Instructions Grippostad Rhino 0.05% nasal drops solution 0.05% bottle 10 ml
Composition
active ingredient: xylometazoline hydrochloride;
1 ml of solution contains xylometazoline hydrochloride 0.5 mg;
Excipients: benzalkonium chloride solution; citric acid, monohydrate; sodium citrate; glycerin (85%); purified water.
Dosage form
Nasal drops, solution.
Main physicochemical properties: transparent, almost colorless solution, does not contain visible extraneous particles, odorless.
Pharmacotherapeutic group
Anti-edematous drugs for topical use in diseases of the nasal cavity. Sympathomimetics, simple drugs. ATX code R01A A07.
Pharmacological properties
Pharmacodynamics
Xylometazoline is an imidazoline derivative, an alpha-adrenergic sympathomimetic. It directly stimulates alpha-adrenergic receptors and constricts blood vessels. When applied topically, it reduces swelling of the nasopharyngeal mucosa. It restores nasal passage patency and facilitates nasal breathing by decongesting the mucosa and improving secretion drainage.
The drug begins to act in 5-10 minutes and continues to act for several hours.
(average 6-8 hours).
With intranasal administration, the amount of agent absorbed may sometimes be sufficient to produce systemic effects, for example, in the central nervous system and cardiovascular system.
Pharmacokinetics
When applied topically, xylometazoline is practically not detected in blood plasma (the concentration in blood plasma is below the detection limit).
Indication
Swelling of the nasal mucosa in case of colds and attacks of rhinitis with a large amount of liquid mucus (vasomotor rhinitis), allergic rhinitis.
Contraindication
- Hypersensitivity to the components of the drug.
- Dry inflammation of the nasal mucosa with crusting (dry rhinitis).
- Transsphenoidal hypophysectomy or history of transsphenoidal hypophysectomy or surgical procedures with exposure of the dura mater.
- Angle-closure glaucoma.
- Concomitant treatment with MAO inhibitors and within 2 weeks after discontinuation of their use.
- Acute coronary diseases, coronary asthma.
- Hyperthyroidism.
Due to the use of benzalkonium chloride as a preservative in the preparation Grippostad® Rhino 0.05% nasal drops, they should not be used in cases of known hypersensitivity to this substance.
Special safety measures.
During treatment with the drug, some side effects may occur (especially shortness of breath). Do not overdose.
The preservative contained in the preparations (benzalkonium chloride) may, especially with prolonged use, cause swelling of the nasal mucosa. If such a reaction is expected (e.g. continuous accumulation of mucus in the nasal passages), nasal preparations that do not contain preservatives should be used.
Grippostad® Rhino 0.05% nasal drops can be used after carefully weighing the benefits of the expected benefit against the possible development of undesirable effects in the following cases:
- increased intraocular pressure;
- some cardiovascular diseases (e.g., coronary heart disease, arterial hypertension);
- pheochromocytoma;
- diabetes;
- porphyria;
- prostatic hyperplasia.
Patients suffering from chronic colds can use Grippostad® Rhino 0.05% nasal drops only under medical supervision due to the risk of thinning of the nasal mucosa.
With prolonged use or overdose, reactive hyperemia and repeated accumulation of mucus in the nasal passages may occur, causing narrowing of the airways; with constant use of the drug, this can lead to chronic accumulation of mucus in the nose (rhinitis medicamentosa) and even atrophy of the nasal mucosa.
In mild cases, the use of the sympathomimetic in one nostril can be discontinued until the above symptoms disappear, in order to maintain some nasal breathing.
Interaction with other medicinal products and other types of interactions
May enhance the effect of sympathomimetics and reduce the effect of drugs that suppress sympathetic nerves. When used together with β-blockers, it may cause bronchial spasm or a decrease in blood pressure. When used together with tricyclic or tetracyclic antidepressants, an increase in the systemic effect of xylometazoline is not excluded. Use in parallel with MAO inhibitors is contraindicated.
Use during pregnancy or breastfeeding
The drug should not be used during pregnancy.
Due to the lack of data on whether the active substance is excreted in breast milk, the drug should not be used during breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
Prolonged use or use of large doses of cold remedies containing xylometazoline does not exclude effects on the cardiovascular system. In this case, the ability to drive a car or operate precision instruments is also impaired.
Method of administration and doses.
Grippostad® Rino 0.05% nasal drops are intended for nasal use.
Children aged 1 to 5 years (under adult supervision) 1-2 drops in each nostril up to 1-2 times a day if necessary, but not more than 3 times a day.
Children aged 6 to 11 years (under adult supervision) 2-4 drops in each nostril up to 2-3 times a day if necessary, but not more than 3 times a day.
The dosage is determined depending on individual sensitivity and symptoms of the disease. Grippostad® Rhino 0.05% nasal drops are not recommended for use for longer than 5 days. Before starting a new course of treatment, you should take a break for several days.
Do not use the drug in excess of the recommended dose.
You should consult a doctor regarding the duration of treatment.
In the case of chronic rhinitis, treatment must be carried out under medical supervision due to the risk of thinning of the nasal mucosa.
Children.
Grippostad® Rino 0.05% nasal drops, do not use in children under 1 year of age. Use in children aged 1 to 11 years is recommended only under adult supervision.
Overdose
Overdose or accidental oral administration may cause the following symptoms: dilated pupils (mydriasis), nausea, cyanosis, fever, fatigue, sweating, pallor, peripheral vasoconstriction, convulsions, cardiovascular disorders (tachycardia, arrhythmia, arterial hypertension), cardiac arrest, pulmonary dysfunction (pulmonary edema, respiratory disorders), mental disorders, drowsiness, decreased body temperature, cold extremities, decreased heart rate, shock-like decrease in blood pressure, respiratory arrest.
In severe overdose, especially in children (e.g. accidental ingestion of high doses of the drug), alternating stages of stimulation and depression of the central nervous system and cardiovascular system may occur. Symptoms of central nervous system stimulation may include anxiety, agitation, hallucinations and, in severe cases, convulsions. Symptoms of central nervous system depression may include decreased body temperature, lethargy, drowsiness and, in the most severe cases, coma.
Treatment: In case of complications arising from overdose, patients should undergo intensive therapy: urgently use activated charcoal (absorbent), sodium sulfate (laxative) or perform gastric lavage, lung ventilation.
Adverse reactions
Cardiac: palpitations, tachycardia, arrhythmia.
From the nervous system: headache, convulsions (mainly in children), insomnia, increased fatigue, dizziness.
Respiratory, thoracic and mediastinal disorders: burning and dryness of the nasal mucosa, sneezing, shortness of breath, increased swelling of the mucous membrane (reduces after drug exposure), nosebleeds.
Cardiovascular system: arterial hypertension.
General disorders and administration site conditions: fatigue, drowsiness.
On the part of the organs of vision: visual impairment.
On the part of the digestive system: nausea.
On the part of the immune system: hypersensitivity reactions (angioedema, skin rash, itching).
On the part of the psyche: agitation, sleep disturbances, hallucinations (mainly in children).
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 exceeding 25 °C.
Keep out of reach of children.
Packaging
10 ml of solution in brown glass vials with a screw cap and a glass pipette in a cardboard box.
Vacation category
Without a prescription.
Producer
STADA Arcneimittel AG, Germany.
Location of the manufacturer and its business address: Stadtstrasse 2-18, 61118 Bad Vilbel, Germany.
