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Gentamicin Injection BP 40mg/ml
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Composition :  
Each ml contains Gentamicin Sulphate BP Gentamich 40 mg
Methylparaben*BP 0.18% W/V
(*as preservatives)
Water for injection BP q.s

Pharmacological Action :

Indications :
Gentamicin is indicated in the treatment of serious systemic infections, including those of the central nervous system, due to organisms sensitive to this anti-infective.

Dosage and direction for use :
As directed by the physician.

Warning :
Do not use if any particle or suspended matter is visible.

Method of administration :   IM

Contraindications :
  • Use in patients hypresensitive to gentamicin.
  • Use concurrently with other potentially nephrotoxic or ototoxic drug substances.
  • Gentamicin should be used with caution in premature infacts because of their renal immatunity, in elderly people and generally in patients with impaired renal function.
  • Diabetes, auditory vestibular dysfunction, otitis media, a history of otitis media, previous use of ototoxic drugs and generally determined high sensitivity to aminoglycoside induces ototoxicity, are other main factors which may pre dispose the patients the toxicity.

Special Warnings and Precautions :
Patients being treated with Gentamicin should be under close clinical observation because of its potential toxicity.

As with other aminoglycosides toxicity is related to serum concentration. With 6-8 hourly dosing, serum levels more than 10 micrograms/ml may be associated with effects on the vestibular mechanism. Toxicity can be minimised by monitoring serum concentrations and its advisable to check serum levels to confirm that peak levels (one hour) do not exceed 2 micrograms/ml. Evidence of toxicity requires adjustment of dosage or withdrawal of the drug.

Concurrent use of other neurotoxic drugs can increase the possibility of Gentamicin toxicity. Co-administration with the following agents should be avoided.

Other potentially nephrotoxic or ototoxic drugs such as cephalosporins and methicilin. Potent diluretics such as ethacrynic acid and frusemide. Other aminoglycosides

Side effects :
Ototoxicity and nephrotoxicity are the most common side effects associated with Gentamicin. Both effects are related to renal impairment and hence the dosage in such patients should be altered as suggested. Other advsrse reactions associated with gentamicin therapy include nausea, vomiting, urticaria, reversible granulocytoperia, allergic contact sensitization and neuromuscular blockade.

Drug Interaction :
  • Antibacterials : Increased risk of nephrotoxicity with cephalosporins notably cephaloyhin.
  • Gentamicin has been known to potentiate anticoagulants such as warfarin and phenindione.
  • Anifungals:Increased risk of nephrotoxicity with amphotencin.
  • Cholinerghics:Antagronism of effect of neostigmine and pyridostigmine.
  • Cyclosporin:Increased wisk of nephrotoxicity.
  • Cytoxics: Increased risk of nephrotoxicity and possible risk of ototoxicity.
  • Diuretics: Increased risk of ototoxicity with loop diuretics.
  • Muscle relazants: Effect of non-depolarising muscle relaxants such as tubocurarine enhanced.

Pregnanvy & Lactation :
Gentamicin should only be used during pregnancy or lactation if consider essential by the physician. The drug crosses the placenta and it is excreted in small amounts in breast milk.

Overdose :
As in the case of other aminoglycosides, toxicity is associated with serum levels above a critical value. In patients with normal renal function it is unlikly that toxic serum levels(in excess of 10 micrograms/ml) will be reached after administration of recommended doses. Where higher levels occur because of renal impaiment, dosage should be reduce. In the evennt of an overdose or toxic reaction, poritoneal dialysis or haemodialysis will lower serum Gentamicin levels.

Stroage :
Store in a cool day place, Protect from light
Keep out of the reach of children.

Presentation :
410x2 ml Ampoule

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