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Gentamicin Ampoule (pediatric)

Gentamicin (as sulphate)

10 mg per ml (Intravenous and Intramuscular)

Composition:
Each ampoule 2 ml contains:
Gentamicin (as sulphate)        20 mg

Properties:
Gentamicin is a bactericidal antibiotic, which acts by inhibiting normal protein synthesis in susceptible microorganisms. It is active against a wide variety of pathogenic bacteria including: E. Coli, Proteus Species (indole-positive & indole-negative), Pseudomonas aeruginosa, Species of the klebsiella-Enterobacter-Serratia group, Citrobacter species & Staphylococcus species (including Penicillin- & Methicillin-resistant strains). Gentamicin is also active against species of Salmonella & Shigella. Bacterial resistance to Gentamicin is generally developed slowly.

Indications & usage:

Gentamicin is indicated in the treatment of serious infections:
      1-  Bacterial neonatal sepsis, bacterial septicemia.
      2-  Serious bacterial infections of the central nervous system (meningitis).
      3-  Urinary tract infections.
      4-  Respiratory tract infections.
      5-  Gastrointestinal tract infections (including peritonitis).
      6-  Skin, bone & soft tissue infections (including burns).

N.B: Gentamicin is not indicated in uncomplicated episodes of urinary tract infections unless the microorganisms are susceptible to these antibiotics and are not susceptible to antibiotics having less potential for toxicity. The decision to continue therapy is based on the susceptibility tests & severity of infections.

Contraindications:
Hypersensitivity to gentamicin or a history of hypersensitivity or serious toxic reactions to other aminoglycosides.

Side effects:
     1- Nephrotoxicity.
     2- Respiratory depression, depression, visual disturbances, hypotension, hypertension, rash, laryngeal oedema, vomiting, nausea, pseudotumor cerebri, acute organic brain syndrome, joint pain and pulmonary fibrosis.
     3- Neurotoxicity: serious adverse effects on both vestibular and auditory branches of the 8th cranial nerves have been reported, in patients with renal impairment, or in patients on high doses and/or prolonged therapy. Symptoms include dizziness, vertigo, ataxia, tinnitus, roaring in the ears and hearing loss.
These side effects may be magnified as with excessive dosage, dehydration and previous exposure to other ototoxic drugs.
     4- Pain at injection site, so local irritation have been reported.
     5- Laboratory test abnormalities which may lead to tetany and muscle weakness due to hypomagnesemia, hypocalcemia and hypokalemia.

Drug interactions:
- Cephalosporins: cephaloridine may poteniate nephrotoxicity if used in conjunction with Gentamicin.
- The possibility of neuromuscular blockade and respiratory paralysis should be considered if aminoglycosides are administered by any route to patients receiving anesthetics, Neuromuscular blocking agents as succinyl choline, tubocurarine or decamethonium or in patients receiving massive transfusions of citrate-anticoagulated blood.

Warnings & precautions:
- Patients treated with aminoglycosides should be under close clinical observation because of the potential toxicity associated with their use.
- As with other aminoglycosides, gentamicin injectable is potentially nephrotoxic. The risk of Nephrotoxicity is greater in patients with impaired renal function and those who receive high dosage or prolonged therapy.
- Neurotoxicity manifested by ototoxicity, both vestibular and auditory can occur in patients treated with gentamicin injectable.
- Serum concentrations of aminoglycosides should be monitored, dosage should be adjusted, so that prolonged levels of peak concentrations above 12 mcg/ml are avoided. When monitoring trough concentrations (just prior to the next dose), dosage should be adjusted so that levels above 2 mcg/ml are avoided.
- Aminoglycosides should be used with caution in patients with neuromuscular disorders, such as myasthenia gravis.
- Patients should be well hydrated during treatment.
- Concurrent use of gentamicin with potent diuretics such as ethacrynic acid or furosemide should be avoided.
- A reduction in Gentamicin serum half life has been reported in patients with severe renal impairment receiving carbenicillin with gentamicin.

Pharmaceutical precautions (physical and chemical incompatibility):
This has been demonstrated with amphotericin, some of the cephalosporins, erythromycin, and heparin, high concentrations of the penicillins, sodium bicarbonate, sulfadiazine sodium & some solutions for parenteral nutrition.

Overdosage:

In the event of overdose or toxic reactions, hemodialysis may aid in the removal of gentamicin from the blood, and is especially important if renal function is/or becomes compromised. The rate of removal of gentamicin is considerably less by peritoneal dialysis than it is by hemodialysis.

Dosage and administration:

Gentamicin (injectable) may be given intramuscularly or intravenously. The patient’s pre-treatment body weight should be obtained for calculation of correct dosage. Dosage should be based on an estimate of the lean body mass in obese patients.

Dosage for patients with normal renal function:
Children:
6 to 7.5 mg/kg/day (2 to 2.5 mg/kg administered every 8 hours).

Infants and neonates:

7.5 mg/kg/day (2.5 mg/kg administered every 8 hours).

Premature or full term neonates one week of age or less:

5 mg/kg/day (2.5 mg/kg administered every 12 hours).

The dosage for patients with impaired renal function
(Dosage at 8-hours intervals after the usual initial dose).
 

Serum creatinine
(mg %)
 Approximate creatinine clearance rate
(ml/min./1.73 m2)
 Percent of usual doses
 <=1.0 > 100 100
 1.1 – 1.3  70 – 100  80
 1.4 – 1.6  55 – 70 65
 1.7 – 1.9  45 – 55  55
 2.0 – 2.2  40 – 45  50
 2.3 – 2.5  35 – 40  40
 2.6 – 3.0  30 – 35  35
 3.1 – 3.5  25 – 30  30
 3.6 – 4.0  20 – 25  25
 4.1 – 5.1  15 – 20  20
 5.2 – 6.6  10 – 15  15
 6.7 – 8.0  < 10 10

N.B: The usual duration of treatment for all patients is 7 to 10 days. In difficult and complicated infections, a longer course of therapy may be necessary.
 
Therapeutic category: Antibacterial.

Legal category:
Prescription only medicine.

Packing: Box containing 6 ampoules.
               Box containing 100 ampoules.

Storage:
Store below 25º C & protect from light.

THIS IS A MEDICAMENT
Medicament is a product, which affects your health and its consumption contrary to instructions is dangerous for you. Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.
- The doctor and the pharmacist are the experts in medicines, their benefits and risks.
- Do not by yourself interrupt the period of treatment prescribed.
- Do not repeat the same prescription without consulting your doctor.
- Keep all medicaments out of reach of children.

Council of Arab Health Ministers, Union of Arab Pharmacists.