Influrine^® Phino (Spray) Instructions for Use

Marketing Authorization Holder

Slavic Pharmacy, LLC (Russia)

ATC Code

R01AA08 (Naphazoline)

Active Substance

Naphazoline (Rec.INN registered by WHO)

Dosage Forms

	Influrine® Rhino	Nasal spray 0.1%: 10 g or 15 g bottle or dropper bottle
		Nasal spray 0.05%: 10 g or 15 g bottle or dropper bottle

Dosage Form, Packaging, and Composition

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

Excipients: boric acid – 20 mg, purified water – up to 1 g.

10 g – polymer dropper bottles (1) – cardboard packs.
15 g – polymer dropper bottles (1) – cardboard packs.
10 g – polymer bottles (1) complete with a nasal spray nozzle or spray applicator – cardboard packs.
15 g – polymer bottles (1) complete with a nasal spray nozzle or spray applicator – cardboard packs.

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

Excipients: boric acid – 20 mg, purified water – up to 1 g.

10 g – polymer dropper bottles (1) – cardboard packs.
15 g – polymer dropper bottles (1) – cardboard packs.
10 g – polymer bottles (1) complete with a nasal spray nozzle or spray applicator – cardboard packs.
15 g – polymer bottles (1) complete with a nasal spray nozzle or spray applicator – cardboard packs.

Clinical-Pharmacological Group

Vasoconstrictor drug for topical use in ENT practice

Pharmacotherapeutic Group

Decongestant – alpha-adrenomimetic

Pharmacological Action

Alpha-adrenomimetic. When applied to the mucous membranes, it has a rapid, pronounced and prolonged vasoconstrictive effect.

Pharmacokinetics

With topical application, systemic absorption is low.

Indications

For intranasal use: acute rhinitis, allergic rhinitis, sinusitis, eustachitis, laryngitis, laryngeal edema of allergic genesis, laryngeal edema due to irradiation, hyperemia of the mucous membrane after operations on the upper respiratory tract, to facilitate rhinoscopy, to stop nosebleeds, to prolong the action of local anesthetics used for superficial anesthesia.

For use in ophthalmology: symptomatic temporary relief of secondary eye hyperemia due to moderate irritant exposure and allergic conjunctivitis.

ICD codes

Dosage Regimen

Administer intranasally or topically in ophthalmology.

Select the appropriate concentration based on patient age: use the 0.05% nasal spray for children aged 2 to 6 years; use the 0.1% nasal spray for adults and children over 6 years.

For intranasal use, clear nasal passages before administration. Tilt head slightly forward. Insert spray tip into nostril, directing it away from the nasal septum. Spray once into each nostril.

Repeat this intranasal administration every 6 hours as needed for nasal congestion. Do not exceed 4 doses in 24 hours for any patient.

For ophthalmic use, instill one to two drops into the conjunctival sac of the affected eye(s).

Repeat ophthalmic instillation every 3 to 4 hours as needed for eye redness relief.

Limit the duration of treatment for all indications. Use for a maximum of 3 to 5 consecutive days.

Avoid prolonged use to prevent rebound congestion (rhinitis medicamentosa) and atrophic rhinitis.

Discontinue use and consult a physician if symptoms persist, worsen, or if systemic effects like tachycardia, hypertension, dizziness, or headache occur.

In pediatric and geriatric patients, use the minimum effective dose due to increased susceptibility to systemic adverse reactions.

Adverse Reactions

Local reactions: when used in ophthalmology – burning, itching, pain in the eye area; reactive conjunctival hyperemia, visual disturbance, dryness of the nasal mucosa, mydriasis, increased intraocular pressure; with intranasal use – reactive hyperemia, swelling of the nasal mucosa, irritation of the nasal mucosa, with use for more than 1 week – swelling of the nasal mucosa, atrophic rhinitis.

Systemic reactions are possible, mainly in children and elderly patients – pallor of the skin, tachycardia, pain in the heart area, increased blood pressure, increased sweating, tremor, headache, agitation, nausea, drowsiness, dizziness.

Contraindications

Hypersensitivity to naphazoline, arterial hypertension, severe atherosclerosis, thyrotoxicosis, chronic rhinitis, atrophic rhinitis, severe eye diseases, angle-closure glaucoma, diabetes mellitus, tachycardia, simultaneous use of MAO inhibitors and the period up to 14 days after their discontinuation; childhood – depending on the dosage form.

With cautioncoronary artery disease, prostate hyperplasia; pheochromocytoma; pregnancy, breastfeeding period; hyperthyroidism, diabetes mellitus, porphyria, dry rhinitis, dry keratoconjunctivitis, glaucoma; use of other drugs that increase blood pressure.

Use in Pregnancy and Lactation

The use of naphazoline during pregnancy and lactation (breastfeeding) is possible only for strict indications in cases where the expected therapeutic effect for the mother outweighs the potential risk of developing side effects in the fetus or child.

Pediatric Use

Use in children is possible according to indications, in age-appropriate recommended doses and dosage forms. It is necessary to strictly follow the instructions in the drug labels for naphazoline regarding contraindications for use in children of different ages for specific naphazoline dosage forms. In children, especially young children, the likelihood of developing systemic adverse reactions to naphazoline is increased.

Geriatric Use

In elderly patients, the likelihood of developing systemic adverse reactions to naphazoline is increased.

Special Precautions

Naphazoline may have a resorptive effect.

With long-term intranasal use, the severity of the vasoconstrictive effect of naphazoline gradually decreases (tachyphylaxis phenomenon), in connection with which it is recommended to take a break for several days after 5-7 days of use. Prolonged use of the product should be avoided.

If no improvement is observed within 72 hours of using the eye drops, or if irritation or hyperemia increases, or eye pain or visual disturbances appear, the use of the product should be discontinued and a doctor should be consulted. Direct contact of the product with contact lenses should be avoided. It is recommended to remove contact lenses before using the eye drops.

Drug Interactions

Should not be used simultaneously with MAO inhibitors or within 14 days after their discontinuation.

Naphazoline slows down the absorption of local anesthetics (prolongs their action during superficial anesthesia).

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.