Lazolvan® Reno (Lasolvan® Rhino)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
Read on
Active substanceTramazolinTramazolin
Similar drugsTo uncover
  • Lazolvan® Reno
    spray nazal. 
    SANOFI RUSSIA, CJSC    
    • Dosage form: & nbspnasal spray
    Composition:

    in 1 dose of spray contains:

    Active substance: tramazolin hydrochloride monohydrate in terms of tramazoline hydrochloride 82 μg.

    Excipients: Citric acid monohydrate 270 g, sodium hydroxide 154 g benzalkonium chloride 14 g, hypromellose (hydroxypropylmethylcellulose) of 3 5 g povidone in 2101 g, glycerol 85% 700 mg, magnesium sulfate heptahydrate 49 g, magnesium chloride hexahydrate, 35 g, dihydrate calcium chloride 11 g sodium hydrogen carbonate 1 g sodium chloride, 183 micrograms, cineole (eucalyptol) 7 g, L-menthol (levomenthol) 14 .mu.g, 14 .mu.g racemic camphor, purified water 66358 g.

    Description:Transparent, pale yellow solution with the smell of eucalyptus.
    Pharmacotherapeutic group:Antitussive medication - alpha-adrenomimetic
    ATX: & nbsp

    R.01.A.A.09   Tramazolin

    Pharmacodynamics:

    Active substance Mucosolvan® Reno - tramazolina hydrochloride, alpha-2-agonists to cause vasoconstriction. When applied to the mucous membranes of the nose due to vasoconstrictive action, the drug reduces puffiness. As a result, the passability of the nasal passages is quickly restored, nasal breathing is facilitated for a long time.

    The drug starts within the first 5 minutes and lasts 8-10 hours.

    Pharmacokinetics:

    Pharmacokinetic studies in humans have not been conducted. The pharmacokinetics of tramazolin have been studied in rats, rabbits and monkeys. It is shown that after application of the preparation, 50 - 80% of the administered dose is absorbed or intranasally absorbed. Tramazolin and its metabolites are distributed in all internal organs, the highest concentration is permanently detected in the liver.

    After oral or topical administration, the main metabolites are determined in the urine. The terminal elimination half-life is between 5 and 7 hours.

    Indications:
    Edema of the nasal mucosa, nasal congestion caused by acute respiratory diseases and / or pollinosis (rhinitis, hay fever); sinusitis and otitis media (eustachiitis) to facilitate the outflow of the paranasal sinuses, at the doctor's recommendation.
    Contraindications:Hypersensitivity to tramazolin hydrochloride or benzalkonium hydrochloride, as well as to other components of the drug, angle-closure glaucoma, atrophic rhinitis, skull operations performed through the nasal cavity, in the anamnesis, children under 6 years old.
    Carefully:

    Patients with hypertension, heart disease, hyperthyroidism, diabetes mellitus, prostatic hypertrophy, pheochromocytoma, porphyria should use Lazolvan® Reno only on the advice of a doctor because of the potential risk of systemic absorption of the drug.

    Caution should be exercised when taking MAO inhibitors, tricyclic antidepressants, vasopressor drugs and antihypertensive drugs.

    Pregnancy and lactation:

    Pregnancy

    Long-term experience shows that Lazolvan® Reno does not adversely affect pregnancy.

    The drug should not be used during the first trimester of pregnancy. At later gestational age, Lazolvan® Reno should be used only after consultation with a physician.

    Breast-feeding

    The safety of the drug Lazolvan® Reno during breastfeeding has not been confirmed. The use of the drug during breastfeeding is allowed only after consultation with a doctor.

    Fertility

    Studies of the effect of Lazolvan® Reno on fertility have not been conducted.

    Based on the available preclinical data, there is no mention of the possible effect of tramazoline hydrochloride on fertility.

    Dosing and Administration:

    Adults and children from 6 years: 1 injection in each nasal passage. Up to 4 injections in each nasal passage per day.

    Do not use the drug for more than 5-7 days without prescribing a doctor.

    Instructions for using a vial with a dosing device:

    Before injection, the nasal passages should be cleared.

    1. Remove the protective cap.

    2. Before the first use it is necessary to make several injections into the air until a stable aerosol cloud appears (Fig. 1)

    After that, the dosing device is ready for use.

    3. Holding the head straight, insert the tip into the nasal passage and make one injection (Fig. 2).

    Repeat the procedure for another nasal passage. After removing the tip, draw a normal breath through the nose.

