Vanceril (Beclomethasone Dipropionate)

VANCERIL®

Schering

Beclomethasone Dipropionate

Asthma Prophylaxis

Action And Clinical Pharmacology: Beclomethasone is a potent anti-inflammatory steroid with a strong topical and weak systemic activity. When inhaled at therapeutic doses it has a direct anti-inflammatory action on the bronchial mucosa with minimal systemic effect.

After administration by inhalation approximately 10 to 25% of a dose reaches the respiratory tract; the remainder is swallowed and absorbed from the gastrointestinal tract. Beclomethasone dipropionate is rapidly hydrolyzed by lung esterases to 17-monopropionate and more slowly to the free base. Orally absorbed drug is metabolized by the liver. After administration of labeled drug approximately 35 to 65% of the radioactivity is recovered in the feces and 10 to 15% in the urine.

Indications And Clinical Uses: Treatment of corticosteroid responsive asthma: 1) In asthmatic patients who do not respond adequately to conventional therapy. 2) In corticosteroid dependent asthmatics where a reduction of systemic corticosteroids is desirable.

Contra-Indications: Active or quiescent untreated pulmonary tuberculosis, or untreated fungal, bacterial and viral infections of the respiratory system. Do not use in children under the age of 6 years, in status asthmaticus, or in patients with moderate to severe bronchiectasis.

Precautions: In patients previously on high doses of systemic corticosteroids, transfer to beclomethasone aerosol may cause withdrawal symptoms such as tiredness, aches and pains and depression. In severe cases, acute adrenal insufficiency may occur necessitating the temporary resumption of systemic corticosteroids.

The development of pharyngeal and laryngeal candidiasis is cause for concern because the extent of its penetration of the respiratory tract is unknown. If candidiasis develops, discontinue beclomethasone aerosol and institute appropriate antifungal therapy. The incidence of candidiasis can generally be held to a minimum by having the patient rinse their mouth with water after each inhalation. The patient must be instructed not to swallow the water used for rinsing.

The replacement of a systemic steroid with beclomethasone aerosol must be gradual and supervised carefully. Follow the guidelines under Dosage in all such cases.

Pregnancy and Lactation: The safe use of this product during pregnancy and lactation has not been established and therefore the compound should be used only if the potential benefit justifies the potential risk to the fetus, particularly during the first trimester of pregnancy, or to the infant.

Patients receiving corticosteroids who are potentially immunosuppressed should be warned of the risk of exposure to certain infections (e.g., chickenpox, measles) and of the importance of obtaining medical advice if such exposure occurs. This is of particular importance in children.

A decreased resistance to localized infection has been observed during corticosteroid therapy. Corticosteroids may mask some signs of infection and new infections may appear.

During long-term therapy, pituitary-adrenal function and hematological status should be periodically assessed.

Fluorocarbon propellants may be hazardous if they are deliberately abused. Inhalation of high concentrations of aerosol sprays has brought about cardiovascular toxic effects and even death, especially under conditions of hypoxia. However, evidence attests to the relative safety of aerosols when used properly and with adequate ventilation.

Instruct patients that beclomethasone aerosol is a preventative agent which must be taken at regular intervals, and is not to be used during an asthmatic attack.

There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis.

Use ASA cautiously in conjunction with corticosteroids in hypoprothrombinemia.

Advise patients to inform subsequent physicians of the prior use of corticosteroids.

Adverse Reactions: No major adverse effects attributable to the use of recommended doses have been reported. No significant systemic effects have been observed when the daily dose was below 1 mg (20 puffs). Above this dose, reduction of plasma cortisol, indicating adrenal cortical suppression, may occur. Immediate and delayed hypersensitivity reactions including bronchospasm, rash, urticaria, angioedema and localized infections with C. albicans or A. niger in the mouth, throat, larynx, bronchus and esophagus have been reported. In a few patients, the appearance of hoarseness, drymouth and pharyngeal irritation has been observed, occasionally necessitating withdrawal of treatment.

Rare cases of glaucoma have been reported with the use of inhaled corticosteroids.

The replacement of systemic steroids with the inhaler may unmask symptoms of allergies which were suppressed previously by the systemic drug. Conditions such as allergic rhinitis and eczema may thus become apparent during therapy after the withdrawal of systemic corticosteroids and should be treated appropriately.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: Overdosage may cause systemic steroid effects resulting in symptoms of hypercorticism and/or adrenal suppression. Decreasing the dose will abolish some of these adverse effects, when due to excessive dosage. Treat adrenal suppression symptomatically.

Dosage And Administration: Optimum doses vary, but the total daily dose should not exceed 1 mg of beclomethasone (20 puffs), and should not be instituted until the severe attack has been controlled with systemic corticosteroids.

For adults, the usual maintenance dose is 2 inhalations (each 50 g) 3 to 4 times/day. In severe cases, it is advisable to control the symptoms with systemic corticosteroids before starting treatment with beclomethasone inhaler. Insufficient information is available to warrant the safe use in children under age 6. For children over 6 years of age, 1 inhalation (50 g) up to 4 times daily.

Maximum daily dose should not exceed 20 inhalations for adults and 10 inhalations for children under 12 years of age.

Since the effect of the inhaler depends on its regular use and on the proper inhalation technique, instruct patients to take inhalations at regular intervals. They should also be instructed in the correct method; to exhale completely, lips to be placed tightly around the mouth piece and actuate the aerosol in the next inspiratory period.

In the presence of excess mucus secretion, severe attacks of asthma, and/or infection or high atmospheric concentrations of appropriate antigens, the drug may fail to reach the bronchioles. Therefore, if an obvious response is not obtained after 7 days, institute appropriate therapy including a short course of systemic corticosteroids before returning to the use of inhaler, as well as the concomitant use of bronchodilator aerosol.

Careful attention must be given to patients treated previously for prolonged periods with systemic corticosteroids when transferring them to beclomethasone aerosol. Initially, beclomethasone aerosol and the systemic steroid must be given concomitantly for 10 to 14 days, followed by a gradual withdrawal of the systemic steroids. Dose reductions should be the equivalent of 1.0 mg of prednisone every 10 to 14 days if close continuous medical supervision is not feasible. It may be possible to withdraw systemic corticosteroids more rapidly if the initial dosage was 7.5 mg daily of prednisone (or equivalent) or less, or if the patient is under close continuous medical supervision. Some patients may not be able to completely discontinue the use of systemic steroids. In such cases, a minimum maintenance dose should be continued in addition to beclomethasone aerosol.

Availability And Storage: Each metered dose of oral inhaler contains: beclomethasone dipropionate USP 50 g. Nonmedicinal ingredients: oleic acid, trichlorofluoromethane and dichlorofluoromethane. Each canister provides 200 metered sprays. Canisters of 100 doses available to hospitals only.

VANCERIL® Schering Beclomethasone Dipropionate Asthma Prophylaxis

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Asthma

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