Pharmacological properties of the drug Otrivin
Xylometazoline is a sympathomimetic agent acting on α-adrenergic receptors. Otrivin causes constriction of the nasal blood vessels, reducing swelling of the nasal mucosa and paranasal sinuses and thus improves nasal breathing when the nose and paranasal sinuses are congested. The effect begins a few minutes after application and lasts up to 12 hours. The drug is well tolerated, including by patients with sensitive mucous membranes. The drug does not reduce mucociliary clearance. Nasal drops and nasal spray Otrivin have a balanced pH value within the boundaries characteristic of the nasal cavity. Thanks to moisturizing components (sorbitol, hypromellose), the drops help with dryness and irritation of the mucous membrane of the nasal passages. Spray (with menthol and eucalyptus) contains cooling aromatic substances that evaporate - menthol and eucalyptol. When applied topically, it is practically not absorbed; the concentration of xylometazoline in the blood plasma is so low that it cannot be determined by modern analytical methods.
Buy Otrivin Complex nasal spray 0.6 mg/ml +0.5 mg/ml 10ml in pharmacies
Otrivin Complex is a complex remedy used for respiratory diseases with symptoms of rhinitis (runny nose)*.
Contains 2 active components:
- Vasoconstrictor component - xylometazoline - reduces swelling and nasal congestion - Anticholinergic component - ipratropium bromide - stops nasal flow.
Helps fight 3 symptoms of a runny nose at once:
— nasal congestion — swelling of the mucous membrane — nasal discharge
The drug begins to act in 5-10 minutes and has a lasting effect for 6-8 hours *.
* Instructions for medical use, RU No. LP-002976 dated 04/27/2015
Composition per 1 ml:
Active ingredients: pratropium 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 - up to pH 4.5, sodium hydroxide - up to pH 4.5, water - up to 1 ml.
pharmachologic effect
Xylometazoline belongs to the group of local vasoconstrictors (decongestants) with an alpha-adrenomimetic effect, causing constriction of the blood vessels of the nasal mucosa, thus eliminating swelling and hyperemia of the nasopharyngeal mucosa. Relieves congestion, facilitating nasal breathing during rhinitis.
Ipratropium bromide has an anticholinergic effect. When administered intranasally, it reduces nasal secretion, stopping nasal flow due to competitive inhibition of cholinergic receptors located in the epithelium of the nasal cavity.
In therapeutic concentrations it does not irritate the mucous membrane and does not cause hyperemia.
The drug begins to act in 5-10 minutes and has a lasting effect for 6-8 hours.
Pharmacokinetics
When administered intranasally, ipratropium bromide and xylometazoline hydrochloride are poorly absorbed and are present in the blood plasma in small quantities.
Indications for use
- symptomatic treatment of swelling and hyperemia of the nasal cavity; - acute respiratory diseases with symptoms of rhinitis (runny nose), accompanied by congestion; - acute allergic rhinitis; - hay fever; - sinusitis.
Contraindications
Hypersensitivity to the components of the drug, hypersensitivity to atropine or similar compounds (hyoscyamine, scopolamine), glaucoma, condition after transsphenoidal hypophysectomy, surgical interventions on the meninges (history), pregnancy and breastfeeding, atrophic rhinitis, age under 18 years.
Carefully
Arterial hypertension, diabetes mellitus, hyperthyroidism, pheochromocytoma, angina pectoris III - IV functional class, obstruction of the bladder neck, stenosis of the interureteric fold, prostatic hyperplasia. It is recommended to exercise caution in the treatment of patients predisposed to nosebleeds, with sensitivity to adrenergic drugs, which can lead to symptoms such as sleep disturbance, dizziness, skeletal muscle tremor, arrhythmia, increased blood pressure; paralytic ileus and patients with cystic fibrosis.
Caution is recommended when using the drug in a patient with a history of immediate hypersensitivity reactions, including urticaria, angioedema, rash, bronchospasm, laryngeal edema and anaphylactic reactions.
If you have one of the listed diseases, be sure to consult your doctor before taking the drug.
Use during pregnancy and lactation
The use of the drug during pregnancy and breastfeeding is contraindicated.
Directions for use and doses
Intranasally.
For patients over 18 years of age: 1 injection into each nasal passage 3 times a day.
The drug is used for no more than 7 days without consulting a doctor.
Long-term use of xylometazoline can cause swelling of the nasal mucosa and increased secretion, which is due to the development of increased sensitivity of cells to the active ingredients of the drug, the so-called reverse effect.
1 injection of Otrivin® Complex contains about 70 mcg of xylometazoline hydrochloride and 84 mcg of ipratropium bromide.
Side effect
Determination of the frequency of adverse reactions: very often (≥10); often (≥1/100,
From the nervous system: often - headache; rarely - dizziness; very rarely - insomnia.
From the digestive system: often - dry mouth; infrequently - dyspepsia, nausea.
From the senses: rarely - increased intraocular pressure, mydriasis, eye pain, worsening of angle-closure glaucoma; very rarely - impaired 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; uncommon - nasal congestion (with frequent and/or long-term use of the drug).
From the cardiovascular system: rarely - rapid heartbeat, supraventricular tachycardia, atrial fibrillation; very rarely - arrhythmic pulse.
From 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 above side effects worsen, or the patient notices any other side effects, he should inform the doctor.
Overdose
When using the drug Otrivin® Complex nasally, an acute overdose is unlikely, because absorption of the drug is extremely insignificant.
