Fluticasone Nasal Spray (Avamys, Flixonase) is a potent corticosteroid that is used intranasally for the treatment of allergic and non-allergic rhinitis.

Fluticasone Nasal Spray Uses:

• Rx products:

  • Allergic rhinitis (Veramyst, Avamys [Canadian product], Flonase [Canadian product]):

    • Management of seasonal and permanent allergic rhinitis in adults, kids older than 2 (Avamys, Veramyst), and patients between the ages of 4 and 17 (Flonase)

  • Nasal polyps (Xhance):

    • used to treat nasal polyps in patients under the age of 18

  • Nonallergic rhinitis (Flonase):

    • Treatment of adults and children older than 4 years old who have persistent non-allergic rhinitis symptoms in the nose.

• OTC products:

  • Upper respiratory allergies:

    • Relief of hay fever or other upper respiratory allergies in adults and children aged 4 or older (Good Sense Nasoflow Clarispray, Flonase Allergy Relief), or aged 2 or older (Good Sense Nasoflow Clarispray, Flonase Allergy Relief), including runny nose, sneezing, itchy nose, itchy and watery eyes, and nasal congestion (Flonase Sensimist).

• Off Label Use of Fluticasone in Adults:

  • Chronic rhinosinusitis
  • Viral rhinosinusitis symptomatic relief
  • Acute bacterial rhinosinusitis, an adjunct to antibiotics (empiric treatment)

Fluticasone Nasal Spray Dose in Adults

Fluticasone Nasal Spray Dose in the treatment of Allergic rhinitis (fluticasone furoate): Intranasal:

• Veramyst (Rx):

  • Initial: Once symptoms are under control, the dosage may be decreased to 1 spray per nostril once per day (55 mcg per day) for maintenance therapy, which is two sprays (27.5 mcg/spray) once per day (110 mcg/day).

• Avamys (Rx) [Canadian product]:

  • Two daily sprays (27.5 mcg each) into each nostril (110 mcg per day). There shouldn't be more than two sprays in each nostril each day in total (110 mcg per day).

Fluticasone Nasal Spray Dose in the treatment of Nasal polyps (fluticasone propionate):

• Intranasal: Xhance (Rx):

  • Some patients may need two sprays per nostril twice daily (93 mcg/spray), making a total of 372 mcg per day (744 mcg per day)
  • The maximum dosage is two nasal sprays twice daily (744 mcg per day).

Fluticasone Nasal Spray Dose in the treatment of Nonallergic rhinitis (fluticasone propionate):

• Intranasal: Flonase (Rx):

  • Initial: Alternatively, the same total daily dosage may be divided and administered as 1 spray each nostril twice a day. The recommended dosage is two sprays (50 mcg/spray) per nostril once day (200 mcg) (200 mcg per day).
  • After the first few days, the dosage may be lowered to 1 spray (100 mcg) in each nostril once a day for maintenance therapy (up to 2 sprays (200 mcg)/day).

Fluticasone Nasal Spray Dose in the treatment of upper respiratory allergies (OTC): Intranasal:

• ClariSpray, Flonase Allergy Relief, Good Sense Nasoflow (fluticasone propionate):

  • Initial: After 7 days, you may reduce the dosage to 1 or 2 sprays per nostril once daily (50 mcg per spray total; 200 mcg total per day) (100 to 200 mcg per day).
  • Use should not last longer than six months unless directed to do so by a healthcare professional.

• Flonase Sensimist (fluticasone furoate):

  • Initial:Two sprays (27.5 mcg per spray) once day (110 mcg per day); after one week, one or two sprays per nostril once daily may be adjusted (55 to 110 mcg per day).
  • Use for no longer than six months unless directed to by a healthcare professional.

Fluticasone Nasal Spray Dose in Children

Note: Use particular caution to ensure proper salt form and dose because product compositions are not interchangeable.

