Instructions for Meralis Advance spray nasal solution 0.1% 10 ml
Composition
active ingredient: xylometazoline hydrochloride;
1 ml of solution contains 1 mg or 0.5 mg of xylometazoline hydrochloride.
Excipients: purified sea water, potassium dihydrogen phosphate, sodium hyaluronate, purified water.
Dosage form
Nasal spray, solution.
Main physical and chemical properties: Clear, colorless solution.
Pharmacotherapeutic group
Drugs used in diseases of the nasal cavity. Sympathomimetics, simple drugs.
ATX code R01A A07.
Pharmacological properties
Pharmacodynamics.
Xylometazoline is a sympathomimetic agent that acts on α-adrenergic receptors.
Meralis®Advance causes constriction of nasal blood vessels, reducing swelling of the nasal mucosa and paranasal sinuses and, thus, improving nasal breathing in case of nasal and paranasal sinus congestion.
The drug's effect begins a few minutes after application and lasts up to 12 hours.
The drug does not reduce mucociliary function. Meralis® Advance has a balanced pH value within the limits characteristic of the nasal cavity. Hyaluronic acid saturates the mucous membrane with moisture and, thus, maintains it in optimal conditions for the healing process, if necessary.
Pharmacokinetics.
When applied nasally, it is practically not absorbed, the concentration in plasma is so low that it cannot be determined by modern analytical methods. In cases of overdose or prolonged use, the absorbed amount of the drug may sometimes be sufficient to cause systemic effects, including manifestations from the central nervous system and cardiovascular system.
Indication
Symptomatic treatment of nasal congestion due to colds, hay fever, allergic rhinitis, sinusitis.
To facilitate the outflow of secretions in diseases of the paranasal sinuses.
Adjunctive therapy in cases of otitis media (to eliminate swelling of the mucous membrane).
To facilitate rhinoscopy.
Contraindication
Meralis® Advance should not be used in the following cases:
- hypersensitivity to the active substance xylometazoline hydrochloride or to any of the excipients of the drug;
- dry inflammation of the nasal mucosa with crust formation (dry rhinitis);
- simultaneous treatment with monoamine oxidase inhibitors (MAOIs), treatment with monoamine oxidase inhibitors (MAOIs) within two weeks before starting Meralis® Advance or other drugs that can increase blood pressure;
- after hypophysectomy or surgical intervention on the dura mater;
- angle-closure glaucoma;
- acute coronary diseases;
- hyperthyroidism;
- coronary asthma;
- children under 2 years of age for 0.05% spray; and children under 12 years of age for 0.1% spray;
- pregnancy period.
Meralis® Advance should be used with caution and only after careful assessment of the benefit-risk ratio in patients with increased intraocular pressure, severe cardiovascular diseases (e.g., coronary heart disease, hypertension), prostatic hyperplasia, pheochromocytoma, porphyria, and metabolic disorders (e.g., diabetes mellitus).
Interaction with other medicinal products and other types of interactions
Monoamine oxidase inhibitors (MAOIs): Xylometazoline may potentiate the effects of monoamine oxidase inhibitors and induce hypertensive crisis. Do not use xylometazoline in patients who are taking or have taken MAOIs within the last two weeks.
Tri- and tetracyclic antidepressants: Concomitant use of tri- or tetracyclic antidepressants and sympathomimetic drugs may enhance the sympathomimetic effect of xylometazoline, therefore concomitant use of such agents is not recommended. Concomitant use with β-blockers may cause bronchospasm or a decrease in blood pressure.
Application features
The drug should be prescribed with caution to patients who have experienced severe adverse reactions such as insomnia, dizziness, tremor, cardiac arrhythmia, and increased blood pressure when using adrenergic drugs.
Patients with long QT syndrome who receive xylometazoline may be at increased risk of serious ventricular arrhythmias.
The recommended dose should not be exceeded, especially when treating children and elderly patients. The drug should not be used for more than 5 consecutive days.
Prolonged use and overdose of sympathomimetic decongestants may cause reactive hyperemia of the nasal mucosa, which may lead to airway obstruction, which in turn requires repeated or continuous use of the drug. This may lead to chronic edema (rhinitis medicamentosa) and, with the remainder, to atrophy of the nasal mucosa. In mild cases, it is necessary to first consider discontinuing the use of sympathomimetics in one nostril, and after the symptoms disappear, in the other nostril, in order to at least partially preserve nasal breathing.
Use during pregnancy or breastfeeding
Pregnancy. The drug should not be used during pregnancy due to the potential vasoconstrictor effect.
Lactation: The drug should not be used in women who are breastfeeding, as it is not known whether it is excreted in breast milk.
Fertility: There are no adequate data on the effect of the drug on fertility. Since the systemic exposure to xylometazoline hydrochloride is very low, the likelihood of an effect on fertility is extremely low.
