Azelastine/flutic 137-50mcg Nsl Spr

Azelastine is a phthalazinone derivative, a potent, long-acting selective H1-receptor antagonist. It also inhibits the release of histamine and other mediators from mast cells and reduces the inflammatory response. Fluticasone propionate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory, vasoconstrictive, and antipruritic effects. It acts by binding to glucocorticoid receptors, inhibiting the release of inflammatory mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) and suppressing the migration of inflammatory cells (e.g., eosinophils, mast cells, lymphocytes, macrophages, neutrophils).

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or discolored sputum
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Signs of a weak adrenal gland, such as:
+ Severe nausea or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Extreme fatigue
+ Mood changes
+ Decreased appetite
+ Weight loss
Crusting in the nose
Runny nose
Whistling sound while breathing
Changes in vision, eye pain, or severe eye irritation
Redness or white patches in the mouth or throat
Excessive sleepiness

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for guidance:

Headache
Nosebleed
Nose irritation
* Changes in taste

This is not an exhaustive list of potential side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking ritonavir, as this may interact with the medication.

This is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. Additionally, inform them about any existing health problems.

Before starting, stopping, or modifying the dose of any medication, including this one, consult with your doctor to confirm that it is safe to do so in conjunction with your other medications and health conditions.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before engaging in activities that require alertness, such as driving, wait until you understand how this drug affects you.

When transitioning from an oral steroid to a different form of steroid, severe and potentially life-threatening side effects may occur. Be aware of symptoms such as weakness, fatigue, dizziness, nausea, vomiting, confusion, or low blood sugar. If you experience any of these symptoms, contact your doctor immediately.

In situations involving severe injury, surgery, or infection, you may require additional doses of oral steroids to help your body cope with stress. Carry a warning card indicating that you may need extra steroids in certain situations.

If you have not been vaccinated against or have not had chickenpox or measles, inform your doctor if you come into contact with someone who has either of these conditions.

Consult your doctor if you have recently undergone nose surgery or have injuries, ulcers, or sores, particularly in the nasal area.

Avoid consuming alcohol, marijuana, or other forms of cannabis, as well as prescription or over-the-counter medications that can impair your reactions.

Long-term use of this medication may increase the risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor and undergo regular eye exams as recommended.

In case of accidental ingestion, this medication can be harmful. If swallowed, immediately contact a doctor or a poison control center.

In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary, so consult your doctor to discuss the potential risks and benefits.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.

• Ritonavir (with fluticasone, due to strong CYP3A4 inhibition, leading to increased systemic corticosteroid exposure and potential for Cushing's syndrome and adrenal suppression)

• Other strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, erythromycin) with fluticasone (potential for increased systemic corticosteroid exposure)
• CNS depressants (e.g., alcohol, sedatives, hypnotics, anxiolytics) with azelastine (additive CNS depression)

• Nasal irritation or burning
• Epistaxis (nosebleeds)
• Headache
• Somnolence (drowsiness)
• Dysgeusia (bad taste)
• Pharyngolaryngeal pain
• Cough
• Signs of systemic corticosteroid effects (e.g., adrenal suppression, Cushing's syndrome symptoms, growth retardation in children)
• Signs of infection (e.g., fever, persistent sore throat, white patches in nose/throat)

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Limited data available for azelastine and fluticasone in human pregnancy. Animal studies have shown some adverse effects at high doses.

Caution is advised. It is not known if azelastine or fluticasone are excreted in human milk. Systemic exposure from nasal spray is low, but potential for infant exposure exists. Weigh the developmental and health benefits of breastfeeding against the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant.

Approved for children 6 years of age and older. For children 6 to 11 years, the recommended dose is 1 spray per nostril once daily. For children 12 years and older, it's 1 spray per nostril twice daily. Long-term use of corticosteroids can affect growth velocity in children; monitor growth regularly.

No specific dose adjustment is required. However, elderly patients may be more susceptible to the systemic effects of corticosteroids, especially if they have co-morbidities or are on other medications. Monitor for adverse effects.

• Instruct patients to shake the bottle gently before each use and to prime the pump if it has not been used for 7 or more days.
• Emphasize the importance of proper administration technique to ensure optimal drug delivery and minimize side effects (e.g., tilting head slightly forward, aiming spray away from the nasal septum).
• Advise patients that azelastine can cause somnolence; caution patients about operating machinery or driving until they know how the medication affects them.
• Remind patients that while azelastine provides rapid relief, the full anti-inflammatory effect of fluticasone may take several days to develop, so consistent use is important.
• Counsel patients on potential local side effects such as epistaxis (nosebleeds) and nasal irritation, and how to manage them (e.g., proper technique, avoiding picking nose).

• Single-ingredient nasal corticosteroids (e.g., fluticasone propionate, mometasone furoate, budesonide)
• Single-ingredient nasal antihistamines (e.g., azelastine nasal spray, olopatadine nasal spray)
• Oral antihistamines (e.g., loratadine, fexofenadine, cetirizine)
• Oral decongestants (e.g., pseudoephedrine, phenylephrine)
• Leukotriene receptor antagonists (e.g., montelukast)
• Cromolyn sodium nasal spray
• Saline nasal rinses

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.