Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Aspen-p
ASPELONE (Liquid) SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): ASPELONE (Liquid) COMPOSITION: Each 5 mL of ASPELONE liquid contains: prednisolone sodium phosphate which is equivalent to 15 mg prednisolone base. Preservatives: Sodium methyl parahydroxybenzoate 0,21% m/v Sodium propyl parahydroxybenzoate 0,022% m/v Contains no sugar and no alcohol. PHARMACOLOGICAL CLASSIFICATION: A.21.5.1 Corticosteroids and analogues. PHARMACOLOGICAL ACTION: Prednisolone is a synthetically derived glucocorticoid analogue used mainly for its anti-inflammatory effects. INDICATIONS: ASPELONE is used for the relief of symptoms associated with inflammatory conditions, where a steroid is indicated. CONTRA-INDICATIONS: Hypersensitivity to ASPELONE or other corticosteroids. ASPELONE should not be used by pregnant or breastfeeding women (see “PREGNANCY AND LACTATION”). ASPELONE is contra-indicated in patients with osteoporosis, oesophagitis, gastritis, peptic ulcer, acute psychosis or severe psychoneuroses. It should not be used in patients with systemic fungal infections, or in patients with uncontrolled, systemic or local bacterial or viral infections. Patients with active or doubtfully quiescent tuberculosis should not be given ASPELONE, except, very rarely, as adjuncts to anti-tubercular treatment. The presence of acute viral infections such as herpes zoster or ocular herpes simplex are contra-indications to the use of ASPELONE. Patients receiving high-dose ASPELONE should not be immunized with live vaccines for up to 3 months after steroid therapy. INTERACTIONS: Concurrent use of barbiturates, carbamazepine, phenytoin, primidone, or rifampicin may lead to an increased metabolism and reduced effect of corticosteroids. Plasma levels of corticosteroids may be elevated by oral contraceptives or ritonavir. Hypokalaemia Read the complete document