Ximelin Extra (Xymelin Extra)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceIpratropium bromide + XylometazolineIpratropium bromide + Xylometazoline
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  • Ximelin Extra
    spray nazal. 
    Takeda Pharma AB     Sweden
  • Otrivin® Complex
    spray nazal. 
    Новартис Консьюмер Хелс СА     Switzerland
    • Dosage form: & nbspnasal dosed
    Composition:

    1 dose contains:

    Active substances:

    Ipratropium bromide monohydrate........ 84 μg

    Xylometazoline hydrochloride .......... 70 μg

    Excipients:

    disodium edetate dihydrate................ 70 μg

    glycerol (85%)................................... 3.91 mg

    hydrochloric acid concentrated....................... up to pH 4.5

    sodium hydroxide..........................to pH 4.5

    purified water............................up to 140 μl

    Description:

    Transparent colorless or slightly colored liquid.

    Pharmacotherapeutic group:anticonvulsant.
    ATX: & nbsp

    S.01.G.A.53   Xylometazoline in combination with other drugs

    Pharmacodynamics:

    Xylometazoline belongs to the group of local vasoconstrictors (decongestants) with alpha-adrenomimetic action, causes narrowing of the blood vessels of the nasal mucosa, thus eliminating the edema and hyperemia of the nasopharyngeal mucosa. Relieves nasal breathing in rhinitis. Ipratropium bromide has antiusolinergic effect. With intranasal application reduces the secretion of the glands of the mucous membrane of the nasal cavity.

    In therapeutic concentrations, it does not irritate the mucous membrane, it does not cause hyperemia. The effect of the drug comes through 5-10 minutes and lasts for 6-8 hours.

    Pharmacokinetics:

    With intranasal application ipratropium bromide and xylometazoline hydrochloride are little absorbed and present in the blood plasma in small amounts.

    Indications:

    - symptomatic treatment of edema and hyperemia of the nasal cavity;

    - acute respiratory diseases with the phenomena of rhinitis (Coryza), acute allergic rhinitis, pollinosis, sinusitis.

    Contraindications:

    Hypersensitivity to the drug components, arterial hypertension, tachycardia, severe atherosclerosis, glaucoma, atrophic rhinitis, thyrotoxicosis, surgical interventions on the meninges (in the anamnesis), pregnancy (I trimester), age to 18 years.

    Carefully:

    Diabetes mellitus, angina pectoris of III-IV functional class, obstruction of the neck of the bladder, prostatic hyperplasia.

    It is advisable to use caution in the treatment of patients prone to nosebleeds, paralytic intestinal obstruction, and patients with a mucous dose.

    During pregnancy (II - III trimesters) and lactation, the drug should only be used after a thorough assessment of the benefit-risk ratio for the mother and fetus, do not exceed the recommended dosage.

    Care must be taken when prescribing Ximelin Extra to patients who are prone to dizziness, tremor of skeletal muscles, to sleep disorders, arrhythmias, and high blood pressure.

    Pregnancy and lactation:contraindicated
    Dosing and Administration:

    Intranasally.

    For adults over 18 years: 1 injection in each nasal passage 3 times a day. The drug is applied no more than 10 days without consulting a doctor.

    One injection of Ximelin Extra contains about 70 μg of xylometazoline hydrochloride and 84 μg of ipratropium bromide.

    Side effects:

    With frequent and / or prolonged use: irritation and / or dryness of the mucous membrane of the nasopharynx, burning and tingling in the nose and throat, edema of the nasal mucosa, sneezing, hypersecretion of the glands of the nasal mucosa, nosebleeds, headache.

    Rarely: systemic allergic reactions, impaired vision; palpitation, tachycardia, arrhythmia, headache, dizziness, increased blood pressure, insomnia.

    Overdose:

    After intranasal administration of Ximelin Extra, an acute overdose is unlikely, because absorption of the drug is very slight.

    In the case of an overdose, the clinical picture is characterized by: dry mouth, violations of accommodation; tachycardia, headache, hypertension.

    Treatment is symptomatic.

    Interaction:

    - simultaneous use with monoamine oxidase inhibitors can lead to increased blood pressure;

    - simultaneous administration with tri- and tetracyclic antidepressants may enhance the sympathomimetic effect of xylometazoline;

    - with the concomitant administration of other anticholinergic drugs, the anticholinergic effect of ipratropium bromide may be enhanced.

    Special instructions:

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

    Do not use for a long time, for example, with chronic rhinitis.

    Patients should be warned about the inadmissibility of spraying Xymelyn Extra in the eyes or around the eyes: If the product gets into the eyes, rinse them with cold water.

    If the symptoms of the disease worsen or the patient's condition does not improve within 3 days of taking Ximelin Extra,it is necessary to consult a doctor.

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

    The use of the drug in therapeutic doses does not affect the ability to drive vehicles and use mechanisms.

    Overdose or ingestion of the drug in the eyes can affect the ability to drive vehicles and use mechanisms.

    Form release / dosage:

    Spray nasal dosed with 84 μg / dose + 70 μg / dose.

    For 10 ml of the drug (not less than 60 doses) in plastic bottle pump metering device with tip and protective cap from polyethylene.

    One bottle together with the instructions for application is placed in cardboard pack.

    Packaging:not less than 60 doses, plastic bottles with dosing device (1) -package cardboard
    Storage conditions:

    Store at a temperature not exceeding 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:LSR-006549/09
    Date of registration:17.08.2009
    The owner of the registration certificate:Takeda Pharma ABTakeda Pharma AB Sweden
    Manufacturer: & nbsp
    Representation: & nbspNycomed Distribution Ltd.Nycomed Distribution Ltd.
    Information update date: & nbsp12.08.2013
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