Sinusephrin (Spray) Instructions for Use

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

ATC Code

R01AX30 (Other nasal preparations for topical use in combination)

Dosage Form

Sinusephrin

Nasal spray: 10 ml, 15 ml, or 20 ml bottle with spray nozzle

Dosage Form, Packaging, and Composition

Nasal spray as a clear, colorless or yellowish liquid.

Excipients: methylparaben – 0.1 g, lithium chloride – 0.34 g, citric acid monohydrate – 0.28 g, lithium hydroxide – 0.1 g, macrogol 4000 – 5 g, polysorbate 80 – 0.2 g, purified water – up to 100 ml.

10 ml – orange glass bottles (1) with a spray nozzle – cardboard packs.
15 ml – orange glass bottles (1) with a spray nozzle – cardboard packs.
20 ml – orange glass bottles (1) with a spray nozzle – cardboard packs.
10 ml – polymer bottles (1) with a spray nozzle – cardboard packs.
15 ml – polymer bottles (1) with a spray nozzle – cardboard packs.
20 ml – polymer bottles (1) with a spray nozzle – cardboard packs.

Clinical-Pharmacological Group

A drug with antibacterial, anti-inflammatory, and vasoconstrictive action for topical use in ENT practice

Pharmacotherapeutic Group

Topical glucocorticosteroid + antibiotics (aminoglycoside + cyclic polypeptide) + alpha-adrenergic agonist

Pharmacological Action

Combined medicinal product for topical use in otorhinolaryngology.

The therapeutic effect is due to the anti-inflammatory action of dexamethasone, the vasoconstrictive action of phenylephrine, and the antibacterial action of the antibiotics neomycin and polymyxin B. The combination of these antibiotics broadens the spectrum of antibacterial action to cover most gram-positive and gram-negative microorganisms that cause infectious and inflammatory diseases of the nasal cavity and paranasal sinuses.

Neomycin is active against Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae.

Polymyxin B is active against gram-negative bacteria Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, Pseudomonas aeruginosa.

Streptococcus spp. (including Streptococcus pneumoniae) and anaerobic bacteria are resistant to the action of these antibiotics.

Indications

Inflammatory and infectious diseases of the nasal cavity, pharynx, paranasal sinuses: acute and chronic rhinitis; acute and chronic rhinopharyngitis; sinusitis.

ICD codes

Dosage Regimen

Administer Sinusephrin intranasally as a nasal spray.

For adults and children over 2.5 years of age, instill one spray into each nostril.

Apply the spray three to five times daily.

The maximum duration of treatment is 10 days.

Do not exceed the recommended dosage or treatment duration.

Prior to first use, prime the pump by spraying several times into the air until a fine mist appears.

Clear nasal passages before administration.

Tilt head slightly forward and insert nozzle into nostril.

Spray while breathing in gently through the nose.

Repeat the procedure for the other nostril.

Wipe the spray tip clean after each use.

Discontinue use and consult a physician if no improvement is observed within 3-5 days.

Do not use for more than 10 consecutive days.

Adverse Reactions

Allergic reactions rarely – skin manifestations.

Contraindications

Suspected angle-closure glaucoma; simultaneous use of MAO inhibitors; kidney disease accompanied by albuminuria; pregnancy; lactation (breastfeeding); children under 2.5 years of age; hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Use in Renal Impairment

Contraindicated in patients with kidney disease accompanied by albuminuria.

The drug is not prescribed to patients with renal failure.

Geriatric Use

The drug is contraindicated for use in elderly patients

Special Precautions

Do not use in patients with renal failure.

Do not use for irrigation of the paranasal sinuses.

Use with caution in patients with arterial hypertension, coronary artery disease, hyperthyroidism.

It should be borne in mind that this combination contains components that may give a positive result during doping control in athletes.

Drug Interactions

Drug interaction is due to the content of phenylephrine. With simultaneous use of guanethidine and drugs of this group, the hypertensive effect of phenylephrine is enhanced and, due to the reduction of sympathetic tone by guanethidine, prolonged mydriasis is possible. If such a combination cannot be avoided, medical supervision is necessary.

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

Rx Only

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.