Qvar Redihaler 80mcg Oralinh (120)

Beclomethasone dipropionate (BDP) is a prodrug that is rapidly converted via esterase enzymes to its active metabolite, beclomethasone-17-monopropionate (B-17-MP). B-17-MP is a potent glucocorticoid with anti-inflammatory activity. It acts by binding to intracellular glucocorticoid receptors, leading to the transcription of anti-inflammatory proteins and the inhibition of pro-inflammatory mediators (e.g., cytokines, chemokines, leukotrienes, prostaglandins). This reduces airway hyperresponsiveness, inflammation, and mucus production 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 stomach upset 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 help.

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you notice any of the following side effects or any other symptoms that bother you or don't go away, contact your doctor:

Headache
Nose or throat irritation
Signs of a common cold

Reporting Side Effects

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.

To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you experience worsening breathing problems, a decrease in the effectiveness of your rescue inhaler, or an increase in the frequency of using your rescue inhaler, contact your doctor immediately.

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

As this medication may increase your susceptibility to 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 had chickenpox or measles before, avoid exposure to these illnesses, as they can be severe or even life-threatening in individuals taking steroid medications like this one. If you have been exposed to chickenpox or measles, consult with your doctor immediately.

When transitioning from an oral steroid to another form of steroid, there is a risk of severe and potentially life-threatening side effects. Monitor for symptoms such as weakness, fatigue, dizziness, nausea, vomiting, confusion, or low blood sugar, and contact your doctor immediately if you experience any of these signs. 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 indicating that you may need extra steroids in certain situations.

Long-term use of this medication may increase the risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor and have your eye pressure checked regularly if you are taking this medication for an extended period. Additionally, long-term use may lead to osteoporosis (weak bones). Consult with your doctor to determine if you are at a higher risk of developing osteoporosis and to discuss any concerns you may have. Your doctor may recommend a bone density test to assess your bone health.

Before receiving any vaccinations, consult with your doctor, as some vaccines may not be effective or may increase the risk of infection when taken with this medication. In children and adolescents, this medication may affect growth in some cases, and regular growth checks may be necessary. Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the potential benefits and risks of this medication to both you and your baby.

• Strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, cobicistat): May increase systemic exposure to beclomethasone and its active metabolite, potentially leading to systemic corticosteroid effects. Clinical significance is generally low due to low systemic absorption of inhaled beclomethasone, but caution is advised, especially with prolonged co-administration.

• Worsening asthma symptoms (e.g., increased wheezing, shortness of breath, cough)
• Increased need for rescue inhaler (e.g., albuterol)
• Nocturnal asthma symptoms
• Signs of oral candidiasis (white patches in mouth or throat, soreness)
• Signs of systemic corticosteroid effects (e.g., easy bruising, moon face, weight gain, fatigue, vision changes - rare with typical inhaled doses)

Beclomethasone is a Category C drug. Studies in animals have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Uncontrolled asthma poses a greater risk to both mother and fetus than the potential risks of inhaled corticosteroids.

Beclomethasone and its active metabolite are excreted in human milk in very small amounts. The amount transferred to the infant is considered clinically insignificant. Use is generally considered compatible with breastfeeding, but caution is advised.

Inhaled corticosteroids, including beclomethasone, may cause a 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 dose adjustments are required for geriatric patients. However, elderly patients may be more susceptible to systemic corticosteroid effects (e.g., osteoporosis, cataracts, glaucoma), so monitoring for these effects is prudent, especially with long-term use.

• Qvar Redihaler is a breath-actuated inhaler, meaning it releases medication when the patient inhales, which can simplify use for some patients compared to traditional metered-dose inhalers requiring coordination.
• It is crucial to emphasize that Qvar Redihaler is a controller medication for asthma prevention and not a rescue inhaler for acute asthma attacks.
• Patients should be instructed on proper inhaler technique and the importance of rinsing their mouth after each use to minimize the risk of oral candidiasis.
• Regular follow-up and adherence to the prescribed regimen are key for optimal asthma control.
• If a patient is transitioning from an oral corticosteroid to Qvar Redihaler, they should be tapered off the oral steroid slowly under medical supervision to prevent adrenal insufficiency.

• Other inhaled corticosteroids (ICS): Fluticasone propionate (Flovent HFA, Arnuity Ellipta), Budesonide (Pulmicort Flexhaler, Pulmicort Respules), Mometasone furoate (Asmanex HFA, Asmanex Twisthaler), Ciclesonide (Alvesco).
• ICS/LABA combinations (for moderate to severe asthma): Fluticasone/salmeterol (Advair), Budesonide/formoterol (Symbicort), Mometasone/formoterol (Dulera), Fluticasone furoate/vilanterol (Breo Ellipta).
• Leukotriene receptor antagonists (e.g., Montelukast, Zafirlukast).
• Long-acting beta-agonists (LABAs) - generally not used as monotherapy for asthma.
• Mast cell stabilizers (e.g., Cromolyn - less commonly used).
• Biologic therapies (for severe asthma, e.g., Omalizumab, Mepolizumab, Reslizumab, Benralizumab, Dupilumab).

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 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 medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it occurred.