QVAR REDIHALER- beclomethasone dipropionate hfa aerosol, metered

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

BECLOMETHASONE DIPROPIONATE (UNII: 5B307S63B2) (BECLOMETHASONE - UNII:KGZ1SLC28Z)

থেকে পাওয়া:

Teva Respiratory, LLC

প্রশাসন রুট:

RESPIRATORY (INHALATION)

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

QVAR REDIHALER is indicated in the maintenance treatment of asthma as prophylactic therapy in adults and pediatric patients 4 years of age and older. Limitations of Use: QVAR REDIHALER is not indicated for the relief of acute bronchospasm.  QVAR REDIHALER is contraindicated in: - the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required [see Warnings and Precautions (5.2)] . - in patients with known hypersensitivity to beclomethasone dipropionate or any of the ingredients in QVAR REDIHALER [see Warnings and Precautions (5.6)] . Risk Summary There are no adequate and well‑controlled studies with QVAR REDIHALER or beclomethasone dipropionate in pregnant women. There are clinical considerations with the use of inhaled corticosteroids (ICS), including beclomethasone dipropionate, in pregnant women [see Clinical Considerations] . Also, no published studies, including studies of large birth registries, have to date related the use of ICS to any increases in congenital malformations or other adverse perinatal outcomes. Thus, available human data do not establish the presence or absence of drug‑associated risk to the fetus. In animal reproduction studies, beclomethasone dipropionate resulted in adverse developmental effects in mice and rabbits at subcutaneous doses equal to or greater than approximately 0.75 times the maximum recommended human daily inhalation dose (MRHDID) in adults (0.64 mg/day) [see Data] . In rats exposed to beclomethasone dipropionate by inhalation, dose‑related gross injury to the fetal adrenal glands was observed at doses greater than 180 times the MRHDID, but there was no evidence of external or skeletal malformations or embryolethality at inhalation doses of up to 440 times the MRHDID. The estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. In the US general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2‑4% and 15‑20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk The risk of complications to the mother and developing fetus from inadequate control of asthma must be balanced against the risks from exposure to beclomethasone dipropionate. In women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age for the neonate. The level of asthma control should be closely monitored in pregnant women and treatment adjusted to maintain optimal control. Labor or Delivery There are no specific human data regarding any adverse effects of inhaled beclomethasone dipropionate on labor and delivery. Data Animal Data In an embryofetal development study in pregnant rats, beclomethasone dipropionate administration during organogenesis from gestation days 6 to 15 at inhaled doses 180 times the MRHDID in adults and higher (on a mg/m2 basis at maternal doses of 11.5 and 28.3 mg/kg/day) produced dose‑dependent gross injury (characterized by red foci) of the adrenal glands in fetuses. There were no findings in the adrenal glands of rat fetuses at an inhaled dose that was 40 times the MRHDID in adults (on a mg/m2 basis at a maternal dose of 2.4 mg/kg/day). There was no evidence of external or skeletal malformations or embryolethality in rat at inhaled doses up to 440 times the MRHDID (on a mg/m2 basis at maternal doses up to 28.3 mg/kg/day). In an embryofetal development study in pregnant mice, beclomethasone dipropionate administration from gestation days 1 to 18 at subcutaneous doses equal to and greater than 0.75 times the MRHDID in adults (on a mg/m2 basis at maternal doses of 0.1 mg/kg/day and higher) produced adverse developmental effects (increased incidence of cleft palate). A no-effect dose in mice was not identified. In a second embryofetal development study in pregnant mice, beclomethasone dipropionate administration from gestation days 1 to 13 at subcutaneous doses equal to and greater than 2.3 times the MRHDID in adults (on a mg/m2 basis at a maternal dose of 0.3 mg/kg/day) produced embryolethal effects (increased fetal resorptions) and decreased pup survival. In an embryofetal development study in pregnant rabbits, beclomethasone dipropionate administration during organogenesis from gestation days 7 to 16 at subcutaneous doses equal to and greater than 0.75 times the MRHDID in adults (on a mg/m2 basis at maternal doses of 0.025 mg/kg/day and higher) produced external and skeletal malformations and embryolethal effects (increased fetal resorptions). There were no effects in fetuses of pregnant rabbits administered a subcutaneous dose 0.2 times the MRHDID in adults (on a mg/m2 basis at a maternal dose of 0.006 mg/kg/day). Risk Summary There are no data available on the presence of beclomethasone dipropionate in human milk, the effects on the breastfed child, or the effects on milk production. However, other inhaled corticosteroids have been detected in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for QVAR REDIHALER and any potential adverse effects on the breastfed child from beclomethasone dipropionate or from the underlying maternal condition. Impairment of fertility was observed in rats and dogs at oral doses of beclomethasone dipropionate corresponding to 250 and 25 times the MRHDID for adults on a mg/m2 basis, respectively. [see Nonclinical Toxicology  (13.1)] . The safety and effectiveness of QVAR REDIHALER for the maintenance treatment of asthma as prophylactic therapy have been established in pediatric patients aged 4 years and older. Use of QVAR REDIHALER for this indication is supported by evidence from adequate and well-controlled studies. Five-hundred and one children between the ages of 4 and 11 were treated with at least one dose of QVAR REDIHALER or QVAR MDI in one 12‑week clinical trial. The safety and effectiveness of QVAR REDIHALER in children below 4 years of age have not been established. Controlled clinical studies have shown that inhaled corticosteroids may cause a reduction in growth velocity in pediatric patients. A 12‑month, randomized, controlled clinical trial evaluated the effects of QVAR MDI versus beclomethasone dipropionate in a CFC propellant‑based formulation (CFC‑BDP) on growth in children age 5 to 11. A total of 520 patients were enrolled, of whom 394 received QVAR MDI (100 to 400 mcg/day ex‑valve) and 126 received CFC‑BDP (200 to 800 mcg/day ex‑valve). Similar