Fluticasone Nasal Spray Dose in the treatment of nonallergic Rhinitis:

• Flonase (fluticasone propionate, 50 mcg/spray):

  • Children ≥4 years and Adolescents:
    • Initial intranasal dosage is one spray per nostril, once daily (total daily dose: 100 mcg).
    • Increase the dosage to two sprays per nostril once daily if the response is insufficient (total daily dose: 200 mcg per day).
    • Reduce the dosage to 1 spray per nostril once daily after the symptoms are under control (total daily dose: 100 mcg per day).
    • The daily dosing cap is two sprays, one in each nostril (total daily dose: 200 mcg per day).
    • Note: Consistent usage of the nasal spray is recommended for best results.

Fluticasone Nasal Spray Dose in the treatment of seasonal and perennial allergic Rhinitis:

• Fluticasone furoate (27.5 mcg/spray):

  • Veramyst, Avamys [Canadian product]: Intranasal:

    • Children 2 to 11 years:
      • Initial: Once symptoms have been controlled, the dosage may be decreased to 1 spray per nostril once daily (total daily dose: 55 mcg/day). If the response is insufficient, the dosage may be increased to 2 sprays per nostril once daily (total daily dose: 110 mcg/day).
      • Maximum daily dosage: two sprays, administered once per nostril (total daily dose: 110 mcg per day)
    • Children ≥12 years and Adolescents:
      • Initial: When symptoms are under control, the dosage can be decreased to 1 spray once a day each nostril (a total daily dose of 110 mcg) (total daily dose: 55 mcg per day)

• Fluticasone propionate (50 mcg/spray):

  • Canadian labeling: Flonase (fluticasone propionate 50 mcg/spray): Intranasal:

    • Children 4 to 11 years:
      • One to two sprays each nostril, once daily (total daily dose: 100 to 200 mcg); two sprays per nostril, once daily (maximum daily dose) (total daily dose: 200 mcg per day).
      • Reduce the dosage to 1 spray per nostril, once daily (total daily dose: 100 mcg), once the symptoms have been managed.
    • Children ≥12 years and Adolescents ≤17 years:
      • Patients with severe rhinitis may benefit from 2 sprays in each nostril twice a day (total daily dose: 400 mcg); 2 sprays per nostril once daily (total daily dose: 200 mcg);
      • The maximum daily dosage is four sprays per nostril, administered once daily for a total of 400 mcg.

Fluticasone Nasal Spray Dose in the treatment of upper respiratory allergies (OTC):

• Fluticasone furoate (27.5 mcg/spray) (eg, Flonase Sensimist): Intranasal:

  • Children 2 to 11 years:
    • Once day, one spray is given into each nostril (total daily dose: 55 mcg).
  • Children ≥12 years and Adolescents:
    • For one week, administer 2 sprays per nostril once a day (total daily dose: 110 mcg); after that, reduce to 1 or 2 sprays per nostril once daily (total daily dose range: 55 to 110 mcg per day)

• Fluticasone propionate (50 mcg/spray) (eg, Flonase allergy relief, ClariSpray): Intranasal:

  • Children 4 to 11 years:
    • Once day, one spray is given into each nostril (total daily dose: 100 mcg).
  • Children ≥12 years and Adolescents:
    • After a week, the dosage may be reduced to 1 or 2 sprays per nostril once a day (total daily dose: 200 mcg) (total daily dose range: 100 to 200 mcg per day)

Fluticasone Nasal Spray Pregnancy Category: C

• Fluticasone and other intranasal corticosteroids may be used to treat rhinitis in pregnancy when taken at the recommended dosages.
• Following maternal inhalation of fluticasone during pregnancy, fluticasone can also be found in cord blood. Intranasal fluticasone was also being used by one woman.
• Monitor for hypoadrenalism in newborns after maternal use of corticosteroids during pregnancy.
• Fluticasone can be continued by pregnant women who have been adequately treated with fluticasone. 

Use during breastfeeding:

• It is unknown if enough fluticasone is absorbed after inhalation to make detectable amounts in breastmilk.
• According to the manufacturer breastfeeding during therapy is a decision that should be made after considering the risks to infants and the benefits to mothers.
• Human milk contains systemic corticosteroids.

Dose in Kidney Disease:

No dosage adjustment required.

