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

Active substanceXylometazoline + [Dexpanthenol]Xylometazoline + [Dexpanthenol]

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SepaNasal®

spray nazal.

KRKA, dd, Novo mesto, AO

Dosage form: & nbsp

nasal dosing spray [for children]

Composition:

1 ml of spray contains:

Active substances:

Xylometazoline hydrochloride 0.50 mg, Dexpanthenol 50.00 mg

Auxiliary substances: potassium dihydrogen phosphate 9.00 mg, sodium hydrophosphate dodecahydrate 0.30 mg, purified water up to 1 ml

1 dose of spray contains:

Active substances: Xylometazoline hydrochloride 0.05 mg Dexpanthenol 5.00 mg.

Auxiliary substances: potassium dihydrogen phosphate 0,90 mg, sodium hydrophosphate dodecahydrate 0.03 mg, water purified to 0.1 ml 1 dose of the drug - about 0.1 ml of the solution.

The nominal number of doses in the bottle is 100 doses.

Description:

A clear, colorless solution.

Pharmacotherapeutic group:nasal disease treatment agent

ATX: & nbsp

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

Pharmacodynamics:

Xylometazoline - a local vasoconstrictor (decongestant) with alpha-adrenomimetic activity, causes narrowing of the blood vessels of the nasal mucosa, restores the passability of the nasal passages,eliminates nasal congestion, facilitates nasal breathing. The effect of xylometazoline usually comes in a few minutes after its application and lasts up to 10 hours. Dexpanthenol - vitamin B group, a derivative of pantothenic acid. Dexpanthenol is converted into an organism into pantothenic acid, which is an integral part of coenzyme A (CoA), and participates in the processes of acetylation, carbohydrate and fat metabolism, in the synthesis of acetylcholine, corticosteroids, porphyrins, stimulates the regeneration of the skin and mucous membranes, normalizes cellular metabolism, accelerates mitosis and increases strength of collagen fibers. It has a regenerating, metabolic and weak anti-inflammatory effect.

Pharmacokinetics:

Xylometazoline with local application is almost not absorbed. Concentrations in the blood plasma are so small that they can not be determined by modern analytical methods.

Dexpanthenol when topically applied quickly absorbed by the skin and converted to pantothenic acid, binds to blood 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 is not exposed in the body to metabolism (except for inclusion in CoA), is excreted unchanged.

Indications:

Acute respiratory diseases with phenomena of rhinitis, acute allergic rhinitis, vasomotor rhinitis, sinusitis, otitis media (as part of combined 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 any of the components of the drug, arterial hypertension, tachycardia, severe atherosclerosis, hyperthyroidism, glaucoma, atrophic rhinitis, surgical interventions on the meninges (in the anamnesis), dry rhinitis, prostatic hyperplasia, concomitant use with monoamine oxidase (MAO) inhibitors and tricyclic antidepressants, pregnancy, the period of breastfeeding, children under 2 years.

Carefully:

Diabetes mellitus, pheochromocytoma, diseases of the cardiovascular system (including ischemic heart disease, angina pectoris), hypersensitivity to the action of adrenergic drugs,accompanied by insomnia, dizziness, arrhythmia, tremor, increased blood pressure (BP).

Pregnancy and lactation:The use of the preparation SepaNazal during pregnancy and during breastfeeding is contraindicated.

Dosing and Administration:

Intranasally.

For children from 2 to 6 years.

One dosage injection in each nasal passage 3-4 times a day.

Before use, remove the protective cap. Before using the spray for the first time or after a long break, it is necessary to press the pump metering device several times until a uniform spraying occurs.
Insert the vertical tip of the vial into the nasal passage, take a slow breath through the nose, simultaneously pressing once on the pump dosing device. Repeat the procedure in the other nasal passage. After use, the tip should be wiped with a paper towel and covered with a protective cap. Duration of therapy is 5-7 days.

Side effects:

With frequent and / or prolonged use: irritation and / or dryness of the nasopharyngeal mucosa, burning, tingling, sneezing, hypersecretion, allergic reactions, edema of the nasal mucosa, nausea, vomiting, headache,dry rhinitis, palpitations, increased blood pressure, tachycardia, insomnia, visual impairment, depression (with prolonged use of high doses).

Overdose:

Symptoms: In cases of overdose or inadvertent ingestion, the following symptoms may occur: mydriasis, nausea, vomiting, cyanosis, fever, convulsions, tachycardia, cardiac arrhythmia, cardiac arrest, increased blood pressure, pulmonary edema, respiratory function, hallucinations.

Patients may also experience symptoms of central nervous system depression, accompanied by drowsiness, decreased body temperature, bradycardia, shock, respiratory arrest and coma.

Treatment: application of activated carbon, gastric lavage, oxygen

ventilation of lungs. To reduce blood pressure, 5 mg of phentolamine is used in a 0.9% solution of sodium chloride by slow intravenous injection or 100 mg of phentolamine inside. Vasoconstrictive drugs are contraindicated. If necessary, antipyretic and anticonvulsant drugs are used.

Interaction:

Simultaneous application with inhibitors of MAO and tricyclic antidepressants may lead to an increase in blood pressure, due to the impact of these drugs on the cardiovascular system.

Special instructions:

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

Do not use more than 7 days. The duration of use of the drug in children is determined after consultation with a doctor.

Does not contain preservatives. After opening the vial, the drug should be used within 12 weeks.

Effect on the ability to drive transp. cf. and fur:During the period of application of the drug, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Spray nasal dosed [for children], 0.05 mg + 5 mg / dose.

100 doses of the preparation (10 ml) in a vial of high-density polyethylene with a metering device (pump) and a colored protective cap from the combined material.

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

Packaging:nasal dosing spray [for children], 0.05 mg + 5 mg / dose (vial) 90 doses (10 ml) x 1 (cardboard pack)

Storage conditions:

At a temperature of no higher than 25 ° C, in the original packaging.

Keep out of the reach of children.

Shelf life:

2 of the year.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-002729

Date of registration:27.11.2014

The owner of the registration certificate:KRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO

Manufacturer: & nbsp

KRKA, dd, Novo mesto, AO Slovenia

Representation: & nbspKRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO

Information update date: & nbsp27.05.2015

Illustrated instructions

Instructions

SepaNasal® (SeptaNazal®)