Specbac Injection 1gm/vial

Specbac Injection 1gm/vial

Meropenem is a carbapenem antibiotic for parenteral use . It exerts its bactericidal action by interfering with bacterial cell wall synthesis. It penetrates bacterial cell walls, its high level of stability to all serine beta-lactamases and its marked affinity for the Penicillin Binding Proteins (PBPs.). It shows potent bactericidal activity against a broad spectrum of Gram-positive and Gram-negative, aerobic and anaerobic bacteria.

Administration

Meropenem should be administered by intravenous Infusion over approximately 15-30 minutes or as intravenous bolus (5 to 20 ml) over approximately 3-5 minutes

Interaction

Probenecid competes with Specbac for active tubular secretion and thus inhibits the renal excretion, with the effect of increasing the elimination half-life and plasma concentration of meropenem. Specbac may reduce serum valproic acid levels. Sub therapeutic levels may be reached in some patients.

Contraindications

Meropenem is contraindicated in patients who have demonstrated hypersensitivity to this product.

Side Effects

Specbac is generally well tolerated. Side effects like inflammation, thrombophlebitis, pain at the site of injection, skin reactions like rash, pruritus, urticaria, abdominal pain, nausea, vomiting, diarrhea, headache may occur.

Pregnancy & Lactation

Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. So this drug should be used during pregnancy only if clearly needed. Because many drugs are excreted in human milk, caution should be exercised when Meropenem is administered to a nursing woman.

Precautions & Warnings

If an allergic reaction to Specbac occurs, the drug should be discontinued and appropriate measures taken. Use of Specbac in patients with hepatic disease should be made with careful monitoring of transaminase and bilirubin levels.

Use in Special Populations

Renal impairment: Dosage should be reduced in patients with creatinine clearance less than 51 ml/min.

Hepatic impairment: No dosage adjustments are necessary with impairment of liver function. Hemodialysis patients should receive Specbac after dialysis has been completed.

Elderly: No dosage adjustments are necessary in elderly patients unless creatinine clearance is <51 ml/min.

Use in Children: Efficacy and tolerability in infants under 3 months have not been established.

Overdose Effects

Accidental overdose could occur during therapy, particularly in patients with renal impairment. Treatment of overdose should be symptomatic. In normal individuals, rapid renal elimination will occur; in subjects with renal impairment, haemodialysis will remove Specbac and its metabolite.

Therapeutic Class

Other beta-lactam Antibiotics

Storage Conditions

Vial store in a cool, dry place (below 30oC), away from light & moisture. Keep out of the reach of children.