• Xhance:
  • There are no dosage adjustments provided in the manufacturer’s labeling; however, dosage adjustment is likely not necessary. Following nasal administration, bioavailability and renal elimination are minimal.

Dose in Liver disease:

The manufacturer’s labeling doesn't provide any dosage adjustments; use caution in moderate to severe impairment due to extensive hepatic metabolism.

Common Side Effects of Fluticasone Nasal Spray:

• Central nervous system:

  • Headache

Less Common Side Effects of Fluticasone Nasal Spray:

• Central Nervous System:

  • Body Pain
  • Generalized Ache
  • Dizziness

• Endocrine & Metabolic:

  • Weight Gain

• Gastrointestinal:

  • Nausea And Vomiting
  • Diarrhea
  • Abdominal Distress
  • Toothache
  • Abdominal Pain

• Local:

  • Local Irritation

• Ophthalmic:

  • Increased Intraocular Pressure

• Respiratory:

  • Epistaxis
  • Nasal Mucosa Ulcer
  • Blood In Nasal Mucosa
  • Bronchitis
  • Flu-Like Symptoms
  • Rhinorrhea
  • Dry Nose
  • Pharyngitis
  • Nasopharyngitis
  • Acute Asthma
  • Nasal Congestion
  • Acute Sinusitis
  • Cough
  • Oropharyngeal Pain
  • Sinusitis

• Miscellaneous:

  • Fever

Contraindications to Fluticasone Nasal Spray:

• hypersensitivity to fluticasone and any other formulation ingredient

OTC labeling

• Use this product for self-medication only in children younger than 2 years old (Flonase Sensimist) or younger than 4 years old (Flonase Allergy Relief) to treat asthma or any current injury to the nasal region that hasn't fully healed from surgery or anaesthesia.
• There is not much evidence of cross-reactivity between intranasal steroids and allergenic steroids. 
• Cross sensitivity is possible due to similarities in chemical structure or pharmacologic effects.

Canadian labeling: Additional contraindications not in US labeling: Flonase

• Tuberculosis, Bacterial, and Untreated Fungal infections of the respiratory tract

Warnings and precautions

• Suppression of the adrenals:

  • May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods.
  • Patients must exercise caution while switching from systemic to inhaled corticosteroids.
  • This is due to potential adrenal insufficiency, steroid withdrawal, and the potential for an increase in allergy symptoms.
  • Suppression of the HPA axis may cause adrenal crisis.
  • It is important to withdraw and stop using a corticosteroid slowly and carefully.
  • Systemic toxicities may be more common in pediatric patients.
  • Prednisone may make adult patients more susceptible if they are taking >=20mg of prednisone daily (or an equivalent).
  • Ritonavir and maybe other effective CYP3A4 inhibitors used concurrently may increase fluticasone levels and its effects on HPA suppression.

• Delay in wound healing

  • Patients who have recently undergone surgery, sustained trauma, or nasal septal ulcers should not be utilised until the healing process is complete.

• Hypersensitivity

  • Hypersensitivity reactions have been reported, including rash, anaphylaxis and angioedema as well as contact dermatitis, hypotension and bronchospasm.

• Immunosuppression:

  • Avoid exposure to measles and chickenpox, particularly if they are not immunized.
  • In the event that the patient has been exposed, varicella-zoster immunoglobulin or pooled infuscular immunoglobulin prophylaxis may be advised. If chickenpox appears, treatment with antiviral medications might also be taken into account.
  • Additionally, corticosteroids can be used for extended periods of time to reduce the effectiveness of vaccines, raise the risk of secondary infections, conceal acute illnesses (including fungal infections), prolong and worsen viral infections, and disguise fungal infections.

• Local nasal effects:

  • Patients should be monitored for any adverse effects to their nasal passages
  • In the event of an infection, medication should be stopped; stop treatment if there is a perforation of the nasal septum.
  • Nasal septal perforation, nasal ulceration, epistaxis, nasal erosion, localised Candida albicans infections in the nose, and throat are all possible.

• Hepatic impairment

  • Patients with severe or moderate hepatic impairment should be treated with caution.

