QVAR REDIHALER (Page 6 of 8)
16 HOW SUPPLIED/STORAGE AND HANDLING
Product: 53002-2436
NDC: 53002-2436-3 1 AEROSOL, METERED in a INHALER / 1 in a CARTON
Product: 53002-3477
NDC: 53002-3477-3 1 AEROSOL, METERED in a INHALER / 1 in a CARTON
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA‑Approved Patient Labeling (Patient Information and Instructions for Use).
Patients should be given the following information:
Oropharyngeal Candidiasis
Inform patients that localized infections with Candida albicans occurred in the mouth and pharynx in some patients. If oropharyngeal candidiasis develops, treat it with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing therapy with QVAR REDIHALER, but at times therapy with QVAR REDIHALER may need to be temporarily interrupted under close medical supervision. Rinsing the mouth with water without swallowing after inhalation is advised to help reduce the risk of thrush.
Status Asthmaticus and Acute Asthma Symptoms
Inform patients that QVAR REDIHALER is not a bronchodilator and is not intended for use as rescue medicine for acute asthma exacerbations. Advise patients to treat acute asthma symptoms with an inhaled, short‑acting beta2 ‑agonist such as albuterol. Instruct the patient to contact their physicians immediately if there is deterioration of their asthma.
Immunosuppression and Risk of Infections
Warn patients who are on immunosuppressant doses of corticosteroids to avoid exposure to chickenpox or measles and, if exposed, to consult their physicians without delay. Inform patients of potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.
Hypercorticism and Adrenal Suppression
Advise patients that QVAR REDIHALER may cause systemic corticosteroid effects of hypercorticism and adrenal suppression. Additionally, instruct patients that deaths due to adrenal insufficiency have occurred during and after transfer from systemic corticosteroids. Patients should taper slowly from systemic corticosteroids if transferring to QVAR REDIHALER.
Immediate Hypersensitivity Reactions
Advise patients that immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, and hypotension), including anaphylaxis, may occur after administration of QVAR REDIHALER. Patients should discontinue QVAR REDIHALER if such reactions occur and contact their healthcare provider or get emergency medical help.
Reduction in Bone Mineral Density
Advise patients who are at an increased risk for decreased BMD that the use of corticosteroids may pose an additional risk.
Reduced Growth Velocity
Inform patients that orally inhaled corticosteroids, including QVAR REDIHALER, may cause a reduction in growth velocity when administered to pediatric patients. Physicians should closely follow the growth of adolescents taking corticosteroids by any route.
Ocular Effects
Long-term use of inhaled corticosteroids may increase the risk of some eye problems (cataracts, glaucoma or blurred vision); consider regular eye examinations.
Pregnancy
Inform patients who are pregnant or nursing that they should contact their physician about the use of QVAR REDIHALER.
Use Daily for Best Effect
Patients should use QVAR REDIHALER at regular intervals as directed. The daily dosage of QVAR REDIHALER should not exceed 8 inhalations per day. Advise patients, if they miss a dose, to take their next dose at the same time they normally do. Individual patients will experience a variable time to onset and degree of symptom relief and the full benefit may not be achieved until treatment has been administered for 1 to 2 weeks or longer. Patients should not increase the prescribed dosage but should contact their physicians if symptoms do not improve or if the condition worsens. Instruct patients to not stop use of QVAR REDIHALER abruptly. Patients should contact their physicians immediately if they discontinue use of QVAR REDIHALER.
Caring for and Storing the Inhaler
For normal hygiene, the mouthpiece of QVAR REDIHALER should be cleaned weekly with a clean, dry tissue or cloth. Never wash or put any part of QVAR REDIHALER in water. Patient should replace QVAR REDIHALER if washed or placed in water.
Instruct patients to store the inhaler at room temperature and to avoid exposure to extreme heat and cold.
Inform patients that shaking the inhaler prior to use is not necessary. Instruct patients not to shake the inhaler with the cap open to avoid possible actuation of the device.
Instruct patients to never take QVAR REDIHALER apart.
Inform patients that QVAR REDIHALER has a dose counter attached to the actuator at the rear of the mouth piece. When the patient receives the inhaler, the number 120 will be displayed. The dose counter will count down each time a spray is released. The dose-counter window displays the number of sprays left in the inhaler in units of two (e.g., 120, 118, 116, etc). When the counter displays 20, the color of the numbers will change to red to remind the patient to contact their pharmacist for a refill of medication or consult their healthcare provider for a prescription refill. When the dose counter reaches 0, the background will change to solid red. Inform patients to discard QVAR REDIHALER when the dose counter displays 0 or after the expiration date on the product, whichever comes first.
Distributed by:
Teva Pharmaceuticals USA
Parsippany, NJ 07054
© 2021 Teva Respiratory, LLC
U.S. Patent 7,637,260; 8,132,712; 8,931,476
QVARH-003
PATIENT INFORMATION
PATIENT INFORMATION QVAR REDIHALER ® (kue’ var red-ee-haye’ ler) (beclomethasone dipropionate HFA) inhalation aerosol |
What is QVAR REDIHALER?
It is not known if QVAR REDIHALER is safe and effective in children less than 4 years of age. |
Who should not use QVAR REDIHALER? Do not use QVAR REDIHALER:
|
What should I tell my healthcare provider before using QVAR REDIHALER? Before using QVAR REDIHALER, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all of the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. |
How should I use QVAR REDIHALER? Read the step-by-step Instructions for Use for QVAR REDIHALER at the end of this Patient Information leaflet.
|
What should I avoid while using QVAR REDIHALER? If you have not had, or have not been vaccinated against, chickenpox or measles, you should stay away from people who are infected. |
What are the possible side effects of QVAR REDIHALER? QVAR REDIHALER may cause serious side effects, including:
○ feeling tired or exhausted (fatigue) ○ lack of energy ○ low blood pressure (hypotension) ○ dizziness or feeling faint ○ nausea and vomiting ○ weakness
○ fever ○ chills ○ pain ○ feeling tired ○ body aches ○ nausea ○ vomiting
○ hives ○ swelling of your lips, tongue or face ○ rash ○ breathing problems
The most common side effects of QVAR REDIHALER include:
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of QVAR REDIHALER. Ask your healthcare provider or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
How should I store QVAR REDIHALER?
Keep QVAR REDIHALER and all medicines out of the reach of children. |
General information about the safe and effective use of QVAR REDIHALER. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use QVAR REDIHALER for a condition for which it was not prescribed. Do not give QVAR REDIHALER to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about QVAR REDIHALER that is written for health professionals. |
What are the ingredients in QVAR REDIHALER? Active ingredient: beclomethasone dipropionate. Inactive ingredients: propellant HFA-134a and ethanol. Distributed by: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054 ©2021 Teva Respiratory, LLC. All rights reserved. For more information, go to www.QVAR.com or call 1-888-483-8279. |
This Patient Information has been approved by the U.S. Food and Drug Administration.
Revised: 01/2021
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