Ipratropium bromide, Xylometazoline
Novartis
1055 Items
2019-09-19
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Clinical Pharmacology
Decongestant
ATX code
R01AV06
Pharmacological properties
Pharmacodynamics
Xylometazoline belongs to the group of local vasoconstrictor agents (decongestants) with α-adrenomimetic action, causes constriction of the blood vessels of the nasal mucosa, thus eliminating the swelling and hyperemia of the nasopharyngeal mucosa. Relieves nasal congestion, facilitating nasal breathing with rhinitis. Ipratropium bromide has an anticholinergic effect. With intranasal use, it reduces nasal secretion, stopping the flow from the nose due to competitive inhibition of cholinergic receptors located in the epithelium of the nasal cavity. In therapeutic concentrations 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 administration, ipratropium bromide and xylometazoline hydrochloride are little absorbed and are present in plasma in small quantities.
Indications
Symptomatic treatment of edema and hyperemia of the nasal cavity, acute respiratory diseases with symptoms of rhinitis (rhinitis), accompanied by congestion, acute allergic rhinitis, pollinosis, sinusitis.
Composition
Active ingredients:
Ipratropium bromide monohydrate 0.6 mg, Xylometazoline hydrochloride 0.5 mg;
Excipients:
Glycerol (85%) 27.9 mg, disodium edetate dihydrate 0.5 mg, concentrated hydrochloric acid to pH 4.5, sodium hydroxide to pH 4.5, water to 1 ml.
Ipratropium bromide, Xylometazoline is marketed under different brands and generic names, and comes in different dosage forms:
| Brand name | Manufacturer | Country | Dosage form |
|---|---|---|---|
| Otrivin | Novartis | Switzerland | spray |
| Xymelin | Takeda GmbH | Japan | spray |
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Dosage and Administration
For patients over the age of 18 years: 1 spray in each nasal passage 3 times a day. The drug is used for no more than 7 days without consulting a doctor. Prolonged use of xylometazoline may cause swelling of the nasal mucosa and increased secretion, due to the development of increased sensitivity of cells to the active ingredients of the drug, the so-called reverse effect.
A single injection of the drug Otrivin® complex contains about 70 mcg xylometazoline hydrochloride and 84 mcg ipratropium bromide.
Adverse reactions
The classification of the frequency of adverse reactions: very often, more than 1/10 of appointments (≥ 10%); often more than 1/100, but less than 1/10 of appointments (≥1%, but ≤ 10%); infrequently - more than 1/1000, but less than 1/100 of appointments (≥ 0.1%, but ≤ 1%); rarely, more than 1/10000, but less than 1/1000 appointments (≥ 0.01%, but ≤ 0.1%); very rarely - less than 1 / 10,000 appointments (≤ 0.01%).
From the nervous system:
Often: headache;
Seldom: dizziness;
Very rarely: insomnia.
From the digestive system:
Often: dry mouth;
Infrequently: dyspepsia, nausea.
From the senses:
Rarely: increased intraocular pressure, mydriasis, eye pain, deterioration of condition with angle-closure glaucoma;
Very rarely: blurred visual perception. From the urinary system:
Rarely: difficulty urinating.
On the part of the respiratory system:
Often: nasal bleeding, irritation and / or dryness of the mucous membrane of the nasopharynx, burning sensation, tingling, sneezing, nasal hypersecretion;
Infrequently: nasal congestion (with frequent and / or long-term use of the drug).
Since the cardiovascular system:
Rarely: rapid heartbeat, supraventricular tachycardia, atrial fibrillation;
Very rare: arrhythmic pulse.
On the part of the skin:
Rarely: itching, skin rash, urticaria.
Allergic reactions:
Rarely: systemic allergic reactions (anaphylactic reaction, angioedema of the tongue, lips and face, laryngospasm).
If any of the side effects indicated in the instruction are aggravated, or you have noticed any other side effects not indicated in the instruction, inform your doctor.
Contraindications
Hypersensitivity to the components of the drug, hypersensitivity to atropine or similar compounds (hyoscyamine, scopolamine), glaucoma, surgical interventions on the brain membranes (in history), pregnancy (I term), atrophic rhinitis, age up to 18 years.
Carefully
Diabetes mellitus, hyperthyroidism, pheochromocytoma, angina III - IV functional class, bladder neck obstruction, prostatic hyperplasia. It is recommended to be careful in treating patients prone to nasal bleeding, dizziness, skeletal muscle tremor, sleep disorders, arrhythmias, high blood pressure, paralytic ileus and cystic fibrosis.
If you have one of these diseases, be sure to consult with your doctor before taking the drug.
Drug interactions
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, resulting in increased blood pressure. With a significant increase in blood pressure treatment with Otrivin® Complex should be canceled, symptomatic treatment should be carried out.
Simultaneous use with tri- and tetracyclic antidepressants can enhance the sympathomimetic effect of xylometazoline.
With the concomitant prescription of other drugs with anticholinergic activity, it is possible to enhance the anticholinergic effect of ipratropium bromide.
Pregnancy and Lactation
During pregnancy (II - III trimesters) and breastfeeding the drug should be used only after a thorough assessment of the ratio of benefits and risks to the mother and the fetus, it is not allowed to exceed the recommended dosage.
Special instructions
Before use, you must clean the nasal passages. It should not be used for a long time, for example, in chronic rhinitis.
Do not allow the drug to get into or around the eyes. In case of contact, there may be temporary blurred vision, irritation, pain, redness of the eyes, possibly the development of acute angle-closure glaucoma. It should be abundantly flush eyes with cold water in case of contact with the drug and consult a doctor if you have eye pain or blurred vision.
Influence on ability to drive vehicles and mechanisms
The use of the drug Otrivin® Complex in therapeutic doses does not affect the ability to drive vehicles and mechanisms.
Overdosage
When nasal use of the drug Otrivin® Complex acute overdose is unlikely, because drug absorption is extremely low.
In the case of Xylometazoline overdose, the clinical picture is characterized by: nausea, sweating, decrease in body temperature, headache, bradycardia, accommodation disorder, arterial hypertension, respiratory depression, coma. Hypertension can be replaced by hypotension. Symptomatic therapy should be carried out under medical supervision.
With excessive use of ipratropium bromide overdose is unlikely due to the extremely low absorption of the substance into the blood, but dry mouth, difficulty in accommodation, tachycardia can develop. Symptomatic treatment.
Significant overdose can cause symptoms associated with the anticholinergic effect of the drug on the part of the central nervous system, including hallucinations, to eliminate which cholinesterase inhibitors are prescribed.
- Active ingredient: Ipratropium bromide, Xylometazoline
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