Flixonase Spray

FLIXONASE SPRAY

Name

• Common Name: Fluticasone propionate nasal spray
• Brand Name: FLIXONASE SPRAY, also known as FLIXONASE Aqueous Nasal Spray or FLIXONASE Allergy & Hayfever 24 Hour

Composition

• Active Ingredient: Fluticasone propionate (0.05% w/w). Each metered dose contains 50 micrograms of fluticasone propionate.
• Excipients: Includes microcrystalline cellulose, sodium carboxymethylcellulose, dextrose, polysorbate 80, purified water, benzalkonium chloride, and phenylethylalcohol.

Uses

FLIXONASE SPRAY is a corticosteroid medication indicated for intranasal use.

• Allergic Rhinitis: Prophylaxis and treatment of seasonal allergic rhinitis (including hay fever) and perennial rhinitis. It helps manage associated sinus pain and pressure.
• Symptom Relief: Effectively reduces inflammation and swelling in the nasal passages, alleviating symptoms such as itching, sneezing, and blocked or runny nose.
• Other Indications: In some contexts, it is also prescribed for the prophylaxis of asthma, chronic severe asthma, chronic obstructive pulmonary disease (COPD), and nasal polyps.

Dosage and Administration

FLIXONASE SPRAY is for intranasal administration only.

• Adults and children over 12 years of age:
  • Typically, two sprays into each nostril once daily, preferably in the morning.
  • In some cases, the dosage may be increased to two sprays into each nostril twice daily.
  • Once symptoms are controlled, a maintenance dose of one spray per nostril once daily may be used.
  • The maximum daily dose should not exceed four sprays into each nostril.
• Children aged 4-11 years:
  • One spray into each nostril once daily, preferably in the morning.
  • If necessary, one spray into each nostril twice daily may be required.
  • The maximum daily dose should not exceed two sprays into each nostril.
• For optimal therapeutic benefit, regular usage is essential, and maximum relief may take 3 to 4 days of continuous treatment to achieve.
• Administration Technique: Shake the spray, clear nostrils, close one nostril, insert the nozzle into the other, and spray while gently breathing in through the nose, aiming away from the nasal septum.

Side Effects

• Common Side Effects: Headache, nosebleeds, irritation or dryness of the nose or throat, and an unpleasant taste or smell.
• Less Common/Rare Side Effects: Skin reactions (e.g., rash, blotches, dry/cracked skin), eye problems (e.g., pain, blurred vision, increased eye pressure, cataracts, glaucoma), nasal septal perforation, nasal ulcers, hoarseness, cough, sore throat, nausea, vomiting, and thrush (yeast infection in the nose, mouth, or throat).
• Serious Allergic Reactions (Very Rare): Symptoms such as wheezing, breathlessness, coughing, difficulty breathing or talking, tightness in the chest or throat, and swelling (particularly of the face, mouth, lips, tongue, or throat) require immediate medical attention.
• Prolonged use of high doses may lead to temporary adrenal function suppression and slowed growth in children.

Precautions

• Contraindications: Do not use if hypersensitive to fluticasone propionate or any other ingredients.
• Nasal Infections: Nasal airway infections should be treated appropriately but typically do not contraindicate Flixonase use.
• Systemic Steroid Transfer: Exercise caution when transitioning patients from systemic steroid therapy, especially if adrenal function is suspected to be impaired.
• Drug Interactions: Avoid concomitant use with potent CYP3A4 inhibitors (e.g., ritonavir, ketoconazole) as this can significantly increase systemic exposure to fluticasone propionate, potentially leading to systemic corticosteroid effects like Cushing's syndrome and adrenal suppression.
• Eye Contact: Avoid direct contact with eyes.
• Long-term Use: Do not use continuously for more than 6 months without medical advice.
• Pediatric Use: Children should be maintained on the lowest dose that effectively controls symptoms due to observed reduced growth velocity with intranasal corticosteroids.
• Pregnancy and Lactation: Consult a healthcare provider before use during pregnancy or lactation to weigh potential benefits against risks.

Storage

• Store below 30°C.
• Protect from frost and light. Do not freeze.
• Keep out of reach of children.
• Discard the spray 3 months after its first use.

FLIXONASE SPRAY by GLAXO SMITHKLINE PHARMACEUTICALS LIMITED is a corticosteroid nasal spray containing fluticasone propionate, used to treat various allergy symptoms. Below are some frequently asked questions about this medication.