control of asthma was noted in each treatment arm. When comparing results at month 12 to baseline, the mean growth velocity in children treated with QVAR MDI was approximately 0.5 cm/year less than that noted with children treated with CFC‑BDP via large‑volume spacer. The long‑term effects of the reduction in growth velocity associated with orally inhaled corticosteroids, including the impact on final adult height, are unknown. The potential for "catch‑up" growth following discontinuation of treatment with orally inhaled corticosteroids has not been adequately studied. The growth of children and adolescents receiving orally inhaled corticosteroids, including QVAR REDIHALER, should be monitored routinely (e.g., via stadiometry). If a child or adolescent on any corticosteroid appears to have growth suppression, the possibility that he/she is particularly sensitive to this effect should be considered. The potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the risks associated with alternative therapies. To minimize the systemic effects of orally inhaled corticosteroids, including QVAR REDIHALER, each patient should be titrated to his/her lowest effective dose [see Dosage and Administration (2.2)] . Clinical studies of QVAR REDIHALER did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Instructions for Use QVAR REDIHALER® (kue' var red-ee-haye’ ler ) (beclomethasone dipropionate HFA) inhalation aerosol Your QVAR REDIHALER Inhaler O verview   When you are ready to use your QVAR REDIHALER for the first time, remove the inhaler from the carton. Important information: - There is no button. You must close the white cap to prepare the inhaler with medicine before each inhalation . - Do not shake. This breath-actuated device does not need to be shaken. This is not  a press-and-breathe inhaler. - Do not prime QVAR REDIHALER . The inhaler does not need to be primed. - Do not use a spacer or volume holding chamber with QVAR REDIHALER. - Always use the inhaler in the upright position (with the mouthpiece down). - After the inhaler is prepared, it will deliver 1 inhalation of medicine when you breathe in (inhale) through the mouthpiece. Your dose might require more than 1 inhalation. - Do not open the white cap or leave it open unless you are ready for your next inhalation. If the cap has been opened for more than 2 minutes or left in the open position, you will need to close the white cap before use. - Do not breathe out or blow into any part of the inhaler.  Breathing out or blowing into the inhaler can damage it. - Do not  suddenly stop using your QVAR REDIHALER. Contact your healthcare provider immediately if you stop using your QVAR REDIHALER. There are 2 main parts of your QVAR REDIHALER including: - the inhaler body with the mouthpiece. See Figure A. - the white cap that covers the mouthpiece of the inhaler. See Figure A. Figure A About the Dose Counter There is a dose counter in the back of the inhaler with a viewing window that shows you how many inhalations of medicine you have left. See Figure B. - Your QVAR REDIHALER contains 120 inhalations. See Figure B. - The counter on the back of your inhaler shows how many inhalations you have left. When there are 20 inhalations left, the numbers in the dose counter will change to red and you should refill your prescription or ask your healthcare provider for another prescription. - When the dose counter shows ‘0’, the background will turn solid red and your inhaler is empty. You should stop using the inhaler and throw it away. Do  not  put your inhaler into a fire or incinerator. See Figure B.   Figure B Important: - The white cap must be closed to prepare the inhaler before each inhalation or you will not receive your medicine. See Figure C. - If the white cap is open, close the white cap to prepare your inhaler and look at the dose counter window to make sure that your inhaler is not empty. See Figure B. - Do not open the cap until you are ready to take your inhalation. Figure C Using your QVAR REDIHALER: Step 1. Open the white cap - Open the white cap. See Figure D. - Breathe out fully, away from the inhaler. Do not blow into the inhaler. Figure D Remember: - Do not open the cap until you are ready to take your inhalation. - Never breathe out or blow into the inhaler . Breathing out or blowing into the inhaler can damage it. Step 2. Inhale 1 Time - Place the mouthpiece in your mouth and close your lips around it so you form a good seal. - Inhale deeply  to release the medicine. - Remove the inhaler and hold your breath for 5 to 10 seconds,  then breathe out slowly, away from the inhaler. Figure E Remember: - Hold the inhaler upright as you take your inhalation. See Figure E. Step 3.  Close the white cap - Close the white cap after inhaling to prepare your next inhalation. See Figure F. Figure F If your healthcare provider has told you to take more than 1 inhalation per dose, make sure the white cap is closed and repeat Step 1 to Step 3. After taking your prescribed number of inhalations, rinse your mouth with water without swallowing  to help reduce the risk of a fungal infection (thrush) in your mouth. How to store your QVAR REDIHALER - Store QVAR REDIHALER at room temperature between 68ºF to 77ºF (20ºC to 25ºC). Avoid exposure to extreme heat or cold. - Keep the white cap on the inhaler closed during storage.  - Keep your QVAR REDIHALER inhaler dry and clean at all times. - If you drop your QVAR REDIHALER, inspect it for damage before use. If the QVAR REDIHALER is damaged, do not use the damaged QVAR REDIHALER. Call your doctor or pharmacist to replace the QVAR REDIHALER. - Do not use or store your QVAR REDIHALER near heat or open flame. Exposure to temperatures above 120ºF (49ºC) may cause the canister to burst.  - Do not throw QVAR REDIHALER into fire or an incinerator. - Throw away QVAR REDIHALER when the dose counter displays ‘0,’ or after the expiration date on the package, whichever comes first. - Keep your QVAR REDIHALER and all medicines out of the reach of children. Cleaning your QVAR REDIHALER - Do not wash or put any part of your QVAR REDIHALER in water. - Clean the mouthpiece of your QVAR REDIHALER weekly with a clean, dry tissue or cloth. Support - If you have any questions about QVAR REDIHALER or how to use your inhaler, go to www.QVAR.com or call 1-888-483-8279. This Instructions for Use has been approved by the U.S. Food and Drug Administration. Distributed by: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054 ©2021Teva Respiratory, LLC. All rights reserved. QVARHIFU-003 Rev. 01/2021

