Instructions for use of the drug Sialor Rhino for children under one year of age


Composition per 1 ml:

Active substance:
Oxymetazoline hydrochloride– 0.1 mg
Excipients:
benzalkonium chloride– 0.1 mg
disodium edetate (trilon B)– 0.5 mg
sodium hydroxide (0.1 M sodium hydroxide solution)– up to pH 6.0-7.0
sodium dihydrogen phosphate dihydrate (sodium phosphate monosubstituted 2-water)– 1.29 mg
sodium hydrogen phosphate dodecahydrate (sodium phosphate disubstituted 12-water)– 1.76 mg
purified water– up to 1 ml

Pharmacological properties

Pharmacodynamics

Oxymetazoline belongs to the group of alpha-agonists for topical use. Has a vasoconstrictor effect. When administered intranasally, it reduces swelling of the mucous membrane of the upper respiratory tract and nasal discharge. Restores nasal breathing. Elimination of swelling of the nasal mucosa helps restore aeration of the paranasal sinuses and middle ear cavity, which reduces the likelihood of bacterial complications (sinusitis, sinusitis, otitis media). When used locally intranasally in therapeutic concentrations, it does not irritate or cause hyperemia of the nasal mucosa. The drug begins to act quickly, within a few minutes. The duration of action of the drug is up to 12 hours.

Pharmacokinetics

When administered locally intranasally, oxymetazoline does not have a systemic effect. The half-life of oxymetazoline when administered intranasally is 35 hours. 2.1% of oxymetazoline is excreted in the urine and about 1.1% in the feces.

Mechanism of action

The active component of the medicine contains up to 8.5% pure silver. When combined with water, the tablet forms a suspension, the particles of which evenly cover the mucous membrane of the nasal passages. Silver has a moderate decongestant, anti-inflammatory, astringent and antibacterial effect. It precipitates proteins of pathogenic cells and forms a thin protective layer on the surface that prevents irritation of nerve endings. At the same time, the metal narrows the lumen of the capillaries, preventing the accumulation of effusion and exudative masses.

By slowing down the inflammatory process, Sialor blocks the activity of gram-positive and gram-negative microbes, preventing an infectious runny nose from developing into a complicated form. Local application does not allow the drug substances to be absorbed into the systemic circulation.

Silver forms an insoluble precipitate with salts of other metals: iron, aluminum, mercury, copper and lead. Upon contact with alkaloids and organic substances, the effect of the drug is neutralized. Sialor does not affect the speed of motor reactions; it is safe when driving vehicles and operating complex mechanisms.

Carefully

In patients with increased intraocular pressure, suffering from diseases of the cardiovascular system (arterial hypertension, coronary heart disease, chronic heart failure, tachycardia, arrhythmias), impaired carbohydrate metabolism (diabetes mellitus), impaired thyroid function (hyperthyroidism), pheochromocytoma, chronic renal insufficiency, prostatic hyperplasia (urinary retention), severe atherosclerosis, porphyria, pregnancy, breastfeeding, as well as patients taking tricyclic antidepressants and bromocriptine.

Directions for use and doses

Intranasally.

  • Children under 1 year: children under 4 weeks of age are prescribed 1 drop of 0.01% solution in each nasal passage 2-3 times a day. From the 5th week of life to 1 year - 1-2 drops in each nasal passage 2-3 times a day.

It is not recommended to use the drug for more than 7 days. With frequent and prolonged use of the drug, the feeling of nasal congestion may reappear or worsen. If these symptoms appear, you should stop treatment and consult a doctor.

Composition and dosage forms

The drug Sialor Protargol is intended for the treatment of runny nose. It is produced in the form of a pharmacological semi-finished product, from which it is necessary to prepare a solution. The cardboard box contains a complex of separately packaged elements:

  • A tablet containing the active substance - silver proteinate in a dosage of 200 mg. Black or dark gray in color, with a metallic sheen and inclusions, round in shape, enclosed in a contour cell shell. An auxiliary component of the drug is povidone.
  • Polymer transparent ampoule with water for injection in a volume of 10 ml.
  • A dark glass bottle equipped with a pipette attachment (for using the product as drops) or with a sprayer (for aerosol administration of the solution into the nasal passages).

The packaging also contains detailed instructions for the purpose and preparation of the drug.

Side effect

Burning or dryness of the mucous membranes of the nasal cavity, dryness of the mucous membranes of the mouth and throat; sneezing; an increase in the volume of secretions released from the nose, nosebleeds; after the effect of using the drug wears off, a strong feeling of “stuffiness” in the nose (reactive hyperemia).

Side effects caused by the systemic effect of the drug: increased blood pressure, headache, dizziness, palpitations, tachycardia, anxiety, restlessness, fatigue, drowsiness, sedation, irritability, sleep disturbances (in children), nausea, insomnia, exanthema, disturbance vision (if it gets into the eyes), hallucinations, Quincke's edema, itching, convulsions, respiratory arrest (in infants). With long-term use - tachyphylaxis, reactive hyperemia of the mucous membrane and atrophy of the nasal mucosa.

The preservative benzalkonium chloride, which is part of the drug, may cause swelling of the nasal mucosa. If this happens, it is necessary to change the drug to another one that does not contain preservatives.

If you experience side effects listed in the instructions or they get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Sialor (Protargol) tablets 2% 10ml + solvent spray

A country

Russia
The country of production may vary depending on the batch of goods. Please check with the operator for detailed information when confirming your order.

