Qvar Redihaler 40mcg Oralinh (120)

Beclomethasone dipropionate (BDP) is a prodrug that is rapidly converted to its active metabolite, beclomethasone-17-monopropionate (B-17-MP), which is a potent glucocorticoid. It exerts its anti-inflammatory effects by binding to glucocorticoid receptors in the cytoplasm, leading to translocation of the receptor-ligand complex into the nucleus. This modulates gene expression, resulting in decreased synthesis of inflammatory mediators (e.g., prostaglandins, leukotrienes, cytokines) and inhibition of inflammatory cell migration and activity (e.g., eosinophils, mast cells, lymphocytes). This reduces airway hyperresponsiveness and inflammation in the lungs.

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 changed sputum production
+ 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
Redness or white patches in the mouth or throat
Changes in vision

Respiratory Emergency

This medication can cause severe breathing problems, which may be life-threatening. If you experience trouble breathing, worsening breathing, wheezing, or coughing after taking this medication, use your rescue inhaler and seek immediate medical attention.

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 notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:

Headache
Nose or throat irritation
Signs of a common cold

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact 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, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may affect or be affected by other drugs or health problems, so it is crucial to disclose this information.

To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have

Carefully review your medications and health conditions to confirm that it is safe to take this medication in conjunction with them. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Monitoring Your Condition

If you experience worsening breathing problems, or if your rescue inhaler becomes less effective or is needed more frequently, contact your doctor immediately.

Stopping or Changing Your Medication

If you have been taking this medication for an extended period, consult your doctor before stopping or reducing the dosage. Your doctor may recommend a gradual tapering of the medication to minimize potential side effects. If you have missed a dose or recently stopped taking this medication and experience symptoms such as extreme fatigue, weakness, shakiness, rapid heartbeat, confusion, sweating, or dizziness, notify your doctor promptly.

Infection Risk

As this medication may increase your risk of developing infections, it is crucial to practice good hygiene by washing your hands frequently and avoiding close contact with individuals who have infections, colds, or flu. If you have not previously had chickenpox or measles, avoid exposure to these illnesses, as they can be severe or even life-threatening in people taking steroid medications like this one. If you have been exposed to chickenpox or measles, consult your doctor immediately.

Changing from Oral Steroids

When transitioning from an oral steroid to another form of steroid, you may be at risk of severe and potentially life-threatening side effects, including weakness, fatigue, dizziness, nausea, vomiting, confusion, or low blood sugar. If you experience any of these symptoms, contact your doctor right away.

Managing Stress and Injuries

In the event of a severe injury, surgery, or infection, you may require additional doses of oral steroids to help your body cope with the stress. Carry a warning card with you to alert healthcare providers of this potential need.

Long-term Use and Eye Health

Prolonged use of this medication may increase your risk of developing cataracts or glaucoma. Consult your doctor to discuss this potential risk, and have your eye pressure checked regularly if you are taking this medication long-term.

Bone Health

Long-term use of this medication may also lead to weakened bones (osteoporosis). Discuss your individual risk factors with your doctor, and follow their recommendations for bone density testing.

Vaccinations

Before receiving any vaccines, consult your doctor, as some vaccines may not be effective or may increase your risk of infection when taken with this medication.

Pediatric Use and Growth

In some cases, this medication may affect growth in children and adolescents. Regular growth checks may be necessary, and your doctor will monitor your child's growth and development.

Pregnancy and Breastfeeding

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

• Strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, cobicistat)

• Worsening asthma symptoms (e.g., increased wheezing, shortness of breath, cough)
• Increased need for rescue inhaler (short-acting beta-agonist)
• Oral candidiasis (white patches in mouth or throat, sore throat)
• Signs of systemic corticosteroid effects (e.g., easy bruising, moon face, weight gain, fatigue, weakness, mood changes) - rare with appropriate dosing
• Signs of adrenal insufficiency (e.g., nausea, vomiting, fatigue, dizziness, weakness) - rare, typically with abrupt discontinuation after prolonged high-dose use

Beclomethasone is generally considered a preferred inhaled corticosteroid for asthma management during pregnancy due to its extensive clinical experience and relatively low systemic absorption. However, it is classified as Pregnancy Category C, meaning animal studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Beclomethasone is considered compatible with breastfeeding. Due to its low oral bioavailability and extensive first-pass metabolism, systemic exposure in the mother is low, and transfer into breast milk is expected to be minimal. The infant's exposure via breast milk is likely negligible.

Inhaled corticosteroids, including beclomethasone, can cause a small reduction in growth velocity in pediatric patients. Growth should be routinely monitored. The lowest effective dose should be used. Qvar Redihaler is approved for children 4 years and older.

No specific dosage adjustments are required for geriatric patients. However, elderly patients may be more susceptible to systemic corticosteroid side effects (e.g., osteoporosis, cataracts, glaucoma), so monitoring for these effects is prudent.

• Qvar Redihaler is a breath-actuated inhaler, meaning it delivers the dose when the patient inhales, which can simplify technique compared to traditional metered-dose inhalers (MDIs) requiring coordination.
• It is crucial to emphasize that Qvar Redihaler is a controller medication for daily maintenance and NOT a rescue inhaler for acute asthma attacks.
• Patients should be instructed to rinse their mouth and spit after each use to minimize the risk of oral candidiasis (thrush) and dysphonia.
• Regular monitoring of asthma control, lung function, and growth in children is important.
• Patients should be advised not to stop the medication abruptly, as this can lead to worsening asthma symptoms or, rarely, adrenal insufficiency.

• Other inhaled corticosteroids (ICS): Fluticasone propionate (Flovent HFA, Arnuity Ellipta), Budesonide (Pulmicort Flexhaler), Mometasone furoate (Asmanex HFA, Twisthaler), Ciclesonide (Alvesco).
• Long-acting beta-agonists (LABAs) - often used in combination with ICS for better control (e.g., Salmeterol, Formoterol).
• Leukotriene receptor antagonists (LTRAs) (e.g., Montelukast, Zafirlukast).
• Long-acting muscarinic antagonists (LAMAs) (e.g., Tiotropium - for severe asthma).
• Oral corticosteroids (for severe exacerbations or refractory asthma).

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 details. If you have any questions or concerns about this 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 information about the medication taken, the amount, and the time it happened.