Asthma treatment

Information on proper use of AEROBID Inhaler System.: Do not use or store near heat or open flame. Exposure to temperatures above 120°F (49°C) may cause container to explode. Never throw container into fire or incinerator. Carcinogenesis: Long-term studies were conducted in mice and rats using oral administration to evaluate the side effects and carcinogenic potential of the drug AEROBID. There was an increase in the incidence of pulmonary adenomas in mice, but not in rats. Female rats receiving the highest oral dose had an increased incidence of mammary adenocarcinoma compared to control rats. An increased incidence of this tumor type has been reported for other corticosteroids. Reproductive performance in the low- (8 mcg/kg/day) and mid-dose (40 mcg/kg/day) groups was comparable to controls. It was also fetotoxic in these animal reproductive studies.

Nursing Mothers: It is not known whether this drug AEROBID is excreted in human milk Pediatric Use: Safety and effectiveness have not been established in children below the age of 6. Oral corticoids have been shown to cause growth suppression in children and adolescents, particularly with higher doses over extended periods.If a child or adolescent on any corticoid appears to have growth suppression, the possibility that they are particularly sensitive to this effect of steroids should be considered. Of those patients, 463 were treated for 3 months or longer, 407 for 6 months or longer, 287 for 1 year or longer, and 122 for 2 years or longer.
Musculoskeletal reactions were reported in 35% of steroid-dependent patients in whom the dose of oral steroid was being tapered.

AEROBID inhaler dosage. Adults: The recommended starting dose is 2 inhalations twice daily, morning and evening, for a total daily dose of 1 mg. The maximum daily dose should not exceed 4 inhalations twice a day for a total daily dose of 2 mg. When the drug is used chronically at 2 mg/day, patients should be monitored periodically for effects on the hypothalamic-pituitary-adrenal (HPA) axis. Pediatric Patients: For children and adolescents 6-15 years of age, two inhalations may be administered twice daily for a total daily dose of 1 mg.

Insufficient information is available to warrant use in children under age 6. With chronic use, pediatric patients should be monitored for growth as well as for effects on the HPA axis. Rinsing the mouth after inhalation is advised. In patients who respond to AEROBID, improvement in pulmonary function is usually apparent within one to four weeks after the start of therapy. Once the desired effect is achieved, consideration should be given to tapering to the lowest effective dose.

Initially, AEROBID should be used concurrently with the patient’s usual maintenance dose of systemic corticosteroid. After approximately one week, gradual withdrawal of the systemic corticosteroid is started by reducing the daily or alternate daily dose. Reductions may be made after an interval of one or two weeks, depending on the response of the patient. A slow rate of withdrawal is strongly recommended. Generally, these decrements should not exceed 2. During withdrawal, some patients may experience symptoms of systemic corticosteroid withdrawal like
joint and/or muscular pain, lassitude and depression, despite maintenance or even improvement in pulmonary function. Such patients should be encouraged to continue with the inhaler but should be monitored for objective signs of adrenal insufficiency. If evidence of adrenal insufficiency occurs, the systemic corticosteroid doses should be increased temporarily and thereafter withdrawal should continue more slowly.

Before the first use, place the AEROBID metal cartridge inside the plastic container. Shake the inhaler system before each inhalation. Before each use, remove dustcap and inspect mouthpiece for foreign objects. Hold the inhaler system upright and put plastic mouthpiece in your mouth as shown, being sure to close your lips tightly around the mouthpiece. At the same time firmly press down on the metal cartridge with your index finger. Hold your breath as long as you can. While holding your breath, stop pressing on the cartridge and remove mouthpiece from your mouth. If your doctor has prescribed two or more inhalations at each use, wait a minute to allow pressure to build up again in the metal canister, then repeat steps again. Be sure to shake the inhaler system again before each inhalation. After the prescribed number of inhalations, rinse out your mouth thoroughly with water. Clean the inhaler system every few days
To do so, remove the metal cartridge, then rinse the plastic inhaler and cap with briskly running warm water.

NOTE: If your mouth becomes sore or develops a rash, after using AEROBID inhaler be sure to mention this to your doctor, but do not stop using your inhaler system unless he tells you.
WARNING: The contents of the metal cartridge AEROBID are under pressure
Exposure to temperature above 120°F (49°C) may cause cartridge to explode
Never throw cartridge into fire or incinerator. Use by children should always be supervised by an adult.

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Drug Interactions of Beclomethasone dipropionate: No interactions have been reported
with Salbutamol. But Salbutamol and non-selective, beta-blocking drugs such as propranolol should not usually be prescribed together. Pregnancy: Administration of this combination of drugs during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus. During lactation this combination should be used only if the expected benefit to the mother is likely to outweigh any potential risk to the neonate. As AEROCORT Inhaler contains salbutamol and beclomethasone dipropionate, the type and severity of side effects associated with each of the compounds may be expected.

Potentially serious hypokalaemia may result from beta 2 agonist therapy
Common undesirable effects are tremor, headache, and tachycardia. Rare side effects are hypokalaemia, and peripheral vasodilatation. Very rare undesirable effects are hypersensitivity reactions including angio-oedema, urticaria, bronchospasm, hypotension and collapse , hyperactivity, cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia, and extrasystoles), and paradoxical bronchospasm.As with other inhalation therapy, paradoxical bronchospasm may occur, with an immediate increase in wheezing after dosing. This should be treated immediately with an alternative presentation or a different, fast-acting inhaled bronchodilator Therapy should be discontinued immediately, the patient assessed, and, if necessary, alternative therapy instituted. Uncommon undesirable effects are palpitations, mouth and throat irritation, and muscle cramps.

