Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Cipla
BECLATE AQUANASE SCHEDULING STATUS S2 PROPRIETARY NAME (and dosage form) BECLATE AQUANASE (aqueous nasal spray) COMPOSITION Beclate Aquanase is an aqueous nasal spray, delivering 50 mcg beclomethasone dipropionate per metered actuation. Preservative: Benzalkonium Chloride 0,02% v/v and Phenyl Ethyl Alcohol 0,25% v/v. PHARMACOLOGICAL CLASSIFICATION Category A. 21.5.1. Corticosteroids and analogues. PHARMACOLOGICAL ACTION Beclomethasone dipropionate is a synthetic glucocorticoid with local anti-inflammatory action within the respiratory tract. INDICATIONS Beclate Aquanase is indicated for the prophylaxis and treatment of seasonal and perennial allergic rhinitis. CONTRA-INDICATIONS Hypersensitivity to any of the ingredients of this preparation. Untreated fungal, bacterial or viral infections, tuberculosis, ocular herpes simplex, unhealed nasal wounds. Bleeding tendencies or a history of recurrent nasal bleeding. Children under the age of 6 years. Safety of beclomethasone dipropionate in pregnancy has not been established. WARNINGS: Infections of the nasal passages and paranasal sinuses should be appropriately treated but do not constitute a specific contra-indication. DOSAGE AND DIRECTIONS FOR USE Beclate Aquanase aqueous nasal spray is for administration through the nasal route only. Adults and children over the age of 12 years: One metered dose (50 mcg) in each nostril, two to four times a day. Alternately a dosage of two metered doses (100 mcg) into each nostril twice daily, can also be used. The total daily recommended dose is 200-400 mcg/day SIDE-EFFECTS AND SPECIAL PRECAUTIONS Intolerance to adrenocorticoids Nasal discomfort, sneezing, epistaxis impaired wound healing and increased intra ocular pressure. Dryness and irritation of the nose and throat unpleasant taste and smell and epistaxis Read the complete document