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Rindelit® oxy (Spray, Drops) Instructions for Use

ATC Code

R01AA05 (Oxymetazoline)

Active Substance

Oxymetazoline (Rec.INN registered by WHO)

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 the swelling of the mucous membrane of the upper respiratory tract.

Pharmacokinetics

When applied intranasally, the T1/2 is 35 hours.

Indications

Difficulty in nasal breathing in colds, sinus inflammation, eustachitis, hay fever, allergic rhinitis.

To relieve swelling before diagnostic manipulations in the nasal passages.

ICD codes

ICD-10 code Indication
H68 Inflammation and obstruction of Eustachian tube
J00 Acute nasopharyngitis (common cold)
J01 Acute sinusitis
J30.1 Allergic rhinitis due to pollen
J30.3 Other allergic rhinitis (perennial allergic rhinitis)
J31.0 Chronic rhinitis (including ozaena, atrophic and hypertrophic rhinitis)
J32 Chronic sinusitis
Z51.4 Preparatory procedures for subsequent treatment or examination, not elsewhere classified
ICD-11 code Indication
AB10.Z Diseases of the auditory [eustachian] tube, unspecified
CA00 Acute nasopharyngitis
CA01 Acute rhinosinusitis
CA08.00 Allergic rhinitis due to pollen
CA08.03 Other allergic rhinitis
CA09.0 Chronic rhinitis
CA0A.Z Chronic rhinosinusitis, unspecified
QB9A Preparatory procedures for subsequent treatment

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer intranasally only. Use the spray or drops according to the specific product form.

For adults and children over 6 years, apply 1-2 drops or 1-2 sprays into each nostril.

Repeat this application 2-3 times per day as needed for nasal congestion relief.

For children aged 2 to 6 years, use only the pediatric formulation. Apply 1 drop or 1 spray into each nostril.

Limit use in children to a maximum of 2 times per day. Do not use in children under 2 years of age unless directed by a physician.

The maximum duration of treatment is 3 to 5 consecutive days.

Exceeding this duration can lead to rebound congestion (medication-induced rhinitis).

Before use, clear nasal passages. For spray, keep the bottle upright and insert the tip into the nostril. Press the applicator quickly and firmly while breathing in gently through the nose.

For diagnostic procedures, administer the dose shortly before the examination as directed by medical personnel.

If symptoms persist beyond 5 days, discontinue use and consult a physician.

Adverse Reactions

Local reactions possibly – burning, dryness of the nasal mucosa, sneezing; rarely – after the effect of 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 increased 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 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

Prolonged use and overdose should be avoided, especially in children.

Influence on the ability to drive vehicles and mechanisms

When used in doses exceeding the recommended ones, a general effect on the cardiovascular system and CNS 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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Bottle OTC Icon Rindelit® oxy Metered-dose nasal spray 22.5 mcg/1 dose with a spray system

Dosage Form, Packaging, and Composition

Metered-dose nasal spray in the form of a transparent, colorless or slightly colored liquid.

1 dose
Oxymetazoline hydrochloride 22.5 mcg

Excipients : benzalkonium chloride, disodium edetate (Trilon B), sodium hydroxide solution 0.1M, sodium dihydrogen phosphate dihydrate (sodium phosphate monobasic dihydrate), disodium hydrogen phosphate dodecahydrate (sodium phosphate dibasic dodecahydrate), purified water.

10 ml (220 doses) – polyethylene bottles (1) with a spray system – cardboard packs.
15 ml (330 doses) – polyethylene bottles (1) with a spray system – cardboard packs.

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Forms

Bottle OTC Icon Rindelit® oxy Nasal drops 0.01%: 2 mL dropper tube 1, 5, or 10 pcs., 10, 15, or 20 mL 1 or 20 pcs.
Nasal drops 0.05%: 2 mL dropper tube 1, 5, or 10 pcs., 10, 15, or 20 mL 1 or 20 pcs.
Nasal drops 0.025%: 2 mL dropper tube 1, 5, or 10 pcs., 10, 15, or 20 mL 1 or 20 pcs.,

Dosage Form, Packaging, and Composition

Nasal drops in the form of a transparent, colorless or slightly brownish-yellowish liquid.

