Freenozol® (Frinozol)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspnasal spray
Composition:

1 ml of the preparation contains:

active ingredients: phenylephrine hydrochloride - 2.5 mg, cetirizine dihydrochloride - 2,5 mg;

Excipients: glycerol - 40.0 mg, sodium hydrophosphate (anhydrous) 2,5 mg, potassium dihydrogen phosphate - 1,5 mg, benzalkonium chloride solution 50% - 0.4 mg in terms of 100%, disodium edetate - 0.2 mg, purified water - up to 1 ml.

Description:

A clear, colorless or pale yellow solution.

Pharmacotherapeutic group:Antiallergic agent combined (H1-histamine receptor blocker + alpha-adrenomimetic)
ATX: & nbsp
  • Phenylephrine in combination with other drugs
    • Pharmacodynamics:

    Combined preparation for local intranasal use for pathogenetic and symptomatic treatment.

    Phenylephrine is an alpha 1-adrenergic receptor agonist (sympathomimetic), causes narrowing of the blood vessels of the nasal mucosa, reduces mucosal edema and tissue flushing, congestion in the mucosa of the nasal cavity. Restoration of air passability of the nasopharynx improves the patient's well-being and reduces the danger of possible complications caused by congestion of the mucous secretion.

    Cetirizine - a blocker of H1-histamine receptors, has an antiallergic effect,reduces the permeability of capillaries, prevents the development of edema of the mucous membrane of the nasal cavity and its adnexal sinuses.

    The composition of the drug includes an auxiliary moisturizer glycerol, conducive to moisture retention, which helps to provide moisture for dryness and irritation of the nasal mucosa.

    Pharmacokinetics:

    The drug is intended for local intranasal use, and its activity does not depend on the concentration of active substances in the blood plasma.

    Indications:

    - Acute rhinitis (including with "cold" diseases);

    - allergic rhinitis (including hay fever);

    - vasomotor rhinitis;

    - chronic rhinitis;

    - acute and chronic sinusitis;

    - acute otitis media (as an auxiliary method of treatment);

    - preparation for surgical interventions in the nose area and elimination of edema of the mucous membrane of the nasal cavity and accessory sinuses after surgical interventions in this area.

    Contraindications:

    - Hypersensitivity to phenylephrine, cetirizine or other components of the drug;

    - atrophic rhinitis;

    - administration of monoamine oxidase inhibitors (simultaneous or in the previous 14 days);

    - angle-closure glaucoma;

    - children under 18 years of age (data on effectiveness and safety in children are absent);

    - pregnancy, the period of breastfeeding.

    Carefully:

    - Cardiovascular diseases, including arterial hypertension, arrhythmias, generalized atherosclerosis;

    - hyperthyroidism;

    - prostate adenoma;

    - chronic renal failure;

    - elderly age;

    - patients with increased convulsive activity;

    - angina pectoris;

    - diabetes;

    - obstruction of the neck of the bladder (eg, due to prostatic hypertrophy);

    - epilepsy;

    - patients with severe reactions to sympathomimetics, manifested as insomnia, dizziness, tremor, cardiac arrhythmia, or increased blood pressure (as with any local vasoconstrictor).

    Pregnancy and lactation:

    Due to the lack of data, the use of the drug is contraindicated in pregnancy and during breastfeeding.

    Dosing and Administration:

    Intranasally.

    For adults, the recommended daily dose is 1-2 injections in each nasal passage 2-3 times a day.

    The drug should not be used continuously for more than 7 days.

    The bottle should be held vertically, with a spray gun upward. Tilt your head, insert the tip of the vial into the nasal passage, 1 time with a short sharp movement, click on spray. During injection, it is recommended to take a slight breath through the nose. Before administering the drug, the nasal passages should be thoroughly cleaned.

    Side effects:

    Cetirizine in combination with phenylephrine in the form of a spray in therapeutic doses is well tolerated, but the following side effects may occur.

    Classification of the incidence of adverse events according to recommendations World Health Organization (WHO):

    very often ≥ 1/10;

    often from ≥ 1/100 to <1/10;

    infrequently from ≥ 1/1000 to <1/100;

    rarely from ≥ 1/10000 to <1/1000;

    very rarely <1/10000, including individual messages;

    the frequency is unknown - it is not possible to establish the frequency of occurrence from the available data.

    Violations from the blood and lymphatic system:

    very rarely: thrombocytopenia.

    Immune system disorders:

    rarely: hypersensitivity reactions;

    very rarely: anaphylactic shock.

