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

What is it?

Neosoro® is a registered trademark of a nasal medication based on naphazoline hydrochloride, being an antiseptic and nasal fluidifier, widely used to relieve 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 for treating 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 mucous membrane, 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 does it work? Pharmacodynamics and Pharmacokinetics

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

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

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

How should I use it?

1. Before using, make sure it is not expired.
2. Drop 1 to 2 drops into each nostril (nose), 4 to 6 times a day.
3. Do not exceed the maximum daily dose of 24 drops.
4. After use, wipe 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 swallowed. To reduce the risk of contamination and transmission of infections, avoid sharing the bottle with others.

Contraindications and warnings

• Neosoro® Adult should not be used by children under 12 years of age. For children over 2 years of age, purchase Neosoro® Children.
• 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 it:
  • Bronchial asthma, 
  • Cardiovascular problems (heart and blood vessels),
  • High blood pressure (hypertension), 
  • Hyperthyroidism (overactive thyroid);
  • Diabetes mellitus (high glucose levels);
  • Prostatic hypertrophy (enlarged prostate). 

Side effects

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

Transient local irritation:

• Burning
• Burning 
• Sneezing

General side effects:

• Nausea (feeling sick)
• Headache
• Increased blood glucose levels in diabetic patients who use the drug chronically

• Rebound nasal congestion (a condition in which sudden cessation of treatment leads to a return of symptoms)
• Drug-induced rhinitis caused by prolonged use of the drug

Cardiovascular reactions:

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

Endocrine/metabolic reactions:

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

Neurological reactions:

• Drowsiness, 
• Piece of cake
• Decrease in body temperature
• Fatigue
• Tiredness
• Headache
• Eat
• Insomnia

Respiratory reactions:

• Epistaxis (nosebleed)
• Burning and pain in the nose
• Sneezing
• Runny nose 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 medicamentosa when used repeatedly. This manifests as inflammation, swelling, and nasal congestion.
• Do not ingest the medication, as it is intended for nasal use only. Ingestion may cause side effects such as nausea, vomiting, tachycardia, drowsiness, among others.

In case of unusual side effects, it is important to notify the drug manufacturer 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 0.017 mg of naphazoline hydrochloride. 

This information is important 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 Nafazoline:

• 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

Trade names 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.
• Rhino: contains only sodium chloride (physiological serum) and does not have a decongestant action, but rather a humidifying and fluidifying effect on nasal secretions.

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

• Nose.
• Multiserum.
• Naridrin.
• Nafazol.
• Nasolin.
• Nasal.
• Nasoflux.
• Nasomax.
• New serum.
• Rinofluimucil: which contains, in addition to naphazoline, acetylcysteine, a mucolytic that helps dissolve nasal mucus.

Interactions with other medicines

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

Additionally, 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 taking other medications.

Overdose: what happens if you take more than the recommended amount?

Excessive application of Neosoro® may 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 you take too much medication, seek medical help quickly and take the medicine packaging or leaflet with you. For further guidance, you can also call 0800 722 6001.

Download the original leaflet

Click on the button below and download the complete Neo Química Manufacturer's leaflet.

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Sources and bibliography:

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

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