Powerzone

Powerzone

Manufacturer:

Zifam Pinnacle

Distributor:

Pinnacle House
Full Prescribing Info
Contents
Sulbactam Na, ceftriaxone Na.
Description
Ceftriaxone is a sterile, semi-synthetic, broad-spectrum cephalosporin antibiotic for IV or IM administration.
Sulbactam acts as a β-lactamase inhibitor thereby preventing destruction of ceftriaxone by β-lactamase-producing bacteria. Sulbactam sodium is a derivative of the basis penicillin nucleus. Chemically, sulbactam sodium is sodium penicillinate sulfone.
Action
Pharmacology: Ceftriaxone is a 3rd-generation cephalosporin antibiotic with a broad-spectrum activity which includes gram-positive and gram-negative aerobic and anaerobic bacteria.
Ceftriaxone has a high degree of stability in the presence of β-lactamase, both penicillinases and cephalosporinase of gram-positive and gram-negative bacteria. The bactericidal activity of ceftriaxone sodium results from inhibition of cell wall synthesis.
Sulbactam is a potent, highly specific inhibitor of a wide variety of β-lactamase produced by common gram-negative and gram-positive aerobes and anaerobes. By forming a protein complex with β-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.
Microbiology: Ceftriaxone is a bactericidal agent, with broad-spectrum activity against most of the gram-positive and gram-negative pathogens. It also shows a good activity against the anaerobes eg, Bacillus fragilis, Clostridium difficile and Pseudomonas.
Sulbactam itself exhibits a moderate antibacterial activity that is related to its affinity for penicillin-binding proteins (PBPs) of various bacterial strains.
Unlike clavulanic acid, sulbactam is also active against inducible chromosomally-mediated enzymes that cause resistance to 3rd-generation cephalosporins.
Indications/Uses
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.
The preoperative administration of Powerzone may reduce the incidence of postoperative infections in patients undergoing surgical procedures.
Dosage/Direction for Use
Adults: The usual adult daily dose (in terms of ceftriaxone) is 1-2 g given once daily (or in equally divided doses twice daily) depending on the type and severity of infection. The total daily dose should not exceed 4 g.
Treatment of Uncomplicated Gonococcal Infections: Single IM dose of 250 mg is recommended.
Preoperative Use (Surgical Prophylaxis): Single dose of 1 g administered intravenously ½-2 hrs before surgery is recommended.
Treatment of Meningitis: Recommended Initial Therapeutic Dose: 100 mg/kg. Maximum Dose: 4 g.
Thereafter, a total daily dose of 100 mg/kg/day (not to exceed 4 g daily) is recommended.
The daily dose may be administered once daily (or in equally divided dose every 12 hrs). The usual duration of therapy is 7-14 days.
Generally, Powerzone therapy should be continued for at least 2 days after the signs and symptoms of infection have disappeared. The usual duration of therapy is 4-14 days; in complicated infections, longer therapy may be required.
When treating infections caused by Streptococcus pyogenes, therapy should be continued for at least 10 days.
Renal or Hepatic Impairment: No dosage adjustment is necessary; however, blood levels should be monitored in patients with severe renal impairment (eg, dialysis patients), and in patients with both renal and hepatic dysfunctions.
Children: Treatment of Skin and Skin Structure Infections: Recommended Total Daily Dose: In terms of ceftriaxone, 50-75 mg/kg given once daily (or in equally divided doses twice daily). Maximum Dose: 2 g.
Treatment of Acute Bacterial Otitis Media: Single IM dose of 50 mg/kg is recommended. Maximum Dose: 1 g.
Treatment of Meningitis: Initial Therapeutic Dose: 100 mg/kg. Maximum Dose: 4 g. Daily dose may be administered once daily or in equally divided doses 12 hourly. The usual duration of therapy is 7-14 days.
Treatment of Serious Miscellaneous Infection Other than Meningitis: Recommended Total Daily Dose: 50-75 mg/kg, given in divided dose every 12 hrs. Maximum Dose: 2 g.
Administration: Powerzone may be administered intravenously or IM.
Contraindications
Hypersensitivity to penicillin or to any of the excipients of Powerzone.
Warnings
Seriously and occasionally, hypersensitivity (anaphylactic) reactions have been reported in patients receiving β-lactam therapy. These reactions are more apt to occur in individuals with history of hypersensitivity reactions to multiple allergens. If any allergic reaction occurs, Powerzone should be discontinued and the appropriate therapy instituted. Serious anaphylactic reactions require immediate emergency treatment with epinephrine, oxygen, IV steroids and airway management, including intubation, should be administered as indicated.
Special Precautions
General: Hypersensitivity and allergy to penicillin. Patients with renal/hepatic dysfunction, renal and haematological status should be monitored, especially during prolonged and high-dose therapy.
Use in pregnancy & lactation: Pregnancy Category: B. Reproductive studies have been performed in mice and rats at doses up to 20 times the usual human dose and no evidence of embryo toxicity, fetotoxicity or teratogenicity. In primates, no teratogenicity or embryogenicity was demonstrated at a dose approximately 3 times the human dose. There are however no well controlled studies in pregnant women.
Because animal reproductive studies are not always predictive of human response, Powerzone should be used during pregnancy only if clearly needed.
Low concentration 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.
Use in children: Safety and effectiveness of ceftriaxone in neonates, infants and children have been established. Sulbactam is also found to be safe in children and infants. Powerzone should not be administered to hyperbilirubinemic neonates, especially to prematures.
Use In Pregnancy & Lactation
Pregnancy Category: B. Reproductive studies have been performed in mice and rats at doses up to 20 times the usual human dose and no evidence of embryo toxicity, fetotoxicity or teratogenicity. In primates, no teratogenicity or embryogenicity was demonstrated at a dose approximately 3 times the human dose. There are however no well controlled studies in pregnant women.
Because animal reproductive studies are not always predictive of human response, Powerzone should be used during pregnancy only if clearly needed.
Low concentration 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.
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 hypersensitivity including pruritus, fever or chills.
Common gastrointestinal side effects include, diarrhea, nausea and vomiting.
Other Side Effects: Haematological complications, hepatic enzymes elevation, blood urea nitrogen elevation, headache, dizziness, vaginitis, flatulence, dyspepsia, palpitations and epistaxis.
Storage
Store at temperatures below 25°C.
MIMS Class
ATC Classification
J01DD63 - ceftriaxone and beta-lactamase inhibitor ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.
Presentation/Packing
Powd for inj (vial) 1.5 g x 1's.
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