Aerocort Forte Rotacap

Aerocort Forte Rotacap is used for: Indicated in the treatment of asthma, once the need for inhaled corticosteroid and bronchodilator therapy has been established.

Adults 2 inhalations, three or four times daily, titrated to the lowest effective dose.

Children: 12 years and above 2 inhalations, three or four times daily, titrated to the lowest effective dose. Children: < 12 years One or two inhalations, two, three or four times daily

Hypersensitivity to any of the components of the formulation. Reactions with levosalbutamol have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema.

This is not for use in acute attacks, but for routine long-term management; so, some patients will require a separate levosalbutamol inhaler for relief of acute bronchospasm. Paradoxical bronchospasm may occur and should be treated immediately with alternative therapy. Need for more doses of levosalbutamol than usual may be a sign of deterioration of asthma and requires re-evaluation of treatment. Cardiovascular effects may occur with beta-adrenergic agonists use. Consider discontinuation of levosalbutamol if these effects occur. Use with caution in patients with underlying cardiovascular disorders. Immediate hypersensitivity reactions may occur. Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma and more rarely a range of psychological or behavourial effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). It is important, therefore, that the dose of inhaled corticosteroid is titrated to the lowest dose at which effective control is maintained. As with all inhaled corticosteroids, special care is necessary in patients with active or quiescent pulmonary tuberculosis. Replacement of systemic steroid treatment with inhaled therapy sometimes unmasks allergies such as allergic rhinitis or eczema previously controlled by the systemic drug. These allergies should be symptomatically treated with antihistamine and/or topical preparations, including topical steroids. Pregnancy Levosalbutamol: There is inadequate evidence of the safety of levosalbutamol in human pregnancy. Beclomethasone dipropionate: There is inadequate evidence of the safety of beclomethasone dipropionate in human pregnancy. Lactation Levosalbutamol: Plasma levels of levosalbutamol after inhalation of therapeutic doses are very low in humans, but it is not known whether levosalbutamol is excreted in human milk. Beclomethasone dipropionate: No specific studies examining the transference of beclomethasone dipropionate into the milk of lactating animals have been performed.

Levosalbutamol and non-selective beta-blocking drugs such as propranolol should not usually be prescribed together. In patients who are currently receiving digoxin and levosalbutamol, serum digoxin levels should be evaluated. Caution is advised in the co-administration of beta-agonists with non-potassium-sparing diuretics, patients treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, patients treated with other short-acting sympathomimetic bronchodilators or epinephrine. Consider alternative therapy in patients taking MAO inhibitors or tricyclic antidepressants.

Side effects of Levosalbutamol + Beclomethasone : Levosalbutamol Common side effects reported by greater than 2% in adults and adolescents were pain, dizziness, asthma, pharyngitis, and rhinitis whereas those observed in children were vomiting, bronchitis and pharyngitis; less than 2% were cyst, flu syndrome, viral infection, constipation, gastroenteritis, myalgia, hypertension, epistaxis, lung disorder, acne, herpes simplex, conjunctivitis, ear pain, dysmenorrhea, hematuria, and vaginal moniliasis. In children, frequently occurring adverse evenst were accidental injury, vomiting, bronchitis, pharyngitis. The incidence of systemic beta-adrenergic adverse effects (e.g., tremor, nervousness) was low. Potentially serious hypokalaemia may result from beta 2-agonist therapy. This effect may be potentiated by hypoxia. Particular caution is advised in severe asthma in such cases, monitoring of serum potassium levels is recommended. Beclomethasone dipropionate Candidiasis of the mouth and throat (thrush), hypersensitivity reactions, easy bruising of the skin, skin thinning, adrenal suppression, growth retardation in children and adolescents, hoarseness and throat irritation are common. Very rare include Cushing's syndrome, decrease in bone mineral density, cataract, glaucoma, paradoxical bronchospasm, rashes, urticaria, pruritus, erythema, oedema of the eyes, face, lips and throat, respiratory symptoms (dyspnoea and/or bronchospasm) , eosinophilic pneumonia and anaphylactoid/anaphylactic reactions, anxiety, sleep disorders and behavioural changes, including hyperactivity, irritability, depression and aggression. Other common respiratory effects were hoarseness, throat irritation and pharyngitis. In some patients, inhaled beclomethasone dipropionate may cause hoarseness or throat irritation. It may be helpful to rinse out the mouth with water immediately after inhalation.

Levosalbutamol leads to activation of beta 2-adrenergic receptors on airways smooth muscle leads to the activation of adenylate cyclase and to an increase in the intracellular concentration of cAMP. The increase in cAMP is associated with the activation of protein kinase A, which in turn, inhibits the phosphorylation of myosin and lowers intracellular ionic calcium concentrations, resulting in muscle relaxation and bronchodilation. Levosalbutamol relaxes the smooth muscles of all airways, from the trachea to the terminal bronchioles. Increased cAMP concentrations are also associated with the inhibition of the release of mediators from mast cells in the airways. The precise mechanisms of Beclomethasone action in asthma are unknown. Inflammation is recognized as an important component in the pathogenesis of asthma. Glucocorticoids have been shown to inhibit multiple cell types (e.g., mast cells, eosinophils, basophils, lymphocytes, macrophages, and neutrophils) and mediator production or secretion (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in the asthmatic response. These anti-inflammatory actions of glucocorticoids may contribute to their efficacy in asthma.

Aerocort Forte 200mcg + 200mcg Rotacap manufactured by Cipla Ltd.. Its generic name is Levosalbutamol + Beclomethasone. Aerocort Forte is availble in Nepal. Farmaco Nepal drug index information on Aerocort Forte Rotacap is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.