    Metabolic and nutritional disorders:

    frequency unknown - increased appetite.

    Mental disorders:

    infrequent excitation;

    rarely - aggression, confusion, depression, hallucinations, sleep disturbance;

    very rarely - tick; frequency is unknown - suicidal ideation, sleep disturbances (including nightmares).

    Impaired nervous system:

    infrequently paresthesia; rarely convulsions;

    very rarely - perversion of taste, dyskinesia, dystonia, fainting, tremor;

    frequency unknown - headache, dizziness, memory impairment, incl. amnesia, deafness.

    Disorders from the side of the organ of vision:

    very rarely - a violation of accommodation, blurred vision, nystagmus;

    frequency is unknown - vasculitis.

    Violations from the organ of hearing and labyrinth:

    frequency unknown - vertigo.

    Heart Disease:

    rarely - tachycardia;

    frequency unknown - arrhythmia.

    Vascular disorders:

    frequency unknown - increased blood pressure.

    Gastrointestinal disorders:

    infrequently diarrhea.

    Disorders from the liver and bile ducts:

    rarely - liver failure with changes in functional liver samples (increased activity of transaminases, alkaline phosphatase, gamma-glutamyltransferase and bilirubin).

    Disturbances from the skin and subcutaneous tissues:

    infrequent - rash, itching;

    rarely - hives;

    very rarely - angioedema, persistent drug erythema.

    Musculoskeletal disorders, skeletal and connective tissue:

    frequency unknown: arthralgia.

    Disorders from the kidneys and urinary tract:

    very rarely: dysuria;

    frequency unknown: urinary retention.

    General disorders and reactions at the site of administration:

    infrequently - asthenia, malaise;

    rarely - discomfort in the nose, dry or burning sensation in the nose, stinging, sneezing; nose bleed. Benzalkonium chloride, which is part of the drug, can cause irritation of the nasal mucosa;

    frequency is unknown - redness and swelling of nasal mucosa, mucous and watery discharge from the nose, nasal breathing difficulty.

    Overdose:

    Extremely low systemic absorption of the drug with topical application makes an overdose almost impossible.

    Symptoms

    If you accidentally single oral cetirizine 50 mg may occur: confusion, diarrhea, dizziness, fatigue, headache, malaise, mydriasis, pruritus, restlessness, fatigue, sedation, somnolence, stupor, tachycardia, tremor, urinary retention.

    An overdose of phenylephrine can be manifested by heart rhythm disturbances, increased blood pressure, agitation.

    Treatment

    Gastric lavage or stimulation of vomiting, the appointment of activated carbon, the intake of a large amount of fluid; supportive and symptomatic therapy. There is no specific antidote. Hemodialysis is ineffective. In case of an overdose, see a doctor.

    Interaction:

    Do not use the drug simultaneously with tri- and tetracyclic antidepressants. beta-blockers, monoamine oxidase inhibitors (procarbazine, selegiline), maprotiline, guanedrel, guanethidine.

    Thyroid hormones with systemic absorption of phenylephrine increase (mutually) associated with them the risk of coronary insufficiency (especially in coronary atherosclerosis).

    Special instructions:

    The drug should not be used continuously for more than 7 days. Prolonged or excessive use of the drug can cause tachyphylaxis and the effect of "rebound" associated with the repeated development of nasal congestion (drug rhinitis), lead to the development of systemic vasoconstrictive action.

    As with other vasoconstrictors, the recommended dosage of the drug should not be exceeded. Otherwise, it is possible to develop manifestations of systemic effects of the drug, especially in elderly patients.

    Do not use phenylephrine patients within 2 weeks after the abolition of monoamine oxidase inhibitors, as they can increase the severity of adrenergic effects of sympathomimetic drugs and increase the risk of side effects from the cardiovascular system.

    The drug is intended for local intranasal use only.

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

    Care should be taken when driving vehicles and mechanisms, as well as performing other activities requiring concentration of attention and speed of psychomotor reactions, as when using the drug there is a possibility of dizziness.

    Form release / dosage:

    Spray nasal.

    Packaging:

    15 ml in a plastic bottle (low pressure polyethylene) with a nebulizer for nasal administration.

    Each vial with instructions for use in a pack of cardboard.

    Storage conditions:

    Store in a dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-004440
    Date of registration:01.09.2017
    Expiration Date:01.09.2022
    The owner of the registration certificate:VERTEKS, AO VERTEKS, AO Russia
    Manufacturer: & nbsp
    Information update date: & nbsp04.10.2017
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