Kacin^®

Kacin® is the preparation of Amikacin which is an aminoglycoside, binds to the prokaryotic ribosome, inhibiting protein synthesis in susceptible bacteria. It is bactericidal in vitro against gram positive and gram negative bacteria.

Kacin ® is a semi-synthetic aminoglycosidic antibiotic, indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria. Kacin ® is effective in bacterial septicemia (including neonatal sepsis); in serious infections of the respiratory tract, bones and joints, central nervous system (including meningitis) and skin and soft tissue; intra abdominal infections (including peritonitis); and in burns and post operative infections (including postvascular surgery). Kacin ® is also effective in serious complicated and recurrent urinary tract infections due to susceptible Gram-negative organisms. Kacin ® may be considered as initial therapy in suspected Gram-negative infections and therapy may be instituted before obtaining the results of susceptibility. Kacin ® is also effective in infections caused by Gentamycin and/or Tobramycin resistant strains of Gram-negative organisms. Kacin ® has also been shown to be effective in Staphylococcal infection and may be considered as initial therapy under certain condition in the treatment of known suspected Staphylococcal disease such as, severe infections where the causative organism may either a Gram-negative bacterium or Staphylococcus infection due to susceptible strains of Staphylococcal / Gram-negative infections. In certain severe infections such as neonatal sepsis, concomitant therapy with a penicillin type drug may be indicated because of the possibility of infections due to Gram positive organism such as streptococci or pneumococci.

Kacin® is a semi synthetic aminoglycosidic antibiotic, indicated in the short term treatment of serious infections due to susceptible strains of gram negative bacteria. Kacin® is effective in bacterial septicemia (including neonatal sepsis); in serious infections of the respiratory tract, bones and joints, central nervous system (including meningitis) and skin and soft tissue; intra-abdominal infections (including peritonitis); and in bums and post-operative infections (including post vascular surgery). Kacin® is also effective in serious complicated and recurrent urinary tract infections due to susceptible gram negative organisms. Kacin® may be considered as initial therapy in suspected gram negative infections and therapy may be instituted before obtaining the results of susceptibility. Kacin® is also effective in infections caused by gentamycin and/or tobramycin resistant strains of gram negative organisms. Kacin® has also been shown to be effective in Staphylococcal infection and may be considered as initial therapy under certain condition in the treatment of known suspected Staphylococcal disease such as, severe infections where the causative organism may either a gram negative bacterium or Staphylococcus infection due to susceptible strains of Staphylococcal/gram negative infections. In certain severe infections such as neonatal sepsis, concomitant therapy with a penicillin type drug may be indicated because of the possibility of infections due to gram positive organism such as Streptococci or Pneumococci.

Route of administration: For most infections the intramuscular route is preferred, but in life threatening infections or in patients in whom intramuscular injection route is not feasible the intravenous route may be used. Kacin® is also given in intraperitoneal route and is used as an irrigant after recovery from anesthesia in concentration of 0.25%. Kacin® in concentration of 0.25% may be used satisfactorily as an irrigating solution in abscess cavities, the pleural space, the peritoneum and the cerebral ventricles. Adults and children: 15 mg/kg/day in two equally divided doses (equivalent to 500 mg bid in adults). Use of the 100 mg/2 ml strength is recommended for children for the accurate measurement of the appropriate dose. Neonates and premature children: An initial loading dose of 10 mg/kg followed by 15 mg/kg/day in two equally divided doses. Elderly : Doses should be adjusted under impaired renal function in elderly. Life threatening infections and/or those caused by pseudomonas: The adult dose may be increased to 500 mg every eight hours but should neither exceed 1.5 g/day nor be administered for a period longer than 10 days. A maximum total adult dose of 15 g should not be exceeded. Urinary tract infection (other than pseudomonal infections): 7.5 mg/kg/day in two equally divided doses (equivalent to 250 mg bid in adults). Kacin® is also recommended in uncomplicated urinary tract infection with a dose of 250 mg twice daily. Impaired renal function: In patient with impaired renal function the daily dose should be reduced and/or the interval between doses increased to avoid accumulation of the drug. Simple doses schedule for renal impairment is given below:

Renal Function	Dose schedule
Mild impairment	500 mg every 18 hours
Moderate impairment	500 mg every 24 hours
Severe impairment	250 mg every 24 hours

Pregnancy: Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycosides cross the placenta and there have been several reports of total irreversible, bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Lactation: It is not known whether amikacin is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from amikacin, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Use in children and adolescents Aminoglycosides should be used with caution in premature and neonatal infants because of the immaturity of these patients and the resulting prolongation of serum half-life of these drugs.

No Data

Patients treated with parenteral aminoglycosides should be under close clinical observation because of the potential ototoxicity and nephrotoxicity associated with their use. The risk of aminoglycoside induced ototoxicity is greater in patients with renal damage. Vertigo may occur and may be evidence of vestibular injury. The risk of hearing loss due to aminoglycosides increases with the degree of exposure to either high peak or high trough serum concentrations. Aminoglycosides are potentially nephrotoxic. The risk of nephrotoxicity is greater in patients with impaired renal function and in those who receive high doses or prolonged therapy. Neuromuscular blockade and respiratory paralysis have been reported following parenteral injection, topical instillation (as in orthopedic and abdominal irrigation or in local treatment of empyema), and following oral use of aminoglycosides

The most common side effects of amikacin are tinnitus, vertigo, partial reversible or irreversible deafness, skin rash, drug fever, headache, paresthesia, nausea and vomiting. Other side effects include urinary signs of renal irritation, azotemia and oliguria

Amikacin is contraindicated in patients with known hypersensitivity to amikacin or any components of this product.

Drug interaction with medication: The use of amikacin with potent diuretics (ethacrynic acid or furosemide) should be avoided since diuretics by themselves may cause ototoxicity. In addition when administered intravenously, diuretics may enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue. Drug interaction with food and others: Not applicable.

In case of overdose, peritoneal dialysis or hemodialysis will aid in the removal of amikacin from the blood. In the newborn infant exchange transfusion may also be considered.

Store in a cool and dry place. Protect from light.

Store in a cool (below 25° C) and dry place protected from light. Keep away from the reach of children.