INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
CLOXAM SYRUP
CLOXAM CAPSULES

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

CLOXAM SYRUP
CLOXAM CAPSULES

COMPOSITION:
Ampicillin trihydrate and cloxacillin sodium available as:

a)	Capsules	Gelatin capsules containing the equivalent of 250 mg ampicillin and 250 mg cloxacillin.
b)	Syrup	Powder for preparing fruit flavoured syrup. When dispensed as directed each 5 mL contains the equivalent of 125 mg ampicillin and 125 mg cloxacillin. The powder contains 0,13% m/v of sodium benzoate as a preservative.

PHARMACOLOGICAL CLASSIFICATION:
A 20.1.2 Penicillins.

PHARMACOLOGICAL ACTION:
In the combination each active ingredient maintains its own spectrum of activity. The meningococcus, pneumococcus, gonococcus, and List. monocytogenes are sensitive in vitro to the combination. Haemophilus influenzae and the viridans group of streptococci are usually inhibited in vitro by low concentrations. This combination is stable in an acidic medium and is adequately absorbed after oral administration. Absorption of the combination is more efficient when they are taken on an empty stomach.

INDICATIONS:
Mixed infections where organisms are susceptible to the combination of Ampicillin and Cloxacillin.

CONTRA-INDICATIONS:
Ampicillin and Cloxacillin (Cloxam) are contra-indicated in patients known to be sensitive to penicillin and it should be used with caution in patients with known histories of allergy. Reduced doses may be required in patients with impaired renal function.

DOSAGE AND DIRECTIONS FOR USE:
The average adult dose for Cloxam is 2 to 4 g in divided doses per day.

Preparation of the syrup:
To make up to 100 mL syrup, add 57 mL water, invert the bottle and shake until all the powder is dispersed.

Adults and children over 10
500 mL (1 x 500 mg capsule or 10 mL of 250 mg per 5 mL syrup) every six hours.
Children 2 - 10 years
250 - 500 mg (5 -10 mL of 250 mg per 5 mL syrup) every six hours.
Children up to 2 years
250 mg (5 mL of 250 mg per 5 mL syrup) every six hours.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Allergic reactions may occur in sensitised persons. When Ampicillin and Cloxacillin (Cloxam) is administered to a hypersensitive patient, anaphylactic shock with collapse and sometimes death may occur within minutes. A generalised sensitivity reaction can occur within 1 to 3 weeks with urticaria, fever, joint pains, angioneurotic oedema, erythema multiforme and exfoliative dermatitis, although an accelerated urticarial reaction can develop within hours. Maculopapular skin rashes can occur and are characteristic of ampicillin and often appear about 5 days after treatment has finished. Most patients with infectious mononucleosis develop a skin rash when treated with ampicillin.
Glossitis, angular and aphthous stomatitis can occur occasionally by injection.
Convulsions and other signs of toxicity to the central nervous system may occur with very high doses particularly when administered intravenously to patients with renal failure. Nephrotoxicity has occurred in some patients with diminished renal function given large doses of cloxacillin and ampicillin. Disturbances of blood electrolytes may follow the administration of large doses.
Some patients in the early stages of syphilis may experience a Herxheimer reaction shortly after starting treatment. Symptoms include fever, sweating, headache, malaise, and reactions at the site of the lesions. The reaction can be dangerous in cardiovascular syphilis or where there is a serious risk of increased local damage such as primary optic atrophy or nerve deafness.
Should a serious allergic reaction occur the drug should be discontinued and the patient treated specifically (adrenalin, aminophyllin, corticosteroids, antihistamines). Administration by mouth may cause diarrhoea, gastro intestinal discomfort, vomiting and pruritus ani. Raised serum transaminase concentrations have occasionally been reported.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
As above.

IDENTIFICATION:

Capsules	Size 0 hard gelatin capsules with an opaque dark blue cap and an opaque amethyst body
Syrup	An off-white free flowing powder.

PRESENTATION:

Capsules	'Securitainers' containing 20, 100 or 500 capsules.
Syrup	Clear glass bottles containing powder for reconstitution to syrup.

STORAGE DIRECTIONS:
Containers should be kept tightly closed in a cool, dry place, below 25°C. Once dispensed, syrup must be stored in a refrigerator and should be used within 7 days.
KEEP ALL MEDICINES OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:

Capsules	N/20.1.2/14.
Syrup	N/20.1.2/108.

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Lennon Limited
7 Fairclough Road
PORT ELIZABETH 6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
1.6.93
        12-02916-93
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