INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
CIDOMYCIN 20 mg INJECTION
CIDOMYCIN 40 mg INJECTION
CIDOMYCIN 80 mg INJECTION

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form)

CIDOMYCIN 20 mg INJECTION
CIDOMYCIN 40 mg INJECTION
CIDOMYCIN 80 mg INJECTION

COMPOSITION

gentamicin (as sulphate)	80 mg per 2 mL ampoule or vial
paediatric -	20  mg per 2 mL ampoule or vial
	40 mg per 1 mL ampoule or vial

Preservatives:

disodium edetate	0,01% m/v
methyl hydroxybenzoate	0,18% m/v for 40 mg and 80 mg injection;
	0,13% m/v for 20 mg injection
propyl hydroxybenzoate	0,02% m/v

PHARMACOLOGICAL CLASSIFICATION
A. 20.1.1 broad and medium spectrum antibiotics.

PHARMACOLOGICAL ACTION
Cidomycin is a potent bactericidal antibiotic with a wide range of activity against both Gram-positive and Gram-negative organisms. Pseudomonas and Proteus organisms are in the main particularly susceptible to the action of cidomycin as also are strains of Staphylococcus resistant to other antibiotics.

INDICATIONS
Cidomycin injectable and cidomycin injectable (paediatric) are indicated in the treatment of systemic infections due to sensitive organisms.

Urinary Tract Infections:
Here, cidomycin's activity against some of the troublesome, generally resistant Gram-negative bacilli is invaluable. Especially to be mentioned are Pseudomonas and Proteus spp. which are often difficult to eradicate.

Chest Infections:
Especially in those conditions in which the causative organism is Gram-negative or resistant to other antibiotics.

Septicaemias:
Cidomycin is indicated in those cases of septicaemia due to organisms resistant to other antibiotics. Pseudomonas septicaemia has been treated successfully with gentamicin.

Infected Burns:
Where the most serious invading organisms, Pseudomonas and Staphylococcus spp., are both covered by the bactericidal activity of cidomycin.

Empyema, Peritonitis, Infected Traumatic and Surgical Wounds:
In these cases, cidomycin is indicated if the organism is sensitive only to cidomycin.

Infections of the Central Nervous System:
Cidomycin has been used successfully in the treatment of meningitis and ventriculitis due to Gram-negative organisms.

CONTRA-INDICATIONS
Should not be used during pregnancy except in life-threatening situations.

DOSAGE AND DIRECTIONS FOR USE
A. ADULTS
1. Normal Renal Function
Systemic Infections:
80 mg 8 hourly for 7 - 10 days is usually an effective dose. If body mass is less than 60 kg, then 60 mg 8 hourly should be used.

Urinary Tract Infections:
Same as above. Alternatively, in selected cases, 160 mg once daily for 7 - 10 days. Concomitant use of sodium bicarbonate or mist.pot.cit. to render the urine pH alkaline is recommended.

Life Threatening Infections:
5 mg/kg per day in equally divided doses at 6 or 8 hour intervals and subsequently increased or decreased as clinically indicated. When such increased dosages are used, or where renal impairment exists, peak serum levels should be monitored to give a measure on adequacy of dosage and to serve to detect levels above 12 µg/mL at which the possibility of ototoxicity should be considered.

2. Patients with Impaired Renal Function
Dosage must be adjusted in patients with impaired renal function. To minimise the 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 cidomycin injection based on the aforementioned renal function tests. In those instances when only a blood urea concentration is available, this value may be utilized 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 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 physician concerned.

TABLE 1

		renal function tests
body mass adult patient	approximate dosage guidelines for cidomycin inject able In adult patients based on renal function	creatinine clearance rate	serum creatinine	blood urea
(kg)	(mg)	(mL/min)	(mg %)	(mg %)	frequency of administration
over 60	80 (2 mL)	over 70	less than 1,4	less than 38	every 8 hours
		35 - 70	1,4 - 1,9	38 - 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	(1,5 mL)	Same as above

B. CHILDREN
Children up to 12 years of age: 6 mg/kg in three divided doses.
Infants up to two weeks: 6 mg/kg daily in two divided doses.
When a longer course of therapy is necessary or higher doses are used, or where impaired renal function exists, there may be an increased risk of vestibulotoxicity. In these cases, it is mandatory to monitor peak serum levels. These levels should not be allowed to exceed 12 µg/mL for prolonged periods.

