Nasik - instructions for use, doses, side effects, contraindications

Active substanceXylometazoline + [Dexpanthenol]Xylometazoline + [Dexpanthenol]

Similar drugsTo uncover

Nazik®

spray nazal.

Casella-honey GmbH & Co. KG Germany

Nazik® for children

spray nazal.

Casella-honey GmbH & Co. KG Germany

Septnazal®

spray nazal.

KRKA, dd, Novo mesto, AO

SepaNasal®

spray nazal.

KRKA, dd, Novo mesto, AO

Dosage form: & nbsp

nasal dosing spray

Composition:

1 dose of the drug contains:

Active substances: xylometazoline hydrochloride 0.1 mg; dexpanthenol 5.0 mg;

Excipients:

benzalkonium chloride (as a 50% solution) 0.04 mg;

potassium dihydrogen phosphate 0.853 mg

sodium hydrogen phosphate dodecahydrate 0.027 mg

purified water 93.98 mg

Description:

A clear, colorless liquid.

Pharmacotherapeutic group:Antitussive medication

ATX: & nbsp

R.01.A.B Sympathomimetics in combination with other drugs (excluding corticosteroids)

Pharmacodynamics:

Xylometazoline belongs to the group local vasoconstrictor (decongestants) with alpha-adrenomimetic activity,causes narrowing of the blood vessels of the mucous membrane of the cavity nose, restores the patency nasal passages, facilitates nasal breath. The action of the drug usually comes in a few minutes after its application and lasts up to 10 hours.

Lexpanthenol is a vitamin B - a derivative of pantothenic acid. Dexpanthenol is converted into an organism into pantothenic acid, which is an integral part of coenzyme A and participates in the processes of acetylation, carbohydrate and fat metabolism, in the synthesis of acetylcholine, corticosteroids, porphyrins; stimulates regeneration of the skin, mucous membranes, normalizes cellular metabolism, accelerates mitosis and increases the strength of collagen fibers. Provides regenerative, metabolic and weak anti-inflammatory effect.

Pharmacokinetics:

Xylometazoline when topical application is practically not absorbed, the plasma concentrations are so small that they are impossible define modern analytical methods.

Dexpanthenol when topically applied quickly absorbed by the skin and converted to pantothenic acid, binds to plasma proteins (mainly with beta-globulin and albumin). Its concentration in the blood is 0.5-1 mg / l, in the blood serum - 100 μg / l. Pantothenic acid does not undergo metabolism in the body (except for inclusion in Ko-A), is displayed unchanged.

Indications:Applied in acute respiratory diseases with phenomena of rhinitis, acute allergic rhinitis, vasomotor rhinitis, sinusitis, with average otitis (as part of combination therapy to reduce edema of the nasopharyngeal mucosa), to facilitate the conduct of a rhinoscopy, to restore impaired nasal breathing after surgical interventions in the nasal cavity.

Contraindications:

Hypersensitivity to the drug components, arterial hypertension, tachycardia, severe atherosclerosis, atrophic rhinitis, hyperthyroidism, porphyria, prostatic hyperplasia, glaucoma, surgical interventions on the meninges (in the anamnesis), children under 6 years. Do not use with simultaneous therapy with monoamine oxidase (MAO) inhibitors and tricyclic antidepressants.

Carefully:

- patients taking monoamine oxidase inhibitors (MAO inhibitors) or other drugs that increase blood pressure;

- patients with pheochromocytoma;

patients with metabolic disorders (eg, hyperthyroidism, diabetes).

Pregnancy and lactation:

Given that there is no data on the reproductive toxicity of the drug, during pregnancy and lactation it is not recommended to use it.

Dosing and Administration:

Intranasalpo.

For adults and children over 6 years. When using a vial with a pump metering device, packaged separately.

Remove the pump dosing device from its packaging. Uncork vial with the drug, screw the dispensing device on the neck of the vial, remove the protective cap. The bottle is ready for use.

Before using the spray for the first time, press the pump dosing device several times until uniform spraying occurs.

When using a vial with a built-in pump metering device.

