INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo KACINTH-A INJECTION 100 mg/2 mL
KACINTH-A INJECTION 250 mg/2 mL
KACINTH-A INJECTION 500 mg/2 mL

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

KACINTH-A INJECTION 100 mg/2 mL
KACINTH-A INJECTION 250 mg/2 mL
KACINTH-A INJECTION 500 mg/2 mL

COMPOSITION:
Each single dose 2 mL vial contains:
100 mg, 250 mg or 500 mg
amikacin (as amikacin sulphate) and 0,13% m/v, 0,33% m/v and 0,66% m/v sodium metabisulphite respectively as antioxidant.

PHARMACOLOGICAL CLASSIFICATION:
A20.1.1 Broad and medium spectrum antibiotics.

PHARMACOLOGICAL ACTION:
Kacinth-A (amikacin) is a semisynthetic aminoglycoside, with a broad antimicrobial activity and exhibits resistance to aminoglycoside-inactivating enzymes. It is bactericidal and is minimally protein bound. It is largely excluded from most cells, from the central nervous system and eye. Low concentrations are found in secretions like the respiratory secretions, as well as the plural and synovial fluid, but this can be increased by repeated administration. High concentrations are found in the renal cortex and in the endolymph and perilymph of the inner ear. Inflammation increases its penetration into peritoneal and pericardial cavities.

Inadequate concentrations for the treatment of meningitis are achieved in the cerebrospinal fluid in adults.

Elimination of Kacinth-A (amikacin) is almost entirely by glomerular filtration, it being suggested that tubular reabsorption occurs. Kacinth-A (amikacin) has a half-life of 2-3 hours, most of the dose being excreted within 24 hours.

Kacinth-A (amikacin) is effective in-vitro against the majority of gram-negative bacteria including species of: Campylobacter, Citrobacter, Escherichia, Enterobacter, Klebsiella, Proteus, Providencia, Pseudomonas and Serratia. It is highly effective against most strains of Staphylococcus aureus. Listeria monocytogenes and some Staph epidermidis may also be sensitive. In-vitro activity does not necessarily imply in-vivo efficacy.

INDICATIONS:
Kacinth-A Injection (amikacin) is the preferred treatment of serious nosocomial gram-negative bacilliary and in some gram-positive infections in hospitals where resistance to gentamicin and tobramycin have been found.

CONTRA-INDICATIONS:
Sensitivity to amikacin or other aminoglycoside antibiotics. Pregnancy and lactation. Patients with myasthenia gravis. Severe renal function impairment.

WARNINGS:
Incompatibility or loss of activity has been reported between Kacinth-A (amikacin) and some antibiotics. It is therefore advised that Kacinth-A (amikacin) should not be physically mixed with other antibacterial agents in syringes, infusion containers or other equipment. Each agent should be administered separately.

DOSAGE AND DIRECTIONS FOR USE:
Should clinical response not occur in 3 to 5 days, alternate therapy should be considered.
Treatment should preferably not continue for longer than 7 to 10 days and the total dosage in adults should not exceed 15 g. Peak plasma concentrations greater than 30 µg/mL or trough values greater than 10 µg/mL, should be avoided.

Intramuscular or intravenous administration:
Adults and children:
15 mg per kg lean body mass daily in divided doses every 8 to 12 hours to a maximum of 1,5 g daily in adults.

Neonates:
A loading dose of 10 mg per kg lean body mass followed by 15 mg per kg daily in two divided doses.
Intravenous injections should be slow over 2 to 3 minutes or by infusion over 30 to 60 minutes in adults or 1 to 2 hours in infants.
Suitable diluents are 100 to 200 mL sodium chloride 0,9% or dextrose 5% injection.

Use in renal impairment:
Adjustment of dosage in renal insufficiency should be calculated according to plasma Kacinth-A (amikacin) concentrations. The patients should be well hydrated. Discard any unused portion.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Irreversible ototoxicity as well as reversible nephrotoxicity may occur and acute renal failure has been reported. Since the incidence of nephrotoxicity and ototoxicity are related to the concentration to which Kacinth-A (amikacin) accumulates, it is crucial to reduce the maintenance dosage of Kacinth-A (amikacin) in patients with impaired renal function. Kacinth-A (amikacin) possesses a neuromuscular blocking action and respiratory depression and muscular paralysis have been reported. Hypersensitivity reactions have occurred, and cross-sensitivity between aminoglycosides may occur.
Hypomagnesaemia, hypocalcaemia and hypokalaemia have occurred in association with antineoplastic agents. Anaemia, purpura, convulsions, visual disturbances, increased serum aminotransferase values and increased serum-bilirubin concentrations have been reported. Pseudomembranous colitis may occur.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "side-effects and special precautions".

Kacinth-A (amikacin) can be removed by haemodialysis or to a lesser extent by peritoneal dialysis. Treatment is symptomatic and supportive.

IDENTIFICATION:
A clear colourless to slightly yellowish solution in 2 mL clear glass vials.

PRESENTATION:
2 mL clear glass vials in packs of 10.

STORAGE INSTRUCTIONS:
Store below 25°C.
Keep out of reach of children.

REGISTRATION NUMBERS:
Kacinth-A 100 mg: Y/20.1.1/175
Kacinth-A 250 mg: Y/20.1.1/176
Kacinth-A 500 mg: Y/20.1.1/178

NAME AND BUSINESS ADDRESS OF APPLICANT:
INTRAMED (PTY) LTD.
6 Gibaud Road
PORT ELIZABETH 6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
June 1991 12-208/4-93
  Tradepak PE

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