and fully [1%).:<150 pg/mL on Day 3 prior to coadministration of ketoconazole or placebo. Following concomitant administration of ketoconazole, 4 out of 12 subjects in the ketoconazole treatment group (n=12) had peak plasma concentrations of mometasone furoate> 200 pg/mL on Day 9 (211-324 pg/mL). Mometasone furoate plasma levels appeared to increase and plasma cortisol levels appeared to decrease upon concomitant administration of ketoconazole. Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment of Fertility In a 2-year carcinogenicity study in Sprague Dawley rats, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 67 mcg/kg (approximately 14 times the MRHD on an AUC basis). In a 19-month carcinogenicity study in Swiss CD-1 mice, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 160 mcg/kg (approximately 9 times the MRHD on an AUC basis). Mometasone furoate increased chromosomal aberrations in an in vitro Chinese hamster ovary cell assay, but did not have this effect in an in vitro Chinese hamster lung cell assay. Mometasone furoate was not mutagenic in the Ames test or mouse lymphoma assay, and was not clastogenic in an in vivo mouse micronucleus assay, a rat bone marrow chromosomal aberration assay, or a mouse male germ-cell chromosomal aberration assay. Mometasone furoate also did not induce unscheduled DNA synthesis in vivo in rat hepatocytes. In reproductive studies in rats, impairment of fertility was not produced by subcutaneous doses up to 15 mcg/kg (approximately 8 times the MRHD on an AUC basis). Clinical Studies Asthma The safety and efficacy of Asmanex HFA was demonstrated in two randomized, double-blind, placebo- or active-controlled multi-center clinical trials of 12 and 26 weeks' duration, conducted as part of a mometasone furoate/formoterol fumarate 100/5 mcg or 200/5 mcg combination product development program. A total of 1509 patients 12 years of age and older with persistent asthma (mean baseline FEV 1 of 66% to 73% predicted) were evaluated. Trial 1: Clinical Trial with Asmanex HFA 100 mcg This 26-week, placebo-controlled trial conducted as part of a mometasone furoate/formoterol fumarate combination product asthma program evaluated 781 patients 12 years of age and older. Of these patients, 192 patients received Asmanex HFA 100 mcg and 196 patients received placebo, each administered as 2 inhalations twice daily by metered dose inhalation aerosols. All other maintenance therapies were discontinued. The study included a 2- to 3-week run-in period with Asmanex HFA 100 mcg, 2 inhalations twice daily. Patients ranged from 12 to 76 years of age, 41% were male and 59% female, and 72% were Caucasian and 28% non-Caucasian. Patients had persistent asthma and were not well controlled on medium dose of inhaled corticosteroids prior to randomization. Mean FEV 1 and mean percent predicted FEV 1 were similar among all treatment groups (2.33 L, 73%). Thirteen (7%) patients receiving Asmanex HFA 100 mcg and 46 (23%) patients receiving placebo discontinued the study early due to treatment failure. The change in mean trough FEV 1 from baseline to Week 12 compared to placebo was assessed to evaluate the efficacy of Asmanex HFA 100 mcg. The change from baseline to week 12 in the mean trough FEV 1 was greater among patients receiving Asmanex HFA 100 mcg 2 inhalations twice daily than among those receiving placebo (treatment difference from placebo 0.12 L and 95% confidence interval [0.05, 0.20]). Clinically judged deteriorations in asthma or reductions in lung function were also assessed to evaluate the efficacy of Asmanex HFA 100 mcg. Deteriorations in asthma were defined as any of the following: a 20% decrease in FEV 1 ; a 30% decrease in PEF on two or more consecutive days; emergency treatment, hospitalization, or treatment with systemic corticosteroids or other asthma medications not allowed per protocol. Sixty-five (34%) patients who received Asmanex HFA 100 mcg reported an event compared to 109 (56%) patients who received placebo. Treatment of asthma patients with Asmanex HFA 100 mcg, two inhalations twice daily also resulted in fewer nocturnal awakenings and improved morning peak flow compared to those who received placebo. Trial 2: Clinical Trial with Asmanex HFA 200 mcg This 12-week randomized, double-blind, active-controlled trial also conducted as part of a mometasone furoate/formoterol fumarate combination product asthma program evaluated a total of 728 patients 12 years of age and older comparing Asmanex HFA 200 mcg (n=240 patients), mometasone furoate/formoterol fumarate 200 mcg/5 mcg (n=255 patients), and mometasone furoate/formoterol fumarate 100 mcg/5 mcg (n=233 patients), each administered as 2 inhalations twice daily by metered dose inhalation aerosols. All other maintenance therapies were discontinued. This trial included a 2- to 3-week run-in period with Asmanex HFA 200 mcg, 2 inhalations twice daily. Patients had persistent asthma and were uncontrolled