1 ml
Oxymetazoline hydrochloride 0.1 mg

Excipients : disodium hydrogen phosphate dodecahydrate (sodium phosphate dibasic dodecahydrate), sodium dihydrogen phosphate dihydrate (sodium phosphate monobasic dihydrate), disodium edetate (Trilon B), benzalkonium chloride, hydrochloric acid solution 1M, purified water.

2 ml – dropper tube (1) – cardboard packs.
2 ml – dropper tube (5) – cardboard packs.
2 ml – dropper tube (10) – cardboard packs.
10 ml – dropper tube (1) – cardboard packs.
10 ml – dropper tube (20) – cardboard packs.
10 ml – dropper tube – cardboard boxes (for hospitals).
15 ml – dropper tube (1) – cardboard packs.
15 ml – dropper tube (20) – cardboard packs.
15 ml – dropper tube – cardboard boxes (for hospitals).
20 ml – dropper tube (1) – cardboard packs.
20 ml – dropper tube (20) – cardboard packs.
20 ml – dropper tube – cardboard boxes (for hospitals).

Nasal drops in the form of a transparent, colorless or slightly brownish-yellowish liquid.

1 ml
Oxymetazoline hydrochloride 0.5 mg

Excipients : disodium hydrogen phosphate dodecahydrate (sodium phosphate dibasic dodecahydrate), sodium dihydrogen phosphate dihydrate (sodium phosphate monobasic dihydrate), disodium edetate (Trilon B), benzalkonium chloride, hydrochloric acid solution 1M, purified water.

2 ml – dropper tube (1) – cardboard packs.
2 ml – dropper tube (5) – cardboard packs.
2 ml – dropper tube (10) – cardboard packs.
10 ml – dropper tube (1) – cardboard packs.
10 ml – dropper tube (20) – cardboard packs.
10 ml – dropper tube – cardboard boxes (for hospitals).
15 ml – dropper tube (1) – cardboard packs.
15 ml – dropper tube (20) – cardboard packs.
15 ml – dropper tube – cardboard boxes (for hospitals).
20 ml – dropper tube (1) – cardboard packs.
20 ml – dropper tube (20) – cardboard packs.
20 ml – dropper tube – cardboard boxes (for hospitals).

Nasal drops in the form of a transparent, colorless or slightly brownish-yellowish liquid.

1 ml
Oxymetazoline hydrochloride 0.25 mg

Excipients : disodium hydrogen phosphate dodecahydrate (sodium phosphate dibasic dodecahydrate), sodium dihydrogen phosphate dihydrate (sodium phosphate monobasic dihydrate), disodium edetate (Trilon B), benzalkonium chloride, hydrochloric acid solution 1M, purified water.

2 ml – dropper tube (1) – cardboard packs.
2 ml – dropper tube (5) – cardboard packs.
2 ml – dropper tube (10) – cardboard packs.
10 ml – dropper tube (1) – cardboard packs.
10 ml – dropper tube (20) – cardboard packs.
10 ml – dropper tube – cardboard boxes (for hospitals).
15 ml – dropper tube (1) – cardboard packs.
15 ml – dropper tube (20) – cardboard packs.
15 ml – dropper tube – cardboard boxes (for hospitals).
20 ml – dropper tube (1) – cardboard packs.
20 ml – dropper tube (20) – cardboard packs.
20 ml – dropper tube – cardboard boxes (for hospitals).

Marketing Authorization Holder

PFKO-1, LLC (Russia)

Manufactured By

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Bottle OTC Icon Rindelit® mint Metered-dose nasal spray, with menthol and eucalyptus scent 22.5 mcg/dose

Dosage Form, Packaging, and Composition

Metered-dose nasal spray, with menthol and eucalyptus scent

1 dose
Oxymetazoline hydrochloride 22.5 mcg

220 doses – bottles – cardboard packs – Over-the-Counter
330 doses – bottles – cardboard packs – Over-the-Counter
440 doses – bottles – cardboard packs – Over-the-Counter

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