Specbac 1gm IV

Indications

Specbac serves as an effective treatment option for adults and children facing various infections caused by single or multiple bacteria sensitive to Specbac, including:

• Pneumonia and Nosocomial Pneumonia
• Urinary Tract Infections
• Intra-abdominal Infections
• Gynaecological Infections, such as endometritis and pelvic inflammatory disease
• Skin and Skin Structure Infections
• Meningitis
• Septicaemia
• Pulmonary infections in cystic fibrosis
• Empiric treatment for presumed infections in patients with febrile neutropenia.

Pharmacology

Meropenem, a carbapenem antibiotic designed for parenteral use, acts by inhibiting bacterial cell wall synthesis, thereby exerting its bactericidal action. It effectively penetrates bacterial cell walls, displaying notable stability against all serine beta-lactamases and exhibiting a strong affinity for the Penicillin Binding Proteins (PBPs). This results in potent bactericidal activity against a broad spectrum of Gram-positive and Gram-negative, aerobic and anaerobic bacteria.

Dosage

The dosage and duration of Specbac therapy should be tailored to the specific type and severity of infection, as well as the patient’s condition. Recommended daily dosages include:

For Adults:

• The usual dose ranges from 500 mg to 1 gm via intravenous administration every 8 hours.
• Specific infections like pneumonia, urinary tract infections, gynaecological infections, and skin and skin structure infections typically require 500 mg IV every 8 hours, while others such as nosocomial pneumonias, peritonitis, and septicaemia may necessitate 1 g IV every 8 hours.
• Dosages for intra-abdominal infections range from 500 mg to 1 gm every 8 hours.
• For cystic fibrosis, dosages may go up to 2 gm every 8 hours, and for meningitis, 2 gm IV every 8 hours is recommended.

For Children:

• Children aged 3 months to 12 years may receive 10 to 40 mg/kg intravenously every 8 hours, with adjustments based on infection type, severity, susceptibility of pathogens, and the patient’s condition.
• Dosages for specific conditions like intra-abdominal infections, cystic fibrosis, meningitis, and febrile neutropenia are provided based on weight and age.

Administration

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

Interaction

Probenecid competes with Specbac for active tubular secretion, thus inhibiting renal excretion and increasing the elimination half-life and plasma concentration of meropenem. Specbac may reduce serum valproic acid levels, potentially leading to sub-therapeutic levels in some patients.

Contraindications

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

Side Effects

Specbac is generally well tolerated, with side effects such as inflammation, thrombophlebitis, pain at the site of injection, skin reactions like rash, pruritus, urticaria, abdominal pain, nausea, vomiting, and diarrhea being possible.

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.

Reconstitution

For intravenous bolus Administration, reconstitute Specbac (500 mg or 1 g) with sterile water for injection. Shake to dissolve and obtain a clear and colorless or pale yellow solution.

For intravenous infusion administration, Specbac for intravenous infusion may be directly constituted with a compatible infusion fluid and then further diluted (50 to 200 ml) with the compatible infusion fluid, as needed.

Storage Conditions

Vials should be stored in a cool, dry place (below 30°C), away from light & moisture. Keep out of the reach of children.