terrific [150:200 pcg/mL on Day 9 (211 324 pcg/mL). 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 8 times the maximum recommended daily inhalation dose in adults on an AUC basis and 2 times the maximum recommended daily inhalation dose in pediatric patients based on an mcg/m 2 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 10 times the maximum recommended daily inhalation dose in adults on an AUC basis and 2 times the maximum recommended daily inhalation dose in pediatric patients based on an mcg/m 2 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 6 times the maximum recommended daily inhalation dose in adults on an AUC basis). Animal Toxicology and/or Pharmacology Reproductive Toxicology Studies : In mice, mometasone furoate caused cleft palate at subcutaneous doses of 60 mcg/kg and above (less than the maximum recommended daily inhalation dose in adults on an mcg/m 2 basis). Fetal survival was reduced at 180 mcg/kg (approximately equal to the maximum recommended daily inhalation dose in adults on an mcg/m 2 basis). No toxicity was observed at 20 mcg/kg (less than the maximum recommended daily inhalation dose in adults on an mcg/m 2 basis). In rats, mometasone furoate produced umbilical hernia at topical dermal doses of 600 mcg/kg and above (approximately 6 times the maximum recommended daily inhalation dose in adults on an mcg/m 2 basis). A dose of 300 mcg/kg (approximately 3 times the maximum recommended daily inhalation dose in adults on an mcg/m 2 basis) produced delays in ossification but no malformations. When rats received subcutaneous doses of mometasone furoate throughout pregnancy or during the later stages of pregnancy, 15 mcg/kg (approximately 6 times the maximum recommended daily inhalation dose in adults on an AUC basis) caused prolonged and difficult labor and reduced the number of live births, birth weight, and early pup survival. Similar effects were not observed at 7.5 mcg/kg (approximately 3 times the maximum recommended daily inhalation dose in adults on an AUC basis). In rabbits, mometasone furoate caused multiple malformations (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at topical dermal doses of 150 mcg/kg and above (approximately 3 times the maximum recommended daily inhalation dose in adults on an mcg/m 2 basis). In an oral study, mometasone furoate increased resorptions and caused cleft palate and/or head malformations (hydrocephaly and domed head) at 700 mcg/kg (less than the maximum recommended daily inhalation dose in adults on an area under the curve [AUC] basis). At 2800 mcg/kg (approximately 2 times the maximum recommended daily inhalation dose in adults on an AUC basis) most litters were aborted or resorbed. No toxicity was observed at 140 mcg/kg (less than the maximum recommended daily inhalation dose in adults on an AUC basis). Clinical Studies Asthma Adults and Adolescents 12 Years of Age and Older: The efficacy of Asmanex TWISTHALER in patients with asthma 12 years and older was evaluated in ten 8- to 12-week, randomized, double-blind, placebo-controlled, parallel-group clinical trials. These trials included 1750 patients ranging from 12 to 83 years of age; 38% male and 62% female; and 83% Caucasian, 8% black, 6% Hispanic, and 3% other race/ethnicity. Patients received Asmanex TWISTHALER 110 mcg twice daily (n=133), 220 mcg once daily in the morning (n=209), 220 mcg once daily in the evening (n=232), 220 mcg twice daily (n=433), 440 mcg once daily in the morning (n=419), 440 mcg once daily in the evening (n=250), or 440 mcg twice daily (n=74). The results of the clinical trials are presented based upon previous asthma therapy. Patients 12 Years of Age Previously Maintained on Bronchodilators Alone: Asmanex TWISTHALER was studied in three 12-week, double-blind trials in 737 patients with mild to moderate asthma (mean baseline FEV 1 2.6 L, 72% of predicted normal) who were maintained on short-acting beta 2 -agonists alone. The first 2 trials evaluated doses of 440 mcg administered as 2 inhalations once daily in the morning and 1 of these studies also evaluated 220 mcg twice daily. In both trials, AM predose FEV 1 was significantly improved at endpoint (last observation) following treatment with 440 mcg Asmanex TWISTHALER once daily in the morning as compared to placebo (14% vs. 2.5%, respectively, in 1 trial and 16% vs. 