Salomax B MDI Inhaler

Salomax B MDI Inhaler is used for: Asthma

Inhaler Salbutamol 90 mcg & Budesonide 80 mcg Immediate relief from bronchoconstriction and airway inflammation Indicated as needed as a rescue inhaler in people 18 years of age and older to treat or prevent symptoms of asthma and help prevent sudden severe asthma attacks or exacerbations. 2 inhalations (puffs) as needed. Not more than 12 inhalations/12 puffs in a 24-hour period

<18 years: Safety and efficacy not established

Priming inhaler Primer inhaler before first use Remove mouthpiece cover, shake, and spray test puff into air facing away from user; repeat for a total of 4 test puffs Re-priming inhaler Re-prime if not used for >7 days, if inhaler dropped, or after rinsing white actuator Remove mouthpiece cover, shake and spray test puff; repeat for a total of 2 test puffs

Hypersensitivity to salbutamol, budesonide, or any of the excipients

Use sympathomimetic amines cautiously in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus and in patients who are unusually responsive to sympathomimetic amines Beta-adrenergic agonists may cause hypokalemia in some patients, possibly through intracellular shunting, and thereby potential for adverse cardiovascular effects may occur; decreased serum potassium is usually transeint, not requiring supplementation Orally inhaled corticosteroids may reduce growth velocity when administered to pediatric patients; safety and effectiveness of albuterol/budesonide have not been established in pediatric patients, and is not indicated for use in this population Deterioration of asthma Asthma may deteriorate acutely over several hours or chronically over several days or longer If symptoms continue after using albuterol/budesonide or requires more doses than usual, evaluate patient and treatment regimen Paradoxical bronchospasm Treatment may produce paradoxical bronchospasm, which may be life threatening If paradoxical bronchospasm occurs following, discontinue immediately, and initiate alternant therapy Paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister Cardiovascular effects Beta2-adrenergic agonists can produce clinically significant cardiovascular (CV) effects (eg, increased pulse rate, blood pressure), ECG changes (flattening of T wave, QT prolongation, ST-segment depression), and/or other symptoms If such effects occur, albuterol/budesonide may need to be discontinued Caution in patients with CV disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension Maximum daily dose Exceeding maximum dose may result in overdose Clinically significant CV effects and fatalities reported in association with excessive use of inhaled sympathomimetic drugs Oropharyngeal candidiasis Inhaled corticosteroid (ICS) may increase risk for localized infections of the mouth and pharynx with Candida albicans Advise patient to rinse their mouth with water, if available, without swallowing following administration to help reduce risk If oropharyngeal candidiasis develops, treat with appropriate local or systemic (ie, oral) antifungal therapy while treatment with albuterol/budesonide continues For some patients, albuterol/budesonide treatment may need to be interrupted Hypercorticism and adrenal suppression Orally inhaled budesonide often helps control asthma symptoms with less suppression of hypothalamic-pituitary-adrenal (HPA) function than therapeutically equivalent oral doses of prednisone Since budesonide is absorbed into the circulation and can be systemically active at higher doses, the beneficial effects in minimizing HPA dysfunction may be expected only when recommended dosages are not exceeded Reduced bone mineral density Decreases in bone mineral density (BMD) observed with long-term administration of ICS Clinical significance of small changes in BMD with regard to long-term consequences (eg, fracture) is unknown Patients with major risk factors for decreased bone mineral content (eg, prolonged immobilization, family history of osteoporosis, post-menopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone mass [eg, anticonvulsants, oral corticosteroids]) should be monitored and treated with established standards of care Glaucoma and cataracts Glaucoma, increased intraocular pressure, and cataracts reported following the long-term administration of ICS Consider referral to an ophthalmologist in patients who develop ocular symptoms

Pregnancy Salbutamol or budesonide: Available data from epidemiological studies and postmarketing case reports of pregnancy outcomes following inhaled Salbutamol or inhaled budesonide use do not consistently demonstrate a risk of major birth defects or miscarriage. Clinical considerations In females with poorly or moderately controlled asthma, risk is increased for several perinatal adverse outcomes (eg, preeclampsia in the mother; prematurity, low birth weight, and small for gestational age in the neonate) Closely monitor pregnant women with asthma and adjust medication as necessary to maintain optimal asthma control Labor or delivery Because of the potential for beta-agonist interference with uterine contractility, use of during labor should be restricted to those patients in whom the benefits clearly outweigh the risk Serious adverse reactions, including pulmonary edema, reported during or following treatment of premature labor with beta2-agonists, including Salbutamol Lactation Data are unavailable on the effects of Salbutamol/budesonide on breastfed children or on milk production Budesonide, like other inhaled corticosteroids, is present in human milk

Strong cytochrome P450 3A4 inhibitors (e.g. ritonavir): Use with caution. May cause systemic corticosteroid effects. Other short-acting bronchodilators: Use judiciously with other short acting beta agonists. Beta blockers: May decrease effectiveness of Salbutamol + Budesonide and produce severe bronchospasm. When there are no acceptable alternatives to the use of beta-adrenergic-blocking agents, consider cardioselective beta blockers and use with caution. Diuretics, or non-potassium-sparing diuretics: May potentiate hypokalemia or ECG changes. Consider monitoring potassium levels with concomitant use. Digoxin: May decrease serum digoxin levels. Carefully evaluate digoxin levels with concomitant use. Monoamine oxidase inhibitors (MAOI) and tricyclic antidepressants: Use with extreme caution with concomitant use.

Side effects of Salbutamol + Budesonide : 1-10% Headache (4.3%) Oral candidiasis (1.3%) Cough (1%)

Salbutamol: Short-acting beta2-adrenergic bronchodilator; increases cyclic AMP which leads to protein kinase A activation, which inhibits myosin phosphorylation and lowers intracellular ionic calcium concentrations; these actions result in bronchial smooth muscle relaxation Budesonide: Anti-inflammatory corticosteroid; has potent glucocorticoid activity and weak mineralocorticoid activity; inflammation is an important component in the pathogenesis of asthma

Salomax B MDI Inhaler manufactured by Eskayef Pharmaceuticals Ltd.. Its generic name is Salbutamol + Budesonide. Salomax B is availble in Bangladesh. Farmaco BD drug index information on Salomax B MDI Inhaler is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.