GENTAM ®
Gentamicin Sulphate
80/20 Injection

Composition | Properties | Indications | Dosage & Administration | Precautions | Contraindications | Side Effects | Overdosage | Presentations

COMPOSITION
GENTAM injection is a sterile aqueous solution for parenteral administration.
Each ml of (GENTAM 80) contains Gentamicin Sulphate BP equivalent to 40 mg Gentamicin base.
Each ml of (GENTAM 20) contains Gentamicin Sulphate BP equivalent to 10 mg Gentamicin base.

PROPERTIES
Gentamicin Sulphate is a bactericidal aminoglycoside antibiotic active against a wide variety of pathogenic gram- negative and some gram-positive bacteria. Susceptible organisms include: Pseudomonas aeruginosa, proteus species (indole-positive and indole-negative), Escherichia Coli, Klebsiella, Enterobacter, Serratia species, Neisseria gonorrhea and Staphylococcus species (penicillinase producing and non penicillinase producing).

INDICATIONS
GENTAM injection is indicated in urinary-tract infections, chest infections, bacteremia, septicaemia, infections following burns, infected traumatic or surgical wounds and other systemic infections due to sensitive organisms. GENTAM is usually given intramuscularly, but may be given intravenously if necessary, e.g. in patients with shock, in severe burns or reduced muscle mass. The same dosages are recommended for intramuscular and intravenous use. Direct injection into a vein should be over a period of two to three minutes. Administration by infusion should be completed over a period not less than 20 minutes and in no greater volume of fluid than 100ml. GENTAM injection should not be mixed in same syringe with any other drug prior to administration.

DOSAGE AND ADMINISTRATION
ADULTS :
1. Serious infections : 5 mg/kg daily in equally divided doses every 6-8 hours.
2. Other systemic infections : 80 mg every 8 hours for 7-10 days.
3. Urinary tract infections : As for systemic infections or if renal function is not impaired,160 mg once daily.
CHILDREN: (1-12 Years) 2 mg/kg every 8 hours.
INFANTS: (Birth-12 months) 3 mg/kg every 12 hours.

GENTAM is excreted by simple glomerular filtration and therefore is given in reduced dosage in the case of renal impairment.
The following table may be used when treating adults:

* 60 mg if body weight is less than 60 kg.

Frequency of dosage in hours may also be approximated as serum creatinine (mg/100 ml) x 8 (eight) or in SI units: as serum levels must be measured . Peak levels of Gentamicin occur approximately one hour after intramuscular injection and 15 minutes after bolus intravenous injection. The possibility of ototoxicity should be considered for peak levels above 10 mcg/ml.

CONTRAINDICATIONS
Hypersensitivity to Gentamicin or to other aminoglycosides. Because of ototoxicity and nephrotoxic hazards of extended administration, Gentamicin, like other aminoglycoside antibiotics is generally not indicated in long term therapy.

PRECAUTIONS
Closely observe all patients treated with aminoglycosides. GENTAM should not be used during pregnancy, except in life threatening situations. Hearing loss (vestibular damage) has seldom been manifested following the use of Gentamicin usually in the presence of impaired renal function following higher dosage or more prolonged administration than that recommended. In some patients with impaired renal function there has been a transient rise in blood urea-nitrogen, which usually returns to normal during or following cessation of therapy. Concurrent administration of Gentamicin and potentially ototoxic or nephrotoxic substances should be avoided. Neuromuscular blockade and respiratory paralysis have been reported from administration of aminoglycosides to patients who have received curare-type muscle relaxants during anaesthesia.

SIDE EFFECTS
Rash, itching, urticaria and pain at injection site. Renal, hepatic, haematologic, auditory and C.N.S. side effects have been reported and are related to dose and duration of treatment.

OVERDOSAGE
In the event of overdosage or toxic reaction, peritoneal dialysis or haemodialysis will aid in removal from the blood. Haemodialysis is preferable because it is more efficient in reducing serum levels.

PRESENTATIONS
GENTAM 80(40 mg/ml): available as 2 ml (80 mg) ampoules, packs of 5 ampoules. GENTAM 20(10 mg/ml): available as 2 ml (20 mg) ampoules, packs of 5 ampoules.