5.5% in the other). There was also a significant improvement in AM predose FEV 1 at endpoint following treatment with Asmanex TWISTHALER 220 mcg twice daily. Other measures of lung function (AM and PM PEFR) also showed improvement compared to placebo. Patients receiving Asmanex TWISTHALER treatment had reduced frequency of beta 2 -agonist rescue medication use compared to those on placebo (mean reductions at endpoint 2.2 and 0.5 puffs per day, respectively, from a baseline of 4.1 puffs/day). Additionally, fewer patients receiving Asmanex TWISTHALER 440 mcg once daily experienced asthma worsening than did patients receiving placebo. In the third trial, 195 asthmatic patients were treated with Asmanex TWISTHALER 220 mcg once daily in the evening or placebo. The AM FEV 1 at endpoint was significantly improved compared to placebo (mean change at endpoint 0.43 L or 16.8% vs. 0.16 L or 6%, respectively, see Figure 1 ). Evening PEF increased 24.96 L/min (7%) from baseline in the Asmanex TWISTHALER group compared to 8.67 L/min (4%) in placebo. Patients 12 Years of Age Previously Maintained on Inhaled Corticosteroids: The efficacy and safety of Asmanex TWISTHALER in doses ranging from 110 mcg twice daily to 440 mcg twice daily was evaluated in 3 trials in 1072 patients previously maintained on inhaled corticosteroids. In the first 2 trials, asthmatic patients (mean baseline FEV 1 ~2.6 L, 76% predicted) were previously on either beclomethasone dipropionate [84 1200 mcg/day], flunisolide [100 2000 mcg/day], fluticasone propionate [110 880 mcg/day], or triamcinolone acetonide [300 2400 mcg/day]. The first trial included 307 patients who were treated in an open-label fashion with Asmanex TWISTHALER 220 mcg (110 mcg 2 inhalations) twice daily for 2 weeks followed by 12 weeks of double-blind treatment with Asmanex TWISTHALER 440 mcg once daily in the morning or placebo. The second trial involved 365 patients who continued on their previous dose of inhaled corticosteroids during a 2-week screening period before being switched to Asmanex TWISTHALER 440 mcg twice daily, 220 mcg twice daily, 110 mcg twice daily, beclomethasone dipropionate 168 mcg twice daily, or placebo for 12 weeks. In the first trial, AM predose FEV 1 was effectively maintained (-1.4% change from baseline to endpoint) over the 12 weeks in the patients who were randomized to Asmanex TWISTHALER 440 mcg once daily in the morning, while decreasing 10% at endpoint in those switched to placebo. In addition, fewer patients treated with Asmanex TWISTHALER experienced worsening of asthma compared to placebo. In the second trial, AM predose FEV 1 was significantly increased at endpoint when patients were switched to Asmanex TWISTHALER 220 mcg twice daily (7% increase) or 440 mcg twice daily (6.2% increase) as compared to a decrease of 7% when switched to placebo. Additionally, beta 2 -agonist rescue medication use was decreased for patients who received Asmanex TWISTHALER treatment relative to those on placebo (mean reduction from baseline to endpoint 1.1 puffs/day vs. increase of 0.7 puffs/day). Fewer patients receiving Asmanex TWISTHALER treatment experienced asthma worsening than did patients receiving placebo. The third trial evaluated the efficacy and safety of Asmanex TWISTHALER compared to placebo in 400 asthmatic patients (mean FEV 1 67% predicted at baseline) previously maintained on beclomethasone dipropionate (hydrofluoroalkane [HFA] or chlorofluorocarbon [CFC]) 168 600 mcg/day, budesonide 200 1200 mcg/day, flunisolide 500 2000 mcg/day, fluticasone propionate 88 880 mcg/day, or triamcinolone acetonide 400 1600 mcg/day. Following a 28-day inhaled corticosteroid dose-reduction phase, patients were randomized to Asmanex TWISTHALER 440 mcg once daily in the evening, 220 mcg once daily in the evening, 220 mcg twice daily, or placebo. At endpoint, patients who received Asmanex TWISTHALER 220 mcg once daily in the evening, 440 mcg once daily in the evening, or 220 mcg twice daily had a significant improvement in AM FEV 1 [0.41 L (19%), 0.49 L (22%), and 0.51 L (24%) in the 220 mcg once daily in the evening, 440 mcg once daily in the evening, and 220 mcg twice daily treatment group, respectively] compared to placebo [0.16 L (8%)] (see Figure 2 ). Evening PEF increased 15.65 L/min (4.1%) with the 220 mcg once daily in the evening dose, 