Oksifrin gerta (Spray) Instructions for Use

Marketing Authorization Holder

Gerta, LLC (Russia)

Manufactured By

Grotex, LLC (Russia)

ATC Code

R01AA05 (Oxymetazoline)

Active Substance

Oxymetazoline (Rec.INN registered by WHO)

Dosage Forms

	Oksifrin gerta	Metered nasal spray 11.25 mcg/dose
		Metered nasal spray 22.5 mcg/dose

Dosage Form, Packaging, and Composition

Metered nasal spray

10 ml (190 doses) – bottles – cardboard packs – Over-the-Counter
15 ml (280 doses) – bottles – cardboard packs – Over-the-Counter

Metered nasal spray

10 ml (190 doses) – bottles – cardboard packs – Over-the-Counter
15 ml (280 doses) – bottles – cardboard packs – Over-the-Counter

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, sinus inflammation, eustachitis, hay fever, allergic rhinitis.

To eliminate edema before diagnostic manipulations in the nasal passages.

ICD codes

Dosage Regimen

Administer intranasally only.

Prime the pump before first use by pressing the actuator several times until a uniform spray is produced.

For the 11.25 mcg/dose strength: Adults and children over 6 years: administer one spray into each nostril. Repeat this dose no more than two times per 24 hours as needed for nasal congestion.

For the 22.5 mcg/dose strength: Adults and children over 12 years: administer one spray into each nostril. Repeat this dose no more than two times per 24 hours as needed.

Do not exceed two administrations in 24 hours for either strength.

The maximum duration of continuous use is 3 to 5 days.

Avoid using the product for more than 5 consecutive days to prevent rebound congestion (medication-induced rhinitis).

Allow at least 10-12 hours to pass between doses.

Clean the spray tip regularly with a clean tissue.

Do not share the bottle with another person to prevent the spread of infection.

Discontinue use and consult a physician if symptoms persist or worsen after 3 days of treatment.

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, ischemic heart disease), thyrotoxicosis, diabetes mellitus, pregnancy, period of breastfeeding.

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 30°C (86°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.