Powerzone

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powerzone

 

COMPOSITON

Each vial (dry powder) contains:

Ceftriaxone Sodium USP equivalent to Ceftriaxone……….1000 mg

Sulbactam Sodium USP equivalent to Sulbactam…………..500 mg

 

DESCRIPTION

Powerzone contains two beta-lactam antibiotic and beta-lactamase inhibitor

Ceftriaxone: Ceftriaxone is a third generation cephalosporin antibiotic with a broad-spectrum activity which includs Gram positive and Gram negative aerobic and anaerobic bacteria.

Ceftriaxone has a high degree of stability in the presence of beta lactamase, both penicillinasesand cephalosporinases of Gram negative and positive bacteria. The bactericidal activity of ceftriaxone sodium results from inhibition of cell wall synthesis.Sulbactam: Sulbactam is a potent, highly specific inhibitor of a wide variety of beta lactamase produced by common Gram negative and Gram positive aerobes and anaerobes. By forming a protein complex with beta-lactamase, sulbactam irreversibly blocks their destructive hydrolytic activity. Thus, the full potential of ceftriaxone against Enterobacter and Pseudomonas species is restored by the addition of sulbactam.

The combination of sulbactam and ceftriaxone sodium is active against all the organisms sensitive to ceftriaxone. In addition, it demonstrates synergistic activity (reduction in minimum inhibitory concentrations (MICs) for the combination versus those of each component) in a variety of organisms.

 

INDICATIONS AND USAGE

Powerzone is indicated for the treatment of the following infections:

  • Lower Respiratory Tract infections
  • Acute Bacterial Otitis Media
  • Skin and Skin Structure infections
  • Urinary Tract infections(complicated and uncomplicated)
  • Pelvic inflammatory Disease
  • Bone and joint infections
  • Intra-Abdominal infections
  • Meningitis
  • Resistant typhoid
  • Sexually transmitted diseases
  • Surgical Prophylaxis
  • Bacterial septicemia

 

 CONTRAINCATIONS

Powerzoneis contraindicated in patients with known allergy to penicillin or any other ingredients of combination.

 

Pregnancy and Lactation

Pregnancy Category B: The drug should be used during pregnancy only when clearly needed.

Low concentrations of ceftriaxone are excreted in human milk. No risk to nursing infants has been reported but caution should be exercised when ceftriaxone is administered to nursing women.

 

Pediatric Use

Safetly and effectiveness of Ceftriaxone in neonates, infants and children have been established, sulbactam is also found to be safe in children and infants.

 

ADVERSE REACTIONS

The most frequent adverse drug reactions are inflammation at injection site with pain and tenderness.

Other common adverse drug reactions that can occur with the combination are hypresensitivity including pruitus, fever or chills.

Common gastrointestinal side effects include,diarrhea, nausea and vomitting.

Other side effects: Haematological complications, Elevation of hepatic enzymes, elevation of BUN, headache, dizziness, vaginitis, flatulence, dyspepsia, palpitations and epistaxis.

 

DOSAGE AND ADMINISTRATION

Powerzone may be administered intravenously or intramuscularly.

Adults: The usual adult daily dose (in terms of Ceftriaxone) is 1-2 grams given once a day (or in equally divided doses twice a day) depending on the type and severity of infection. The total daily dose should not exceed 4 grams.

For the treatment of uncomplicated gonococcal infections, a single intramuscular dose of 250 mg is recommended.

For the preoperative use (surgical prophylaxis), a single dose of 1 gram administered intravenously

½ to 2hours before surgery is recommended.

No dosage adjustment is necessary for patients with impairment of renal or hepatic function.

Children: For the treatment of skin and skin structure infections, the recommended total daily dose is 50 to 75 mg/kg given once a day (or in equally divided doses twice a day). The total daily doses should not exceed 2 grams.

For the treatment of acute bacterial otitis media, a single intramuscular does of 50 mg/kg (not to exceed 1 gram)is recommended.

For the treatment of serious miscellaneous infections other than meningitis, the recommended total daily dose is 50 to 75 mg/kg, given in divided doses every 12 hours. The total daily dose should not exceed 2 grams.