39.26 L/min (10.7%) with the 440 mcg once daily in the evening dose, and 36.7 L/min (10.8%) with the 220 mcg twice daily dose, respectively, compared to a 1.4 L/min (1%) increase with placebo. Patients receiving all doses of Asmanex TWISTHALER treatment had reduced frequency of beta-agonist rescue medication use compared to those on placebo (mean reductions at endpoint of 1.4 1.8 puffs/day from a baseline of more than 3 puffs/day compared to an increase in use by 0.5 puffs/day for placebo). In addition, fewer patients receiving Asmanex TWISTHALER experienced asthma worsening than did those on placebo. Patients 12 Years of Age Previously Maintained on Oral Corticosteroids: The efficacy of Asmanex TWISTHALER 440 mcg and 880 mcg twice daily was evaluated in one 12-week, double-blind trial in patients previously maintained on oral corticosteroids. A total of 132 patients requiring oral prednisone (baseline mean daily oral prednisone requirement approximately 12 mg; baseline FEV 1 of 1.8 L, 59% of predicted normal), most of whom were also on inhaled corticosteroids (baseline inhaled steroid: beclomethasone dipropionate [168 840 mcg/day], budesonide [800 1600 mcg/day], flunisolide [1000 2000 mcg/day], fluticasone propionate [440 1760 mcg/day], or triamcinolone acetonide [400 2400 mcg/day]) were studied. Patients who received Asmanex TWISTHALER 440 mcg twice daily had a significant reduction in their oral prednisone (46%) as compared to placebo (164% increase in oral prednisone dose). Additionally, 40% of patients on Asmanex TWISTHALER 440 mcg twice daily were able to completely discontinue their use of prednisone, whereas 60% of patients on placebo had an increase in daily prednisone use. Patients on Asmanex TWISTHALER had significant improvement in lung function (14% increase) compared to a 12% decrease in FEV 1 in the placebo group. Additionally, mean rescue beta 2 -agonist use was reduced to approximately 3 puffs/day from a baseline of 4 5 puffs/day with Asmanex TWISTHALER treatment, compared to an increase of 0.3 puffs/day on placebo. Patients who received Asmanex TWISTHALER 880 mcg twice daily experienced no additional benefit beyond that seen with 440 mcg twice daily. Pediatric Patients 4 to 11 Years of Age: The efficacy of Asmanex TWISTHALER in patients with asthma 4 to 11 years of age was evaluated in three 12-week, randomized, double-blind, placebo-controlled, parallel-group clinical trials. These trials included 630 patients receiving Asmanex TWISTHALER, ranging from 4 to 11 years of age; 63% male and 37% female; and 67% Caucasian, 13% black, 17% Hispanic, and 3% other race/ethnicity. Patients received Asmanex TWISTHALER 110 mcg once daily in the evening (n=98), 110 mcg once daily in the morning (n=181), 110 mcg twice daily (n=179), or 220 mcg once daily in the morning (n=172). The results for 1 clinical trial are described below. The other 2 clinical trials support the efficacy of Asmanex TWISTHALER. A 12-week, placebo-controlled trial of 296 patients 4 to 11 years of age with asthma of at least 6 months duration (mean % predicted FEV 1 at baseline ranging from 77.3% 79.7%) was conducted to demonstrate the efficacy of the Asmanex TWISTHALER in the treatment of asthma. Patients were treated with Asmanex TWISTHALER 110 mcg once daily in the evening (n=98) or placebo (n=99) for 12 weeks. Assessment of efficacy was based upon morning predose FEV 1 . The primary endpoint was the mean change from baseline to endpoint in percent-predicted FEV 1 . For the primary endpoint, improvement in the Asmanex TWISTHALER 110 mcg once daily in the evening treatment group (4.73) was statistically significant compared to placebo (-1.77). Figure 3 displays the results for % predicted FEV 1 change from baseline at endpoint. In this study, secondary endpoints of morning and evening peak expiratory flow and rescue medication use were supportive of efficacy of Asmanex TWISTHALER. How Supplied/Storage and Handling The Asmanex TWISTHALER 220 mcg product is comprised of an assembled plastic cap activated dosing mechanism with dose counter, drug-product storage unit, drug-product formulation (135 mg for the 14 and 30 inhalation units and 240 mg for the 60 and 120 inhalation units), and mouthpiece, covered by a white screw cap that bears the product label. The body of the inhaler is white and the turning grip is