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QVAR REDIHALER

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Overview

What is QVAR REDIHALER?

The active component of QVAR REDIHALER 40 mcg Inhalation Aerosol and QVAR REDIHALER 80 mcg Inhalation Aerosol is beclomethasone dipropionate, USP, a corticosteroid having the chemical name 9-chloro-11ß,17,21-trihydroxy-16ß-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate. Beclomethasone dipropionate is a diester of beclomethasone, a synthetic corticosteroid chemically related to dexamethasone. Beclomethasone differs from dexamethasone in having a chlorine at the 9‑alpha carbon in place of a fluorine, and in having a 16‑beta-methyl group instead of a 16‑alpha-methyl group. Beclomethasone dipropionate is a white to creamy white, odorless powder with a molecular formula of CHClO and a molecular weight of 521.1. Its chemical structure is:

QVAR REDIHALER is a pressurized, breath‑actuated, metered‑dose aerosol with a dose counter intended for oral inhalation only. Each unit consists of a sealed breath‑actuated inhaler device enclosing a canister containing a solution of beclomethasone dipropionate in propellant HFA‑134a (1,1,1,2 tetrafluoroethane) and ethanol (0.85 g). QVAR REDIHALER 40 mcg delivers 40 mcg of beclomethasone dipropionate from the actuator mouthpiece and 50 mcg from the canister valve. QVAR REDIHALER 80 mcg delivers 80 mcg of beclomethasone dipropionate from the actuator mouthpiece and 100 mcg from the canister valve. Both products deliver 50 microliters (59 milligrams) of solution formulation as an aerosol from the canister valve with each actuation. The 40‑mcg canisters and the 80‑mcg canisters provide 120 inhalations each. Since the QVAR REDIHALER canister is fitted with a primeless valve, no priming actuations are required before use. For both products, an actuation was always triggered by a 20 L/min inspiratory flow rate.



What does QVAR REDIHALER look like?



What are the available doses of QVAR REDIHALER?

Inhalation Aerosol. QVAR REDIHALER is a pressurized, breath‑actuated, metered-dose aerosol with a dose counter intended for oral inhalation containing beclomethasone dipropionate in the following 2 strengths:

What should I talk to my health care provider before I take QVAR REDIHALER?

How should I use QVAR REDIHALER?

QVAR REDIHALER is indicated in the maintenance treatment of asthma as prophylactic therapy in patients 4 years of age and older.

Important Limitations of Use:

Administer QVAR REDIHALER by the orally inhaled route in patients 4 years of age and older. After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis.

Patients should be instructed on the proper use of their inhaler.

Consistent dose delivery is achieved, whether using the 40‑ or 80‑mcg strengths, due to proportionality of the 2 products (i.e., 2 actuations of 40‑mcg strength should provide a dose comparable to 1 actuation of the 80‑mcg strength).

Priming

Shaking the inhaler prior to use is not necessary. Do not shake the inhaler with the cap open to avoid possible actuation of the device.

Do not use QVAR REDIHALER with a spacer or volume holding chamber.

Cleaning

Dose Counter

see Patient Counseling Information ()


What interacts with QVAR REDIHALER?

Sorry No Records found


What are the warnings of QVAR REDIHALER?

Sorry No Records found


What are the precautions of QVAR REDIHALER?

Sorry No Records found


What are the side effects of QVAR REDIHALER?

Sorry No records found


What should I look out for while using QVAR REDIHALER?

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What might happen if I take too much QVAR REDIHALER?

Sorry No Records found


How should I store and handle QVAR REDIHALER?

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Mupirocin Ointment USP, 2% is supplied in 22‑gram tubes.Each gram of Mupirocin Ointment USP, 2% contains 20 mg mupirocin in a water-miscible ointment base.NDC 0168-0352-22 (22-gram tube)Store at controlled room temperature 20°C to 25°C (68°F to 77°F). [See USP Controlled Temperature.]Mupirocin Ointment USP, 2% is supplied in 22‑gram tubes.Each gram of Mupirocin Ointment USP, 2% contains 20 mg mupirocin in a water-miscible ointment base.NDC 0168-0352-22 (22-gram tube)Store at controlled room temperature 20°C to 25°C (68°F to 77°F). [See USP Controlled Temperature.]Mupirocin Ointment USP, 2% is supplied in 22‑gram tubes.Each gram of Mupirocin Ointment USP, 2% contains 20 mg mupirocin in a water-miscible ointment base.NDC 0168-0352-22 (22-gram tube)Store at controlled room temperature 20°C to 25°C (68°F to 77°F). [See USP Controlled Temperature.]Mupirocin Ointment USP, 2% is supplied in 22‑gram tubes.Each gram of Mupirocin Ointment USP, 2% contains 20 mg mupirocin in a water-miscible ointment base.NDC 0168-0352-22 (22-gram tube)Store at controlled room temperature 20°C to 25°C (68°F to 77°F). [See USP Controlled Temperature.]


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Beclomethasone dipropionate is a corticosteroid demonstrating potent anti‑inflammatory activity. The precise mechanism of corticosteroid action on asthma is not known. Corticosteroids have been shown to have multiple anti‑inflammatory effects, inhibiting both inflammatory cells (e.g., mast cells, eosinophils, basophils, lymphocytes, macrophages, and neutrophils) and release of inflammatory mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines). These anti‑inflammatory actions of corticosteroids contribute to their efficacy in asthma.

Beclomethasone dipropionate is a prodrug that is rapidly activated by hydrolysis to the active monoester, 17‑monopropionate (17‑BMP). Beclomethasone‑17‑monopropionate has been shown to exhibit a binding affinity for the human glucocorticoid receptor which is approximately 13 times that of dexamethasone, 6 times that of triamcinolone acetonide, 1.5 times that of budesonide and 25 times that of beclomethasone dipropionate. The clinical significance of these findings is unknown.

Studies in patients with asthma have shown a favorable ratio between topical anti‑inflammatory activity and systemic corticosteroid effects with recommended doses of QVAR REDIHALER.

Non-Clinical Toxicology
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Nephrotoxicity has been reported following concomitant administration of cephalosporins with aminoglycoside antibacterial drugs or potent diuretics such as furosemide. Renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibacterial drugs. Nephrotoxicity and ototoxicity were not noted when ceftazidime was given alone in clinical trials.

Chloramphenicol has been shown to be antagonistic to beta-lactam antibacterial drugs, including ceftazidime, based on in vitro studies and time kill curves with enteric gram-negative bacilli. Due to the possibility of antagonism in vivo, particularly when bactericidal activity is desired, this drug combination should be avoided.

In common with other antibacterial drugs, ceftazidime may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.

Localized infections with have occurred in the mouth and pharynx in some patients receiving QVAR REDIHALER. If oropharyngeal candidiasis develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing with QVAR REDIHALER therapy, but at times therapy with QVAR REDIHALER may need to be temporarily interrupted under close medical supervision. After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis.

Systemic and local corticosteroid use may result in the following:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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