Septnazal® (Septanazal®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceXylometazoline + [Dexpanthenol]Xylometazoline + [Dexpanthenol]
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    • Dosage form: & nbspnasal dosing spray
    Composition:

    1 ml of spray contains:

    Active substances: Xylometazoline hydrochloride 1.00 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 0.10 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 - Local vasoconstrictor (decongestant) with alpha-adrenomimetic activity, causes narrowing of the blood vessels of the nasal mucosa, restores 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, glaucoma, atrophic rhinitis, hyperthyroidism, porphyria, prostatic hyperplasia, surgical
    interventions on the meninges (in the anamnesis), simultaneous use with monoamine oxidase (MAO) inhibitors and tricyclic antidepressants, pregnancy, the period of breastfeeding, children under 6 years of age.

    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:

    Given that there is no data on the reproductive toxicity of the preparation SeptAzal®, its use in pregnancy and during breastfeeding is not recommended.

    Dosing and Administration:

    Intranasally.

    For adults and children over 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 3-5 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 rhythm disorder, vascular insufficiency, 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: gastric lavage, intake of enterosorbents (Activated carbon),

    oxygen ventilation of the 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 can lead to increased systemic action.

    Special instructions:

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

    Do not use more than 5 days.

    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:

    Precautions should be taken during the use of the drug, or
    Avoid driving and other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

    Form release / dosage:

    Spray nasal dosed, 0.1 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 transparent protective cap from the combined material.

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

    Packaging:polyethylene bottles with dosing device (1) -package cardboard
    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-002731
    Date of registration:27.11.2014
    The owner of the registration certificate:KRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO
    Manufacturer: & nbsp
    Representation: & nbspKRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO
    Information update date: & nbsp27.11.2014
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