Symptoms: in case of xylometazoline overdose, the clinical picture is characterized by nausea, sweating, decreased body temperature, headache, bradycardia, impaired accommodation, arterial hypertension, respiratory depression, coma. Arterial hypertension may give way to hypotension.
With excessive use of ipratropium bromide, an overdose is unlikely due to the extremely insignificant absorption of the substance into the blood, but dry mouth, difficulty in accommodation, and tachycardia may develop.
Treatment: symptomatic therapy is carried out under the supervision of a doctor. Significant overdose can cause symptoms associated with the anticholinergic effect of ipratropium bromide on the central nervous system, including hallucinations, for the elimination of which cholinesterase inhibitors are prescribed.
Interaction with other drugs
The drug is incompatible with MAO inhibitors, tri- and tetracyclic antidepressants, because the sympathomimetic effect of xylometazoline may be enhanced.
Sympathomimetic drugs cause the release of catecholamines, incl. norepinephrine, which has a vasoconstrictor effect, resulting in an increase in blood pressure. If there is a significant increase in blood pressure, treatment with Otrivin® Complex should be discontinued and symptomatic treatment administered.
With concomitant administration of other drugs with anticholinergic activity, the anticholinergic effect of ipratropium bromide may be enhanced.
special instructions
Before use, it is necessary to clean the nasal passages.
Should not be used for a long time, for example, for chronic rhinitis.
Do not allow the drug to get into or around the eyes. In case of contact, temporary blurred vision, irritation, pain, redness of the eyes may occur, and an exacerbation of angle-closure glaucoma may develop. You should rinse your eyes generously with cold water if the drug gets into them and consult a doctor if there is eye pain or blurred vision.
Impact on the ability to drive vehicles and machinery
The use of the drug Otrivin® Complex in therapeutic doses does not affect the ability to drive vehicles and machines.
Release form
10 ml of the drug in a PVP bottle equipped with a pump dispensing device with a polypropylene tip and a protective polyethylene cap. The bottle along with instructions for use is placed in a cardboard box.
Storage conditions
The drug should be stored out of the reach of children at a temperature not exceeding 25°C.
Best before date
3 years. Do not use after the expiration date stated on the packaging.
Use of the drug Otrivin
Before administering the drug, you should thoroughly clean your nose. Drops of 0.05% are used on the recommendation of a doctor in infants and children under 6 years of age. 1-2 drops in each nasal passage 1-2 times a day. Apply every 8–10 hours, no more than 3 times a day in each nasal passage. Drops 0.1% - adults and children over 6 years of age. 2-3 drops in each nasal passage 3-4 times a day. Nasal spray dosed for adults and children over 6 years of age. 1 injection (0.14 mg xylometazoline) into each nasal passage 3-4 times a day. The duration of treatment depends on the course of the disease and should not exceed 10 consecutive days.
Special instructions for the use of Otrivin
The drug should not be used for more than 10 days in a row. Longer treatment with the drug may cause the opposite effect. Prescribe with caution to patients who, when using adrenergic drugs, experience strong reactions, expressed in the form of insomnia, dizziness, yeast, arrhythmias, and increased blood pressure. The recommended dose of the drug should not be exceeded, especially when treating children and the elderly. Prescribe the drug with caution to patients with cardiovascular diseases, hypertension (arterial hypertension), closed-angle glaucoma, diabetes mellitus, and thyroid diseases. Use during pregnancy and lactation. The drug is contraindicated during pregnancy due to its vasoconstrictor effect. There is no evidence of side effects of the drug in infants, during maternal treatment with the drug and breastfeeding. It is not known whether xylometazoline passes into breast milk, so women who are breastfeeding can use the drug when the expected benefit to the mother outweighs the potential risk to the baby. The drug does not affect the ability to drive vehicles or operate complex machinery when used in recommended doses.
Otrivin Complex
Classification of the frequency of occurrence of adverse reactions:
Very common (≥ 1/10); often (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10000, <1/1000); very rare (<1/10000). Immune system disorders: Not known: hypersensitivity. Nervous system disorders: Common: taste disturbance, headache; Uncommon: impaired sense of smell, dizziness, tremor; Very rare: insomnia. Eye disorders: Uncommon: eye irritation, dry eyes; Frequency unknown: increased intraocular pressure, mydriasis, eye pain, photopsia, worsening of angle-closure glaucoma, impaired visual clarity, pupil dilation, halo effect (rainbow circles around the light source in the field of view). Cardiac disorders: Uncommon: palpitations, supraventricular tachycardia; Very rare: arrhythmic pulse; Frequency unknown: atrial fibrillation. Respiratory, thoracic and mediastinal disorders: Very common: nosebleeds, irritation and/or dryness of the nasopharyngeal mucosa; Common: burning sensation, tingling sensation, sneezing, nasal hypersecretion; nasal congestion (with frequent and/or long-term use of the drug), dry throat, sore throat, rhinalgia; Uncommon: nasal ulcer, sneezing, sore throat, cough, dysphonia; Rarely: runny nose; Frequency unknown: discomfort in the paranasal sinuses, laryngeal spasm, pharyngeal edema. Gastrointestinal disorders: Common: dry mouth; Uncommon: dyspepsia, nausea; Frequency unknown: difficulty swallowing. Skin and subcutaneous tissue disorders: Frequency unknown: itching, skin rash, urticaria. Renal and urinary tract disorders: Frequency unknown: difficulty urinating. General disorders and disorders at the injection site: Uncommon: discomfort, fatigue; Frequency unknown: chest discomfort, thirst. 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 instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.
Be sure to read the instructions for use.