Compatibilities and Incompatibilities:
1. With antibiotics:
When considering the administration of other antibiotics with gentamicin, it should be borne in mind that although the following have been shown to be physically compatible in vitro, there may be some interaction in vivo which may be undesirable:

Potassium penicillin G
Sodium methicillin
Sodium ampicillin
Tetracycline hydrochloride
Chloramphenicol succinate

In general it is not recommended that gentamicin be mixed with other antibiotics prior to administration.

N.B. Carbenicillin and gentamicin are mutually inactivated when mixed. However, if the two drugs are administered concurrently, but separately, carbenicillin may enhance the activity of gentamicin. There is evidence that the nephrotoxicity of cephalosporins is increased in the presence of gentamicin

2. With other drugs:
Gentamicin sulphate is physically incompatible with the following:
Lipiphysan injection
Heparin

Gentamicin sulphate is physically compatible with the following:
Sodium chloride 0,9%
Ringer's solution U.S.P.
Dextrose 5%
Dextrose and sodium chloride injection U.S.P.
Fructose injection U.S.N.F.
Mannitol injection 25%
Aminosol 5%
Lomodex in normal saline
Dextraven 150 in 5% dextrose
Sodium bicarbonate injection B.P.

(Carbon dioxide may be liberated on the addition of the two solutions. Normally this will dissolve in the solution, but under some circumstances small bubbles may form. Special care should therefore be taken in using the I.V. route).

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
In the patient with normal renal function it is virtually impossible to achieve toxic levels at standard dosage. With gentamicin the vestibular mechanism may be affected when serum levels of 10-12 µg/mL are exceeded.
Where renal function is impaired through disease or old age the frequency, but not the amount of each dose should be reduced according to the degree of impairment.
Gentamicin is excreted by glomerular filtration and dosage frequency may be predicted by assessing blood urea or creatinine, or creatinine clearance rates and reducing the dose accordingly. It is also advisable to check serum levels to confirm that peak (one hour) levels do not exceed 10 µg/mL. The nephrotoxicity due to cephalosporins may be potentiated by gentamicin. Gentamicin should not be administered concurrently with ototoxic aminoglycosides or curare-type muscle relaxants. It should be remembered that gentamicin is a dialysable antibiotic and that further dosage may be required during and immediately after dialysis.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
In patients with renal impairment blood levels of higher than 10-12 µg/mL can lead to ototoxicity. This is reversible if observed in time and the dose adjusted.

CONDITIONS OF REGISTRATION
To be advertised to the professions only.

IDENTIFICATION
A clear, bright, colourless solution in an easy open ampoule or white neutral glass vial.

PRESENTATION
Cidomycin 20 mg injection(paediatric) is available in multidose 2 mL vials or ampoules each containing 20 mg gentamicin (as sulphate).

Cidomycin 40 mg injection is available in 1 mL ampoules each containing 40 mg gentamicin (as sulphate).

Cidomycin 80 mg injection is available in multidose 2 mL vials or ampoules each containing 80 mg gentamicin (as sulphate).

Note: Sensitivity discs are available containing 10 µg gentamicin base.

STORAGE INSTRUCTIONS
Store at room temperature, below 25°C.
Keep out of reach of children.

REGISTRATION NUMBER
Cidomycin 20 mg injection : B/20.1.1/9
Cidomycin 40 mg injection : J/20.1.1/133
Cidomycin 80 mg injection : J/20.1.1/421

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Roussel Laboratories (Pty) Limited,
REG. NO. 66/01057/07
5th Street, Marlboro Extension 1,
SANDTON 2199

DATE OF PUBLICATION OF THIS PACKAGE INSERT
22 December, 1977.
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