pink with a clear plastic window indicating the number of doses remaining. The inhaler will not deliver subsequent doses once the counter reaches zero ("00"). The Asmanex TWISTHALER 110 mcg product is comprised of an assembled plastic cap activated dosing mechanism with dose counter, drug-product storage unit, drug-product formulation (135 mg), and mouthpiece, covered by a white screw cap that bears the product label. The body of the inhaler is white and the turning grip is gray with a clear plastic window indicating the number of doses remaining. The inhaler will not deliver subsequent doses once the counter reaches zero ("00"). The Asmanex TWISTHALER product is available as: Asmanex TWISTHALER 220 mcg, which delivers 200 mcg mometasone furoate from the mouthpiece: 14 inhalation units (Institutional Use Only; NDC# 0085-1341-04 and NDC# 0085-1341-06); 30 inhalation units (NDC# 0085-1341-07); 60 inhalation units (for more than 1 inhalation daily; NDC# 0085-1341-02); or 120 inhalation units (for more than 2 inhalations daily; NDC# 0085-1341-01). Asmanex TWISTHALER 110 mcg, which delivers 100 mcg mometasone furoate from the mouthpiece: 7 inhalation units (Institutional Use Only; NDC# 0085-1461-07); 30 inhalation units (NDC# 0085-1461-02). Each inhaler is supplied in a protective foil pouch with Patient's Instructions for Use. Store in a dry place at 25 C (77 F); excursions permitted to 15 30 C (59 86 F) [see USP Controlled Room Temperature]. Discard the inhaler 45 days after opening the foil pouch or when dose counter reads "00", whichever comes first. Patient Counseling Information See FDA-Approved Patient Labeling (Patient Information). Oral Candidiasis Patients should be advised 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 TWISTHALER therapy, but at times therapy with Asmanex TWISTHALER may need to be temporarily interrupted under close medical supervision. Rinsing the mouth after inhalation is advised [see Warnings and Precautions (5.1) ] . Acute Asthma Episodes Patients should be advised that Asmanex TWISTHALER 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 [see Warnings and Precautions (5.2) ]. Hypersensitivity Reactions Including Anaphylaxis Hypersensitivity reactions including rash, pruritus, angioedema and anaphylactic reaction have been reported with use of Asmanex TWISTHALER. Discontinue Asmanex TWISTHALER if such reactions occur [see Contraindications (4.2) , Warnings and Precautions (5.3) , and Adverse Reactions (6.2) ]. Asmanex TWISTHALER contains small amounts of lactose, which contains trace levels of milk proteins. In postmarketing experience with Asmanex TWISTHALER, anaphylactic reactions in patients with milk protein allergy have been reported [see Contraindications (4.2) and Adverse Reactions (6.2) ]. Immunosuppression Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles and, if exposed, to consult their physician without delay. Patients should be informed of potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex [see Warnings and Precautions (5.4) ] . Hypercorticism and Adrenal Suppression Patients should be advised that Asmanex TWISTHALER may cause systemic corticosteroid effects of hypercorticism and adrenal suppression. Additionally, patients should be instructed 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 TWISTHALER [see Warnings and Precautions (5.6) ] . Reduction in Bone Mineral Density Patients who are at an increased risk for decreased BMD should be advised 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 (5.7) ] . Reduced Growth Velocity Patients should be informed that orally inhaled corticosteroids, including mometasone furoate inhalation powder, may cause a reduction in growth velocity when administered to pediatric patients. Physicians should closely follow the growth of children and adolescents taking corticosteroids by any route [see Warnings and Precautions (5.8) ] . Use Daily for Best Effect Patients should be advised to use Asmanex TWISTHALER at regular intervals, since its effectiveness depends on regular use. Maximum benefit may not be achieved for 1 to 2 weeks or longer after starting treatment. If symptoms do not improve in that time frame or if the condition worsens, patients should be instructed to contact their physician. Instructions for Use Patients should be instructed to record the date of pouch opening