Rankof^® Pino (Spray) Instructions for Use

Marketing Authorization Holder

Rankof LLC (Russia)

Manufactured By

Vips-Med, LLC (Russia)

ATC Code

R01AA05 (Oxymetazoline)

Active Substance

Oxymetazoline (Rec.INN registered by WHO)

Dosage Forms

	Rankof® Pino	Nasal spray 0.25 mg/ml: 10 ml or 20 ml bottle
		Nasal spray 500 mcg/ml: 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, sodium dihydrogen phosphate dodecahydrate – 1.76 mg, sodium hydroxide solution 0.1M – to pH 6.2-7.0, purified water – to 1 ml.

10 ml – bottles (1) – carton packs.
20 ml – bottles (1) – carton 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, sodium dihydrogen phosphate dodecahydrate – 1.76 mg, sodium hydroxide solution 0.1M – to pH 6.2-7.0, purified water – to 1 ml.

10 ml – bottles (1) – carton packs.
20 ml – bottles (1) – carton 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 procedures in the nasal passages.

ICD codes

Dosage Regimen

Administer intranasally only. Use the 0.25 mg/ml concentration for children and the 0.5 mg/ml concentration for adults.

For adults and children over 6 years, instill one injection into each nostril. For children aged 2 to 6 years, use the pediatric formulation (0.25 mg/ml) and instill one injection into each nostril.

Limit application to two or three times per day. Do not exceed three applications within a 24-hour period.

The maximum duration of continuous use is 3 to 5 days. Do not use for more than seven consecutive days.

Before first use, prime the pump by pressing the actuator several times until a full spray is produced. Tilt head slightly forward. Insert tip into nostril, pointing away from the nasal septum. Press firmly to release spray while breathing in gently through the nose. Repeat for the other nostril.

Wipe the spray tip clean after each use. Replace the protective cap securely.

Discontinue use and consult a physician if symptoms persist, worsen, or if irritation occurs. Avoid contamination of the dropper tip.

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, period of breastfeeding.

Use in Pregnancy and Lactation

Use with caution during pregnancy and during 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.