Dimetindene + Phenylephrine (Spray, Drops) Instructions for Use
ATC Code
R01AB01 (Phenylephrine in combination with other drugs)
Active Substances
Phenylephrine (Rec.INN registered by WHO)
Dimetindene (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Drug with vasoconstrictive and antiallergic action for topical use in ENT practice
Pharmacotherapeutic Group
Drugs for the treatment of nasal diseases; decongestants and other drugs for topical use; sympathomimetics, combinations without corticosteroids
Pharmacological Action
A combined drug with vasoconstrictive and antiallergic action for topical use in diseases of the ENT organs.
Phenylephrine is a sympathomimetic agent; with topical application, it has a moderate vasoconstrictive effect (due to stimulation of α1-adrenergic receptors located in the venous vessels of the nasal mucosa), eliminating swelling of the nasal mucosa and its paranasal sinuses.
Dimetindene is an antiallergic agent – an antagonist of histamine H1-receptors; it does not reduce the activity of the ciliated epithelium of the nasal mucosa.
Pharmacokinetics
For topical application.
Indications
Acute rhinitis (including in colds); allergic rhinitis (including hay fever); vasomotor rhinitis; chronic rhinitis; acute and chronic sinusitis; acute otitis media (as an auxiliary agent); preparation for surgical interventions in the nasal area and elimination of edema of the nasal mucosa and paranasal sinuses after surgical intervention in this area.
ICD codes
| ICD-10 code | Indication |
| H66.9 | Otitis media, unspecified |
| J00 | Acute nasopharyngitis (common cold) |
| J01 | Acute sinusitis |
| J06.9 | Acute upper respiratory infection, unspecified |
| J30.0 | Vasomotor rhinitis |
| J30.1 | Allergic rhinitis due to pollen |
| J30.3 | Other allergic rhinitis (perennial allergic rhinitis) |
| J31.0 | Chronic rhinitis (including ozaena, atrophic and hypertrophic rhinitis) |
| J32 | Chronic sinusitis |
| Z51.4 | Preparatory procedures for subsequent treatment or examination, not elsewhere classified |
| ICD-11 code | Indication |
| AA9Z | Unspecified suppurative otitis media |
| CA00 | Acute nasopharyngitis |
| CA01 | Acute rhinosinusitis |
| CA07.0 | Acute upper respiratory tract infection of unspecified site |
| CA08.00 | Allergic rhinitis due to pollen |
| CA08.03 | Other allergic rhinitis |
| CA08.3 | Vasomotor rhinitis |
| CA09.0 | Chronic rhinitis |
| CA0A.Z | Chronic rhinosinusitis, unspecified |
| QB9A | Preparatory procedures for subsequent treatment |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Administer the dosage individually, based on the indication, patient age, and clinical presentation.
For the nasal spray, prime the pump before first use. Tilt the head slightly forward. Insert the tip into the nostril. Spray once into each nostril while breathing in gently through the nose. Avoid deep inhalation.
For nasal drops, use the calibrated dropper. Tilt the head back. Instill the prescribed number of drops into each nostril. Remain in this position for a few minutes to allow the solution to spread.
For adults and children over 6 years, use one to two sprays or two to four drops in each nostril. The standard frequency is up to four times daily. Maintain a minimum interval of four hours between applications.
For children under 6 years, use only the nasal drops formulation. Administer one drop into each nostril. The standard frequency is up to three times daily. Adhere strictly to the pediatric dosage to prevent systemic effects.
Limit the duration of treatment to a maximum of five to seven consecutive days. Prolonged use increases the risk of rebound congestion and medication-induced rhinitis.
Do not exceed the recommended dosage or frequency. If symptoms persist, discontinue use and consult a physician. Do not share the container between individuals to prevent cross-contamination.
Adverse Reactions
From the respiratory system: rarely – discomfort in the nasal area, dryness in the nose, nosebleed.
Local reactions: rarely – burning at the application site.
Contraindications
Atrophic rhinitis (including with foul-smelling discharge – ozaena); simultaneous use of MAO inhibitors and the period up to 14 days after their withdrawal; children under 6 years of age; angle-closure glaucoma; hypersensitivity to phenylephrine, dimetindene maleate, or other components of the drug.
