Medication info

Fluticasone Propionate Nasal Spray (Unmicronized)

Prescription medicationSuspensionApproval withdrawn
Ingredient · strength
Fluticasone Propionate Micronized›0.05g / 100g
Manufacturer / importer
(주)글락소스미스클라인
Appearance
An opaque white suspension in a container that dispenses a measured dose.
Packaging
120 doses/spray bottle
Approval status
Approval withdrawn

MFDS item code 199403093 · Approved 1994.10.08

This product's status changed to Approval withdrawn on 2023.12.22. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Prevention and treatment of seasonal and perennial allergic rhinitis
Who uses it
Adults · Children
Adult dosage
Adults and children 12 years and older should administer 2 sprays (2×50 μg) into one nostril while blocking the other nostril with a finger. Then, perform the same procedure for the other nostril with 2 sprays. The recommended dosage is 2 sprays into each nostril once daily in the morning. In some cases, it may be necessary to administer 2 sprays into each nostril twice a day. However, the maximum daily dose should not exceed 4 sprays into each nostril.
Children's dosage
For children under 12 years: 1) Seasonal Allergic Rhinitis: For children aged 4-11 years, administer 1 spray (50 μg) into each nostril once daily. The maximum daily dose is 2 sprays (2×50 μg) into each nostril.

Ingredients

Importer
(주)글락소스미스클라인

Efficacy & effects

Prevention and treatment of seasonal and perennial allergic rhinitis

  • Seasonal allergic rhinitis
  • hay fever
  • perennial rhinitis
View approved original text

This medication is used for the prevention and treatment of seasonal allergic rhinitis, perennial rhinitis, and allergic diseases such as hay fever.

Dosage and Administration

Adult dosage

Adults and children 12 years and older should administer 2 sprays (2×50 μg) into one nostril while blocking the other nostril with a finger. Then, perform the same procedure for the other nostril with 2 sprays. The recommended dosage is 2 sprays into each nostril once daily in the morning. In some cases, it may be necessary to administer 2 sprays into each nostril twice a day. However, the maximum daily dose should not exceed 4 sprays into each nostril.

Children's dosage

For children under 12 years: 1) Seasonal Allergic Rhinitis: For children aged 4-11 years, administer 1 spray (50 μg) into each nostril once daily. The maximum daily dose is 2 sprays (2×50 μg) into each nostril.

Precautions

This medication is a corticosteroid and is used to relieve symptoms of allergic rhinitis by spraying into the nasal cavity. Patients who are on systemic corticosteroid treatment before using this medication should be monitored closely for symptoms of adrenal insufficiency or withdrawal. Patients with asthma or those requiring long-term systemic corticosteroid therapy should be careful as abrupt dosage reduction may worsen symptoms. Patients taking immunosuppressants are more susceptible to infections, so special care should be taken regarding infections such as chickenpox or measles, and appropriate treatment should be received if an infection occurs. When used in combination with other medications, the risk of adrenal suppression may increase, thus careful usage is required, especially for patients taking every-other-day prednisone. Patients allergic to this medication or its components, children under 4 years of age, or those with a recent history of septal ulceration or non-surgical, non-traumatic events should not use this medication. Caution should be exercised in patients with active tuberculosis, fungal or bacterial infections, systemic viral infections, or ocular herpes simplex. During use, side effects such as headache, taste or smell disturbances, nasal dryness, nosebleeds, cough, sore throat may occur, and rarely, allergic reactions, septal ulcers, perforation, glaucoma, increased intraocular pressure, or cataracts may appear. In the presence of nasal infections, appropriate treatment should be administered first, and caution is advised with prolonged high-dosage use, as systemic actions may occur. This medication should be used regularly, and if symptoms do not improve or worsen, do not increase the dose without consulting a healthcare professional. Due to the risk of infection with chickenpox or measles, verify medical history and vaccination status and take precautions against infections. Optimal effects may take several days to manifest after administration, so patience is necessary during use. This medication does not affect driving or machine operation abilities. In children, a decrease in growth rate may be observed, so it is important to monitor growth regularly and adjust to the minimum effective dose. Vision disturbances may occur, so if there is blurriness or other visual abnormalities, consult an ophthalmologist. This medication contains benzalkonium chloride, which may cause bronchospasm or irritation and swelling in the nasal cavity, so caution is advised. Interactions with other medications are rare, but particularly when used with ritonavir, serious side effects such as adrenal suppression and Cushing's syndrome may occur, so it should be avoided. The safety of this medication in pregnant or breastfeeding women has not been sufficiently established, so it should be used only when the therapeutic benefits outweigh the risks. Children under 4 years of age should avoid use as safety and efficacy have not been established. Acute toxicity has not been reported with overdose, but long-term high-dosage use may cause adrenal suppression and growth delays, so caution is advised. Finally, the bottle should be shaken gently before use to mix well.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • swelling of the face or tongue
  • hypersensitivity
  • anaphylaxis/anaphylactic reaction
  • angioedema
  • wheezing
  • difficulty breathing
  • septal ulcers
  • septal perforation
  • glaucoma
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  • increased intraocular pressure
  • cataracts

Mild side effects

Altered taste, loss of taste or smell, headache, unpleasant taste or smell, skin rash, itching, sore throat, cough, hoarseness, voice change, dryness and irritation of the nasal cavity or throat, nosebleeds, dry and irritated eyes, conjunctivitis, blurred vision, visual disturbances, angioedema, increased blood pressure, swelling, nasal mucosa edema

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. Additionally, it is important to keep it in a cool place below 30 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

An opaque white suspension in a container that dispenses a measured dose.

Package unit

120 doses/spray bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.