Asthma treatment

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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What is the most important information you should know about beclomethasone dipropionate inhalation? Carry an identification card or wear a medical alert ID to let others know that you may need an oral steroid in an emergency. What should you avoid while taking beclomethasone dipropionate  inhalation?  Beclomethasone inhalation can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill. Avoid being near people who are sick or have infections. Contact your doctor if you have been exposed to someone with measles or chicken pox.

What other drugs will affect beclomethasone inhalation? If you are also using a bronchodilator (a drug that opens the airways to improve breathing), use it first before using the beclomethasone inhaler This will allow more beclomethasone to reach your lungs There may be other drugs that can affect beclomethasone inhalation

What happens if you have an overdose of beclomethasone inhalation?
Seek emergency medical attention if you think you have used too much of this medicine
An overdose of beclomethasone inhalation is not expected to produce life-threatening symptoms. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect.

Drug information contained herein may be time sensitive and has been compiled for use by healthcare practitioners and consumers in the United States. These effects were similar to those obtained by the inhalation of a single dose of salmeterol before the control inhalation test, and significantly better than those observed after a single dose of beclomethasone inhaled before the allergen test. Neither salmeterol nor beclomethasone had any significant effect on sputum or blood inflammatory changes 7-48 h after allergen inhalation. The latter result excludes a more positive judgement on the possible anti-inflammatory action of salmeterol .

However, the results do indicate that potent functional effects of a single dose of salmeterol can mask the airway inflammatory cell influx caused by inhaled allergen. Withdrawal and discontinuation of the corticosteroid should be done slowly and carefully. Controlled clinical studies have shown that orally-inhaled and intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. To minimize the systemic effects of orally-inhaled and intranasal corticosteroids, each patient should be titrated to the lowest effective dose. May suppress the immune system, patients may be more susceptible to infection. Use with caution in patients with systemic infections or ocular herpes simplex.

Corticosteroids should be used with caution in patients with diabetes, hypertension, osteoporosis, peptic ulcer, glaucoma, cataracts, or tuberculosis, Central nervous system: Agitation, depression, dizziness, dysphonia, headache, lightheadedness, mental disturbances. Dermatologic: Acneiform lesions, angioedema, atrophy, bruising, pruritus, purpura, striae, rash, urticaria
Endocrine & metabolic: Cushingoid features, growth velocity reduction in children and adolescents, HPA function suppression, weight gain.

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Beclomethasone dipropionate may also be used for purposes other than those listed in medication guide. Before using this medication, tell your doctor if you have been sick or had an infection of any kind (especially tuberculosis). You may not be able to use beclomethasone inhalation until you are well. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether Beclomethasone dipropionate passes into breast milk or if it could harm a nursing baby.

Do not use beclomethasone inhalation without telling your doctor if you are breast-feeding a baby. Talk with your doctor if you think your child is not growing at a normal rate while using this medication. Do not give this medicine to a child younger than 5 years old. Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough vitamin D or calcium in your diet, or if you have a family history of osteoporosis. Talk with your doctor about your risk of osteoporosis. Use beclomethasone medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Beclomethasone comes with patient instructions for safe and effective use.

Ask your doctor or pharmacist if you have any questions. Beclomethasone will not work fast enough to reverse your symptoms. To reduce the chance of developing a yeast infection in your mouth, rinse with water after using beclomethasone inhalation.To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor. It is important to use beclomethasone inhalation regularly to get the most benefit.

Get your prescription refilled before you run out of medicine completely. Carry an identification card or wear a medical alert ID to let others know that you may need an oral steroid in an emergency. Store beclomethasone inhalation at room temperature away from moisture and heat. Keep the medicine canister away from high heat, such as open flame or in a car on a hot day. The canister may explode if it gets too hot. What happens if you miss a dose of beclomethasone inhalation? Use the medication as soon as you remember. If it is almost time for the next dose, skipthe missed dose and wait until your next regularly scheduled dose. Do not useextra medicine to make up the missed dose.

Where can you get more information about Beclomethasone dipropionate inhalation?
Your pharmacist has information about beclomethasone inhalation written for health professionals that you may read. What are the possible side effects of beclomethasone inhalation? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Other, less serious side effects may be more likely to occur, such as: headache; dryness in your mouth, nose, or throat; white patches or sores inside your mouth or on your lips;stuffy nose, sinus pain, sore throat, cough; or hoarseness or deepened voice.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

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