Instructions Rint nasal spray with menthol 0.5 mg/g bottle with pump dispenser with sprayer 10 g
Composition
active ingredient: oxymetazoline;
1 ml of the drug contains oxymetazoline hydrochloride 0.5 mg, calculated on 100% dry matter;
excipients: racemic camphor, menthol (levomenthol), benzalkonium chloride, disodium edetate (Trilon B), benzyl alcohol, polyethylene glycol 400 (macrogol 400), povidone, sodium carboxymethylcellulose - microcrystalline cellulose, sodium dihydrogen phosphate, dihydrate; sodium hydrogen phosphate, dodecahydrate; water for injections.
Dosage form
Nasal spray.
Main physicochemical properties: opaque, whitish, gel-like liquid or solution with a specific odor and thixotropic properties (thickens on standing and thins when shaken).
Pharmacotherapeutic group
Anti-edematous and other drugs for local use in diseases of the nasal cavity. Sympathomimetics, simple drugs. ATX code R01A A05.
Pharmacological properties
Pharmacodynamics
Rint nasal spray® with menthol belongs to the group of local vasoconstrictors. Oxymetazoline has a sympathomimetic and vasoconstrictor effect, eliminating swelling of the nasal mucosa. Narrows the vessels at the site of application, reduces swelling of the nasal mucosa and upper respiratory tract, reduces nasal discharge. Restores nasal breathing. Elimination of swelling of the nasal mucosa contributes to the restoration of aeration of the paranasal sinuses and middle ear cavity, which prevents the development of bacterial complications.
Oxymetazoline has antiviral, anti-inflammatory, immunomodulatory and antioxidant effects. Thanks to this combined mechanism of action, clinical studies have proven a faster and more effective elimination of symptoms of acute rhinitis (nasal congestion, rhinorrhea, sneezing, malaise).
Pharmacokinetics
The drug begins to act quickly (a few minutes after application).
When applied topically to the nose in therapeutic concentrations, it does not irritate the nasal mucosa or cause hyperemia. The half-life is about 35 hours after application. 2.1% of the drug is excreted by the kidneys, about 1.1% with feces.
The duration of action of the drug is up to 12 hours.
Indication
Acute respiratory diseases accompanied by nasal congestion. Allergic rhinitis. Vasomotor rhinitis. To restore drainage and nasal breathing in diseases of the paranasal sinuses of the nasal cavity, eustachitis. To eliminate edema before diagnostic manipulations in the nasal passages.
Contraindication
Hypersensitivity to the components of the drug. Atrophic rhinitis. When using monoamine oxidase inhibitors (MAO) and within 2 weeks after stopping treatment with MAO inhibitors, as well as other drugs that contribute to an increase in blood pressure. With increased intraocular pressure, especially with angle-closure glaucoma. With severe forms of cardiovascular diseases (for example, ischemic heart disease, arterial hypertension). Pheochromocytoma. Metabolic disorders (hyperthyroidism, diabetes mellitus, porphyria). Prostatic hypertrophy. After transsphenoidal hypophysectomy or other surgical intervention with exposure of the dura mater.
Interaction with other medicinal products and other types of interactions
Do not use MAO inhibitors and other drugs that increase blood pressure due to the risk of increased blood pressure. Concomitant use of other vasoconstrictor drugs increases the risk of side effects.
Application features
Long-term use and overdose of the drug should be avoided. Long-term use of a nasal decongestant may lead to a weakening of the drug's effect. Abuse of this drug may cause mucosal atrophy and reactive hyperemia with rhinitis medicamentosa.
After using the drug, special observation is necessary for patients with chronic rhinitis and in cases of edema removal before diagnostic manipulations. Doses above the recommended ones should be used only under the supervision of a physician.
The presence of benzalkonium chloride in the composition of the drug in an amount of 10 mcg in a single dose may cause the development of bronchospasm.
Ability to influence reaction speed when driving vehicles or other mechanisms
After prolonged use of the drug in doses exceeding the recommended ones, a general effect on the cardiovascular system cannot be excluded. In such cases, the ability to drive may be reduced.
Use during pregnancy or breastfeeding
During pregnancy or breastfeeding, the drug should be used with extreme caution. Do not exceed the recommended dosage.
Method of administration and doses
Shake the bottle vigorously before each use. Remove the safety cap. Before using the dosing device for the first time, press it several times until a jet of aerosol appears. Insert the tip into the nostril and press the dosing device, taking a deep breath through the nose, without tilting your head back. Then repeat the procedure, inserting the tip into the other nostril. After use, wipe the tip clean and close the bottle with the safety cap.
The drug is prescribed to adults and children over 6 years of age - 1 injection into each nasal passage 2-3 times a day. Doses above the recommended ones should be used only under the supervision of a doctor.
The drug should not be used for longer than 5-7 days. The drug can be used again only after a few days.
Before each use, shake the bottle vigorously because the product tends to thicken during storage and thin out when shaken. Before using the dosing device for the first time, press it several times until an aerosol jet appears. Insert the tip into the nostril and press the dosing device while taking a deep breath through the nose. There is no need to tilt your head back. Repeat the procedure by inserting the tip into the other nostril. After use, wipe the tip clean and close the bottle with the safety cap.
Children
The drug should not be used in children under 6 years of age.
Overdose
After a significant overdose or accidental ingestion, the following symptoms may occur: mydriasis, nausea, vomiting, cyanosis, fever, cramps, tachycardia, palpitations, arrhythmia, cardiovascular failure, cardiac arrest, increased sweating, agitation, convulsions, arterial hypertension, pulmonary edema, respiratory disorders, pallor, miosis, hyposmia, mental disorders.
In addition, central nervous system depression may occur, manifested by drowsiness, decreased body temperature, bradycardia, hypotension, apnea, and possible development of coma.
Therapeutic measures in case of overdose: gastric lavage, administration of activated charcoal, ventilation of the lungs. In case of lowering of blood pressure, phentolamine should be used. Vasopressors should not be taken. If necessary, anticonvulsant therapy is indicated.
Adverse reactions
Respiratory system
Common (≥1% - <10%): nasal discomfort, burning or dryness of the nasal mucosa, sneezing.
Rare (≥0.01% - <0.1%): After the effect of oxymetazoline wears off, a feeling of severe nasal congestion (reactive hyperemia) may occur.
Frequency not known/uncommon: nosebleeds. Apnoea in newborns and young children (especially in case of overdose).
From the nervous system
Rare (≥0.01% - <0.1%): headache, drowsiness, fatigue, seizures, hallucinations (especially in children).
Cardiovascular system
Uncommon (≥0.1% - <1%): Topical nasal administration may cause systemic effects such as palpitations, tachycardia, arterial hypertension.
On the part of the immune system
Allergic reactions may occur, including rashes, itching, angioedema.
Expiration date
2 years. Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 ml in a glass bottle with a pump-dispenser with a nasal spray, enclosed in a pack.
Vacation category
Without a prescription.
Producer
JSC "Farmak".
Location of the manufacturer and its business address
Ukraine, 04080, Kyiv, Kyrylivska St., 74.