Ability to influence reaction speed when driving vehicles or other mechanisms
In cases of prolonged use of Meralis® Advance in high doses, the drug may have an undesirable effect on the cardiovascular system, which may negatively affect the ability to drive vehicles and operate machinery.
Method of administration and doses
Before using the drug, you should thoroughly clean your nose.
Meralis® Advance, 0.05% nasal spray, is prescribed to children aged 2 to 12 years, 1 spray into each nasal passage 1-2 times a day.
Meralis® Advance, 0.1% nasal spray, is prescribed for adults and children aged 12 years and over.
1 spray into each nasal passage 2-3 times a day.
The drug should be used for no more than 5 days, unless the doctor has recommended a different duration of treatment.
The use of Meralis® Advance can be resumed after a break of several days.
Long-term use of the drug may cause atrophy of the nasal mucosa. In case of chronic rhinitis, the drug Meralis® Advance should be used under the supervision of a physician due to the risk of atrophy of the nasal mucosa.
Before the first use, the drug must be sprayed into the air several times (5 times) to achieve a uniform dose.
If the bottle of the drug is not used for several days, it is necessary to spray it into the air at least once to achieve a uniform dose.
For hygiene reasons and to prevent the spread of infection, each spray bottle should be used by only one person.
Children
Meralis® Advance, nasal spray 0.05% is intended for the treatment of children aged 2 to 12 years. Meralis® Advance, nasal spray 0.1% is intended for the treatment of children aged 12 years and older.
Overdose
Symptoms
With nasal administration, systemic effects are unlikely due to local vasoconstriction, which inhibits absorption. In the case of systemic absorption, xylometazoline, as an α2-adrenergic agonist, can be expected to have effects similar to clonidine: a short-term increase in blood pressure followed by more prolonged hypotension and sedation.
Symptoms of intoxication with imidazole derivatives may be clinically unclear, as periods of stimulation may alternate with periods of depression of the central nervous and cardiovascular systems.
Symptoms of central nervous system stimulation include anxiety, agitation, hallucinations, and seizures.
Symptoms of central nervous system depression include decreased body temperature, lethargy, drowsiness, and coma.
Additional symptoms may include: miosis, mydriasis, sweating, nausea, cyanosis, fever, pale skin, CNS paralysis, sedation, dry mouth, arrhythmia, tachycardia, bradycardia, cardiac arrest, hypertension, shock-like hypotension, pulmonary edema, respiratory distress, and apnea.
Overdose, especially in children, can lead to significant effects on the central nervous system, causing spasms, coma, bradycardia, apnea, and hypertension, which may progress to hypotension.
Treatment
Severe overdose will require hospital treatment. Since xylometazoline hydrochloride is rapidly absorbed, activated charcoal (absorbent), sodium sulfate (laxative) or gastric lavage (when using higher doses) should be administered immediately. Lowering blood pressure can be achieved with non-selective alpha-blockers. Vasoconstrictors are contraindicated. If necessary, antipyretics and anticonvulsants, as well as artificial oxygen respiration, are used.
Adverse reactions
Adverse reactions that may occur during the use of the drug are classified according to their frequency: very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1000 to <1/100); rare (≥ 1/10000 to <1/1000); very rare (<1/10000), including isolated cases, unknown.
On the part of the immune system
Uncommon: hypersensitivity reactions including angioedema, rash, pruritus.
From the nervous system
Rare: headache, insomnia, dizziness, fatigue, convulsions (usually in children).
Very rare: nervousness, drowsiness/inhibition (usually in children)
From the organs of vision
Cardiovascular system
Uncommon: palpitations, tachycardia.
Very rare: arrhythmia, arterial hypertension.
Respiratory, thoracic and mediastinal disorders
Common: dryness or discomfort of the nasal mucosa.
From the gastrointestinal system:
Common: nausea.
General disorders and administration site conditions:
Common: burning sensation at the application site.
Prolonged or frequent use with high doses of xylometazoline may cause a burning sensation or dryness of the mucous membrane and increased swelling of the mucous membrane, which worsen with continued use of the drug (rhinitis medicamentosa). This effect may be observed after as little as 7 days of treatment and, when treatment is continued, may lead to long-term damage to the mucous membrane with crusting (rhinitis sicca).
Expiration date
3 years. Shelf life after first opening the package is no more than 180 days.
Storage conditions
Does not require any special storage conditions. Keep out of the reach of children.
Packaging
10 ml of solution in a bottle with a dosing device; 1 bottle in a cardboard box.
Vacation category
Without a prescription.
Producer
Jadran-Galensky Laboratories, Dr.
Location of the manufacturer and its address of the place of implementation of the activity
Svilno 20, 51000 Rijeka, Croatia.
