Amibac 500 mg/2 ml (IM/IV Injection)

Indications

• Short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria
• Effective in bacterial septicemia, respiratory tract infections, bone and joint infections, central nervous system infections, skin and soft tissue infections, intra-abdominal infections, burns, postoperative infections, complicated and recurrent urinary tract infections

Pharmacology

Amikacin Sulfate is a semi-synthetic aminoglycoside antibiotic active against pseudomonas species, Escherichia coli, Proteus species, Providencia species, Klebsiella-Enterobacter species, Acinetobacter species, Citrobacter freundii, and penicillinase and nonpenicillinase-producing Staphylococcus species including methicillin-resistant strains

Dosage

• 15 mg/kg/day in two equally-divided doses for adults and children
• Initial loading dose of 10 mg/kg followed by 15 mg/kg/day in two equally divided doses for neonates and premature children
• Dosage adjustment for elderly and impaired renal function
• Increased dose for life-threatening infections and/or those caused by Pseudomonas
• Lower dose for urinary tract infections (other than pseudomonal infections)

Administration

• Intramuscular or intravenous administration preferred for most infections
• Intravenous route may be used in life-threatening infections or when intramuscular route is not feasible
• Intraperitoneal use as an irrigant after recovery from anesthesia in concentration of 0.25%

Interaction

Concurrent administration with myorelaxants, other Aminoglycoside antibiotics, fast acting diuretics, Cephalosporins, or Polymixins increases the risk of adverse effects

Contraindications

Contraindicated in patients with a known history of hypersensitivity to Amikacin or any constituents of the injection

Side Effects

• Tinnitus
• Vertigo
• Partial reversible or irreversible deafness
• Skin rash
• Drug fever
• Headache
• Paraesthesia
• Nausea
• Vomiting

Pregnancy & Lactation

Potential risk of ototoxicity in the fetus and no safety information available for breastfeeding

Precautions & Warnings

Patients should be well hydrated to minimize chemical irritation of the renal tubules, and renal function monitoring is important during treatment with aminoglycosides

Use in Special Populations

Safety and effectiveness in children or adolescents under 16 years have not been established

Overdose Effects

Peritoneal dialysis or haemodialysis will aid in the removal of Amibac from the blood in case of overdose or toxic reaction

Therapeutic Class

Aminoglycosides

Storage Conditions

Keep below 30°C temperature, away from light and moisture. Keep out of the reach of children.

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