Invanz 20 Ml Vl
Each vial contains ertapenem sodium 1.046 g equivalent to ertapenem 1 g. The sodium content is approximately 137 mg (approximately 6 mEq).
Invanz is [4R-[3(3S*,5S*),4a,5?,6?(R*)]]-3-[[5-[[(3-carboxyphenyl)amino]carbonyl]-3-pyrrolidinyl]thio]-6-(1-hydroxyethyl)-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid monosodium salt.
Its empirical formula is C22H24N3O7SNa.
Ertapenem sodium is a white to off-white hygroscopic, weakly crystalline powder, with a molecular weight of 497.5. It is soluble in water and 0.9% sodium chloride solution, practically insoluble in ethanol and insoluble in isopropyl acetate and tetrahydrofuran.
Invanz is supplied as sterile lyophilized powder for IV infusion after reconstitution with appropriate diluent (see Instructions for Use under Dosage & Administration) and transfer to 50 mL of 0.9% sodium chloride injection or for IM injection following reconstitution with 1% lidocaine HCl.
Indications / Uses :
Treatment: Treatment of patients with moderate to severe infections caused by susceptible strains of microorganisms, as well as, initial empiric therapy prior to the identification of causative organisms in the infections listed as follows:
Adults: Complicated intra-abdominal infections; complicated skin and skin structure infections including diabetic lower extremity infections; community-acquired pneumonia; complicated urinary tract infections including pyelonephritis; acute pelvic infections including postpartum endomyometritis, septic abortion and post-surgical gynecologic infections; bacterial septicemia.
Pediatric Patients 3 Months to 17 Years: Complicated intra-abdominal infections, complicated skin and skin structure infections including diabetic lower extremity infections, community-acquired pneumonia, complicated urinary tract infections including pyelonephritis, acute pelvic infections including postpartum endomyometritis, septic abortion and postsurgical gynecologic infections.
Prevention: Invanz is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery.
Hypersensitivity to any of the excipients of Invanz or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to ?-lactams.
Due to the use of lidocaine HCl as a diluent, Invanz administered IM is contraindicated in patients with a known hypersensitivity to local anesthetics of the amide type and in patients with severe shock or heart block. (Refer to the prescribing information for lidocaine HCl.)
Special Precautions :
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with ?-lactams. These reactions are more likely to occur in individuals with a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe hypersensitivity reactions when treated with another ?-lactam. Before initiating therapy with Invanz, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, other ?-lactams and other allergens. If an allergic reaction to ertapenem occurs, discontinue the drug immediately. Serious anaphylactic reactions require immediate emergency treatment.
Case reports in the literature have shown that co-administration of carbapenems, including ertapenem, to patients receiving valproic acid or divalproex sodium results in a reduction in valproic acid concentrations. The valproic acid concentrations may drop below the therapeutic range as a result of this interaction, therefore increasing the risk of breakthrough seizures. Increasing the dose of valproic acid or divalproex sodium may not be sufficient to overcome this interaction. The concomitant use of ertapenem and valproic acid/divalproex sodium is generally not recommended. Antibacterials other than carbapenems should be considered to treat infections in patients whose seizures are well controlled on valproic acid or divalproex sodium. If administration of Invanz is necessary, supplemental anticonvulsant therapy should be considered (see Interactions).
As with other antibiotics, prolonged use of Invanz may result in overgrowth of nonsusceptible organisms. Repeated evaluation of the patient’s condition is essential. If superinfection occurs during therapy, appropriate measures should be taken.
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including ertapenem, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of “antibiotic-associated colitis”.
Caution should be taken when administering Invanz IM, to avoid inadvertent injection into a blood vessel (see Dosage & Administration).
Lidocaine HCl is the diluent for IM administration of ertapenem (Invanz). Refer to the prescribing information for lidocaine HCl.
Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. Invanz should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.
Use in lactation: Invanz is excreted in human milk. Caution should be exercised when the drug is administered to a nursing woman.
Use in children: Safety and effectiveness in pediatric patients 3 months to 17 years are supported by evidence from adequate and well-controlled studies in adults, pharmacokinetic data in pediatric patients and additional data from comparator-controlled studies in pediatric patients 3 months to 17 years with the following infections (see Indications): Complicated intra-abdominal infections, skin and skin structure infections, community-acquired pneumonia, complicated urinary tract infections, acute pelvic infections. Invanz is not recommended in infants <3 months as no data are available.
Use in the elderly: In clinical studies, the efficacy and safety of Invanz in the elderly (=65 years) was comparable to that seen in younger patients (<65 years).