Rhinoclenil (Spray) Instructions for Use

Marketing Authorization Holder

Chiesi Farmaceutici, S.p.A. (Italy)

ATC Code

R01AD01 (Beclomethasone)

Active Substance

Beclometasone (Rec.INN registered by WHO)

Dosage Form

Rhinoclenil

Dosed nasal spray 770 mcg/1 ml: 120 dose or 200 dose bottle

Dosage Form, Packaging, and Composition

Dosed nasal spray in the form of a white, opalescent, homogeneous or slightly sedimented suspension.

Excipients: polysorbate 20 – 1 mg, microcrystalline cellulose and carmellose sodium – 8 mg, benzalkonium chloride – 0.27 mg, phenylethanol – 2.55 mg, dextrose monohydrate – 51 mg, water – up to 1 ml.

120 doses – plastic bottles (1) with a dosing sprayer – cardboard packs.
200 doses – plastic bottles (1) with a dosing sprayer – cardboard packs.

Clinical-Pharmacological Group

Intranasal corticosteroids

Pharmacotherapeutic Group

Topical glucocorticosteroid

Pharmacological Action

Glucocorticosteroid for intranasal use.

Beclomethasone in the form of dipropionate is a prodrug and has weak tropism for glucocorticoid receptors. Under the action of esterases, it is converted into an active metabolite – beclomethasone-17-monopropionate, which has a pronounced local anti-inflammatory effect by reducing the formation of chemotaxis substance (effect on delayed-type allergic reactions). By suppressing the production of arachidonic acid metabolites and reducing the release of inflammatory mediators from mast cells, it inhibits the development of an immediate-type allergic reaction.

It prevents the marginal accumulation of neutrophils, reduces inflammatory exudation and the production of lymphokines, inhibits macrophage migration, reduces the intensity of infiltration and granulation processes, and the formation of chemotaxis substance. It reduces swelling of the nasal mucosa and mucus production. Improves mucociliary transport.

It does not have mineralocorticoid activity and practically does not have a resorptive effect.

Pharmacokinetics

After intranasal application, it is rapidly absorbed through the nasal mucosa. Part of the administered drug is swallowed. Absorption from the gastrointestinal tract is low. Plasma protein binding is 87%.

Most of the drug that enters the gastrointestinal tract is metabolized during the “first pass” through the liver. T_1/2 is 15 hours. The main part of the drug (35-76%), regardless of the route of administration, is excreted within 96 hours with feces, mainly in the form of polar metabolites; 10-15% is excreted by the kidneys.

Indications

Seasonal and perennial allergic rhinitis; vasomotor rhinitis.

ICD codes

Dosage Regimen

Adults and children over 12 years: 50-100 mcg (1-2 doses) into each nostril 2 times/day; the daily dose is 200-400 mcg. The maximum daily dose is 400 mcg. The daily dose can be divided into 2-4 doses.

Children aged 6 to 12 years: initial dose – 50 mcg (1 dose) into each nostril 2 times/day, if necessary – 100 mcg (2 doses) into each nostril 2 times/day. The maximum daily dose is 400 mcg. The daily dose can be divided into 2-4 doses.

When a therapeutic effect is achieved, the drug is discontinued, gradually reducing the dose.

Elderly patients do not require dose adjustment.

Adverse Reactions

Allergic reactions: rarely – skin rash, urticaria, angioedema.

Nervous system disorders: rarely – impaired sense of smell and taste, drowsiness, headache, dizziness.

Eye disorders: unknown – increased intraocular pressure, including glaucoma, cataract (with long-term use), conjunctival hyperemia, decreased vision.

Respiratory system disorders: rarely – dryness and irritation of the nasopharynx, sneezing, burning, nasal congestion, nosebleeds, atrophy of the nasal mucosa, cough, rhinorrhea; very rarely – ulceration of the nasal mucosa, perforation of the nasal septum (usually in patients who have previously undergone nasal surgery).

Other: rarely – myalgia, candidiasis of the oral cavity and upper respiratory tract (with long-term use and/or in high doses (more than 400 mcg/day)); unknown – with long-term use, the development of adrenal insufficiency, decreased growth rate in children, decreased bone mineral density is possible.

Contraindications

Hemorrhagic diathesis; frequent nosebleeds; tuberculosis of the respiratory organs; fungal infections; viral infections; children under 6 years of age; first trimester of pregnancy; hypersensitivity to beclomethasone and excipients of the drug used.

With caution

Amebiasis; glaucoma; severe hepatic insufficiency; hypothyroidism; recent myocardial infarction; ulcerations of the nasal septum; after recent nasal surgery or nasal trauma; during the second and third trimesters of pregnancy; lactation period (breastfeeding).

Use in Pregnancy and Lactation

Contraindicated in the first trimester of pregnancy.

Intranasal use of beclomethasone in the second and third trimesters of pregnancy is allowed only if the expected benefit to the mother outweighs the potential risk to the fetus.

During breastfeeding, beclomethasone should be used with caution intranasally.

Pediatric Use

Contraindication: children under 6 years of age.

Geriatric Use

The drug is approved for use in elderly patients

Special Precautions

Avoid getting the drug into the eyes.

Relief of rhinitis symptoms usually occurs within a few days of starting treatment.

Patients in whom glucocorticosteroid therapy may lead to decreased immunity should be warned about the danger of contact with patients with certain infections (e.g., chickenpox, measles) and the need to consult a doctor in case of such contact. This is especially important for children.

Since beclomethasone slows down wound healing, patients who have recently suffered nasal trauma or surgery should not use the drug until the wounds have completely healed.

Drug Interactions

Phenobarbital, phenytoin, rifampicin – reduced effectiveness of beclomethasone (induction of microsomal oxidation enzymes).

Methandrostenolone, estrogens, beta₂-adrenomimetics, theophylline, oral glucocorticosteroids – enhanced action of beclomethasone.

Beta-adrenomimetics – when used concomitantly, beclomethasone enhances the effect of beta-adrenomimetics.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.