Neosoro® (nafazolin): leaflet, how to take it, contraindications and side effects.

What is it?

Neosoro® is a registered brand of a nasal medicine based on naphazoline hydrochloride, being an antiseptic and nasal fluidizer, widely used to relieve the symptoms of nasal congestion.

It is known for its effectiveness in providing quick and lasting relief, facilitating breathing and promoting a feeling of well-being, making it a reliable product to treat nasal discomfort.

What is it for?

Neosoro® is indicated for the relief of nasal congestion, which can be caused by different conditions, including colds, flu, rhinitis, sinusitis and allergies. 

Nasal congestion is characterized by the narrowing of blood vessels in the upper airways, caused by the mucosa, resulting in difficulty breathing, a feeling of heaviness in the nose and general discomfort. 

Neosoro® acts directly on these symptoms, providing effective and immediate relief.

How it works? Pharmacodynamics and Pharmacokinetics

The active ingredient in Neosoro® is naphazoline, a substance that is vasoconstrictive. Naphazoline works by stimulating alpha-adrenergic receptors present in the blood vessels of the nose. 

This action promotes constriction of the vessels, resulting in a reduction in swelling and nasal congestion. In this way, Neosoro® unblocks the airways, allowing freer and more comfortable breathing.

After nasal application of Neosoro®, naphazoline is quickly absorbed by the nasal mucosa. It starts to take effect, usually around 10 minutes after application, and its effect lasts between 2 and 6 hours. The substance is metabolized mainly in the liver and excreted mainly through the kidneys.

How should I use it?

1. Before using, make sure it has not expired.
2. Place 1 to 2 drops in each nostril (nose), 4 to 6 times a day.
3. Do not exceed the maximum daily dose of 24 drops.
4. After use, clean the applicator with a dry tissue and replace the protective cap.
5. Respect a minimum interval of 3 hours between applications.
6. Avoid using the product for more than 3 to 5 consecutive days and do not exceed the recommended dose.

Remember that Neosoro® is intended for nasal use only and should not be ingested. To reduce the risk of contamination and transmission of infections, avoid sharing the bottle with other people.

Contraindications and warnings

• Neosoro® Adult should not be used by children under 12 years of age. For children over 2 years old, purchase Neosoro® Infantil.
• Pregnant women: use without medical supervision is not recommended.
• Do not use if you are allergic to any component of the formula.
• It should not be used in people with narrow-angle glaucoma.
• During use, it is recommended not to drive vehicles or operate machinery, as the medication may affect ability and attention, causing drowsiness or other effects that may compromise safety in these activities.
• People who have the following conditions should inform their doctor before starting and be more careful when using:
  • bronchial asthma, 
  • Cardiovascular problems (heart and blood vessels),
  • Arterial hypertension (high blood pressure), 
  • Hyperthyroidism (excessive thyroid function);
  • Diabetes mellitus (high glucose levels);
  • Prostatic hypertrophy (enlarged prostate). 

Side effects

Neosoro® may cause some adverse reactions. Here we list the main ones:

Temporary local irritation:

• Burning
• Burning 
• Sneezing

General side effects:

• Nausea (sickness)
• Headache (headache)
• Increased blood glucose levels in diabetic patients who use the medication chronically

• Nasal congestion due to rebound effect (condition in which the sudden suspension of treatment leads to the return of symptoms)
• Medicinal rhinitis caused by prolonged use of the medication

Cardiovascular reactions:

• Arterial hypertension (high blood pressure)
• Tachycardia (increased heart rate)
• Caution in elderly patients with severe cardiac disease and arrhythmias as systemic absorption of naphazoline may aggravate these conditions

Endocrine/metabolic reactions:

• Worsening hyperglycemia (excess blood glucose) in patients with diabetes, especially those with diabetic ketoacidosis

Neurological reactions:

• Somnolence, 
• Easy
• Decrease in body temperature
• Fatigue
• Tiredness
• Headache
• With the
• Insomnia

Respiratory reactions:

• Epistaxis (nosebleed)
• Burning and pain in the nose
• Sneezing
• Nasal runny and discomfort
• Rhinitis

Ophthalmic reactions:

• Conjunctivitis
• Eye irritation and pain
• Visual changes
• Eye redness and irritation
• Pupil dilation
• Increased intraocular pressure

Other adverse reactions described:

• Benzalkonium chloride can cause rhinitis drug when used repeatedly. This manifests as inflammation, swelling and nasal congestion.
• Do not ingest the medicine as it is intended for nasal use only. Ingestion can cause side effects such as nausea, vomiting, tachycardia, drowsiness, among others.

In case of unusual side effects, it is important to notify the company that manufactures the medicine and also register the incident in the Adverse Drug Event Reporting System – Vigimed. You can access it through the website: http://portal.anvisa.gov.br/vigimed.

Composition: 

Each mL of Neosoro® solution may contain:

*Each mL corresponds to 30 drops.

*Each drop of the solution contains 0.017mg of naphazoline hydrochloride. 

This information is relevant to ensure the correct dosage and administration of the medication. Consult the leaflet of the specific medication you are using to check the composition and excipients present. There may be variations between different brands/products.

Technical information: 

The information below refers to the active ingredient Naphazoline:

• Molecular formula: C₁₄H₁₄N₂
• CAS Number: 835-31-4
• Molar mass: 210.274 g/mol
• IUPAC name: 2-(naphthalen-1-ylmethyl)-4,5-dihydro-1H-imidazole

Commercial and similar names of Neosoro®

• Neosoro® H2: contains, in addition to naphazoline, benzalkonium chloride, a nasal antiseptic.
• Neosoro® Infantil: a lower concentration of naphazoline (0.25 mg/mL) and is indicated for children over 2 years old.
• Rinosoro: contains only sodium chloride (physiological saline) and does not have a decongestant action, but rather humidifies and fluidifies nasal secretions.

There are also other medicines that contain naphazoline in their composition, but with different trade names, such as:

• Narix.
• Multiserum.
• Naridrin.
• Nafazol.
• Nasolin.
• Nasaliv.
• Nasoflux.
• Nasomax.
• Novosoro.
• Rinofluimucil: which contains, in addition to naphazoline, acetylcysteine, a mucolytic that helps dissolve nasal mucus.

Interactions with other medications

It is important to be careful when using Neosoro® if you are being treated with medications known as monoamine oxidase inhibitors, such as phenelzine, tranylcypromine and moclobemide. These medications may increase the blood pressure-elevating effects of naphazoline.

Furthermore, if you are taking tricyclic antidepressants such as amitriptyline, imipramine or clomipramine, it is recommended to exercise caution when using Neosoro® as there may be an increase in blood pressure.

It is important to remember that these drug interactions are not exclusive to naphazoline, but it is essential to consider this possibility. Always inform your doctor if you are using other medicines.

Overdose: what happens if you take more than recommended?

Excessive application of Neosoro® can cause adverse effects such as nasal redness, cardiac arrhythmias, decreased or increased heart rate, headache, nausea and vomiting, depression of the Central Nervous System, drop or increase in blood pressure.

If the medication is ingested excessively, seek medical help quickly and take the medication package or leaflet with you. For further guidance, you can also call 0800 722 6001.

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Sources and bibliography:

This article was manually extracted from the original leaflet of the medicines produced by Neo Química® 30mL in June 2022, under technical supervision of the responsible pharmacist.

To access the Neosoro® or Nafazolina leaflet, you can visit the ANVISA electronic leaflet and search for the manufacturer of your choice.