Remove the protective cap from the built-in pump dosing device. The bottle is ready for use.

Before using the spray for the first time, press the built-in pump dosing unit several times until a uniform spray appears. When applying the spray, the bottle should be kept in a vertical position.

During the injection, it is easy to breathe in with your nose. One injection into each nostril 3-4 times a day. The duration of therapy is 3 to 5 days.

Side effects:

Respiratory, thoracic and mediastinal disorders.

Very rarely: temporary, mild irritations (burning or dryness of the nasal mucosa), especially in patients with increased sensitivity.

Very rarely or in single messages: increased edema of the mucous membrane of the nasal cavity.

With frequent and / or prolonged use or with the use of large doses of xylometazoline hydrochloride, burning and paresthesia of the nasal mucosa may appear, development of a reactive edema with rhinitis medicamentosa. This effect can occur as early as 5 days from the start of treatment and with prolonged use lead to the development of permanent damage to the mucous membrane with the formation of scabs (rhinitis sicca). Violation of the nervous system.

Rarely or very rarely: headache, vomiting, insomnia or fatigue, impaired vision; depression (with prolonged use in high doses).

Disorders from the cardiovascular system:

Rarely: palpitations, tachycardia, increased blood pressure. Very rarely: allergic reactions may occur.

Overdose:

In cases of overdose or accidental oral administration, the following symptoms may occur: mydriasis, nausea, vomiting, cyanosis, fever, convulsions, tachycardia, cardiac rhythm disorder, vascular insufficiency, cardiac arrest, hypertension, pulmonary edema, respiratory function, hallucinations.
Patients may also have symptoms of CNS depression, accompanied by drowsiness, lower body temperature, bradycardia, shock, stopping breathing and coma.
Treatment.

The use of activated carbon, gastric lavage, oxygen ventilation of the lungs. To reduce blood pressure prescribe 5 mg of phentolamine in a 0.9% solution of sodium chloride by slow intravenous injection or 100 mg of phentolamine orally. Vasoconstrictors are contraindicated. If necessary, antipyretic and anticonvulsant drugs are used.

Interaction:With the simultaneous use of MAO inhibitors and tricyclic antidepressants, it is possible to enhance systemic action.

Special instructions:

Before application, it is necessary to clean the nasal passages. Do not use more than 5 days.

During the period of drug use, measures precautions, or to avoid driving and other potentially dangerous activities that require increased attention and speed of psychomotor reactions.

Effect on the ability to drive transp. cf. and fur:

With prolonged use or when used in high doses, it is impossible to exclude systemic reactions of the drug, including effects on the cardiovascular system and the central nervous system.

In such cases, the ability to drive vehicles and work with machinery can be compromised.

Form release / dosage:

Spray nasal dosed with 0.1 mg + 5 mg / dose.

Vial with a metering pump, packed separately. For 10 ml (not less than 100 doses) in a vial of amber glass, sealed with polypropylene screw-on cover.

Pump dosing device with protective cap of polypropylene packed in individual packaging. 1 bottle and 1 pump metering device together with the instruction for use are placed in a pack of cardboard.

Vial with built-in pump metering device.

For 10 ml (not less than 100 doses) in a vial of amber glass with a built-in pump dispenser and a protective cap made of polypropylene.

1 bottle together with the instruction for use is placed in a pack of cardboard.

Packaging:amber glass bottles with pump-dispenser (1) -package cardboard
bottles of amber glass (1) / complete with a pump-dispenser / tacks of cardboard

Storage conditions:

At a temperature of no higher than 25 ° C.

Shelf life:

3 years.

After the opening, 12 weeks.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:PL-000985

Date of registration:18.10.2011

The owner of the registration certificate: Casella-honey GmbH & Co. KG Casella-honey GmbH & Co. KG Germany

Manufacturer: & nbsp

KLOSTERFRAU BERLIN, GmbH Germany

Representation: & nbspEmSiEl-Pharma, LLCEmSiEl-Pharma, LLC

Information update date: & nbsp23.03.2015

Illustrated instructions

Instructions

Nazik® (Nasic®)