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

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

RIFADIN Syrup

COMPOSITION:
Each 5 mL contains rifampicin 100 mg.
Preservatives:
Methylparaben 0,12% m/v, propylparaben 0,03% m/v and potassium sorbate 0,13% m/v.

PHARMACOLOGICAL CLASSIFICATION:
A 20.1.1 Broad and medium spectrum antibiotics.

PHARMACOLOGICAL ACTION:
Rifampicin is active in vitro against tubercle bacilli and a variety of gram-positive and gram-negative microorganisms. The sensitive organisms include Mycobacterium tuberculosis, Mycobacterium leprae and Neisseria meningitidis. No cross resistance has been shown between rifampicin and other anti-tuberculosis drugs. In adults an oral dose of 450-600 mg rifampicin produces therapeutically effective levels in the blood with the peak being observed approximately 2 hours after administration. After absorption, rifampicin is rapidly eliminated in the bile, and an enterohepatic circulation ensues.
Up to 30% of the dose is excreted in the urine. Absorption of rifampicin is reduced when the drug is ingested with food. Rifampicin is widely distributed throughout the body. It is present in effective concentrations in many organs and body fluids, including cerebrospinal fluid.

INDICATIONS
Rifampicin is indicated in the treatment of all forms of tuberculosis, including fresh, advanced, chronic and drug-resistant cases. Rifampicin must always be used in conjunction with at least one other antituberculosis drug.

CONTRA-INDICATIONS:
Rifampicin is contra-indicated in the presence of jaundice and in patients with a history of hypersensitivity to any of the rifamycins. Rifampicin is contra-indicated during the first trimester of pregnancy and should be used only when absolutely necessary and after careful consideration in the second and third trimesters.

DOSAGE AND DIRECTIONS FOR USE:
In the treatment of tuberculosis rifampicin should always be administered with at least one other antituberculosis drug to prevent the possible emergence of rifampicin-resistant strains of mycobacteria. Oral dosage should be taken on an empty stomach at least 30 minutes before a meal or 2 hours after a meal.
Children: The dosage for children should normally be calculated on the basis of 8 - 12 mg/kg body mass. In more severe infections doses up to 20 mg/kg body mass may be used, but should not exceed 600 mg daily.
SHAKE THE BOTTLE WELL BEFORE USE.
Adults: The recommended single daily dose is 8 - 12 mg/kg body mass.
Usual daily dose:
Patients with body mass less than 50 kg. . . 450 mg. Patients with body mass of 50 kg or more. . .600 mg.
Doses towards the lower end of the scale are recommended for frail and elderly patients. In patients with impaired liver function the daily dose should generally not exceed 8 mg/kg daily.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Side Effects - Reactions occurring with either daily or intermittent dosage regimens include:

•	Cutaneous reactions which are self-limiting may occur and do not appear to be hypersensitivity reactions. Typically they consist of flushing and itching with or without a rash. More serious hypersensitivity cutaneous reactions may also occur.
•	Gastrointestinal reactions consist of anorexia, nausea, vomiting, abdominal discomfort, and diarrhoea.
•	Hepatitis can be caused by rifampicin and liver function tests should be monitored.
•	Thrombocytopenia with or without purpura may occur. Cerebral haemorrhage and fatalities have been reported when rifampicin administration has been continued or resumed after the appearance of purpura.

Eosinophilia, leucopenia, oedema, muscle weakness and myopathy have been reported.
Reactions usually occurring with intermittent dosage regimens and most probably of immunological origin include:

•	“Flu Syndrome” consisting of episodes of fever, chills, headache, dizziness, and bone pain.
•	Shortness of breath and wheezing.
•	Decrease in blood pressure and shock.
•	Acute haemolytic anaemia.
•	Acute renal failure.

Patients should be cautioned against interruption of dosage regimens.
Occasional disturbances of the menstrual cycle have been reported in women receiving rifampicin. Rifampicin may produce reddish colouration of the urine, sputum, and tears and the patient should be forewarned of this. Soft contact lenses may be permanently stained.
Patients with impaired liver function should only be given rifampicin in cases of necessity and then with caution and under strict medical supervision. In these patients, careful monitoring of liver function should be carried out during therapy. If signs of hepatocellular damage occur, rifampicin should be withdrawn.
In patients with impaired liver function, the elderly, malnourished and possibly children under two years of age caution is particularly recommended when instituting therapeutic regimens in which Isoniazid is to be used concurrently with rifampicin.
In some cases hyperbilirubinaemia, resulting from competition between rifampicin and bilirubin for excretory pathways of the liver at the cell level, can occur in the early days of treatment.
The decision to interrupt treatment should be made after evaluating the patient’s clinical condition in conjunction with repeated liver function tests.

Drug Interactions: Rifampicin has liver enzyme-inducing properties and may reduce the activity of a number of drugs including anticoagulants, corticosteroids, cyclosporin, digitalis preparations, quinidine, oral contraceptives, oral hypoglycaemic agents, dapsone, narcotics and analgesics. It may be necessary to adjust the dosage of these drugs if they are given concurrently with rifampicin. Patients using oral contraceptives should be advised to change to non-hormonal methods of birth control during rifampicin therapy. Also, diabetes may become more difficult to control. Rifampicin may interfere with diagnostic tests.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
In case of overdosage gastric lavage should be performed as soon as possible. Intensive supportive measures should be instituted and individual symptoms treated as they arise. Although it has not been observed in man, animal studies suggest that a possible neuro-depressant action is associated with very high doses of rifampicin.

IDENTIFICATION:
Red suspension with raspberry flavour.

PRESENTATION:
Bottles of 180 mL.

STORAGE CONDITION:
Store below 25°C. Keep out of reach of children.
Discard 20 days after opening

REGISTRATION NUMBER:
E/20.1.1/20.

NAME AND ADDRESS OF APPLICANT:
The Premier Pharmaceutical Company Limited
Epsom Downs Office Park
Sloane Street, Bryanston, 2152

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
02/06/1986.

07233
02/94
Britepak
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