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

Logo GENTAMYCIN-FRESENIUS (injection)
SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

GENTAMYCIN-FRESENIUS (injection)
Gentamycin-Fresenius 20 mg/2 mL (vials)
Gentamycin-Fresenius 80 mg/2 mL (vials)
Gentamycin-Fresenius 20 mg/2 mL (ampoules)
Gentamycin-Fresenius 40 mg/1 mL (ampoules)
Gentamycin-Fresenius 80 mg/2 mL (ampoules)

COMPOSITION:
Gentamicin sulphate equivalent to base 10 mg/mL (in 2 mL vials) - preserved with Methylhydroxybenzoate 0,18% m/v and Propylhydroxybenzoate 0,02% m/v.
Gentamicin sulphate equivalent to base 40 mg/mL (in 2 mL vials) - preserved with Methylhydroxybenzoate 0,18% m/v and Propylhydroxybenzoate 0,02% m/v.
Gentamicin sulphate equivalent to base 10 mg/mL (in 2 mL ampoules).
Gentamicin sulphate equivalent to base 40 mg/mL (in 1 mL ampoules).
Gentamicin sulphate equivalent to base 40 mg/mL (in 2 mL ampoules).

PHARMACOLOGICAL CLASSIFICATION:
A 20.1.1 Broad and medium spectrum antibiotics.

PHARMACOLOGICAL ACTION:
Gentamicin is a potent bactericidal antibiotic with a wide range of activity against both Gram-positive and Gram-negative organisms including strains of Staphylococcus aureus, Escherichia coli, Klebsiella, Proteus and Pseudomonas species.

INDICATIONS:
Gentamicin injection is indicated for the following conditions, when caused by susceptible organisms:
1. Acute and chronic urinary tract infections;
2. Severe systemic infections, e.g. sepsis, peritonitis, meningitis;
3. Bone and soft-tissue infections, e.g. acute osteomyelitis, wound and soft- tissue infections;
4. Infected burns;
5. Respiratory tract infections;
6. Eye infections.

CONTRA-INDICATIONS:
Gentamicin is contra-indicated in patients with a known history of allergy to it, and probably in those allergic to other aminoglycosides. Great care is required in patients with myasthenia gravis, parkinsonism and other conditions characterised by muscular weakness. Impaired hepatic function or auditory function, bacteraemia, fever, and perhaps exposure to loud noises have also been reported to increase the risk of ototoxicity, while volume depletion or hypotension, liver disease, or female sex have been reported as additional risk factors for nephrotoxicity.

DOSAGE AND DIRECTIONS FOR USE:
Intramuscular Administration:
Gentamicin injection is generally administered intramuscularly. Intravenous administration should only be utilised in special cases. (Refer Intravenous Administration). Adult patients with normal renal function:
1. Urinary Tract Infections:
In infections of moderate severity: 2 mg/kg/day in 3 equal doses (8 hourly). In patients with severe infections 3 mg/kg/day in 3 equal doses (8 hourly). In the treatment of urinary tract infections with gentamicin, alkalis should be given concomitantly to raise the urinary pH above 7.
2. Systemic Infections:
In infections of moderate severity: 2 mg/kg/day in 3 equal doses (8 hourly). In patients with severe infections: 3 mg/kg/day in 3 equal doses (8 hourly).
3. Life-threatening Infections (e.g. sepsis)
  (a) Adults: For patients with life-threatening infections up to 5 mg/kg/day in 3 equal doses (8 hourly). This dosage should be reduced to 3 mg/kg/day as soon as clinically indicated.
  (b) Children, Infants and Neonates:
Children: A dose of 3 to 6 mg/kg/day is administered in three equally divided doses every 8 hours.
Infants older than 1 week: Administer 3 to 6 mg/kg/day as for “Children”above, or in two equal doses every 12 hours.
Neonates and Infants less than 1 week: 6 mg/kg/day is administered in two equally divided doses every 12 hours.
Duration of treatment:
In all cases, the general duration of treatment is 7 to 10 days. When treatment exceeds this period, and in the administration of high dosage levels, it is advisable to monitor renal, auditory and vestibular functions (see Side-effects and Special Precautions).
Intravenous Administration:
This form of administration is only recommended when circumstances do not permit the intramuscular route. The recommended dose and precautions for intravenous administration are identical to those stipulated for the intramuscular route. Intravenous administration is to be carried out slowly or may be infused over a period up to 2 hours.
Patients with impaired renal function:
Dosage must be adjusted in patients with impaired renal function. To minimise risk of toxicity in these patients, the first dose should be that normally recommended. Subsequent doses should be administered less frequently depending on the degree of renal impairment.
Since the serum half-life of gentamicin has a close correlation with creatinine clearance and serum creatinine, the serum half-life (in hours) of gentamicin may be estimated by multiplying the serum creatinine (expressed in mg % ), by four. The interval between doses, in hours, may be approximated by doubling the serum half-life.
Table 1 provides the guidance for adjustment of the interval between doses of Gentamicin Injection based on the aforementioned renal function tests. In those instances when only a blood serum urea concentration is available this value may be utilised initially; however, it should be supplemented with a serum creatinine level or creatinine clearance rate whenever possible.
This dosage schedule is not intended as a rigid recommendation. It is provided as a guide to dosage when the measurement of gentamicin serum levels is not feasible. It should be used in conjunction with close clinical and laboratory observation of the patient, and modified as deemed necessary by the treating physician.

