Tyzine^® Panthenol (Spray) Instructions for Use

ATC Code

R01AB06 (Xylometazoline in combination with other drugs)

Active Substances

Dexpanthenol (Rec.INN registered by WHO)

Xylometazoline (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Vasoconstrictor drug for topical use in ENT practice

Pharmacotherapeutic Group

Decongestant

Pharmacological Action

Xylometazoline belongs to the group of topical vasoconstrictors (decongestants) with alpha-adrenomimetic activity. It causes constriction of the blood vessels of the nasal mucosa, restores the patency of the nasal passages, eliminates nasal congestion, and facilitates nasal breathing. The action of xylometazoline begins 2 minutes after its application and lasts up to 12 hours.

Dexpanthenol is a B vitamin, a derivative of pantothenic acid. Dexpanthenol is converted in the body into pantothenic acid, which is a component of coenzyme A (CoA), and participates in acetylation processes, carbohydrate and fat metabolism, and in the synthesis of acetylcholine, corticosteroids, and porphyrins. It stimulates the regeneration of the skin and mucous membranes, normalizes cellular metabolism, accelerates mitosis, and increases the strength of collagen fibers. It has a regenerating, metabolic, and weak anti-inflammatory effect.

Pharmacokinetics

Xylometazoline is practically not absorbed when applied topically. Plasma concentrations are so low that they cannot be determined by modern analytical methods.

Dexpanthenol, when applied topically, is rapidly absorbed by the skin and converted into pantothenic acid, which binds to plasma proteins (mainly to beta-globulin and albumin). Its concentration in the blood is 0.5-1 mg/L, and in the blood serum is 100 µg/L. Pantothenic acid is not metabolized in the body (except for incorporation into CoA) and is excreted unchanged in the urine.

Indications

• Acute respiratory diseases with symptoms of rhinitis;
• Acute allergic rhinitis;
• Vasomotor rhinitis;
• Sinusitis;
• Otitis media (as part of combination therapy to reduce swelling of the nasopharyngeal mucosa);
• To facilitate rhinoscopy, to restore impaired nasal breathing after surgical interventions in the nasal cavity.

ICD codes

Dosage Regimen

Spray

Intranasally.

For adults and children over 6 years old.

General administration instructions

Remove the protective cap. Before the first use, press the spray nozzle several times (fig. 1) until a uniform cloud of “mist” appears. The bottle is ready for further use. When applying, press once (fig. 2). Inhale the medication through the nose. If possible, hold the spray bottle vertically. Do not spray horizontally or downwards. After use, the bottle should be closed with the cap.

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One metered spray into each nostril 3-4 times/day. The duration of therapy is 5-7 days.

The drug should not be used for more than 7 days. The duration of use in children aged 6 to 18 years is determined after consultation with a doctor.

Repeated use is possible only after a break of several days.

If after 5 days of treatment there is no improvement, or the symptoms worsen, or new symptoms appear, it is necessary to consult a doctor.

The drug should be used only according to the indications, method of application, and doses specified in the instructions.

Adverse Reactions

Adverse reactions were classified as follows: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (<1/10000), frequency unknown (frequency cannot be estimated from the available data).

Nervous system disorders very rare – anxiety, insomnia, headache, fatigue (drowsiness), hallucinations (mainly in children).

Cardiovascular system disorders rare – palpitations, tachycardia, increased blood pressure; very rare – arrhythmia.

Respiratory system disorders very rare – swelling of the nasal mucosa, hypersecretion, nosebleed; frequency unknown – burning and dryness of the nasal mucosa, sneezing.

Musculoskeletal system disorders very rare – convulsions (especially in children).

Immune system disorders very rare – allergic reactions (angioedema, skin rash, itching).

If any of the side effects mentioned in the instructions worsen, or any other side effects not listed in the instructions are noted, the patient should inform the doctor.

Contraindications

• Hypersensitivity to any of the components of the drug;
• Arterial hypertension;
• Tachycardia;
• Severe atherosclerosis;
• Hyperthyroidism;
• Glaucoma;
• Atrophic rhinitis;
• Dry rhinitis;
• Porphyria;
• Prostatic hyperplasia;
• Surgical interventions on the meninges (in history);
• Simultaneous use with MAO inhibitors and tricyclic antidepressants;
• Pregnancy;
• Breastfeeding period;
• Children under 6 years of age.

With caution

Diabetes mellitus, pheochromocytoma, cardiovascular diseases, including coronary artery disease and long QT syndrome (patients with long QT syndrome taking xylometazoline are at increased risk of developing ventricular arrhythmias), hypersensitivity to the action of adrenergic drugs, accompanied by insomnia, dizziness, arrhythmia, tremor, increased blood pressure.

Use in Pregnancy and Lactation

The drug should not be used during pregnancy. The use of the drug during breastfeeding should be avoided.

Pediatric Use

Contraindicated for use in children under 6 years of age.

Special Precautions

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

The duration of use of the drug in children is determined after consultation with a doctor.

Patients with long QT syndrome using xylometazoline may be at increased risk of developing serious ventricular arrhythmias.

If the medicine is unusable or the expiration date has passed, it should not be disposed of in sewage or on the street. It is necessary to place the medicine in a bag and put it in a trash container. These measures will help protect the environment.

Effect on the ability to drive vehicles and mechanisms

When used according to the instructions, the drug does not affect the ability to drive vehicles and mechanisms; however, if adverse events occur, one should refrain from performing these activities.

Overdose

Symptoms

In case of overdose or accidental oral application, the following symptoms may occur: mydriasis, nausea, vomiting, cyanosis, fever, convulsions, tachycardia, heart rhythm disturbance, vascular insufficiency, cardiac arrest, hypertension, pulmonary edema, respiratory dysfunction, hallucinations.

Patients may also develop symptoms of CNS depression, accompanied by drowsiness, decreased body temperature, bradycardia, shock, respiratory arrest, and coma.

Treatment

Use of activated charcoal, gastric lavage, oxygen ventilation of the lungs. To reduce blood pressure, phentolamine 5 mg in 0.9% sodium chloride solution is administered by slow intravenous injection or 100 mg of phentolamine orally.

Vasoconstrictors are contraindicated. If necessary, antipyretic and anticonvulsant drugs are used.

Drug Interactions

With simultaneous use of MAO inhibitors and tricyclic antidepressants, an increase in systemic action is possible.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 3 years. Do not use the drug after the expiration date.

After first use, use within 6 months.

Dispensing Status

Available without a prescription.

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.