Clinical and pharmacological group: & nbsp

An anticongestants

M-holinoblokatory

Included in the formulation
  • Ximelin Extra
    spray nazal. 
    Takeda Pharma AB     Sweden
  • Otrivin® Complex
    spray nazal. 
  • АТХ:

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

    Pharmacodynamics:
    Combination drug for topical application in ENT-practice.
    Xylometazoline-alpha2-adrenomimetic. It causes constriction of the blood vessels of the nasal mucosa, thus eliminating the edema and hyperemia of the mucous membrane of the nasopharynx. Relieves nasal breathing in rhinitis.
    Ipratropium bromide has an anticholinergic effect. With intranasal application, M blocks3-cholinoreceptors and reduces the secretion of the glands of the mucous membrane of the nasal cavity.
    In therapeutic doses, it does not irritate the mucous membrane, it does not cause hyperemia. The action comes in 5-10 minutes and lasts for 6-8 hours.
    Pharmacokinetics:With intranasal application of xylometazoline hydrochloride and ipratropium bromide little absorbed and present in blood plasma in small amounts.
    Indications:

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

    - acute respiratory diseases with phenomena of rhinitis (common cold);

    acute allergic rhinitis;

    - Pollinosis;

    - Sinusitis.

    X.J00-J06.J00   Acute nasopharyngitis (runny nose)

    X.J00-J06.J01   Acute Sinusitis

    X.J00-J06.J06   Acute upper respiratory tract infections of multiple and unspecified sites

    X.J30-J39.J30   Vasomotor and allergic rhinitis

    X.J30-J39.J30.1   Allergic rhinitis caused by pollen of plants

    X.J30-J39.J30.3   Other allergic rhinitis

    X.J30-J39.J32   Chronic Sinusitis

    Contraindications:Arterial hypertension; tachycardia; severe atherosclerosis; glaucoma; atrophic rhinitis; thyrotoxicosis; surgical interventions on the meninges (in the anamnesis); I trimester of pregnancy; age to 18 years; hypersensitivity to the components of the drug.
    Carefully:With caution should be used in patients with diabetes mellitus, angina pectoris III-IV functional class, obstruction of the neck of the bladder, prostatic hyperplasia, in patients with cystic fibrosis; in patients who are predisposed tox to nasal bleeding, paralytic obstruction of the intestine, dizziness, tremor of skeletal muscles, to sleep disorders, arrhythmias, increased blood pressure.
    Pregnancy and lactation:

    Contraindicated use of the drug in the I trimester of pregnancy.

    The FDA recommendation category is B.In the II and III trimesters of pregnancy and lactation (breastfeeding), the drug should be used only after a thorough evaluation of the expected benefit of therapy for the mother and the possible risk to the fetus. Do not exceed the recommended dose.

    Dosing and Administration:

    The drug is administered intranasally.

    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.

    Side effects:

    From the nervous system: often - headache; rarely - dizziness; very rarely - insomnia.

    From the digestive system: often - dry mouth; infrequently - dyspepsia, nausea.

    From the sense organs: rarely - increase intraocular pressure, mydriasis, pain in the eyes, deterioration of the condition with angle-closure glaucoma; very rarely - a violation of the clarity of visual perception.

    From the urinary system: rarely - difficulty urinating.

    From the respiratory system: often - nosebleeds, irritation and / or dryness of the nasopharyngeal mucosa, burning sensation, tingling, sneezing, nasal hypersecretion; edema of the nasal mucosa; infrequent - nasal congestion (with frequent and / or prolonged use of the drug).

    From the cardiovascular system: rarely - heart palpitations, supraventricular tachycardia, atrial fibrillation, increased blood pressure; very rarely - arrhythmic pulse.

    From the skin: rarely - itching, skin rash, hives.

    Allergic reactions: rarely - systemic allergic reactions (anaphylactic reaction, angioedema, tongue, lips and face, laryngospasm).

    Overdose:

    After intranasal use, an acute overdose is unlikely, since the absorption of the drug is extremely low.

    Symptoms: dry mouth, disorders of accommodation, tachycardia, headache, arterial hypertension.

    Treatment: withdrawal of the drug, symptomatic therapy.

    Interaction:

    Antidepressants are tetracyclic. Simultaneous application of the combination ipratropium bromide + xylometazoline with tetracyclic antidepressants can enhance the sympathomimetic effect of xylometazoline.

    MAO inhibitors. Simultaneous application of the combination ipratropium bromide + xylometazoline with MAO inhibitors can lead to increased blood pressure.

    Anticholinergic drugs.With the concomitant administration of other anticholinergic drugs, the anticholinergic effect of ipratropium bromide (in combination ipratropium bromide + xylometazoline).

    Antidepressants tricyclic. Simultaneous application of the combination ipratropium bromide + xylometazoline with tricyclic antidepressants may enhance the sympathomimetic effect of xylometazoline.

    Special instructions:

    Before applying the drug, it is necessary to clean the nasal passages.

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

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

    If the symptoms worsen or the patient's condition does not improve within three days of admission, you should consult your doctor.

    Impact on the ability to drive vehicles and manage mechanisms

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

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