on high-dose inhaled corticosteroids prior to study entry. Patients ranged from 12 to 84 years of age, 44% were male and 56% female, and 89% were Caucasian and 11% non-Caucasian. Mean FEV 1 and mean percent predicted FEV 1 values were similar among all treatment groups (2.05 L, 66%). The number of patients who discontinued the trial early due to treatment failure were 11 (5%) in the mometasone furoate/formoterol fumarate 100 mcg/5 mcg group, 8 (3%) in the mometasone furoate/formoterol fumarate 200 mcg/5 mcg group, and 13 (5%) in the Asmanex HFA 200 mcg group. In order to assess the added benefit of a higher dose of mometasone in the 200 mcg/actuation mometasone furoate product compared to the lower dose 100 mcg/actuation product, trough FEV 1 at 12 weeks was compared between the combination mometasone furoate/formoterol fumarate 200 mcg/5 mcg and 100 mcg/5 mcg treatment groups as a secondary endpoint. Improvement in trough FEV 1 from baseline to week 12 in patients who received mometasone furoate 200 mcg in combination with formoterol fumarate 5 mcg was numerically greater than among patients who received mometasone furoate 100 mcg in combination with formoterol fumarate 5 mcg (treatment difference of 0.05 L and 95% confidence interval [-0.02, 0.10]). Other Studies In addition to Trial 1 and Trial 2, the safety and efficacy of mometasone furoate MDI 100 mcg and 200 mcg, in comparison to placebo were demonstrated in three other 12-week, placebo-controlled trials which evaluated the mean change in FEV 1 from baseline as a primary endpoint. How Supplied/Storage and Handling How Supplied Asmanex HFA is available in two strengths and supplied in the following package size (Table 4): Table 4 Package NDC Asmanex HFA 100 mcg 120 metered actuations 0085-4333-01 Asmanex HFA 200 mcg 120 metered actuations 0085-4334-01 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. Storage and Handling The Asmanex HFA canister should only be used with the Asmanex HFA actuator. The Asmanex HFA actuator should not be used with any other inhalation drug product. Actuators from other products should not be used with the Asmanex HFA canister. The canister should not be removed 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. The inhaler should be discarded when the labeled number of actuations has been used (the dose counter will read "0"). Store at controlled room temperature 20-25 C (68-77 F); excursions permitted to 15-30 C (59-86 F) [see USP Controlled Room Temperature]. For best results, the canister should be 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. 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. Acute asthma symptoms should be treated with an inhaled, short-acting beta 2 -agonist such as albuterol. Prescribe the patient with such medication and instruct the patient in how it should be used [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 beta 2 -agonist than usual Advise patients not to increase the dose or frequency of Asmanex HFA. The daily dosage of Asmanex HFA should not exceed 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, it should be treated 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. Advise patients to rinse the mouth after inhalation of Asmanex HFA [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. Patients should taper slowly 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); regular eye examinations should be considered [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. 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: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA Manufactured by: 3M Health Care Ltd., Loughborough, United Kingdom. For patent information: www.merck.com/product/patent/home.html Copyright 2014 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. uspi-mk0887-ao-1607r002 Patient Information ASMANEX HFA (AZ-ma-neks) (mometasone furoate) Inhalation Aerosol This Patient Information has been approved by the U.S. Food and Drug Administration. Revised Date: August 2015 What is Asmanex HFA? Asmanex HFA is an inhaled prescription medicine used as maintenance treatment for the prevention and control of asthma symptoms in people 12 years of age and older. Asmanex HFA is not used to treat sudden severe symptoms of asthma. Asmanex HFA should not be used as a rescue inhaler. It is not known if Asmanex HFA is safe and effective in children less than 12 years of age. Who should not use Asmanex HFA? Do not use Asmanex HFA: to treat sudden severe symptoms of asthma if you are allergic to mometasone furoate or any of the ingredients in Asmanex HFA. See the end of this Patient Information leaflet for a complete list of ingredients in 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: have liver problems have osteoporosis have an immune system problem have eye problems such as increased pressure in the eye, glaucoma, or cataracts are allergic to any medicines are exposed to chickenpox or measles have or had tuberculosis (TB) have any other medical problems are pregnant or planning to become pregnant. It is not known if Asmanex HFA may harm your unborn baby. are breastfeeding. It is not known if Asmanex HFA passes into your breast milk and if it can harm your baby. You and your healthcare provider should decide if you will either take Asmanex HFA or breastfeed. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Asmanex HFA may affect the way other medicines work, and other medicines may affect how Asmanex HFA works. Especially, tell your healthcare provider if you take antifungal medicines or anti-HIV medicines such as: ritonavir atazanavir ketoconazole clarithromycin nefazodone saquinavir nelfinavir telithromycin indinavir itraconazole Ask your healthcare provider if you are not sure if any of your medicines are the kinds listed above. 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. Use Asmanex HFA exactly as prescribed. Do not use Asmanex HFA more often than prescribed. You must use Asmanex HFA regularly. It may take 1 week or longer after you start using Asmanex HFA for your asthma symptoms to get better. Do not stop using Asmanex HFA even if you are feeling better, unless your healthcare provider tells you to. Do not change or stop using Asmanex HFA or other asthma medicines used to control or treat your breathing problems unless told to do so by your healthcare provider. Your healthcare provider will change your medicines as needed. Asmanex HFA comes in 2 strengths. Your healthcare provider has prescribed the strength that is best for you. Pay attention to the differences between Asmanex HFA and your other inhaled medicines, including their prescribed use and the way they look. Take Asmanex HFA every day, with 2 puffs in the morning and 2 puffs in the evening. If you miss a dose of Asmanex HFA, skip your missed dose and take your next dose at your regular time. Do not take Asmanex HFA more often or use more puffs than you have been prescribed. If you take more Asmanex HFA than your healthcare provider has prescribed, call your healthcare provider right away. Asmanex HFA does not relieve sudden asthma symptoms. Always have a rescue inhaler with you to treat sudden symptoms. Use your rescue inhaler if you have breathing problems between doses of Asmanex HFA. If you do not have a rescue inhaler, call your healthcare provider to have a rescue inhaler prescribed for you. Do not use the Asmanex HFA canister or actuator with any other medicines. Do not use any other medicine canister or actuator with Asmanex HFA. Rinse your mouth with water after each dose (2 puffs) of Asmanex HFA. This will help to lessen the chance of getting a yeast infection (thrush) in your mouth and throat. Do not spray Asmanex HFA in your eyes. If you accidentally get Asmanex HFA in your eyes, rinse your eyes with water and if redness or irritation continues, call your healthcare provider. Call your healthcare provider or get medical care right away if: your breathing problems worsen with Asmanex HFA you need to use your rescue inhaler more often than usual your rescue inhaler does not work as well for you at relieving symptoms you need to use 4 or more inhalations of your rescue inhaler for 2 or more days in a row you use 1 whole canister of your rescue inhaler within 8 weeks your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you. you have asthma and your symptoms do not improve after using Asmanex HFA regularly for 1 to 2 weeks What are the possible side effects of Asmanex HFA? Asmanex HFA can cause serious side effects, including Thrush in your mouth and throat. You may develop a yeast infection (Candida albicans) in your mouth or throat. Rinse your mouth with water after using Asmanex HFA to help prevent an infection in your mouth or throat. Immune system effects and a higher chance for infections. Tell your healthcare provider about any signs of infection such as: fever feeling tired body aches vomiting pain nausea chills Adrenal insufficiency that can lead to death can happen when you stop taking oral corticosteroid medicines and start using inhaled corticosteroid medicines. Adrenal insufficiency can also happen in people who take higher doses of Asmanex HFA than recommended over a long period of time. When your body is under stress such as from fever, trauma (such as a car accident), infection, or surgery, adrenal insufficiency can get worse. Symptoms of adrenal insufficiency include: feeling tired or exhausted (fatigue) weakness lack of energy nausea and vomiting low blood pressure (hypotension) dizziness or feeling faint Increased wheezing right after taking Asmanex HFA. Always have a rescue inhaler with you to treat sudden wheezing. Serious allergic reactions. Stop taking Asmanex HFA and call your healthcare provider or get emergency medical care right away if you get any of the following symptoms of a serious allergic reaction: rash hives swelling, including swelling of the face, mouth, and tongue breathing problems Lower bone mineral density. This may be a problem for people who already have a higher chance for low bone density (osteoporosis). Slowed growth in children. A child's growth should be checked often. Eye problems including glaucoma and cataracts. You should have regular eye exams while using Asmanex HFA. The most common side effects of Asmanex HFA include: inflammation of the nose and throat (nasopharyngitis) inflammation of the sinuses (sinusitis) headache bronchitis flu infection (influenza) 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? Store Asmanex HFA at room temperature between 68 F to 77 F (20 C to 25 C). The contents of your Asmanex HFA are under pressure. Do not puncture. Do not use or store near heat or open flame. Storage above 120 F may cause the canister to burst. Do not throw container into fire or incinerator. Keep Asmanex HFA and all medicines out of the reach of children. 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 1-877-888-4231. 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 Instructions for Use ASMANEX HFA (mometasone furoate) Inhalation Aerosol Read these Instructions for Use before you start using Asmanex HFA and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or your treatment. The parts of your Asmanex HFA: There are 2 main parts to your Asmanex HFA inhaler: the metal canister that holds the medicine and the blue plastic actuator that sprays the medicine from the canister. The inhaler also has a pink cap that covers the mouthpiece of the actuator (see Figure 1 ) . The cap from the mouthpiece must be removed before use. The inhaler contains "120" actuations (puffs). Figure 1 The inhaler comes with a dose counter located on the plastic actuator (see Figure 1 ). The counter display will show the number of actuations (puffs) of medicine remaining. The first time you use Asmanex HFA the dose counter will show "124" actuations remaining. Each time you press the canister, a puff of medicine is released and the counter will count down by 1 . The counter will stop counting at 0 . Important Information: Use Asmanex HFA exactly as your healthcare provider tells you to. Remove the cap from the mouthpiece of the actuator before using Asmanex HFA. Do not remove the canister from the actuator because: you may not receive the correct amount of medication. the dose counter may not function properly. if you try to insert the canister back into the actuator this may cause the dose counter to count down by 1 and may discharge a puff. Use the Asmanex HFA canister only with the actuator supplied with the product. Do not use parts of the Asmanex HFA inhaler with parts from any other inhalation medicine. Before using your Asmanex HFA: Remove the cap from the mouthpiece of the actuator before using Asmanex HFA (see Figure 2 ) . Check the mouthpiece for objects before use. Make sure the canister is fully inserted into the actuator. Figure 2 Priming your Asmanex HFA Inhaler: Before you use Asmanex HFA for the first time, you must prime the inhaler. 1. To prime the inhaler, hold it in the upright position away from your face, and press down firmly and fully on the top of the canister until it stops moving in the actuator. Do this 4 times to release a total of 4 actuations (puffs) into the air. 2. Shake the inhaler well before each of the priming actuations. After priming 4 times, the dose counter should read "120" . 3. If you do not use your Asmanex HFA for more than 5 days, you will need to prime it again before use. Using your Asmanex HFA: 4. Remove the cap from the mouthpiece of the actuator (see Figure 3 ) . Check the mouthpiece for objects before use. Make sure the canister is fully inserted into the actuator. 5. Shake the inhaler well before each use. 6. Breathe out as fully as you comfortably can through your mouth. Push out as much air from your lungs as possible. Hold the inhaler in the upright position and place the mouthpiece into your mouth (see Figure 4 ) . Close your lips around the mouthpiece. Figure 3 Figure 4 7. Take a deep breath (inhale) in slowly through your mouth. While doing this, press down firmly and fully on the top of the canister until it stops moving in the actuator. Take your finger off the canister. 8. When you have finished breathing in, hold your breath as long as you comfortably can, up to 10 seconds . Then remove the inhaler from your mouth and breathe out through your nose, while keeping your lips closed. 