Xylokt^® extra (Spray) Instructions for Use

Marketing Authorization Holder

Grotex, LLC (Russia)

ATC Code

R01AB06 (Xylometazoline in combination with other drugs)

Active Substances

Xylometazoline (Rec.INN registered by WHO)

Ipratropium bromide (Rec.INN registered by WHO)

Dosage Form

Xylokt® extra

Dosed nasal spray 84 mcg+70 mcg/1 dose: 10 ml (60 doses) or 15 ml (90 doses) bottle with dosing nozzle

Dosage Form, Packaging, and Composition

Dosed nasal spray as a clear, colorless or slightly colored liquid.

Excipients: benzalkonium chloride – 21 mcg, glycerol – 3.32 mg, disodium edetate dihydrate – 70 mcg, 1M hydrochloric acid solution or 1M sodium hydroxide solution – to pH 3.7-4.7, purified water – 140 µl.

10 ml (60 doses) – polyethylene bottles (1) with a dosing nozzle – cardboard packs.
15 ml (90 doses) – polyethylene bottles (1) with a dosing nozzle – cardboard 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, combinations without corticosteroids

Pharmacological Action

A combined agent for topical use in ENT practice.

Xylometazoline is an alpha-adrenergic agonist. It causes constriction of the blood vessels of the nasal mucosa, thereby eliminating swelling and hyperemia of the nasopharyngeal mucosa. It facilitates nasal breathing in rhinitis.

Ipratropium bromide has an anticholinergic effect. When applied intranasally, it reduces the secretion of the glands of the nasal mucosa.

Pharmacokinetics

When applied intranasally, Xylometazoline hydrochloride and ipratropium bromide are poorly absorbed and are present in the blood plasma in insignificant amounts.

Indications

Symptomatic treatment of edema and hyperemia of the nasal cavity; acute respiratory diseases with symptoms of rhinitis (runny nose); acute allergic rhinitis; hay fever; sinusitis.

ICD codes

Dosage Regimen

Administer intranasally only.

For adults over 18 years of age, administer one single dose into each nostril.

Do not exceed three administrations per day.

Before first use, prime the spray pump by pressing it several times until a fine mist appears.

Before each administration, gently blow your nose to clear the nasal passages.

Keep your head upright. Insert the nozzle into the nostril. Close the opposite nostril with your finger.

Spray once into the nostril while breathing in gently through your nose.

Repeat the procedure for the other nostril.

Wipe the nozzle clean after use and replace the protective cap.

Avoid contact with eyes. If contact occurs, rinse eyes immediately with cold water.

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

Do not use for prolonged periods due to the risk of rebound congestion and medication-induced rhinitis.

If symptoms worsen or do not improve after 3 days of use, discontinue the spray and consult a physician.

Adverse Reactions

Immune system disorders: frequency unknown – hypersensitivity reactions (anaphylactic reaction, angioedema, rash, itching, laryngospasm).

Nervous system disorders common – taste disturbance, headache; uncommon – smell disorders, dizziness, tremor; very rare – insomnia, convulsions, hallucinations.

Eye disorders uncommon – eye irritation, dry eye; frequency unknown – increased intraocular pressure, mydriasis, eye pain, photopsia, worsening of angle-closure glaucoma, impaired visual acuity, pupil dilation, halo effect (presence of rainbow-colored circles around a light source in the field of vision).

Cardiac and vascular disorders rare – palpitations, supraventricular tachycardia, arterial hypertension; very rare – arrhythmia.

Respiratory, thoracic and mediastinal disorders very common – epistaxis, irritation and/or dryness of the nasal mucosa; common – burning sensation, tingling sensation, nasal hypersecretion, sneezing, nasal congestion (with frequent and/or prolonged use of the drug), dry throat, throat irritation, rhinalgia, rhinorrhea; uncommon – ulcer of the nasal mucosa, sneezing, pharyngeal pain, cough, dysphonia; frequency unknown – discomfort in the paranasal sinus area, laryngeal spasm, pharyngeal edema.

Gastrointestinal disorders common – dry mouth; uncommon – dyspepsia, nausea; frequency unknown – difficulty swallowing.

Skin and subcutaneous tissue disorders frequency unknown – itching, skin rash, urticaria.

Renal and urinary disorders frequency unknown – difficulty urinating.

General disorders and administration site conditions uncommon – fatigue, thirst.

Contraindications

Arterial hypertension; tachycardia; severe atherosclerosis; glaucoma; atrophic rhinitis; hyperthyroidism; condition after transsphenoidal hypophysectomy; condition after surgical interventions on the meninges (in history); pregnancy; age under 18 years; therapy with MAO inhibitors or tricyclic antidepressants, including the period of 14 days after their withdrawal.

With caution

Diabetes mellitus; pheochromocytoma; cardiovascular diseases, including coronary artery disease, angina pectoris III-IV functional class; bladder neck obstruction; interureteric fold stenosis; prostatic hyperplasia; porphyria.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is contraindicated.

Pediatric Use

Use is contraindicated in children and adolescents under 18 years of age.

Geriatric Use

Experience of use in elderly patients (over 70 years old) is limited.

Special Precautions

Before use, it is necessary to clean the nasal passages.

Should not be used for a long time, for example, in chronic rhinitis.

Patients should be warned about the inadmissibility of spraying into the eyes or around the eyes. If it gets into the eyes, they should be rinsed with cold water.

If the symptoms of the disease worsen or the patient’s condition does not improve within 3 days, it is necessary to consult a doctor.

Influence on the ability to drive vehicles and mechanisms

Use in therapeutic doses does not affect the ability to drive vehicles and work with mechanisms. Overdose or getting the drug into the eyes may affect the ability to drive vehicles and engage in other potentially hazardous activities.

Drug Interactions

Concomitant use with MAO inhibitors, tri- and tetracyclic antidepressants is contraindicated, as well as if these drugs have been taken within the previous 2 weeks. Concomitant use or use within the previous 2 weeks of tri- and tetracyclic antidepressants and sympathomimetic drugs may enhance the sympathomimetic effect of xylometazoline, therefore it is not recommended.

Sympathomimetic drugs cause the release of catecholamines, including norepinephrine, which has a vasoconstrictive effect, resulting in increased blood pressure.

With concomitant use of other drugs with anticholinergic activity, the anticholinergic effect of ipratropium bromide may be enhanced.

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.