on the cap label and discard the inhaler 45 days after opening the foil pouch or when the dose counter reads "00" and the final dose has been inhaled, whichever comes first. The inhaler should be held upright while removing the cap. The medication should be taken as directed, breathing rapidly and deeply, and patients should not breathe out through the inhaler. The mouthpiece should be wiped dry and the cap replaced immediately following each inhalation and rotated fully until the click is heard. Rinsing of mouth after inhalation is advised. Patients should store the unit as instructed. The dose counter displays the doses remaining. When the dose counter indicates zero, the cap will lock and the unit must be discarded. Patients should be advised that if the dose counter is not working correctly, the unit should not be used and it should be brought to their physician or pharmacist. Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA Manufactured by: MSD International GmbH (Singapore Branch) Singapore 638030, Singapore For patent information: www.merck.com/product/patent/home.html Copyright 2008, 2011 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. uspi-mk0887-pwih-1409r015 Patient Information Asmanex TWISTHALER 220 mcg (mometasone furoate inhalation powder) Asmanex TWISTHALER 110 mcg (mometasone furoate inhalation powder) FOR ORAL INHALATION ONLY Please read this leaflet carefully before taking Asmanex TWISTHALER . This leaflet does not contain the complete information about this medication. If you have any questions about Asmanex TWISTHALER, ask your health care provider or pharmacist. IMPORTANT POINTS TO REMEMBER ABOUT Asmanex TWISTHALER Your health care provider has prescribed Asmanex TWISTHALER for you or your child. It contains a medicine called mometasone furoate, which is a man-made corticosteroid. This medicine is used as maintenance treatment that helps prevent and control asthma symptoms. Asmanex TWISTHALER is not a bronchodilator and should not be used for sudden symptoms of shortness of breath. Use an inhaled short-acting bronchodilator such as albuterol to relieve sudden symptoms of shortness of breath. Your health care provider may prescribe bronchodilators such as albuterol for emergency relief if an acute asthma attack occurs. Use your Asmanex TWISTHALER regularly and at the same time each day, as prescribed by your health care provider. You or your child may not get the most benefit for 1 to 2 weeks or longer after starting Asmanex. If you or your child's symptoms do not improve in that time frame or if your condition gets worse, contact your health care provider. The cap is needed to use the Asmanex TWISTHALER. Do not twist the mouthpiece with your hand. When the cap is removed from the TWISTHALER, the dose counter will count down by one, and show the number of doses available after this use. The inhaler delivers your medicine as a very fine powder that you or your child may not taste, smell, or feel . Do not take or give extra doses unless your health care provider has told you to. It is important to replace the cap after each inhalation to protect the inhaler from moisture. Do not use the inhaler if you notice that it is not working correctly. Take it to your health care provider or pharmacist. WHO SHOULD NOT USE Asmanex TWISTHALER Do not use Asmanex TWISTHALER : To treat sudden, severe symptoms of asthma. If you have an allergy to milk proteins. Ask your health care provider if you are not sure. HOW TO USE Asmanex TWISTHALER OR GIVE TO YOUR CHILD Remove the Asmanex TWISTHALER from its foil pouch and write the date on the cap label. Throw away the inhaler 45 days after this date or when the dose counter reads "00", indicating the final dose has been inhaled, whichever comes first. Follow steps 1 and 2 below each time you inhale a dose from your Asmanex TWISTHALER. Inhaler Parts: See Figures 1 and 2 below to become familiar with the inhaler parts. Step 1: Open inhaler Hold the inhaler straight up (upright position) with the colored portion (the base) on the bottom (see Figure 3 below) . It is important that you remove the cap of the TWISTHALER while it is in this upright position to make sure that you get the right amount of medicine with each dose. Holding the colored base, twist the cap in a counterclockwise direction to remove it (see Figure 3 below) . As