9. Wait at least 30 seconds to take your second puff of Asmanex HFA. 10. Shake the inhaler well again and repeat steps 6 through 8 to take your second puff of Asmanex HFA. After using your Asmanex HFA inhaler: 11. Replace the cap over the mouthpiece right away after use (see Figure 5 ) . Figure 5 12. After you finish taking Asmanex HFA ( 2 puffs), rinse your mouth with water. Reading the counter: The dose counter identifies the number of inhalations (puffs) left in your inhaler (see Figure 6 ) . The counter will count down each time you release a puff of medicine (either when preparing your Asmanex HFA inhaler for use or when using the medicine). Figure 6 When to replace your Asmanex HFA: It is important that you pay attention to the number of inhalations (puffs) left in your Asmanex HFA inhaler by reading the counter. When the counter reads "20" , you should refill your prescription or ask your healthcare provider if you need a new prescription for Asmanex HFA. Throw away Asmanex HFA after the counter reaches "0" , indicating that you have used the number of actuations on the product label and box. Your inhaler may not feel empty and it may continue to operate, but you will not get the right amount of medicine if you keep using it. Never try to change the numbers on the counter or remove the counter from the actuator. Do not use the inhaler after the expiration date. How to clean your Asmanex HFA: The mouthpiece should be cleaned using a dry wipe after every 7 days of use. Routine cleaning instructions: Remove the cap off the mouthpiece. Wipe the inside and outside surfaces of the actuator mouthpiece with a clean, dry, lint-free tissue or cloth. Do not wash or put any parts of your inhaler in water. Put the cap back on the mouthpiece after cleaning. Do not remove the canister from the actuator. Do not attempt to unblock the actuator with a sharp object, such as a pin. This Instructions for Use has been approved by the U.S. Food and Drug Administration. Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA Manufactured by: 3M Health Care Ltd., Loughborough, United Kingdom. For patent information: www.merck.com/product/patent/home.html The trademarks depicted herein are owned by their respective companies. Copyright 2014 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. Revised: 08/2015 usppi-mk0887-ao-1508r001 PRINCIPAL DISPLAY PANEL - 100 mcg Canister Carton NDC 0085-4333-01 Asmanex HFA (mometasone furoate) Inhalation Aerosol 100 mcg per actuation For oral inhalation only Asmanex HFA canister to be used with Asmanex HFA actuator only. SHAKE WELL BEFORE USING. Rx only 120 Metered Actuations Net Wt. 13g PRINCIPAL DISPLAY PANEL - 200 mcg Canister Carton NDC 0085-4334-01 Asmanex HFA (mometasone furoate) Inhalation Aerosol 200 mcg per actuation For oral inhalation only Asmanex HFA canister to be used with Asmanex HFA actuator only. SHAKE WELL BEFORE USING. Rx only 120 Metered Actuations Net Wt. 13g Asmanex HFA mometasone furoate aerosol Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0085-4333 Route of Administration RESPIRATORY (INHALATION) DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MOMETASONE FUROATE (MOMETASONE) MOMETASONE FUROATE 100 ug Inactive Ingredients Ingredient Name Strength ALCOHOL OLEIC ACID APAFLURANE Product Characteristics Color WHITE (White to off-white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description 1 NDC:0085-4333-01 1 CANISTER in 1 CARTON 1 120 AEROSOL in 1 CANISTER 2 NDC:0085-4333-02 1 CANISTER in 1 CARTON 2 120 AEROSOL in 1 CANISTER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205641 04/25/2014 Asmanex HFA mometasone furoate aerosol Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0085-4334 Route of Administration RESPIRATORY (INHALATION) DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MOMETASONE FUROATE (MOMETASONE) MOMETASONE FUROATE 200 ug Inactive Ingredients Ingredient Name Strength ALCOHOL OLEIC ACID APAFLURANE Product Characteristics Color WHITE (White to off-white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description 1 NDC:0085-4334-01 1 CANISTER in 1 CARTON 1 120 AEROSOL in 1 CANISTER 2 NDC:0085-4334-02 1 CANISTER in 1 CARTON 2 120 AEROSOL in 1 CANISTER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205641 04/25/2014 Labeler - Merck Sharp & Dohme Corp. (001317601) Revised: 07/2016 Merck Sharp & Dohme Corp. Next Interactions Print this page Add to My Med List More about Asmanex HFA (mometasone) Side Effects During Pregnancy Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: inhaled corticosteroids Consumer resources Asmanex HFA Asmanex HFA (Advanced Reading) Professional resources Mometasone Furoate (AHFS Monograph) Other brands: Asmanex Twisthaler Related treatment guides Asthma, Maintenance ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer Merck & Co., Inc. Drug Class Inhaled corticosteroids Related Drugs inhaled corticosteroids fluticasone , budesonide , mometasone , Qvar , Flovent , Flovent HFA Asthma, Maintenance Symbicort , albuterol , fluticasone , montelukast , ProAir HFA , Singulair , Advair Diskus , budesonide , Breo Ellipta , Ventolin , Medrol , methylprednisolone , mometasone , Ventolin HFA , tiotropium , Dulera , Qvar , Flovent , Proventil , Medrol Dosepak , theophylline , Xopenex , fluticasone / salmeterol , Flovent HFA , More... Asmanex HFA Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first!} } an additional
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