Neotison Nasal Spray

Indications

Neotison Nasal Spray is designed to alleviate symptoms associated with seasonal and perennial allergic rhinitis in individuals aged 2 years and older.

Neotison Inhalation Powder is indicated for the daily maintenance treatment of asthma in patients aged 5 years and older. It serves as a prophylactic therapy and is not intended for the relief of acute bronchospasm.
Consult a registered healthcare professional before use.

Description

Neotison is a synthetic corticosteroid, specifically fluorinated, that exhibits significant anti-inflammatory properties. The formulation is a microfine aqueous suspension delivered via a metered spray pump, designed for effective topical administration to the nasal mucosa. It’s important to prime the pump before the first use or after a week of non-use. Each Neotison nasal spray bottle contains 120 metered sprays. Once the 120 sprays are exhausted, the spray delivery may become inconsistent, necessitating disposal of the bottle.

Pharmacology

Fluticasone Furoate, the active ingredient in Neotison, is a powerful synthetic trifluorinated corticosteroid known for its potent anti-inflammatory effects. It interacts with various cell types, including mast cells, eosinophils, neutrophils, macrophages, and lymphocytes, as well as mediators such as histamine, eicosanoids, leukotrienes, and cytokines, to combat inflammation effectively.

Dosage

Fluticasone Furoate Nasal Spray:

• Adults & Children over 12 years: 2 sprays in each nostril once daily, with an option for 2 sprays twice daily in some cases, not exceeding 4 sprays in total.
• Children (2-11 years): 1 spray in each nostril once daily. Regular usage is essential for optimal effectiveness.
• Children under 2 years: Usage is not recommended due to insufficient data.

Fluticasone Furoate Inhalation Capsule: Administer 1 inhalation once daily via the orally inhaled route, ensuring consistency by using it at the same time every day. Do not exceed one dose every 24 hours.

• Adults and Adolescents Aged 12 and Older: Starting doses should be determined based on asthma severity, typically beginning at 100 mcg for those not previously on inhaled corticosteroids (ICS). If there’s no improvement after 2 weeks, consider increasing to 200 mcg for better asthma control.

If current therapy does not achieve adequate asthma control, reevaluate the treatment plan. Options may include increasing the dose, adding a combination of ICS and long-acting beta-2 agonist (LABA), or initiating oral corticosteroids.

The maximum recommended daily dose for adults and adolescents is 200 mcg. After achieving stability, it is advisable to titrate down to the lowest effective dose to minimize side effects.

Pediatric Patients Aged 5 to 11 Years: The recommended dosage is 50 mcg administered once daily.
Consult a registered healthcare professional before use.

Administration

How to Use the Nasal Spray:

1. Shake the bottle gently and remove the dust cover.
2. Hold the spray with your thumb under the bottle and forefinger and middle finger on either side of the nozzle. Press down until a fine spray is produced. If it’s the first use or hasn’t been used for over a week, pump several times until a fine mist is emitted.
3. Clear your nostrils by gently blowing your nose.
4. Close one nostril and insert the nasal applicator into the open nostril. Tilt your head slightly forward, keeping the spray upright. Breathe in through your nose while firmly pressing the nasal applicator to release a spray.
5. Exhale through your mouth.
6. Repeat the process in the other nostril for additional doses.

Cleaning Instructions: Clean the nasal spray at least once a week by following these steps:

1. Remove the dust cover.
2. Gently detach the nasal applicator.
3. Wash both the applicator and dust cover in warm water.
4. Shake off excess water and let them air dry at room temperature. Avoid applying heat.
5. Reattach the applicator to the bottle and secure the dust cover.

Consult a registered healthcare professional before use.

Interaction

Using potent inhibitors of cytochrome P450 3A4 (CYP3A4) can increase the exposure to Neotison. Co-administration with ritonavir is discouraged. Caution is advised when combining Neotison with other strong CYP3A4 inhibitors, such as ketoconazole.

Important Note: Patients must prime the device before first use and if the cap has been left off, if the device is not functioning correctly, or if the nasal spray hasn’t been used for 30 days or more. To prime, shake the nasal spray vigorously for 10 seconds while capped, then press the button firmly six times until a fine mist appears. Remember to shake vigorously before each use.

Contraindications

Neotison nasal spray is contraindicated in individuals with known hypersensitivity to any of its components.

Side Effects

Neotison nasal spray has minimal systemic absorption, resulting in fewer side effects. Possible side effects may include nasal dryness and an increased risk of nosebleeds.

The most frequently reported adverse reactions for Neotison inhalation capsules (≥5% incidence in adults and adolescents) include nasopharyngitis, bronchitis, upper respiratory infections, and headaches. For pediatric patients aged 5 to 11 years, common side effects reported (≥3% incidence) include pharyngitis, bronchitis, and viral infections.

Pregnancy & Lactation

Use during Pregnancy: Classified as Pregnancy Category C. Adequate studies are lacking in pregnant women, so Neotison nasal spray should only be used during pregnancy if the benefits outweigh potential risks to the fetus.

Use during Lactation: The excretion of Fluticasone Furoate in human breast milk is not established. However, as other corticosteroids can be present in breast milk, caution is advised when administering this product to nursing mothers.

Precautions & Warnings

Rarely, immediate hypersensitivity reactions or contact dermatitis may occur following Neotison nasal spray administration. Instances of wheezing, nasal septum perforation, cataracts, glaucoma, and increased intraocular pressure have been documented with the use of intranasal corticosteroids, including Neotison. While systemic effects are minimal at recommended doses, the risk increases with higher doses; therefore, exceeding recommended dosages is not advisable.

Use in Special Populations

Geriatric Use: Exercise caution in dosing for elderly patients, considering the potential for reduced hepatic, renal, or cardiac function, along with the likelihood of concurrent diseases or medication therapies.

Hepatic Impairment: Caution is recommended for patients with severe hepatic impairment.

Renal Impairment: No dosage adjustments are necessary for patients with renal impairment.

Therapeutic Class

Nasal Steroid Preparations

Storage Conditions

Store Neotison at temperatures not exceeding 30°C. Avoid refrigeration. Protect from light and moisture, and keep out of children’s reach.