REZPIRA Salmeterol Xinafoate / Fluticasone Propionate 25mcg / 250mcg per Actuation Metered-Dose Inhaler (Suspension) 120Actuations
RXDRUG-DR-XY44500
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
In the regular treatment of asthma, where use of a combination product (long-acting beta-2 agonist and inhaled corticosteroid) is appropriate.
Patients not adequately controlled with inhaled corticosteroids and as needed inhaled short acting beta-2 agonist.
Patients already adequately controlled on both inhaled corticosteroid and long-acting beta-2 agonist.
Patients not adequately controlled with inhaled corticosteroids and as needed inhaled short acting beta-2 agonist.
Patients already adequately controlled on both inhaled corticosteroid and long-acting beta-2 agonist.
Dosage/Direction for Use
See table.
Overdosage
The available information on overdose with Salmeterol + Fluticasone propionate (Rezpira), salmeterol and/or fluticasone propionate is given as follows: The expected symptoms and signs of salmeterol overdose are those typical of excessive beta2-adrenergic stimulation, including tremor, headache, tachycardia, increases in systolic blood pressure and hypokalemia. There is no specific treatment for an overdose of salmeterol and fluticasone propionate. If overdose occurs, the patients should be treated supportively with appropriate monitoring as necessary.
Acute Inhalation of fluticasone propionate doses in excess of those approved may lead to temporary suppression of the hypothalamic-pituitary-adrenal axis. This does not usually require emergency action as normal adrenal function typically recovers within a few days. If higher than approved doses of Salmeterol+Fluticasone propionate (Rezpira) are continued over prolonged periods, significant adrenocortical suppression is possible. There have been very rare reports of acute adrenal crisis, mainly occurring in children exposed to higher than approved doses over prolonged periods (several months or years); observed features have included hypoglycaemia associated with decreased consciousness and/or convulsions. Situations which could potentially trigger acute adrenal crisis include exposure to trauma, surgery, infection or any rapid reduction in the dosage of the inhaled fluticasone propionate component. It is not recommended that patients receive higher than approved doses of Salmeterol + Fluticasone propionate (Rezpira). It is important to review therapy regularly and titrate down to the lowest approved dose at which effective control of disease is maintained (see Dosage & Administration).
Acute Inhalation of fluticasone propionate doses in excess of those approved may lead to temporary suppression of the hypothalamic-pituitary-adrenal axis. This does not usually require emergency action as normal adrenal function typically recovers within a few days. If higher than approved doses of Salmeterol+Fluticasone propionate (Rezpira) are continued over prolonged periods, significant adrenocortical suppression is possible. There have been very rare reports of acute adrenal crisis, mainly occurring in children exposed to higher than approved doses over prolonged periods (several months or years); observed features have included hypoglycaemia associated with decreased consciousness and/or convulsions. Situations which could potentially trigger acute adrenal crisis include exposure to trauma, surgery, infection or any rapid reduction in the dosage of the inhaled fluticasone propionate component. It is not recommended that patients receive higher than approved doses of Salmeterol + Fluticasone propionate (Rezpira). It is important to review therapy regularly and titrate down to the lowest approved dose at which effective control of disease is maintained (see Dosage & Administration).
Contraindications
Rezpira is contraindicated in patients with the history of hypersensitivity to any of its ingredients.
Warnings
Do not puncture, break or incinerate the pressurized canister even when apparently empty.
Avoid storage in direct sunlight or heat.
Keep away from eyes.
Avoid storage in direct sunlight or heat.
Keep away from eyes.
Special Precautions
Rezpira should not be used to treat acute asthma symptoms for which a fast- and short-acting bronchodilator is required. Patients should be advised to have their inhaler to be used for relief in an acute asthma attack available at all times. Treatment with Rezpira should not be stopped abruptly. Both non-selective and selective beta-blockers should be avoided in patients with asthma, unless there are compelling reasons for their use. As with all inhaled medication containing corticosteroids, it should be administered with caution in patients with active or quiescent pulmonary tuberculosis. Rezpira should be administered with caution in patients with severe thyrotoxicosis.
Special patient groups: There is no need to adjust the dose in elderly patients or in those with renal impairment. There are no data available for use of Rezpira in patients with hepatic impairment.
Use in Children: Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. The long term effects of this reduction including the impact of final adult height are unknown.
Special patient groups: There is no need to adjust the dose in elderly patients or in those with renal impairment. There are no data available for use of Rezpira in patients with hepatic impairment.
Use in Children: Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. The long term effects of this reduction including the impact of final adult height are unknown.
Use In Pregnancy & Lactation
There are insufficient experiences of the use of Salmeterol and Fluticasone Propionate in human pregnancy and lactation. Administration of drugs during pregnancy and lactation should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus or child.
Adverse Reactions
The pharmacological side effects of Salmeterol treatments such as tremor, subjective palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy. Cardiac arrhythmias may occur, usually in susceptible patients. Systemic effects may occur with any inhaled corticosteroid. Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, decrease in bone mineral density, cataract and glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression.
In case of Fluticasone Propionate, hoarseness and candidiasis (thrush) of the mouth and throat can occur in some patients. Gargling with water after use of Rezpira HFA Inhalation Aerosol may relieve both hoarseness and incidence of candidiasis.
In case of Fluticasone Propionate, hoarseness and candidiasis (thrush) of the mouth and throat can occur in some patients. Gargling with water after use of Rezpira HFA Inhalation Aerosol may relieve both hoarseness and incidence of candidiasis.
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacology: Salmeterol is a selective, long acting (12 hour) beta-2 agonist with a long side chain which binds to the exo-site of the receptor. It produces a longer duration of bronchodilator, lasting for at least 12 hours, than recommended doses of conventional short acting beta-2 agonists. It is used in the treatment of asthma & other forms of diffuse airway obstruction.
Fluticasone Propionate is a synthetic corticosteroid of glucocorticoid family, which has potent anti-inflammatory action within the lungs, resulting in reduced symptoms and exacerbations of asthma. It is stated to exert topical effects on the lungs without systemic effects at usual dose.
Fluticasone Propionate is a synthetic corticosteroid of glucocorticoid family, which has potent anti-inflammatory action within the lungs, resulting in reduced symptoms and exacerbations of asthma. It is stated to exert topical effects on the lungs without systemic effects at usual dose.
MedsGo Class
Antiasthmatic & COPD Preparations
Features
Brand
REZPIRA
Full Details
Dosage Strength
25mcg / 250mcg per Actuation
Drug Ingredients
- Fluticasone
- Salmeterol
Drug Packaging
Metered-Dose Inhaler (Suspension) 120 act.
Generic Name
Salmeterol Xinafoate / Fluticasone Propionate
Dosage Form
Metered-Dose Inhaler (Suspension)
Registration Number
DR-XY44500
Drug Classification
Prescription Drug (RX)
Please sign in so that we can notify you about a reply