Use with caution in cardiovascular diseases (arterial hypertension, arrhythmias, generalized atherosclerosis), hyperthyroidism, prostate adenoma, diabetes mellitus, obstruction of the bladder neck (for example, due to prostate hypertrophy), epilepsy; in patients with severe reactions to sympathomimetics, manifested as insomnia, dizziness, tremor, cardiac arrhythmia, or increased blood pressure.
Use in Pregnancy and Lactation
Contraindicated for use during pregnancy and lactation (breastfeeding).
Pediatric Use
In children under 6 years of age, only nasal drops are used. If the recommended dose is exceeded, manifestations of the systemic action of the drug may develop.
Geriatric Use
If the recommended dose is exceeded, manifestations may develop in elderly patients.
Special Precautions
Long-term or excessive use of the drug may cause tachyphylaxis and a “rebound” effect, associated with the re-development of nasal congestion (medication-induced rhinitis), and lead to the development of systemic vasoconstrictive action.
If the recommended dose is exceeded, manifestations of the systemic action of the drug may develop, especially in children and elderly patients.
Drug Interactions
Contraindicated in patients receiving MAO inhibitors at the present time or who have received them within the previous 2 weeks.
The drug should not be prescribed simultaneously with tri- and tetracyclic antidepressants, beta-blockers.
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Over-the-Counter
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Dosed nasal spray 35.125 mcg/dose+351.25 mcg/dose
Marketing Authorization Holder
Atoll LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Dosage Form
 |
Dimetindene + Phenylephrine | Dosed nasal spray 35.125 mcg/dose+351.25 mcg/dose |
Dosage Form, Packaging, and Composition
Dosed nasal spray
| 1 dose | |
| Dimetindene maleate | 35.125 mcg |
| Phenylephrine (in the form of hydrochloride) | 351.25 mcg |
15 ml (107 doses) – bottles – carton packs – Over-the-Counter
Dosed nasal spray 35.125 mcg/dose+351.25 mcg/dose
Marketing Authorization Holder
Moscow Endocrine Plant FSUE (Russia)
Dosage Form
|
Dimetindene + Phenylephrine | Dosed nasal spray 35.125 mcg/dose+351.25 mcg/dose |
Dosage Form, Packaging, and Composition
Dosed nasal spray
| 1 dose | |
| Dimetindene (in the form of maleate) | 35.125 mcg |
| Phenylephrine (in the form of hydrochloride) | 351.25 mcg |
20 ml (120 doses) – bottles – carton packs – Over-the-Counter
Nasal drops 0.25 mg+2.5 mg/1 ml: bottle or dropper bottle 10 ml, 15 ml, 20 ml, 30 ml, 40 ml, or 50 ml
Marketing Authorization Holder
Pharmregister LLC (Russia)
Manufactured By
Tula Pharmaceutical Factory, LLC (Russia)
Dosage Form
|
Dimetindene + Phenylephrine | Nasal drops 0.25 mg+2.5 mg/1 ml: bottle or dropper bottle 10 ml, 15 ml, 20 ml, 30 ml, 40 ml, or 50 ml |
Dosage Form, Packaging, and Composition
Nasal drops in the form of a transparent solution from colorless to pale yellow, with a weak specific smell of lavender.
| 1 ml | |
| Dimetindene maleate | 0.25 mg |
| Phenylephrine Hydrochloride | 3.045 mg, |
| Which corresponds to the content of phenylephrine | 2.5 mg |
Excipients : anhydrous sodium hydrogen phosphate – 4.4 mg, citric acid monohydrate – 2.6 mg, sorbitol – 35 mg, benzalkonium chloride – 0.1 mg, lavender oil – 0.2 mg, purified water – up to 1 ml.
10 ml – bottles (1) – carton packs.
15 ml – bottles (1) – carton packs.
20 ml – bottles (1) – carton packs.
30 ml – bottles (1) – carton packs.
40 ml – bottles (1) – carton packs.
50 ml – bottles (1) – carton packs.
10 ml – dropper bottles (1) – carton packs.
15 ml – dropper bottles (1) – carton packs.
20 ml – dropper bottles (1) – carton packs.
30 ml – dropper bottles (1) – carton packs.
40 ml – dropper bottles (1) – carton packs.
50 ml – dropper bottles (1) – carton packs.
![Dimetindene + Phenylephrine [Spray, Drops] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Dimetindene + Phenylephrine [Spray, Drops] 2")