• Infections

  • If there is a localized, untreated infection of the nasal mucosa, you should not use it.
  • If the infection is verified, concurrent antibiotic medication should also be utilised.
  • Patients with active, dormant, or systemic viral, bacterial, parasitic, or ocular herpes simplex infections of the respiratory tract should be careful or avoided.

• Ocular disease:

  • Routine eye exams are recommended for long-term users and patients with visual impairments.
  • Patients who have cataracts or glaucoma should exercise caution, and those who have developed cataracts as a result of using the device for an extended period of time should be warned.

Fluticasone (nasal): Drug Interaction

Monitoring parameters:

• Growth 
• HPA axis suppression/adrenal insufficiency
• possible eosinophilic conditions 
• ocular changes
•  Candida infection
• hepatic function

How to administer Fluticasone Nasal Spray?

• Only for intranasal usage; avoid spraying into mouth or eyes.
  administer on a regular basis. Before each usage, give the bottle a light shake.
• Clear your nostrils by blowing. Close off the other nostril while inserting the applicator into the nose while maintaining the bottle's upright position.
• Inhale through your nose. Press the pump to let the spray out while breathing it in.
• Even if the bottle isn't quite empty, throw it away once the designated number of doses has been consumed.

Flonase:

• Prior to usage or if the spray has been sitting unused for a weak or longer than a weak, prime the pump (push it six times until a fine spray occurs).
• Once inserted, a nasal applicator that is weak can be withdrawn and cleaned by rinsing it in warm water.

Veramyst, Avamys [Canadian product]:

• If the spray has been sitting unused for 30 days or longer, or if the bottle cap has been off for more than 5 days, prime the pump (push it six times until a thin spray appears) before using it.
• The nozzle should be cleaned with a fresh, dry tissue after each usage. The interior of the cap should be wiped with a fresh, dry tissue after each use.

Xhance:

• Steer clear of spraying the septum directly. When using the pump for the first time, prime it by gently shaking and pressing the bottle seven times to release a fine mist. If it has been seven days since usage, prime it once again by shaking and releasing two sprays into the air.
• Place the flexible mouthpiece into the mouth after inserting the nosepiece deeply into one nostril to create a tight seal. Blow into the mouthpiece and, as you continue to blow, push the bottle up to activate the spray pump. At the moment of activation, do not inhale or exhale through the nose.
• Repeat in the other nostril for the full dose.

Flonase Sensimist:

• Before usage, give the bottle a good shake. Pump prime.
• Lightly inhale after each spritz. After each usage, cleanly dry the spray nozzle with a tissue before replacing the cap.

Mechanism of action of Fluticasone:

• A fluorocarbothioate ester linkage is used at the 17-carbon position in the corticosteroid fluticasone.
• It has exceptionally strong anti-inflammatory and vasoconstrictive effects.

The onset of action:

• The maximal benefit may take several days or several months.

Protein binding:

• 99 percent

Metabolism:

• Hepatic via CYP3A4 to 17 beta-carboxylic acid (negligible activity)

Bioavailability:

• less than 2 percent.

Half-life elimination:

• IV: Fluticasone propionate: ~8 hours (~7.8 hours [Xhance]);
• Fluticasone furoate: ~15 hours

Excretion when administered orally:

• Feces (as parent drug and metabolites);
• Urine (<5% as metabolites)

International Brand Names of Fluticasone Nasal Spray:

• Flonase Allergy Relief
• Flonase Sensimist
• APO-Fluticasone
• Avamys
• Flonase
• RATIO-Fluticasone
• TEVA-Fluticasone
• GoodSense Nasoflow
• Ticaspray
• Veramyst
• Xhance
• Alenys
• Alisade
• Allegro
• Allermist
• Avamys
• Avaspray
• Clefan
• Dalmam AQ
• Flixonas
• Flixonase
• Flixonase Nasule
• Flomist
• Flusort
• Flutaide
• Flutica
• Fluticone
• Flutide
• Flutimate
• Flutinasal
• Flutinase
• Flutinide
• Flutitrim
• Lutisone
• Nasofan
• Nasoflo
• Novex
• Perinase

Fluticasone Nasal Spray Brand Names in Pakistan: