Beclomethasone — Membership Pricing

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What Beclomethasone is approved for (FDA label)

Beclomethasone dipropionate HFA inhalation aerosol is indicated in the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. Important Limitations of Use: Beclomethasone dipropionate HFA inhalation aerosol is NOT indicated for the relief of acute bronchospasm. Beclomethasone dipropionate HFA inhalation aerosol is a corticosteroid indicated for: Maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. (1) Important Limitations: Not indicated for the relief of acute bronchospasm. (1)

Source: Read the full FDA label on DailyMed. Label effective date: July 31, 2020.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Beclomethasone (FDA label)

Inhalation Aerosol: Beclomethasone dipropionate HFA inhalation aerosol is a pressurized, metered-dose aerosol with a dose counter intended for oral inhalation containing beclomethasone dipropionate, USP in the following 2 strengths: Beclomethasone dipropionate HFA inhalation aerosol 40 mcg is supplied in a pressurized aluminum canister with a plastic actuator (beige actuator with light blue dust cap). Each actuation delivers 50 mcg of beclomethasone dipropionate, USP from the valve and 40 mcg from the actuator. Beclomethasone dipropionate HFA inhalation aerosol 40 mcg is available as a 120-inhalation/8.7 g canister. Beclomethasone dipropionate HFA inhalation aerosol 80 mcg is supplied in a pressurized aluminum canister with a plastic actuator (dark pink actuator with gray dust cap).

Source: FDA prescribing information (DailyMed). Set ID: d853c96f-21a3-4def-931d-4d47d16acd62. SPL document ID: e351b5e4-d97c-4b2b-8d12-ca34987d2b88. Label effective date: July 31, 2020. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Beclomethasone (FDA label)

Systemic and local corticosteroid use may result in the following: Candida albicans infection [see Warnings and Precautions (5.1) ] Immunosuppression [see Warnings and Precautions (5.4) ] Hypercorticism and adrenal suppression [see Warnings and Precautions (5.7) ] Growth effects [see Warnings and Precautions (5.8) and Use in Specific Populations (8.4) ] Eye Disorders [see Warnings and Precautions (5.10) ] Most common adverse reactions (incidence ≥3% and > placebo) include headache, pharyngitis, oral symptoms (inhalation route), and sinusitis. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Source: FDA prescribing information (DailyMed). Set ID: d853c96f-21a3-4def-931d-4d47d16acd62. SPL document ID: e351b5e4-d97c-4b2b-8d12-ca34987d2b88. Label effective date: July 31, 2020. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Beclomethasone (FDA label)

Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. (4) Hypersensitivity to any of the ingredients of beclomethasone dipropionate HFA inhalation aerosol. (4) 4.1 Status Asthmaticus Beclomethasone dipropionate HFA inhalation aerosol is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. 4.2 Hypersensitivity Beclomethasone dipropionate HFA inhalation aerosol is contraindicated in patients with known hypersensitivity to beclomethasone dipropionate or any of the ingredients in beclomethasone dipropionate HFA inhalation aerosol [see Warnings and Precautions (5.6) ] .

Source: FDA prescribing information (DailyMed). Set ID: d853c96f-21a3-4def-931d-4d47d16acd62. SPL document ID: e351b5e4-d97c-4b2b-8d12-ca34987d2b88. Label effective date: July 31, 2020. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Beclomethasone (FDA label)

Localized infections: 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. (5.1) Deterioration of asthma and acute episodes: Do not use beclomethasone dipropionate HFA inhalation aerosol for relief of acute symptoms. Patients require immediate re-evaluation during rapidly deteriorating asthma. (5.2) Transferring patients from systemic corticosteroids: Risk of impaired adrenal function when transferring from oral steroids. Taper patients slowly from systemic corticosteroids if transferring to beclomethasone dipropionate HFA inhalation aerosol. (5.3) Immunosuppression: Potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.

Source: FDA prescribing information (DailyMed). Set ID: d853c96f-21a3-4def-931d-4d47d16acd62. SPL document ID: e351b5e4-d97c-4b2b-8d12-ca34987d2b88. Label effective date: July 31, 2020. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.