you lift off the cap, the dose counter on the base will count down by one. Removing the cap loads the TWISTHALER with the medicine that you are now ready to inhale. IT IS IMPORTANT TO NOTE that the indented arrow (located on the white portion of the TWISTHALER, directly above the colored base) is pointing to the dose counter (see Figure 2 ) . Step 2: Inhale dose Breathe out fully. Then bring the TWISTHALER up to your mouth or your child's mouth with the mouthpiece facing toward you or your child. Place the mouthpiece in your mouth or your child's mouth, holding it in a horizontal (on its side) position as shown below (see Figure 4 ) . Firmly close your lips around the mouthpiece and take in a fast, deep breath. Since the medicine is a very fine powder, you may not be able to taste, smell, or feel it after inhalation. Do not cover the ventilation holes while inhaling the dose. Remove the TWISTHALER from your mouth and hold your breath for about 10 seconds, or as long as you comfortably can. IMPORTANT: DO NOT BREATHE OUT (EXHALE) INTO THE INHALER. After you take your medicine, it is important that you wipe the mouthpiece dry, if needed, and then REPLACE THE CAP, firmly closing the TWISTHALER right away (see Figures 5 and 6 below) . Be sure that the indented arrow is in line with the dose counter. Put the cap back onto the inhaler and turn it in a clockwise direction, as you gently press down. You'll hear a "click" to let you know that the cap is fully closed. This is the only way to be sure that your next dose is loaded the right way. IT IS IMPORTANT TO REPEAT STEPS 1 AND 2 EACH TIME YOU INHALE. Rinse your mouth after using. STORING YOUR INHALER Keep your inhaler clean and dry at all times. If the mouthpiece needs cleaning, gently wipe the mouthpiece with a dry cloth or tissue as needed. Do not wash the inhaler. Avoid contact with any liquids. Store in a dry place at 25 C (77 F) [may range between 15 30 C (59 86 F)]. Keep your inhaler out of the reach of children. HOW TO KNOW WHEN YOUR INHALER IS EMPTY The inhaler has a dose counter on the colored base, which shows the number of doses left to use. As you lift off the cap to take your dose, the dose counter on the base will count down by one (if you began with the dose counter reading "30" this will cause the dose counter to now read "29"). Read the numbers from top to bottom. When the unit reads "01" this indicates the last remaining dose. After dose "01" the counter will read "00". When you replace the cap, the unit will lock and then must be thrown away. Start using a new Asmanex TWISTHALER as instructed by your health care provider. POSSIBLE SIDE EFFECTS WITH Asmanex TWISTHALER Serious Side Effects may include: Fungal infections in the mouth and throat . Patients who use inhaled steroid medicines for asthma may develop a fungal infection of the mouth. Rinse your mouth after using Asmanex TWISTHALER. Worsening asthma or sudden asthma attacks Serious allergic reactions. Call your health care provider or get emergency medical care if you get any symptoms of a serious allergic reaction, including: Rash Swelling of the face, mouth and tongue Breathing problems Possible increased risk of infection due to a weakened immune system with using steroid medicines. Tell your health care provider if you or your child have or had TB, are exposed to anyone with chickenpox or measles, or about any other infections you or your child had before or while using Asmanex TWISTHALER. Adrenal insufficiency (your adrenal gland cannot produce enough steroids since you were on oral steroid medicine). If you or your child took steroids by mouth and are having them decreased (tapered) or you are being switched to Asmanex TWISTHALER, you should be followed closely by your health care professional. Death can occur. Tell your health care professional right away about any symptoms such as feeling tired or exhausted, weakness, nausea, vomiting, or symptoms of low blood pressure (such as dizziness or faintness). If you or your child is under stress, such as with surgery, after surgery or trauma, you may need steroids by mouth again. Decreased bone mass (bone mineral density). Patients who use inhaled steroid medicines for a long time may have an increased risk of decreased bone mass, which can affect bone strength. Talk with your health care provider about any questions about bone health. The most common side effects with Asmanex TWISTHALER include: headache, nasal allergy symptoms, sore throat, upper respiratory tract infection, sinus infection, fungal infections in the mouth, painful menstrual periods, muscle and bone pain, back pain, and upset stomach. Tell your health care professional about any side effects that bother you or do not go away. These are not all of the possible side effects with Asmanex TWISTHALER. For more information, ask your health care professional. Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA Manufactured by: MSD International GmbH (Singapore Branch) Singapore 638030, Singapore For patent information: www.merck.com/product/patent/home.html Copyright 2008, 2011 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. Revised: 09/2014 usppi-mk0887-pwih-1409r010 PRINCIPAL DISPLAY PANEL - 220 mcg - 120 Dose Carton NDC 0085-1341-01 For Oral Inhalation Rx only Asmanex Twisthaler mometasone furoate inhalation powder 220 mcg per actuation 120 Metered Doses (For more than 2 inhalations daily) Discard Twisthaler inhaler 45 days after opening foil pouch or when dose counter reads "00", whichever comes first. Attention Pharmacist: Detach Patient's Instructions for Use and dispense with inhaler PRINCIPAL DISPLAY PANEL - 110 mcg - 30 Dose Carton NDC 0085-1461-02 For Oral Inhalation Rx only Asmanex Twisthaler mometasone furoate inhalation powder 110 mcg per actuation Usual Dose for 4 to 11 years of age is 110 mcg 30 Metered Doses Discard Twisthaler inhaler 45 days after opening foil pouch or when dose counter reads "00", whichever comes first. Attention Pharmacist: Detach Patient's Instructions for Use and dispense with inhaler Asmanex mometasone furoate inhalant Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0085-1341 Route of Administration RESPIRATORY (INHALATION) DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Mometasone Furoate (Mometasone) Mometasone Furoate 220 ug Inactive Ingredients Ingredient Name Strength Anhydrous Lactose Packaging # Item Code Package Description 1 NDC:0085-1341-04 1 POUCH in 1 CARTON 1 1 INHALER in 1 POUCH 1 14 INHALANT in 1 INHALER 2 NDC:0085-1341-06 1 POUCH in 1 CARTON 2 1 INHALER in 1 POUCH 2 14 INHALANT in 1 INHALER 3 NDC:0085-1341-07 1 POUCH in 1 CARTON 3 1 INHALER in 1 POUCH 3 30 INHALANT in 1 INHALER 4 NDC:0085-1341-02 1 POUCH in 1 CARTON 4 1 INHALER in 1 POUCH 4 60 INHALANT in 1 INHALER 5 NDC:0085-1341-01 1 POUCH in 1 CARTON 5 1 INHALER in 1 POUCH 5 120 INHALANT in 1 INHALER 6 NDC:0085-1341-05 1 POUCH in 1 CARTON 6 1 INHALER in 1 POUCH 6 14 INHALANT in 1 INHALER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021067 03/30/2005 Asmanex mometasone furoate inhalant Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0085-1461 Route of Administration RESPIRATORY (INHALATION) DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Mometasone Furoate (Mometasone) Mometasone Furoate 110 ug Inactive Ingredients Ingredient Name Strength Anhydrous Lactose Packaging # Item Code Package Description 1 NDC:0085-1461-06 1 POUCH in 1 CARTON 1 1 INHALER in 1 POUCH 1 7 INHALANT in 1 INHALER 2 NDC:0085-1461-07 1 POUCH in 1 CARTON 2 1 INHALER in 1 POUCH 2 7 INHALANT in 1 INHALER 3 NDC:0085-1461-02 1 POUCH in 1 CARTON 3 1 INHALER in 1 POUCH 3 30 INHALANT in 1 INHALER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021067 03/30/2005 Labeler - Merck Sharp & Dohme Corp. (001317601) Establishment Name Address ID/FEI Operations Merck Sharp & Dohme Corp. 039138862 MANUFACTURE(0085-1341, 0085-1461) Establishment Name Address ID/FEI Operations MSD International GmbH (Singapore Branch) 659186902 MANUFACTURE(0085-1341, 0085-1461) Establishment Name Address ID/FEI Operations Merck Sharp & Dohme Corp. 101740835 PACK(0085-1341, 0085-1461), LABEL(0085-1341, 0085-1461) Establishment Name Address ID/FEI Operations MSD International GmbH (Singapore Branch) 595320830 API MANUFACTURE(0085-1341, 0085-1461) Revised: 09/2014 Merck Sharp & Dohme Corp. Next Interactions Print this page Add to My Med List More about Asmanex Twisthaler (mometasone) Side Effects During Pregnancy Dosage Information Drug Interactions Support Group Pricing & Coupons 13 Reviews Add your own review/rating Drug class: inhaled corticosteroids Consumer resources Asmanex ... +8 more addiction
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