ASMANEX HFA (Page 6 of 8)
16.2 Storage and Handling
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.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Not for Acute Symptoms
Advise patients that ASMANEX HFA is not indicated to relieve acute asthma symptoms, and extra doses should not be used for that purpose. ASMANEX HFA is not a bronchodilator and should not be used to treat status asthmaticus or to relieve acute asthma symptoms. Treat acute asthma symptoms with an inhaled, short-acting beta2 -agonist such as albuterol. Prescribe the patient with such medication and instruct the patient on how to use it [see Warnings and Precautions (5.1)].
Instruct patients to seek medical attention immediately if they experience any of the following:
- If their symptoms worsen
- Significant decrease in lung function as outlined by the physician
- If they need more inhalations of a short-acting beta2 -agonist than usual
Advise patients not to increase the dose or frequency of ASMANEX HFA. Do not exceed the daily dosage of ASMANEX HFA two inhalations twice daily. If they miss a dose, instruct patients to take their next dose at the same time they normally do.
Advise patients not to stop or reduce ASMANEX HFA therapy without physician/provider guidance since symptoms may recur after discontinuation.
Local Effects
Advise patients that localized infections with Candida albicans occurred in the mouth and pharynx in some patients. If oropharyngeal candidiasis develops, treat with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing with ASMANEX HFA therapy, but at times therapy with ASMANEX HFA may need to be temporarily interrupted under close medical supervision. After dosing, advise patients to rinse their mouth with water and spit out contents without swallowing [see Warnings and Precautions (5.2)].
Immunosuppression
Warn patients who are on immunosuppressant doses of corticosteroids to avoid exposure to chickenpox or measles and, if exposed, to consult their physician without delay. Inform patients of potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex [see Warnings and Precautions (5.3)].
Hypercorticism and Adrenal Suppression
Advise patients that ASMANEX HFA 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. Instruct patients to slowly taper from systemic corticosteroids if transferring to ASMANEX HFA [see Warnings and Precautions (5.4 and 5.5)].
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 and should be monitored and, where appropriate, be treated for this condition [see Warnings and Precautions (5.9)].
Reduced Growth Velocity
Inform patients that orally inhaled corticosteroids, including ASMANEX HFA, may cause a reduction in growth velocity when administered to pediatric patients. Physicians should closely follow the growth of pediatric patients taking corticosteroids by any route [see Warnings and Precautions (5.10)].
Glaucoma and Cataracts
Advise patients that long-term use of inhaled corticosteroids may increase the risk of some eye problems (glaucoma or cataracts); consider regular eye examinations [see Warnings and Precautions (5.11)].
Hypersensitivity Reactions Including Anaphylaxis
Advise patients that hypersensitivity reactions, such as urticaria, flushing, allergic dermatitis, bronchospasm, rash, pruritus, angioedema, and anaphylactic reaction, may occur after administration of ASMANEX HFA. Instruct patients to discontinue ASMANEX HFA if such reactions occur [see Warnings and Precautions (5.8)].
Use Daily for Best Effect
Advise patients to use ASMANEX HFA at regular intervals, since its effectiveness depends on regular use. Maximum benefit may not be achieved for 1 week or longer after starting treatment. If symptoms do not improve after 2 weeks of therapy or if the condition worsens, instruct patients to contact their physician.
Instructions for Use
Instruct patients regarding the following:
- Read the Patient Information before use and follow the Instructions for Use carefully.
- Remind patients to:
- Remove the cap from the mouthpiece of the actuator before use.
- After dosing, rinse their mouth with water and spit out contents without swallowing. This will help reduce the risk of oropharyngeal candidiasis.
- Not remove the canister from the actuator.
- Not wash inhaler in water. The mouthpiece should be cleaned using a dry wipe after every 7 days of use.
Manufactured for: Organon LLC, a subsidiary of
ORGANON & Co.,
Jersey City, NJ 07302, USA
Manufactured by: Kindeva Drug Delivery Limited, Loughborough, United Kingdom.
For patent information: www.organon.com/our-solutions/patent/
Copyright © 2021 Organon Global Inc. All rights reserved.
uspi-og0887-ao-2106r000
Patient InformationASMANEX® HFA (AZ-ma-neks) 50 mcg ASMANEX® HFA 100 mcgASMANEX® HFA 200 mcg (mometasone furoate) Inhalation Aerosol | ||||||
---|---|---|---|---|---|---|
This Patient Information has been approved by the U.S. Food and Drug Administration. | Revised Date: 6/2021 | |||||
What is ASMANEX HFA? ASMANEX HFA is an inhaled corticosteroid (ICS) prescription medicine used as maintenance treatment for the prevention and control of asthma symptoms in people 5 years of age and older.
| ||||||
Who should not use ASMANEX HFA?Do not use ASMANEX HFA:
| ||||||
What should I tell my doctor before and during treatment with ASMANEX HFA?Before you use ASMANEX HFA, tell your healthcare provider if you:
| ||||||
|
|
|
|
| ||
Ask your healthcare provider if you are not sure if any of your medicines are the kinds listed above.For some medicines (including medicines for HIV such as ritonavir, cobicistat-containing products, and certain antifungals and antibiotics) your doctor may wish to monitor you carefully. Know the medicines you take. Keep a list and show it to your healthcare provider and pharmacist each time you get a new medicine. | ||||||
How should I use ASMANEX HFA?Read the step-by-step instructions for using ASMANEX HFA in the Instructions for Use.
| ||||||
What are the possible side effects of ASMANEX HFA?ASMANEX HFA can cause serious side effects, including | ||||||
| ||||||
|
|
|
|
|
|
|
| ||||||
|
|
| ||||
| ||||||
|
|
|
| |||
| ||||||
The most common side effects reported while using ASMANEX HFA include: | ||||||
|
|
| ||||
Other side effects: Worsening asthma or sudden asthma attacks have been reported with the use of inhaled mometasone furoate. Tell your healthcare provider about any side effect that bothers you or that does not go away.These are not all the side effects with ASMANEX HFA. 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 ASMANEX HFA?
| ||||||
General Information about the safe and effective use of ASMANEX HFA. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ASMANEX HFA for a condition for which it was not prescribed. Do not give your ASMANEX HFA to other people, even if they have the same condition that you have. It may harm them.This Patient Information leaflet summarizes the most important information about ASMANEX HFA. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ASMANEX HFA that was written for healthcare professionals.For more information about ASMANEX HFA go to www.ASMANEX.com, or to report side effects call 1-844-674-3200. | ||||||
What are the ingredients in ASMANEX HFA? Active ingredient: mometasone furoate Inactive ingredients: hydrofluoroalkane (HFA-227: 1,1,1,2,3,3,3-heptafluoropropane), ethanol and oleic acid |
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.