Compound

1 tablet contains: silver proteinate (protargol) 200 mg, polyvinyl-N-pyrrolidone.
Solvent: purified water.

pharmachologic effect

Sialor is a hygienic product for topical use. The main component of Sialor® is silver proteinate, which has an astringent effect with a pronounced antiseptic and protective effect. The antibacterial effect of silver proteinate is observed against Staphylococcus spp. Streptococcus spp, Moraxella spp., as well as fungal flora. Silver proteinate prevents the penetration of microorganisms by forming a protective protein film.

Indications for use

- adenoids, acute, allergic, vasomotor rhinitis, chronic diseases of the nasal cavity, nasopharynx, paranasal sinuses, incl. accompanied by dryness of the nasal mucosa; — prevention of nasal cavity infections in the autumn-winter period, with changing climatic conditions (rooms with air conditioning and/or central heating), the presence of polluted atmospheric air (smokers, vehicle drivers, hot and dusty workshops); — washing wounds of the nasal cavity and paranasal sinuses before and after surgical interventions; - hygiene procedures for the nasal cavity.

Mode of application

Locally.
To prepare a 2% solution, dissolve 1 tablet (200 mg) in 10 ml of the supplied solvent. Before using the 2% solution, rinse and clean the nasal mucosa. Apply 1-3 drops 3 times a day for 5-7 days. Method of preparing the solution: Pour the solvent into the bottle. Add a Sialor tablet to the varnish. Shake until the tablet is completely dissolved (8-10 minutes).

Interaction

Before using Protargol, be sure to tell your doctor if you are using other medications. In most cases, Protargol can be used in combination with other drugs (there is no data on the interaction of Protargol with other drugs).

Side effect

Burning, itching.

Contraindications

— individual intolerance to individual components; - pregnancy; - lactation period.

Overdose

As a rule, when using the drug Protargol, there are no signs and symptoms of a drug overdose.

special instructions

Before use, apply a small amount of the product to the elbow to identify individual intolerance. If symptoms of individual intolerance to the components of the product occur (irritation, burning, itching of the skin, mucous membranes), rinse with plenty of water for 15 minutes, and if necessary, consult a doctor. The simultaneous use of products containing alkaloid salts and organic bases (adrenaline) is not recommended.

Overdose

If the drug is accidentally ingested or overdose, the following symptoms may appear: anxiety, restlessness, hallucinations, convulsions, decreased body temperature, lethargy, drowsiness, coma, constriction or dilation of the pupils, fever, sweating, pallor, cyanosis, palpitations, bradycardia, arrhythmia, cardiac arrest, increased blood pressure, decreased blood pressure, nausea, vomiting, respiratory depression, respiratory arrest.

Treatment: symptomatic. In case of accidental ingestion, gastric lavage and administration of activated charcoal. Vasopressor drugs are contraindicated.

Interaction with other drugs

When used concomitantly with monoamine oxidase inhibitors (including a period of 14 days after their discontinuation), tricyclic antidepressants or other drugs that increase blood pressure, an increase in blood pressure may occur. The drug slows down the absorption of local anesthetic drugs and prolongs their effect.

Co-administration of other vasoconstrictor drugs increases the risk of side effects.

If you are using the above or other medications (including over-the-counter medications), consult your doctor before using Sialor®rino.

Side effects and contraindications

During the period of application of the suspension, the nasal mucosa and secretions under the influence of silver may take on a grayish or blue tint. It can be easily removed with water. The drug may cause mild soreness, irritation, or slight itching. If the symptoms do not cause severe discomfort, it is not recommended to stop using Sialor.

The use of the solution is contraindicated:

  • children under 3 years old;
  • pregnant and lactating women (if pregnancy is detected, you need to interrupt the course and consult a doctor);
  • those diagnosed with atrophic rhinitis;
  • having hypersensitivity to silver preparations.

Signs of an allergic reaction to the solution may include increased swelling, bronchospasm, skin rash, and severe headaches.

special instructions

Use the recommended dose for no more than 7 days without consulting a doctor. If symptoms worsen or improvement does not occur within 3 days, you should consult your doctor. Avoid getting the drug into your eyes.

To avoid the spread of infection, it is necessary to use the drug individually. After opening, use within 14 days.

With prolonged use and overdose of oxymetazoline, the therapeutic effect may weaken, and the risk of reactive hyperemia (rhinitis medicamentosa) and atrophy of the nasal mucosa may increase.

When is Sialor shown?

It is necessary to use the drug for inflammatory processes of the nasal mucosa:

  • with acute infectious rhinitis;
  • acute sinusitis of various origins;
  • nasopharyngitis;
  • chronic diseases of the paranasal sinuses, adenoids.

The silver preparation helps reduce inflammation and has an antimicrobial effect directly at the site of contact with the mucous membrane. Sialor is used as a symptomatic remedy: it facilitates breathing, eliminates burning, reduces discharge and swelling. It does not affect the general course of the disease and its causes.

Release form

Nasal drops 0.01%, 0.025% and 0.05%.

1 ml in a dropper tube with a valve (for a concentration of 0.01%) or 2 ml in a dropper tube with a valve (for a concentration of 0.025%) or 10 ml in polymer ampoules (for a concentration of 0.05%).

Labels are placed on dropper tubes, ampoules, and bottles.

2.5 dropper tubes of 1 ml (for a concentration of 0.01%) or 2.5 dropper tubes of 2 ml (for a concentration of 0.025%) with instructions for use are placed in a cardboard pack.

1 polymer ampoule of 10 ml (for a concentration of 0.05%) complete with a dark glass bottle with a screw neck, sealed with a spray nozzle, with instructions for use, is placed in a cardboard pack.

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