(and dosage form):
Each 5 mL contains 0,60 mg betamethasone (equivalent in anti-inflammatory activity to about 5 mg prednisolone).
Preservative: Sodium benzoate 0,15% m/v
A 21.5.1 Corticosteroids and analogues.
Betamethasone is a synthetic glucocorticoid analogue primarily used for its anti-inflammatory effects.
Symptomatic treatment of inflammatory conditions where a steroid is indicated.
The safety of the use of BETANOID SYRUP during pregnancy and in nursing mothers has not been established.
BETANOID SYRUP is contra-indicated in patients with systemic fungal infections, sensitivity to betamethasone or other corticosteroids. Contra-indicated in patients with peptic ulceration, osteoporosis, psychosis 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 BETANOID SYRUP.
DOSAGE AND DIRECTIONS FOR USE:
DOSING REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALISED ON THE BASIS OF THE SPECIFIC DISEASE, ITS SEVERITY AND THE RESPONSE OF THE PATIENT.
Betamethasone has a usual dose range of 0,6 mg to 4,8 mg daily in divided doses (5 mL to 40 mL BETANOID SYRUP) 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.
Dosage 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 discontinued.
Once a day dosage: The total daily maintenance dose can be administered once early in the morning.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Corticosteroids may produce symptoms typical of hyperactivity of the adrenal cortex, with moonface, 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 susceptibility to all kinds of infection, including sepsis and fungal infections. Growth retardation in children. Disturbances of electrolyte balance are 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 heart failure or hypertension in patients with diabetes mellitus, infectious diseases, chronic renal failure and uraemia and in elderly persons. 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. BETANOID SYRUP 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 of 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.
Clear orange syrup with a fruity odour and taste.
Amber glass or brown plastic bottles of 100 mL or brown plastic bottles of 500 mL
Store below 25°C, protect from light.
KEEP OUT OF REACH OF CHILDREN.
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
7 Fairclough Road,
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
30 April 1993
Updated on this site: October 2005
Source: Community Pharmacy
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