Instructions Grippostad Rhino 0.1% nasal drops nasal solution 0.1% bottle 10 ml
Composition
active substance: xylometazoline hydrochloride;
1 ml of solution contains xylometazoline hydrochloride 1 mg;
auxiliary substances: benzalkonium chloride solution; citric acid, monohydrate; sodium citrate; glycerin (85%); the water is purified.
Medicinal form
Nasal drops, solution.
Basic physical and chemical properties: transparent, almost colorless solution, does not contain visible excess particles, odorless.
Pharmacotherapeutic group
Anti-edema drugs for local use in diseases of the nasal cavity. Sympathomimetics, simple drugs. ATX code R01A A07.
Pharmacological properties
Pharmacodynamics
Xylometazoline is a derivative of imidazoline, an alpha-adrenergic sympathomimetic. It directly excites alpha-adrenoceptors and constricts blood vessels. Under the condition of local application, swelling of the mucous membrane of the nasopharynx is reduced. Restores the patency of the nasal passages and facilitates nasal breathing by decongesting the mucous membrane and improving secretion drainage.
The drug begins to act after 5-10 minutes and continues to act for several hours (6-8 hours on average).
When administered intranasally, the amount of medicine that is absorbed can sometimes be sufficient for the development of systemic effects, for example, in the central nervous system and cardiovascular system.
Pharmacokinetics
With local application, xylometazoline is almost not detected in the blood plasma (the concentration in the blood plasma is less than the detection limit).
Indications for use
Symptomatic treatment of nasal congestion in colds, hay fever, other allergic rhinitis, sinusitis; to facilitate secretion outflow in diseases of paranasal sinuses; auxiliary therapy in cases of otitis media (to eliminate swelling of the mucous membrane); to facilitate rhinoscopy.
Contraindications
Hypersensitivity to xylometazoline or any other component of the drug, acute coronary disease, coronary asthma, hyperthyroidism, angle-closure glaucoma, transphenoidal hypophysectomy and surgical interventions with exposure of the meninges in history, dry rhinitis (rhinitis sicca) or atrophic rhinitis. Concomitant treatment with MAO inhibitors and within 2 weeks after stopping their use.
Interaction with other medicinal products and other types of interactions
Monoamine oxidase inhibitors (MAO inhibitors): xylometazoline can potentiate the action of MAO inhibitors and induce a hypertensive crisis. Do not apply xylometazoline to patients who take or have taken MAO inhibitors during the last two weeks.
Tri- and tetracyclic antidepressants: with the simultaneous use of tri- or tetracyclic antidepressants and sympathomimetic drugs, it is possible to increase the sympathomimetic effect of xylometazoline, therefore, the simultaneous use of such agents is not recommended.
When used together with beta-blockers, it can cause bronchial spasm or a decrease in blood pressure.
Features of application
GRIPPOSTAD® RINO 0.1% should be used by adults and children over 12 years of age.
The drug should not be used for longer than 10 days in a row. Too long or excessive use may lead to renewed nasal congestion and/or atrophy of the nasal mucosa.
The drug, like other sympathomimetics, should be prescribed with caution to patients who have strong reactions to adrenergic agents, manifested in the form of insomnia, dizziness, tremors, cardiac arrhythmia or increased blood pressure.
Do not exceed the recommended dose of the drug, especially when treating children and the elderly.
The drug should be prescribed with caution to patients with cardiovascular diseases, arterial hypertension, diabetes mellitus, hyperfunction of the thyroid gland, pheochromocytoma, hypertrophy of the prostate gland, and also should not be used in patients who received concomitant treatment with MAO inhibitors and within 2 weeks after stopping their use.
Patients with long QT syndrome receiving xylometazoline may have an increased risk of serious ventricular arrhythmias.
The drug contains benzalkonium chloride, which can cause irritation of the nasal mucosa.
The ability to influence the speed of reaction when driving a motor vehicle or other mechanisms
Usually, the drug has no or little effect on the ability to drive vehicles or operate machinery.
Use during pregnancy or breastfeeding
The drug should not be used during pregnancy due to its potential vasoconstrictive effect.
There is no evidence of any adverse effect on the baby. Due to the lack of data on whether the active substance is excreted in breast milk, the drug cannot be used during breastfeeding.
Adequate data on the effect of the drug on fertility are absent. Since the systemic exposure of xylometazoline hydrochloride is very low, the likelihood of an effect on fertility is extremely low.
Method of application and dosage
GRIPPOSTAD® RINO 0.1% NASAL DROPS should be used by adults and children over 12 years of age, 2-4 drops in each nasal passage up to 3 times a day. Apply no more than 3 times in each nasal passage per day.
The duration of treatment depends on the course of the disease and should not exceed 10 days in a row.
It is necessary to apply drops as follows:
clean the nose thoroughly before using the drug; tilt the head back as far as is comfortable; drip drops into each nostril and keep the head tilted back for a short time so that the drug is distributed throughout the nose; after use, clean the dropper before placing it in the bottle; in order to prevent infection, only one person can use each vial with the drug.
The last application is recommended immediately before going to bed.
Children
GripPostad® Rino 0.1% Nasal Spray should not be used by children under 12 years of age.
Overdose
Excessive local application of xylometazoline hydrochloride or its accidental ingestion may lead to severe dizziness, increased sweating, a significant decrease in body temperature, headache, bradycardia, arterial hypertension, respiratory depression, coma, and convulsions. High blood pressure can change to low blood pressure. Younger children are more sensitive to toxicity than adults.
All patients with suspected overdose should be prescribed appropriate supportive measures, as well as, if necessary, urgent symptomatic treatment under medical supervision. Medical care should include observation of the patient for several hours. In the event of a severe overdose accompanied by cardiac arrest, resuscitation measures should last at least 1 hour.
Adverse reactions
From the side of the immune system:
rare (<1/10,000): hypersensitivity reaction, including angioedema, rash, itching.
From the side of the nervous system:
frequent (³1/100, <1/10): headache.
On the part of the organs of vision:
rare (<1/10000): temporary visual impairment.
From the side of the cardiovascular system:
rare (<1/10,000): irregular or rapid heartbeat.
From the respiratory organs, chest and mediastinum:
frequent (³1/100, <1/10): dryness or discomfort from the mucous membrane of the nose.
From the side of the digestive system:
frequent (³1/100, <1/10): nausea.
General disorders and reactions at the injection site:
frequent (³1/100, <1/10): burning sensation at the application site.
Expiration date
5 years.
Shelf life after opening the bottle: 6 months.
Do not use the drug after the expiration date.
Storage conditions
Store at a temperature not higher than 25 °C.
Store in a place inaccessible to children.
Packaging
10 ml of the solution in brown glass bottles with an automatic atomizer and a nasal tip in a cardboard box.
Leave category
Without a prescription.
Manufacturer
STADA Artsnaimittel AG, Germany.
The location of the manufacturer and its address of the place of implementation of the activity
Stadashstrasse 2-18, 61118 Bad Philbel, Germany.
