.73 m²) should receive 500 mg daily. A supplementary dose of 150 mg is recommended if ertapenem is administered within 6 hours prior to hemodialysis. There are no data in pediatric patients with renal impairment.
Patients on Hemodialysis: When adult patients on hemodialysis are given the recommended daily dose of 500 mg of INVANZ within 6 hours prior to hemodialysis, a supplementary dose of 150 mg is recommended following the
hemodialysis session. If INVANZ is given at least 6 hours prior to hemodialysis, no supplementary dose is needed. There are no data in patients undergoing peritoneal dialysis or hemofiltration. There are no data in pediatric patients on hemodialysis.
When only the serum creatinine is available, the following formula1 may be used to estimate creatinine clearance. The serum creatinine should represent a steady state of renal function (See prescribing information for full details).
Patients with Hepatic Impairment: No dose adjustment recommendations can be made in patients with hepatic impairment.
For the treatment of adult patients with the following moderate to severe infections caused by susceptible strains of the designated microorganisms: Complicated intra-abdominal infections; complicated skin and skin structure infections; community acquired pneumonia; complicated urinary tract infections including pyelonephritis; acute pelvic infections including postpartum endomyometritis, septic abortion and post surgical gynecologic infections. Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify the causative organisms and to determine their susceptibility to ertapenem. Therapy may be initiated empirically before results of these tests are known; once results become available, antimicrobial therapy should be adjusted accordingly.
In patients with known hypersensitivity to any component of this product, to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactams. Due to the use of lidocaine Hcl as a diluent, administration intramusculary is contraindicated in patients with a known hypersensitivity to local anesthetics of the amide type (Refer to the prescribing information for lidocaine HCl).
Patients with CNS disorders (e.g., brain lesions or history of seizures) and/or compromised renal functions. Close adherence to the recommended dosage regimen is urged, especially in patients with known factors that predispose to convulsive activity. Anticonvulsant therapy should be continued in patients with known seizure disorders. Dosage adjustment is recommended in patients with reduced renal function. Prolonged use may result in overgrowth of non-susceptible organisms. Caution should be taken when administering intramuscularly to avoid inadvertent injection into a blood vessel. Lidocaine HCI is the diluent for intramuscular administration. Periodic asessment of organ system function is advisable during prolonged therapy.
The most common drug-related side effects were diarrhea, infused vein complication, nausea, headache, vaginitis in females, phlebitis/thrombophlebitis and vomiting. For a complete list of side effects please refer to the approved data sheet.
When co-administered with probenecid, probenecid competes for active tubular secretion and reduced the renal clearance of ertapenem. Other than with probenecid, no specific clinical drug interaction studies have been conducted.