For the use of a Registered Medical Practitioner, a Hospital or a Laboratory only
MIKARAB injection
Each vial of MIKARAB contains
Amikacin - 100 mg, 250 mg and 500 mg
CATEGORY Antibiotics and Anti- Infectives
DESCRIPTION
Amikacin is a semisynthetic aminoglycoside effective against a variety of aerobic gram-negative bacilli including those that are resistant to gentamicin and other Aminoglycosides (Escherichia Coli, Pseudomonas Aeruginosa, Indole positive and negative Proteus species Klebsiella,
Enterobacter, Serratia, Acinetobacter, Citobacter Freundii and providencia stuarti).
It is effective against both penicillinase and non-penicillinase producing Staphylococcus Aureus.
Amikacin also shows excellent activity against Mycobacterium Tuberculosis and Atypical Mycobacteria.
INDICATIONS
MIKARAB injection is indicated in the short-term treatment of1 Serious infections due to susceptible strains of Gram-negative bacteria.
2 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 post vascular surgery).
3 serious complicated and recurrent urinary tract infections due to Gram-negative organisms.
4 suspected Gram-negative infections and therapy may be instituted before obtaining the results of susceptibility testing. Clinical trials demonstrated that amikacin was effective in
infections caused by gentamicin and/or tobramycin-resistant strains of Gram-negative organisms.
4 may be considered as initial therapy under certain conditions in the treatment of known or suspected staphylococcal disease such as severe infections where the causative organism may be either a Gram-negative bacterium or staphylococcus.
DOSAGE
The recommended dosage of MIKARAB for adults, children, and older infants with normal renal function is 15 mg/kg/day divided into 2 or 3 equal doses administered at equally-divided intervals, i.e. 7,5 mg/kg every 12 hours
Neonates and premature infants: An initial loading dose of 10 mg/kg followed by 15 mg/kg/day in two equally divided doses.
Treatment should preferably not continue for longer than 7 to 10 days, and the total dosage in adults should not exceed 15g.
CONTRA-INDICATIONS
1 history of hypersensitivity to amikacin or any component of the formulation,and other aminoglycoside antibiotics.2. Patients with myasthenia gravis
SIDE EFFECTS
When the recommended precautions and dosages are followed the incidence of toxic reactions, such as tinnitus, vertigo, partial reversible or irreversible deafness, skin rash, drug fever, headache, paraesthesia, nausea and vomiting is low. Urinary signs of renal irritation (albumin, casts and red or white blood cells), azotaemia and oliguria have been reported. There have been reports of retinal toxicity following intravitreal injection of amikacin.
PREGNANCY AND LACTATION
Pregnancy category D. Safety in pregnancy is not established. It is not known whether amikacin is excreted in breast milk. Since the possible harmful effect on the infant is not known, it is recommended that if nursing mothers must be given amikacin, the infants should not be breast fed during therapy.
DRUG INTERACTIONS
Concurrent use with other potentially nephrotoxic or ototoxic drug substances should be avoided. The risk of ototoxicity is increased when amikacin is used in conjunction with rapidly acting diuretic drugs, particularly when the diuretic is administered intravenously. Such agents include frusemide and ethacrynic acid, which is itself an ototoxic agent. Irreversible deafness may result.
OVERDOSAGE
In the event of overdosage or toxic reaction of MIKARAB inj. peritoneal dialysis or haemodialysis will aid in the removal of amikacin from the blood.
WARNING!
Be sure to consult your doctor before taking any medication!
"The information containes herein is not intended to cover all possible uses,directions,precautions,warnings,drug interactions, allergic reactions,or adverse effects.if you have questions about the drugs you are taking, check with your doctor"
