Flustoprino (Spray) Instructions for Use

Marketing Authorization Holder

Profit Medica JSC (Russia)

Manufactured By

Vips-Med, LLC (Russia)

ATC Code

R01AA05 (Oxymetazoline)

Active Substance

Oxymetazoline (Rec.INN registered by WHO)

Dosage Forms

	Flustoprino	Nasal spray 0.05%: 10 ml or 20 ml bottle
		Nasal spray 0.025%: 10 ml or 20 ml bottle

Dosage Form, Packaging, and Composition

Nasal spray as a clear, colorless or slightly yellowish liquid.

Excipients : benzalkonium chloride – 0.15 mg, disodium edetate dihydrate – 0.5 mg, sodium dihydrogen phosphate dihydrate – 1.29 mg, disodium hydrogen phosphate dodecahydrate – 1.76 mg, sodium hydroxide 0.1 M solution – to pH 6.2 – 7, purified water – to 1 ml.

10 ml – bottles – cardboard packs.
20 ml – bottles – cardboard packs.

Nasal spray as a clear, colorless or slightly yellowish liquid.

Excipients : benzalkonium chloride – 0.15 mg, disodium edetate dihydrate – 0.5 mg, sodium dihydrogen phosphate dihydrate – 1.29 mg, disodium hydrogen phosphate dodecahydrate – 1.76 mg, sodium hydroxide 0.1 M solution – to pH 6.2 – 7, purified water – to 1 ml.

10 ml – bottles – cardboard packs.
20 ml – bottles – cardboard packs.

Clinical-Pharmacological Group

Vasoconstrictor drug for topical use in ENT practice

Pharmacotherapeutic Group

Drugs for the treatment of nasal diseases; decongestants and other drugs for topical use; sympathomimetics

Pharmacological Action

Adrenomimetic agent for topical use. It has a vasoconstrictive effect. When applied intranasally, it reduces swelling of the mucous membrane of the upper respiratory tract.

Pharmacokinetics

When applied intranasally, T_1/2 is 35 hours.

Indications

Difficulty in nasal breathing during colds, inflammation of the nasal sinuses, eustachitis, hay fever, allergic rhinitis.

To relieve swelling before diagnostic manipulations in the nasal passages.

ICD codes

Dosage Regimen

Administer intranasally only. Use the 0.05% solution for adults and children over 6 years of age. Use the 0.025% solution for children from 1 to 6 years of age.

For adults and children over 6 years: instill 1-2 drops or administer 1 injection into each nostril. For children from 1 to 6 years: instill 1 drop or administer 1 injection into each nostril.

Apply the spray with the head held upright. Insert the tip into the nostril and press firmly and quickly once. Inhale gently through the nose during administration.

Repeat the application 2-3 times a day as needed for nasal congestion. The interval between applications should be at least 4 hours.

Limit the duration of treatment to 3-5 consecutive days. Do not exceed the recommended duration to avoid rebound congestion (medication-induced rhinitis).

If symptoms persist after 5 days, discontinue use and consult a physician. Do not use the product more frequently or in larger doses than recommended.

Before first use, prime the pump by pressing it several times until a fine spray is produced. If the product has not been used for several days, re-prime with one or two sprays.

Clean the spray tip regularly with hot water and allow it to air dry. Keep the bottle tightly closed when not in use.

Adverse Reactions

Local reactions possibly – burning, dryness of the nasal mucosa, sneezing; rarely – after the effect of the application wears off, the development of a strong feeling of nasal congestion (reactive hyperemia).

Systemic reactions multiple overdoses with topical application can lead to tachycardia and increased blood pressure; very rarely – anxiety, insomnia, fatigue, headaches, nausea.

Contraindications

Atrophic rhinitis, closed-angle glaucoma, hypersensitivity to oxymetazoline.

With caution

Use of MAO inhibitors and the period up to 10 days after their intake; use of drugs that promote an increase in blood pressure and the period up to 10 days after their intake; increased intraocular pressure; severe forms of cardiovascular diseases (arterial hypertension, coronary artery disease), thyrotoxicosis, diabetes mellitus, pregnancy, breastfeeding period.

Use in Pregnancy and Lactation

Use with caution during pregnancy and lactation (breastfeeding).

Pediatric Use

Used in children according to indications in appropriate dosage forms.

Geriatric Use

Use with caution in elderly patients to avoid exacerbation of chronic diseases.

Special Precautions

Avoid prolonged use and overdose, especially in children.

Effect on the ability to drive vehicles and mechanisms

When used in doses exceeding the recommended ones, a general effect on the cardiovascular system and central nervous system cannot be excluded. In such cases, a decrease in the ability to drive vehicles and engage in other potentially hazardous activities is possible.

Drug Interactions

With simultaneous use of MAO inhibitors and tricyclic antidepressants, an increase in blood pressure is possible.

Oxymetazoline slows down the absorption of local anesthetics and prolongs their action.

Concomitant use of other vasoconstrictor drugs increases the risk of side effects.

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

Over-the-Counter

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.