1. What is FLIXONASE SPRAY used for?

FLIXONASE SPRAY is used to prevent and treat symptoms of seasonal allergic rhinitis (like hay fever) and perennial rhinitis (year-round allergies) in adults and children aged 4 years and over. It helps alleviate symptoms such as itchy, blocked, runny, or sniffly nose, sneezing, and can also relieve associated sinus pain, pressure, and eye-related allergy symptoms like itching and watery eyes.

2. How does FLIXONASE SPRAY work?

FLIXONASE SPRAY contains fluticasone propionate, a potent anti-inflammatory corticosteroid. It works by reducing inflammation and swelling in the nasal passages. This active ingredient inhibits the immune system's inflammatory response to allergens by blocking key inflammatory mediators like histamine, prostaglandins, and cytokines. When applied topically to the nasal mucosa, it primarily acts locally with minimal systemic absorption.

3. What is the usual dosage for FLIXONASE SPRAY?

For adults and children over 12 years, the typical starting dose is two sprays into each nostril once a day, preferably in the morning. This may be increased to two sprays into each nostril twice daily if necessary. Once symptoms are under control, the dose can often be reduced to one spray per nostril once daily. The maximum daily dose should not exceed four sprays into each nostril. For children aged 4 to 11 years, the usual dose is one spray into each nostril once daily, preferably in the morning, which may be increased to one spray into each nostril twice daily if required, not exceeding two sprays per nostril per day. For full therapeutic benefit, regular usage is essential, and maximum relief may not be felt for 3 to 4 days after starting treatment.

4. What are the possible side effects of FLIXONASE SPRAY?

Common side effects (affecting up to 1 in 10 users) include headaches, nosebleeds, irritation or dryness of the nose or throat, and an unpleasant taste or smell. Less common or rare side effects can include skin reactions, problems with eyes (such as pain, blurred vision, or increased pressure), damage to the nose, or a yeast infection (thrush) in the nose. Serious allergic reactions are very rare but can include wheezing, breathlessness, and swelling of the face, lips, tongue, or throat, requiring immediate medical attention. In children, prolonged use of corticosteroids can rarely lead to slowed growth.

5. Is FLIXONASE SPRAY safe during pregnancy or breastfeeding?

Pregnancy: FLIXONASE SPRAY can generally be used during pregnancy, as very little of the medication is absorbed into the bloodstream and even less reaches the baby, posing minimal risk. However, it's always advisable to consult a healthcare provider to discuss the benefits and risks for your specific situation.

Breastfeeding: It is generally considered safe to use FLIXONASE SPRAY while breastfeeding. While it's not definitively known how much fluticasone enters breast milk, it is believed to be a very small amount and is unlikely to cause adverse effects in the infant due to minimal systemic absorption. Nevertheless, caution is advised, and consultation with a healthcare provider is recommended.

6. Can FLIXONASE SPRAY be taken with other medications?

FLIXONASE SPRAY can typically be used with most other non-prescription and prescription medications. However, caution is advised when used with certain medicines. It should generally be avoided with strong CYP3A4 inhibitors, such as ritonavir (used for HIV treatment) and ketoconazole (an antifungal medication), as these can significantly increase fluticasone levels in the body and potentially lead to systemic corticosteroid side effects. Additionally, inform your doctor or pharmacist if you are using other steroid-containing medications (e.g., eczema creams, asthma inhalers, steroid tablets, eye drops), as this could increase the risk of side effects. There is limited information on interactions with herbal remedies and supplements.

7. What precautions should be taken when using FLIXONASE SPRAY?

Avoid spraying FLIXONASE directly into your eyes. It is crucial to use the spray regularly as prescribed, as its full therapeutic effect may not be achieved for several days. If your symptoms do not improve after 7 days of continuous use, or if they worsen, consult your doctor. Do not use the spray continuously for more than 6 months without medical advice. If you are switching from systemic steroid treatment, your doctor should supervise the transition, especially if there's a concern about adrenal function. For children, use the lowest effective dose for the shortest possible duration to manage symptoms, and discuss any prolonged use with their doctor due to potential effects on growth.

8. What happens if a dose of FLIXONASE SPRAY is missed?

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.

9. How should FLIXONASE SPRAY be stored?

FLIXONASE SPRAY should be stored below 30°C and protected from frost and light; do not freeze it. Keep the spray in a safe place, out of the reach of children. After the first use, the spray should be discarded after 3 months. Store the bottle upright with the cap on when not in use.