ASMANEX HFA- mometasone furoate aerosol

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MOMETASONE FUROATE (UNII: 04201GDN4R) (MOMETASONE - UNII:8HR4QJ6DW8)

Available from:

Organon LLC

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ASMANEX® HFA is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. Important Limitations of Use - ASMANEX HFA is NOT indicated for the relief of acute bronchospasm. ASMANEX HFA is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. ASMANEX HFA is contraindicated in patients with known hypersensitivity to mometasone furoate or any of the ingredients in ASMANEX HFA [see Warnings and Precautions (5.8)] . Risk Summary There are no randomized clinical studies of ASMANEX HFA in pregnant women. There are clinical considerations with the use of ASMANEX HFA in pregnant women [see Clinical Considerations] . In animal reproduction studies with pregnant mice, rats, or rabbits, mometasone furoate caused increased fetal malformations and decreased fetal survival and growth following administration of doses that produced exposures approximately 1/3 to 8 times the maximum recommend

Product summary:

ASMANEX HFA is available in three strengths and supplied in the following package size (TABLE 3): Each strength is supplied as a pressurized aluminum canister that has a blue plastic actuator integrated with a dose counter and a pink dust cap. Each canister has a net fill weight of 13 grams. Each inhaler is placed into a carton. Each carton contains 1 inhaler. Initially the dose counter will display "124" actuations. After the initial priming with 4 actuations, the dose counter will read "120" and the inhaler is now ready for use. Only use the ASMANEX HFA canister with the ASMANEX HFA actuator. Do not use the ASMANEX HFA actuator with any other inhalation drug product. Do not use actuators from other products with the ASMANEX HFA canister. Do not remove the canister from the actuator because the correct amount of medication may not be discharged; the dose counter may not function properly; reinsertion may cause the dose counter to count down by 1 and discharge a puff. The correct amount of medication in each inhalation cannot be ensured after the labeled number of actuations from the canister has been used, even though the inhaler may not feel completely empty and may continue to operate. Discard the inhaler when the labeled number of actuations has been used (the dose counter will read "0"). Store at controlled room temperature 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. For best results, keep the canister at room temperature before use. Shake well and remove the cap from the mouthpiece of the actuator before using. Keep out of reach of children. Avoid spraying in eyes. Contents Under Pressure: Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator.

Authorization status:

New Drug Application

Summary of Product characteristics

ASMANEX HFA- MOMETASONE FUROATE AEROSOL
ORGANON LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ASMANEX HFA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ASMANEX HFA.
ASMANEX® HFA (MOMETASONE FUROATE) INHALATION AEROSOL, FOR
ORAL INHALATION USE
INITIAL U.S. APPROVAL: 1987
INDICATIONS AND USAGE
ASMANEX HFA is a corticosteroid indicated for:
Maintenance treatment of asthma as prophylactic therapy in patients 5
years of age and older. (1.1)
Important limitations:
Not indicated for the relief of acute bronchospasm. (1.1)
DOSAGE AND ADMINISTRATION
For oral inhalation only. (2.1)
Treatment of asthma in patients 12 years of age and older: 2
inhalations twice daily of ASMANEX HFA
100 mcg or 200 mcg. Starting dosage is based on prior asthma therapy.
(2.2)
Treatment of asthma in patients aged 5 to less than 12 years: 2
inhalations twice daily of ASMANEX
HFA 50 mcg. (2.2)
DOSAGE FORMS AND STRENGTHS
Inhalation aerosol containing 50 mcg, 100 mcg, or 200 mcg of
mometasone furoate per actuation. (3)
CONTRAINDICATIONS
Primary treatment of status asthmaticus or acute episodes of asthma
requiring intensive measures.
(4.1)
Hypersensitivity to any of the ingredients of ASMANEX HFA. (4.2)
WARNINGS AND PRECAUTIONS
Deterioration of asthma and acute episodes: ASMANEX HFA should not be
used for relief of acute
symptoms. Patients require immediate re-evaluation during rapidly
deteriorating asthma. (5.1)
Localized infections: _Candida albicans_ infection of the mouth and
throat may occur. Monitor patients
periodically for signs of adverse effects on the oral cavity. After
dosing, advise patients to rinse their
mouth with water and spit out contents without swallowing. (5.2)
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. Use with caution in
patients with these