Active substanceIpratropium bromide + XylometazolineIpratropium bromide + Xylometazoline
Similar drugsTo uncover
Dosage form: & nbspspray nasal.
Composition:

Composition (per ml):

Active substances:

Ipratropium bromide monohydrate 0.6 mg, xylometazoles per hydrochloride 0.5 mg;

Excipients:

Glycerol (85%) - 27.9 mg, disodium edetate dihydrate 0.5 mg,

hydrochloric acid concentrated to pH 4.5, sodium hydroxide to pH 4.5, water to 1 ml.

Description:a clear, colorless or slightly colored solution with virtually no odor.
Pharmacotherapeutic group:anticonvulsant.
ATX: & nbsp

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

Pharmacodynamics:

Ksilometazolim refers to a group of local vasoconstrictive agents (decongestants) with a-adrenomimeticheskim action causes vasoconstriction of nasal mucosa, thus eliminating edema and hyperemia of the mucosa of the nasopharynx. Relieves nasal congestion, facilitating nasal breathing in rhinitis.

Ipratropium bromide has an anticholinergic effect. When intranasal application reduces nasal secretion during ostanvlivaya nose due to competitive ingibirovaniyatshodiredgicheskih receptors located in the epithelium of the nasal cavity.In therapeutic concentrations, it does not irritate the mucous membrane, does not cause its hyperemia.

The drug begins to act after 5-10 minutes and has a lasting effect for 6-8 hours.

Pharmacokinetics:With intranasal application ipratropium bromide and xylometazoline hydrochloride are little absorbed and are present in the blood plasma in the aircritical quantities.
Indications:Symptomatic treatment of edema and hyperemia of the nasal cavity, acute respiratory diseases from phenomena of rhinitis (coryza), accompanied by zalozhennostju, an acute allergic rhinitis, a pollinosis, a sinusitis.
Contraindications:

Hypersensitivity to the components of the drug, increased sensitivity to atropine or similar compounds (hyoscyamine, scopolamine), glaucoma, surgical interventions on the membranes of the brain (in the anamnesis), pregnancy (1 trimester), atrophic rhinitis, age before

18 years.

Carefully:

Diabetes mellitus, hyperthyroidism, pheochromocytoma, angina pectoris III - IV functional class, obstruction of the neck of the bladder, prostatic hyperplasia. Care should be taken in treating patients,prone to nosebleeds, dizziness, tremor of skeletal muscles, to sleep disorders, arrhythmia, high blood pressure, paralytic ileus and patients

cystic fibrosis. If you have any of the listed diseases before using the drug, be sure to consult a doctor.

Pregnancy and lactation:During pregnancy (II - III trimesters) and breastfeeding formulation should be applied only after careful evaluation of risk-benefit ratio for the mother and fetus is not permitted to exceed the recommended dosage.
Dosing and Administration:

Intranasally.

For patients aged over 18 years: 1 injection in each nostril, 3 times a day. The drug is used no more than 7 days without consulting a doctor. Prolonged use ksilometazol and pa can cause swelling of the nasal mucosa and increase secretions, which is due to the development of hypersensitivity of cells to the active ingredients of the drug, so called backfire.

One injection preparation Otrivin® complex contains about 70 mcg ksilometazol and hydrochloride and 84 mg of ipratropium bromide.

Side effects:

Classification of incidence of adverse reactions:

very often - more than 1/10 appointments (> = 10%); often more than 1/100, but less than 1/10 of prescriptions (> = 1%, but <= 10%); infrequently - more than 1/1000, but less than 1/100 of prescriptions (> = 0,1%, but <= 1%); rarely - more than 1/10000, but less than 1/1000 appointments (> = 0.01%, at <= 0.1%); very rarely - less than 1/10000 prescriptions (<= 0.01%).

From the nervous system:

Often: headache;

Rarely: dizziness;

Very rarely: insomnia.

From the digestive system:

Often: dry mouth;

Infrequently: indigestion, nausea.
From the sense organs:

Rarely: increased intraocular pressure, mydriasis, pain in the eyes, worsening of the condition with closed-angle glaucoma;

Very rarely: 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; Infrequent: nasal congestion (with frequent and / or prolonged use of the drug).

From the cardiovascular system:

Rarely: heart palpitations, supraventricular tachycardia, atrial fibrillation;

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).

If any of the side effects indicated in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell those to the doctor.

Overdose:

With nasal application of the drug Otrivin® Complex acute overdose is unlikely, because absorption of the drug is very low.

In the case of an overdose of xylometazoline, the clinical picture is characterized by: nausea, sweating, lowering of body temperature, headache, bradycardia, accommodation disorder, hypertension, respiratory depression, coma. Hypertension can be replaced by hypotension. Symptomatic therapy should be performed under the supervision of a physician.

In case of excessive use of ipratropium bromide, an overdose is unlikely due to very little absorption of the substance into the blood, but dry mouth, difficulty in accommodation, tachycardia can develop. Treatment is symptomatic.A significant overdose can cause symptoms associated with the anticholinergic effect of the drug from the side of the central nervous system, including hallucinations, for the elimination of which cholinesterase inhibitors are prescribed.

Interaction:

The drug is incompatible with monoamine oxidase inhibitors, tri- and tetracyclic antidepressants.

Sympathomimetic drugs cause the release of catecholamines, including norepinephrine, which has a vasoconstrictive effect, which increases blood pressure. With a significant increase in blood pressure, treatment with Otrivin Complex should be abolished, symptomatic treatment should be performed.

Simultaneous use with tri- and tetracyclic antidepressants can enhance the sympathomimetic effect of xylometazoline.

With the concomitant administration of other drugs with anticholinergic activity, perhaps gain anticholinergic effect of ipratropium bromide.

Special instructions:

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

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

Avoid contact with eyes or eyes.In case of contact, there may be temporary blurred vision, irritation,

pain, redness of the eyes, possible development of exacerbation of the closed-angle glaucoma. It is necessary to rinse abundantly with cold water in the case of getting into the drug and consult a doctor with eye pain or blurred vision.

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

Application of the drug Otrivin® The complex in therapeutic doses does not affect the ability to drive vehicles and mechanisms.

Form release / dosage:Spray nasal, 0.6 mg / ml + 0.5 mg / ml.
Packaging:For 10 ml of the drug in a vial of PVP, equipped with a pump dosing device with a tip made of polypropylene and a protective cap made of polyethylene. The bottle, together with the instructions, 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 the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe
Registration number:LP-002976
Date of registration:27.04.2015
The owner of the registration certificate:Новартис Консьюмер Хелс САНовартис Консьюмер Хелс СА Switzerland
Manufacturer: & nbsp
Representation: & nbspNOVARTIS CONSUMER HELS S.A. (part of Novartis groups) NOVARTIS CONSUMER HELS S.A. (part of Novartis groups) Switzerland
Information update date: & nbsp27.04.2015
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