Instructions for Edem Rino spray nasal solution bottle 10 ml
Composition
active ingredients: phenylephrine, dimethindene maleate;
1 ml of the drug contains phenylephrine 2.5 mg, dimethindene maleate 0.25 mg;
Excipients: benzalkonium chloride; lavender extract; sorbitol (E 420); citric acid, monohydrate; sodium hydrogen phosphate, dodecahydrate; water for injections.
Dosage form
Nasal spray, solution.
Main physicochemical properties: clear, colorless or slightly yellowish liquid with a faint lavender odor.
Pharmacotherapeutic group
Decongestants and other rhinological preparations for topical use. Sympathomimetics, combinations, excluding corticosteroids. ATX code R01A B.
Pharmacological properties
Pharmacodynamics
Edem® Rino is a combination drug that contains phenylephrine and dimethindene.
The drug reduces nasal discharge and helps cleanse the nasal passages without disrupting the physiological functions of the ciliated epithelium and nasal mucosa.
Phenylephrine belongs to the sympathomimetic amines. It is used as a nasal decongestant with a moderate vasoconstrictor effect, selectively stimulating α1-adrenergic receptors of the cavernous venous tissue of the nasal mucosa, thus quickly and permanently eliminating swelling of the nasal mucosa and its paranasal sinuses.
Dimetindene is a histamine H1 receptor antagonist, has antiallergic effects. It is effective when used in low doses and is well tolerated.
Edem® Reno is applied topically, so its activity does not correlate with the concentration of active substances in blood plasma.
Pharmacokinetics
With accidental oral administration, the bioavailability of phenylephrine was reduced to approximately 38%, with a half-life of approximately 2.5 hours.
The systemic bioavailability of dimethindene after oral administration in solution is about 70%, the half-life is about 6 hours.
Indication
In adults and children aged 6 years and over:
symptomatic treatment of colds, nasal congestion, acute and chronic rhinitis, seasonal (hay fever) and non-seasonal allergic rhinitis, acute and chronic sinusitis, vasomotor rhinitis. Adjunctive therapy in acute otitis media.
Preparation for surgical intervention in the nasal area, elimination of swelling of the nasal mucosa and paranasal sinuses after surgical intervention.
Contraindication
Hypersensitivity to phenylephrine, dimethindene maleate or to any of the excipients of the drug.
Due to the content of phenylephrine, the drug, like other vasoconstrictors, is contraindicated in atrophic rhinitis, angle-closure glaucoma, as well as in patients who are taking monoamine oxidase inhibitors (MAOIs) or have taken them in the previous 14 days.
Interaction with other medicinal products and other types of interactions
Simultaneous use of the drug with MAO inhibitors and within 14 days after their use is contraindicated.
Vasoconstrictors should be prescribed with caution with tricyclic and tetracyclic antidepressants and antihypertensive drugs such as β-blockers, as their concomitant administration may potentiate the pressor effect of phenylephrine.
Application features
Edem® Rino, like other sympathomimetics, should be used with caution in patients with a pronounced reaction to adrenergic substances, manifested by symptoms such as insomnia, dizziness, tremor, cardiac arrhythmias or increased blood pressure.
Edem® Rhino should not be used continuously for more than 3 days. If symptoms persist for more than 3 days or worsen, consult a doctor. Prolonged or excessive use of the drug may cause tachyphylaxis and rebound effect (rhinitis medicamentosa).
As with other vasoconstrictors, the recommended dose should not be exceeded. Excessive use of the drug, especially in children and elderly patients, may cause systemic effects of the drug.
The drug should be prescribed with caution to patients with cardiovascular diseases, patients with arterial hypertension, hyperthyroidism, diabetes mellitus, and patients with bladder neck obstruction (e.g., with prostatic hypertrophy).
Due to the content of the H1-antihistamine dimethindene maleate, Edem® Reno should be used with caution in patients with epilepsy.
Ability to influence reaction speed when driving vehicles or other mechanisms
Data is missing.
Use during pregnancy or breastfeeding
Phenylephrine and dimethindene maleate have not been studied during pregnancy or breastfeeding. Given the potential systemic vasoconstrictor effect of phenylephrine, it is recommended that the drug be avoided during pregnancy.
It is recommended to refrain from using the drug during breastfeeding.
Fertility
There are no adequate data on the effects of phenylephrine and dimethindene maleate on human fertility.
Method of administration and doses
Before administering the drug, the nose should be thoroughly cleaned.
1–2 sprays into each nasal passage 3–4 times a day.
The bottle should be held vertically, with the spray upwards. Keeping your head straight, insert the tip into the nasal passage, press the spray once with a short, sharp movement and, having pulled the tip out of the nose, release it. During the injection, it is recommended to inhale slightly through the nose for an even distribution of the drug. The duration of continuous treatment should not exceed 3 days and depends on the course of the disease.
The use of the drug in children aged 6 to 12 years should be carried out under adult supervision.
Children
This dosage form of the drug is used in children aged 6 years and older.
Overdose
In case of overdose, Edem® Rino nasal spray may cause sympathomimetic and anticholinergic effects such as increased heart rate, premature contraction of the ventricles of the heart, pain in the nape of the neck, trembling or tremor, mild tachycardia, increased blood pressure, mydriasis, numbness, agitation, hallucinations, convulsions, insomnia and pallor. Overdose of the drug may cause moderate sedation, dizziness, increased fatigue, coma, stomach pain, nausea, vomiting.
No serious side effects were noted after accidental use of Edem® Reno. Accidental ingestion of doses of dimetinden up to 20 mg into the gastrointestinal tract did not lead to severe symptoms.
Treatment: Use activated charcoal, possibly laxatives for younger children (gastric lavage is not necessary); adults and older children are given plenty of fluids to drink.
Phenylephrine-induced hypertension that is poorly responsive to benzodiazepines can be reversed by using an alpha-adrenergic blocker.
Central anticholinergic symptoms can be treated with physostigmine. It is advisable to consult a doctor about the use of antidotes. Since there are no data on the gastrointestinal tract absorption of doses of dimetindena in excess of 20 mg, patients with significant overdose should be medically monitored and, if prescribed by a doctor, given a single dose of activated charcoal.
Severe cases of agitation and seizures should be treated with benzodiazepines.
Adverse reactions
The drug is generally well tolerated. The adverse reactions listed below are classified according to frequency as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
From the respiratory system, thoracic organs and mediastinum: rarely - discomfort in the nasal cavity, dryness of the nasal cavity, nosebleeds.
General disorders and administration site reactions: rarely - burning sensation at the application site; very rarely - general weakness, development of allergic reactions (in particular, local skin reactions, itching of the body, swelling of the eyelids and face).
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 bottle. 1 bottle 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.