TABLE 1
Approximate dosage guidelines for Gentamicin Injection in Adult Patients based on renal function.

                                Renal Function Tests 
Mass of Adult Patient
(kg)		         Dose
        (mg)		 Creatinine Clearance Rate
(mL/min)		 Serum Creatinine
(mg %)		 Blood Urea
(mg %)		 Frequency of Administration
over 60
(132 lb.)		 80 (2 mL) over 70 less than 1,4 less than 38 every 8 hours
            35-70         1,4-1,9 36-63 every 12 hours
            24-34         2,0-2,8 64-84 every 18 hours
            16-23         2,9-3,7 85-105 every 24 hours
            10-15         3,8-5,3 106-159 every 36 hours
            *5-9         5,4-7,2 160-214 every 48 hours
60 or less
(132 lb.)		 (1,5 mL) (same as above) . . .

* When the creatinine clearance level is less than 5 mL/min, then haemodialysis is indicated. Gentamicin is dialysable and the dose should be individually adapted to the patient after each period of dialysis.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
In patients with normal renal function untoward side-effects are not anticipated at the recommended dosage.
In patients with impaired renal function or those patients treated with Gentamicin injection for longer periods or at higher dosage than recommended, ototoxicity (both vestibular and auditory) may occur, should gentamicin serum concentration levels exceed 12 mcg/mL, for prolonged periods.
In such patients, the frequency of Gentamicin administration should be reduced as indicated under dosage and directions for use, by assessing blood urea, creatinine or creatinine clearance rates. It is also considered advisable to check auditory and vestibular function and to monitor peak (one hour) gentamicin serum levels, to ensure they do not exceed 12 mcg/mL.
The concurrent use of gentamicin with diuretics such as ethacrynic acid and furosemide, should be avoided, as these two diuretics may individually result in ototoxicity. Similarly gentamicin should not be administered concurrently with other potentially ototoxic drugs (e.g. kanamycin, neomycin, streptomycin, etc.). The nephrotoxicity due to cephalosporins may be potentiated by gentamicin and caution should generally be exercised in the simultaneous administration of potentially nephrotoxic substances together with gentamicin.
Large doses of gentamicin should not be administered concurrently with neuromuscular blocking agents. As a result of this respiratory depression and muscular paralysis have been reported. Electrolyte disturbances (notably hypomagnesaemia, but also hypocalcaemia and hypokalaemia) have occurred.
Hypersensitivity reactions have occurred, especially after local use, and cross-sensitivity between aminoglycosides may occur. Very rarely, anaphylactic reactions to gentamicin have occurred. Some hypersensitivity reactions have been attributed to the presence of sulphites in parenteral formulations, and endotoxic shock has also been reported.
Administer with caution to patients with myasthenia gravis.
Pregnancy:
Studies in animals have not revealed teratogenic, ototoxic or nephrotoxic effects on the foetus. However, Gentamicin injection should only be administered to pregnant patients on the advice of the physician.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
In patients with renal impairment, gentamicin serum-blood levels in excess of 12 mcg/mL may result in ototoxicity. This is reversible if timeously observed and the dose is suitably adjusted. In the event of overdosage or toxic reactions, peritoneal dialysis or haemodialysis will aid in the removal of gentamicin from the blood.

IDENTIFICATION:
A clear, colourless glass ampoule or vial containing a clear colourless to slightly yellow solution.

PRESENTATION:
2 mL vials of 10 mg/mL (pack of 10 units)
2 mL vials of 40 mg/mL (pack of 10 units)
2 mL ampoules of 10 mg/mL (pack of 10 units)
1 mL ampoules of 40 mg/mL (pack of 10 units)
2 mL ampoules of 40 mg/mL (pack of 10 units)

STORAGE INSTRUCTIONS:
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
Gentamycin-Fresenius 20 mg/2 mL (vials)         N/20.1.1/71
Gentamycin-Fresenius 80 mg/2 mL (vials)         L/20.1.1/165
Gentamycin-Fresenius 20 mg/2 mL (ampoules)         L/20.1.1/162
Gentamycin-Fresenius 40 mg/1 mL (ampoules)         L/20.1.1/163
Gentamycin-Fresenius 80 mg/2 mL (ampoules)         L/20.1.1/164

NAME AND BUSINESS ADDRESS OF APPLICANT:
BODENE (PTY) LIMITED trading as Intramed, 6 Gibaud Road,
Port Elizabeth, 6001, South Africa

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
06/04/1981

        12-171/05-03
        Pro-Print

Updated on this site: May 2006
Source: Hospital Pharmacy

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