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

Logo PRELONE SYRUP

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

PRELONE SYRUP

COMPOSITION:
Each 5 mL contains:
Prednisolone 15 mg
Preservative:
Benzoic Acid 0,1% m/v
Alcohol (95%) 5% v/v
PHARMACOLOGICAL CLASSIFICATION:
A 21.5.1 Corticosteroids and analogues.

PHARMACOLOGICAL ACTION:
Prednisolone is a synthetic glucocorticoid analogue primarily used for its anti-inflammatory effects.

INDICATIONS:
Symptomatic treatment of inflammatory conditions where a steroid is indicated.

CONTRA-INDICATIONS:
Prednisolone is contra-indicated in pregnancy and lactation.

Prednisolone is contra-indicated in patients with systemic fungal infections, sensitivity to prednisolone or other corticosteroids. Contraindicated in patients with peptic ulceration, osteoporosis, psychoses or severe psychoneuroses.

Patients with active or doubtfully quiescent tuberculosis should not be given corticosteroids except, very rarely, as adjuncts to treatment with anti-tubercular medication.

Contra-indicated in the presence of acute viral infections including herpes zoster or herpes simplex ulceration of the eye. Vaccination with live vaccine is contra-indicated with the use of prednisolone.

DOSAGE AND DIRECTIONS FOR USE:
DOSING REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE SPECIFIC DISEASE, ITS SEVERITY AND THE RESPONSE OF THE PATIENT.

Prednisolone has a usual dose range of 5 mg to 60 mg daily in divided doses depending on the specific disease being treated. In situations of less severity, low doses generally will suffice while in selected patients higher initial doses may be required. Dosages for infants and children should be governed by the same considerations as adults rather than strict adherence to ratios indicated by age or body weight.

The initial dose should be maintained or adjusted until a satisfactory response is observed.

If a period of spontaneous remission occurs in a chronic condition, treatment should be gradually discontinued.

Once a day dosage: The total daily maintenance dose can be administered once early in the morning or as a double dose on alternative days.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Corticosteroids may produce symptoms typical of hyperactivity of the adrenal cortex, with moon-face, sometimes with hirsutism, buffalo hump, flushing, increased bruising, striae and acne, sometimes leading to a fully developed Cushing's syndrome. Acute adrenal insufficiency during prolonged treatment, or on cessation of treatment. Excessive metabolic effects include osteoporosis and spontaneous fractures, nitrogen depletion and hyperglycaemia with accentuation or precipitation of the diabetic state. The insulin requirements of diabetic patients are increased. Increased appetite is often reported. Delayed wound healing.

Increased suspectibility to all kinds of infection, including sepsis and fungal infections.

Growth retardation in children.

Disturbances of electrolyte balance is manifest in retention of sodium and water with oedema and hypertension and in the increased excretion of potassium with the possibility of hypokalaemic alkalosis. Cardiac failure may be induced in extreme cases.

Use with caution in presence of congestive heart failure or hypertension in patients with diabetes mellitus, infectious diseases, chronic renal failure and uraemia and in elderly patients.

Other adverse effects include amenorrhoea, hyperhidrosis, mental and neurological disturbances, intra-cranial hypertension, acute pancreatitis and aseptic necrosis of bone.

Thrombo-embolic complications and muscular weakness have been reported.

Prednisolone may mask some signs of infection.

During long courses of corticosteroid therapy, patients should be seen regularly and checked for hypertension, glycosuria, hypokalaemia, gastric discomfort and mental changes. Sodium intake may need to be reduced and potassium supplements may be necessary.

Concurrent administration of barbiturates, phenytoin or rifampicin may enhance the metabolism and reduce the effects of corticosteroids.

Concurrent administration with potassium-depleting diuretics such as the thiazides or furosemide may cause excessive potassium loss.

Response to anticoagulants may be reduced or enhanced.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side effects and Special Precautions". Treatment is symptomatic and supportive.

IDENTIFICATION:
Clear, cherry red viscous solution with a characteristic cherry flavour.

PRESENTATION:
20 mL, 60 mL, 240 mL and 480 mL.

STORAGE INSTRUCTIONS:
Store below 25°C, protect form light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
28/21.5.1/0158

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Medpro Pharmaceutica (Pty) Ltd,
Unit 9 &10, Rosen Heights, Pasita Street, Rosenpark, BELLVILLE.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
NOVEMBER 1993

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