পণ্য সারাংশ:

How Supplied QVAR REDIHALER (beclomethasone dipropionate HFA) inhalation aerosol: The correct amount of medication in each inhalation cannot be assured after 120 actuations from the 10.6‑g canister even though the canister is not completely empty. Patients should be informed to discard the QVAR REDIHALER when the dose counter displays 0 or after the expiration date on the product, whichever comes first. Storage and Handling Store at 25ºC (77ºF). Excursions between 15ºC and 30ºC (59ºF and 86ºF) are permitted (see USP Controlled Room Temperature). For optimal results, QVAR REDIHALER should be at room temperature when used. Contents under pressure. Do not use or store near heat or open flame. Exposure to temperatures above 49ºC (120ºF) may cause bursting. Never throw QVAR REDIHALER into fire or incinerator. Keep out of reach of children.

অনুমোদন অবস্থা:

New Drug Application

পণ্য বৈশিষ্ট্য

QVAR REDIHALER- BECLOMETHASONE DIPROPIONATE HFA AEROSOL, METERED
TEVA RESPIRATORY, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE QVAR
REDIHALER SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR QVAR REDIHALER.
QVAR REDIHALER (BECLOMETHASONE DIPROPIONATE HFA) INHALATION AEROSOL,
FOR ORAL
INHALATION USE
INITIAL U.S. APPROVAL: 1976
INDICATIONS AND USAGE
QVAR REDIHALER is a corticosteroid indicated for maintenance treatment
of asthma as prophylactic
therapy in adults and pediatric patients 4 years of age and older. (1)
Limitations of Use:
Not indicated for the relief of acute bronchospasm. (1)
DOSAGE AND ADMINISTRATION
For oral inhalation only. (2.1)
Starting dosage is based on prior asthma therapy and disease severity.
(2.2)
Treatment of asthma in patients 4 to 11 years of age: 40 mcg or 80 mcg
twice daily. (2.2)
Treatment of asthma in patients 12 years of age and older: 40 mcg, 80
mcg, 160 mcg, or 320 mcg
twice daily (2.2)
Discard QVAR REDIHALER inhaler when the dose counter displays 0 or
after the expiration date on the
product, whichever comes first. (2.1)
Do not use a spacer or volume holding chamber (2.1)
DOSAGE FORMS AND STRENGTHS
Inhalation aerosol: 40 mcg or 80 mcg per breath actuation. (3)
CONTRAINDICATIONS
Primary treatment of status asthmaticus or other acute episodes of
asthma where intensive measures
are required. (4)
Hypersensitivity to any of the ingredients of QVAR REDIHALER. (4)
WARNINGS AND PRECAUTIONS
Oropharyngeal candidiasis: _Candida albicans_ infection of the mouth
and throat may occur. Monitor
patients periodically for signs of adverse effects on the oral cavity.
Advise patients to rinse the mouth
with water without swallowing after inhalation to help reduce the
risk. (5.1)
Deterioration of asthma and acute episodes: Do not use QVAR REDIHALER
for relief of acute
symptoms. Patients require immediate re-evaluation during rapidly
deteriorating asthma. (5.2)
Transferring patients from systemic corticosteroids: Ris