    4. Put the protective cap on.

    It is recommended that the tip be cleaned after each use.

    Side effects:

    Disturbances from the nervous system

    Rarely (≥0.01% and <0.1%): dizziness, taste disorders.

    Infrequently (≥0.1% and <1%): headache.

    Frequency not established *: drowsiness, sedation.

    Mental disorders

    Infrequently (≥0.1% and <1%): anxiety.

    Frequency not established *: hallucinations, insomnia.

    Disorders from the cardiovascular system

    Infrequently (≥0.1% and <1%): palpitation.

    Frequency not established *: arrhythmia, tachycardia, increased blood pressure.

    Disturbances from the respiratory, thoracic and mediastinal organs

    Often (≥1% and <10%): nasal discomfort.

    Infrequently (≥0.1% and <1%): nasal edema, dry nose, rhinorrhea, sneezing.

    Rarely (≥0.01% and <0.1%): nasal bleeding.

    Disorders from the gastrointestinal tract

    Infrequently (≥0.1% and <1%): nausea.

    Immune system disorders

    Frequency not established *: hypersensitivity.

    Disturbances from the skin and subcutaneous tissues **

    Frequency not established *: rash, itching, swelling of the skin.

    General and local violations

    Frequency not established *: mucosal edema **, fatigue.

    * Adverse events, the relationship of which with the drug was regarded as possible, recorded with a wide application of the drug. The frequency of these rare phenomena is difficult to assess.

    ** as symptoms of hypersensitivity.

    Overdose:

    Following the increase in blood pressure and tachycardia, it is possible (especially in children) to reduce blood pressure, develop shock, reflex bradycardia, lower body temperature.

    By analogy with other alpha-sympathomimetics, the clinical picture of intoxication can be indistinct, since the phases of stimulation and depression of the central nervous system and the cardiovascular system can change each other.

    Especially in children, intoxication leads to effects on the central nervous system with the development of convulsions and coma, bradycardia, respiratory depression. Symptoms of CNS stimulation are anxiety, agitation, hallucinations and convulsions. Symptoms of CNS depression include a decrease in body temperature, lethargy, drowsiness and to whom. In addition, the following symptoms may develop: mydriasis, miosis, increased sweating, fever, pallor, cyanosis of the lips, impaired cardiovascular system (including cardiac arrest); respiratory failure (including respiratory failure, respiratory arrest); psychological disorders.

    Treatment

    In case of nasal overdose, immediately flush or clean the nose. Symptomatic treatment may be required.

    Interaction:

    Some antidepressants (MAO inhibitors and tricyclic antidepressants) and vasoconstrictive drugs with simultaneous administration can cause an increase in blood pressure.

    Combination with tricyclic antidepressants may lead to arrhythmia.

    Simultaneous reception with antihypertensive drugs (especially those that affect the sympathetic nervous system) can lead to various cardiovascular effects.

    Special instructions:

    If after 7 days of taking the drug there is no positive dynamics of symptoms, you should see a doctor to decide whether to stop taking the drug or about continuing treatment.

    Long-term use of nasal vasoconstrictive drugs can lead to the development of chronic inflammation and nasal congestion, as well as atrophy of the nasal mucosa.

    Avoid contact with the eyes.

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

    Studies on the effect of the drug on the ability to drive and machine equipment were not conducted. However, when taking the drug, such unwanted effects as hallucination, drowsiness, sedation,dizziness and fatigue. Therefore, care must be taken when driving and machinery.

    When these side effects appear, it is necessary to avoid such potentially dangerous tasks as driving and machinery.

    Form release / dosage:
    Spray nasal dosed with 82 mcg / dose.
    Packaging:10 ml vial of brown glass equipped with a dosing device and a nasal adapter with a protective cap. The bottle with instructions for use is placed in a cardboard box.
    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:
    3 years. Do not use after expiry date.
    Terms of leave from pharmacies:Without recipe
    Registration number:П N015956 / 01
    Date of registration:24.08.2011 / 02.08.2017
    Expiration Date:Unlimited
    The owner of the registration certificate:SANOFI RUSSIA, CJSCSANOFI RUSSIA, CJSC
    Manufacturer: & nbsp
    Representation: & nbspSanofi Russia, JSCSanofi Russia, JSCRussia
    Information update date: & nbsp09.02.2018
    Illustrated instructions
    Instructions
    Up