Clenil UDV (Beclomethasone) 800mcg/2ml 20 vials suspension for inhalation

Composition

1 ampoule contains: beclomethasone dipropionate 800 mcg.

Excipients: Polysorbate 20, sorbitan laurat, sodium chloride, purified water.

Packaging

In a strip of 5 plastic ampoules of 2 ml In a carton box 4 strip.

Pharmacological action

Clenil of differe anti-inflammatory and antiallergic action. Inhibits the release of mediators of inflammation, increases production of lipomodulin inhibitor of phospholipase A, reduces the release of arachidonic acid, inhibits the synthesis of prostaglandins. Warns boundary accumulation of neutrophils, reducing the formation of inflammatory exudate and production of lymphokines, inhibits the migration of macrophages, which leads to a slow process of infiltration and granulation.

Increases the number of active a-adrenergic receptors, neutralize their desensitization and restores the patient’s response to bronchodilators, allowing to reduce the frequency of their use.

Under the action of beclomethasone decreases the number of fat cells in the mucous membrane of the bronchial tubes, decreases edema of epithelium and secretion of mucus bronchial disorders. Causes relaxation of bronchial smooth muscle, reduces hyperactivity and improves respiratory function. Has no mineralocorticoid activity. In therapeutic doses does not cause side effects typical of systemic corticosteroids. In intra application eliminates edema, hyperemia of the mucosa of the nasal cavity. The therapeutic effect usually develops within 5-7 days of the course beclomethasone. When external and local application has anti-allergic and anti-inflammatory effect.

Testimony

For inhalation applications: the treatment of bronchial asthma (including the lack of effectiveness of bronchodilators and/or kromoglikata sodium, and hormone-dependent bronchial asthma severe course in adults and children).

For intranasal use: prevention and treatment of perennial and seasonal allergic rhinitis including rhinitis with hay fever, vasomotor rhinitis.

For external and local application: in combination with antimicrobial agents, infectious-inflammatory diseases of the skin and ear.

Contraindications

• Severe attacks of asthma that require intensive therapy.
• Tuberculosis.
• Candidiasis of the upper respiratory tract.
• I trimester of pregnancy.
• Hypersensitivity to beclomethasone.

Application of pregnancy and breastfeeding

Application in II and III trimestrah pregnancy is possible only in the case when expected benefit for mother exceeds the potential risk to the fetus. Newborns of mothers who received beclomethasone during pregnancy, should be carefully evaluated at the lack of adrenal function.

If necessary, use during lactation should decide the issue of termination of breastfeeding.

Method of application and doses

For adults in inhalation introduction the average dose is 400 mg/day., frequency of use – 2-4 times/day. If necessary, the dose may be increased to 1 g/day.

For children single dose – 50-100 mcg, frequency of use – 2-4 times/day.

When administered intranasally, the dose is 400 mcg/day, frequency of use 1-4 times/day.

When external and local application dose depends on the indication and used dosage form of the drug.

Side effects

The respiratory system: hoarseness, irritation in the throat, sneezing, sometimes cough. In individual cases, eosinophilic pneumonia, paradoxical bronchospasm. In intra application – perforation of the nasal septum. Possible candidiasis of the oral cavity and upper respiratory tract, especially with prolonged use, held at a local antifungal therapy without termination of treatment.

Allergic reactions: rash, urticaria, itching, erythema and swelling of the eyes, face, lips and larynx.

Effects due to systemic action: reduced function of the adrenal cortex, osteoporosis, cataracts, glaucoma, growth retardation in children.

Special instructions

Beclomethasone is not intended for cupping acute asthma attacks. It also should not be used in severe attacks of asthma that require intensive therapy. You should follow the recommended route of administration for the dosage form.

With caution and under close medical supervision should be applied beclomethasone in patients with adrenal insufficiency.

Transfer of patients constantly receiving GCS orally, inhalation form can be produced only when a stable condition.

In the case of the probability of development of paradoxical bronchospasm for 10-15 min before the introduction of beclomethasone conduct inhalation of bronchodilators (e.g. salbutamol).

With the development of oral candidiasis and upper respiratory tract shows local antifungal therapy without termination of treatment with beclomethasone. Infectious-inflammatory diseases of nasal cavity and paranasal sinuses in the appointment of appropriate therapy are not a contraindication to treatment with beclomethasone.

Drugs for inhalation use, containing in 1 dose of 250 micrograms of beclomethasone, not intended for children under 12 years.

Drug interactions

While the use of beclomethasone with other corticosteroids for systemic or intranasal use may increase suppression function of the adrenal cortex.

Prior use of inhaled beta-agonists may increase the clinical efficacy of beclomethasone.

Storage conditions

Keep at temperature not exceeding 25 C in original package to protect from light, away from heating devices, in a vertical position.

Shelf life

2 years.