For Beclomethasone dipropionate very common side effects are candidiasis of the mouth and throat, and hoarseness/throat irritation. Candidiasis of the mouth and throat (thrush) occurs in some patients, the incidence of which is increased with doses greater than 400 mcg beclomethasone dipropionate per day. Patients with high blood levels of Candida precipitins , indicating a previous infection, are most likely to develop this complication
Patients may find it helpful to rinse out their mouth with water after using the inhaler.
Symptomatic candidiasis can be treated with topical anti-fungal therapy while continuing with beclomethasone dipropionate treatment. 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. Very rare undesirable effects are oedema of the eyes, face, lips and throat, respiratory symptoms (dyspnoea and/or bronchospasm), anaphylactoid/anaphylactic reactions, Cushing`s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract, glaucoma, paradoxical bronchospasm, anxiety, sleep disorders, and behavioural changes, including hyperactivity and irritability (predominantly in children).

As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing. This should be treated immediately with a fast-acting inhaled bronchodilator The beclomethasone dipropionate preparation should be discontinued immediately, the patient assessed, and if necessary, alternative therapy instituted Uncommon undesirable effects are rashes, urticaria, pruritis, and erythema.

Beclomethasone dipropionate : Inhalation of the drug in doses in excess of those recommended may lead to temporary suppression of adrenal function. This does not necessitate any emergency action to be taken. Chronic side effects: Use of inhaled beclomethasone dipropionate in daily doses in excess of 1,500 mcg over prolonged periods may lead to adrenal suppression. Monitoring of adrenal reserve may be indicated.

Salbutamol side effects : Hypokalaemia may occur following overdose with salbutamol
The preferred antidote for overdosage with salbutamol is a cardioselective beta-blocking agent, but beta-blocking drugs should be used with caution in patients with a history of bronchospasm. Generic beclomethasone inhalation aerosols are not yet available
What should your health care professional know before you use beclomethasone
They need to know if you have any of these conditions: infection, such as herpes, measles, tuberculosis or chickenpox an unusual or allergic reaction to beclomethasone, other corticosteroids, other medicines, foods, dyes, or preservatives
breast-feeding.

Salbu­tamol is a beta-adrenergic stimulant that has a highly selective action on the recep­tors in bronchial muscle, resulting in bronchodilation Beclomethasone dipropionate is a synthetic gluco­corticoid with a potent anti-inflammatory activity and weak mineralocorticoid acti­vity. This association of salbutamol and beclomethasone dipropionate is specially provided for those patients who require regular doses of both drugs for treatment of their asthma obstructive airways disease.

Pharmacodynamics AEROCORT Inhaler is a combination of beclomethasone dipropionate and salbutamol, which have different modes of action and show additive effects. Salbutamol: The primary action of beta-adrenergic drugs, including salbutamol, is to stimulate adenyl cyclase, the enzyme which catalyses the formation of cyclic-3,5-adenosine monophosphate (cyclic AMP) from adenosine triphosphate (ATP) in beta-adrenergic cells. The cyclic AMP thus formed mediates the cellular responses
Increased cyclic AMP levels are associated with relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells. Glucocorticoids have been shown to inhibit multiple cell types ( mast cells, eosinophils, basophils, lymphocytes, macrophages, and neutrophils) and mediator production or secretion.

 Because of its gradual absorption from the bronchi, systemic levels of salbutamol are low after inhalation at recommended doses Administration of tritiated salbutamol by inhalation to four subjects resulted in maximum plasma concentrations within 2 to 4 hours Due to the insensitivity of the assay method, the metabolic rate and half-life of elimination of salbutamol in plasma could not be determined. However, data from urinary excretion studies indicated that salbutamol has an elimination half-life of 3.
Approximately 72% of the inhaled dose is excreted in the urine within 24 hours - 28% as unchanged drug and 44% as metabolite. Beclomethasone dipropionate when administered via inhalation there is extensive conversion of beclomethasone dipropionate to the active metabolite, beclomethasone 17-monopropionate (B-17-MP), within the lungs prior to systemic absorption. The systemic absorption of B-17-MP arises from both lung deposition and oral absorption of the swallowed dose.

When administered orally in healthy male volunteers, the bioavailability of beclomethasone dipropionate is negligible, but pre-systemic conversion to B-17-MP results in 41% (95% CI 27-62 %) of the dose being available as B-17-MP.Beclomethasone dipropionate is cleared very rapidly from the systemic circulation, owing to extensive first-pass metabolism. The main product of metabolism is the active metabolite (B-17-MP). Minor inactive metabolites, beclomethasone-21-monopropionate (B-21-MP) and beclomethasone (BOH), are also formed, but these contribute little to systemic exposure. The tissue distribution at steady state for beclomethasone dipropionate is moderate (20L), but more extensive for B-17-MP (424L). Following oral administration of tritiated beclomethasone dipropionate, approximately 60% of the dose was excreted in the faeces within 96 hours, mainly as free and conjugated polar metabolites. AEROCORT Inhaler is contraindicated in patients with a history of hypersensitivity to any of the components of the drug product. AEROCORT Inhaler is not for use in acute attacks, but for routine long-term management; so, some patients will require a separate Asthalin Inhaler for relief of acute bronchospasm. For those patients who are steroid-dependent, it is advisable to commence therapy with beclomethasone diproprionate ( Beclate Inhaler ) as a separate inhaler. Patients who have been weaned in the previous few months from long-term systemic corticosteroids need special consideration until the hypothalamic­-pituitary-adrenal system has recovered sufficiently to enable the patient to cope with emergencies such as trauma, sur­gery, or infections. These patients should also be given a supply of oral steroids to use in an emergency when their airways obstruction worsens.

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