Product Details
FLOVENT HFA 44 MCG INH 10.6 GM
Manufacturer: Glaxo Smith Kline
MFG#: 00173-0718-20
NDC: 00173-0718-20
PID: 330081
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Product Properties:
| Description | - |
|---|---|
| DESI Drug Ind | - |
| DESI2 Drug Ind | - |
| Drug Category | S |
| Drug Type Code | 1 |
| FDA Approval Date | 05/14/2004 |
| FDA Therap Equiv | NR |
| HCPCS | - |
| Market Entry Date | 03/09/2005 |
| Medical Coverage | - |
| Termination Date | - |
| Unit | GM |
| Units Per Pkg | 10 |
| Active Ingredients | 3593 fluticasone propionate 80474142 |
| AHFS Class | 48100808 ORALLY INHALED PREPARATIONS (STEROIDS); 68040000 ADRENALS |
| DEA Class | NC |
| Dose Form | AEROSOL WITH ADAPTER (GRAM) |
| Fine Line Class | 850085008510 All Rx Products |
| Gen Code and Des | 21253 fluticasone propionate INHALATION AER W/ADAP 44 MCG |
| Inactive Ingredients | - |
| OMP Family | - |
| Product Category | RX Pharmaceuticals |
| Strength | 44MCG |
| Common Brand Name | COMMON BRAND NAME(S): Flovent HFA |
| Drug Interaction | DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Other medications can affect the removal of fluticasone from your body, which may affect how fluticasone works. Examples include some azole antifungals (such as ketoconazole), HIV protease inhibitors (such as lopinavir), ritonavir, among others. |
| Allocation Period | Weekly |
| Case Quantity | 96 |
| Drug Form Pack Size | 10 |
| Form | INHALANT |
| Hazard Code | UN1950 AEROSOLS, NON-FLAMMABLE, (EACH NOT EXCEEDING 1 L CAPACITY) |
| Listed Chemical | - |
| NIOSH Code | - |
| Orange Book | ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs. |
| Retail Pack Quantity | 1 |
| Returnable Status | Returnable |
| Special Storage Cond | 01 Aerosol |
| Temp Zone | 10 Room Temperature |
| Unit | EA |
| Unit Size | 10.6 |
| How to Use | HOW TO USE: Read the Patient Information Leaflet that comes with this product before you start using fluticasone and each time you get a refill. Read the patient instructions on how to use this inhaler properly. If you have any questions, ask your doctor or pharmacist. Follow the instructions for priming the inhaler if you are using it for the first time, if you have not used it for more than 1 week, or if you dropped the inhaler. When priming the inhaler, make sure to spray away from your face so that you do not get the medication into your eyes. Shake the inhaler well for 5 seconds before each use. Inhale this medication by mouth as directed by your doctor, usually twice a day (in the morning and evening). The dosage is based on your medical condition and response to treatment. Talk to your doctor or pharmacist if you have trouble using this inhaler. Young children may get better results using a spacer device and face mask with this medication. If two inhalations/puffs are prescribed, wait about 30 seconds between them. Shake the inhaler well between each puff. If you are using other inhalers at the same time, wait at least 1 minute between the use of each medication, and use this drug (the corticosteroid) last. To prevent dry mouth, hoarseness, and oral yeast infections from developing, gargle, rinse your mouth with water and spit out after each use. Do not swallow the rinse water. Use this medication regularly to get the most benefit from it. This medication works best if used at evenly spaced intervals. To help you remember, use it at the same times each day. Do not increase your dose, use this medication more often, or stop using it without first consulting your doctor. If you are regularly taking a different corticosteroid by mouth (such as prednisone), you should not stop taking it unless directed by your doctor. Some conditions (such as asthma, allergies) may become worse when the drug is suddenly stopped. If you suddenly stop taking the drug, you may also have withdrawal symptoms (such as weakness, weight loss, nausea, muscle pain, headache, tiredness, dizziness). To help prevent withdrawal, your doctor may slowly lower the dose of your old medication after you begin using fluticasone. Tell your doctor or pharmacist right away if you have withdrawal. See also Precautions section. Clean the inhaler regularly as directed. Keep track of the number of inhalations used. Discard the canister after using the labeled number of inhalations on the package, even if it feels as though there is medication left in the canister. It may take up to 2 weeks or longer before the full benefit of this drug takes effect. Tell your doctor if your condition does not improve or if it worsens. Learn which of your inhalers you should use every day (controller drugs) and which you should use if your breathing suddenly worsens (quick-relief drugs). Ask your doctor ahead of time what you should do if you have new or worsening cough or shortness of breath, wheezing, increased sputum, worsening peak flow meter readings, waking up at night with trouble breathing, if you use your quick-relief inhaler more often (more than 2 days a week), or if your quick-relief inhaler does not seem to be working well. Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away. |
| Missed Dose | MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up. |
| Notes | NOTES: Do not share this medication with others. Lab and/or medical tests (such as lung function, eye exams, bone density tests, cortisol levels) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details. Learn to use a peak flow meter, use it daily, and promptly report signs of worsening asthma (such as readings in the yellow/red range, increased use of quick-relief inhalers). Avoid allergens/irritants such as smoke, pollen, pet dander, dust, or molds that may worsen asthma. Because the flu virus can also worsen breathing problems, ask your doctor or pharmacist if you should have a flu shot every year. In adults, this medication can increase the risk of bone loss (osteoporosis) if used for a long time. Talk with your doctor about your risk, and about available treatments for osteoporosis. Lifestyle changes that reduce the risk of bone loss include doing weight-bearing exercise, getting enough calcium and vitamin D, stopping smoking, and limiting alcohol. To help prevent osteoporosis later in life, encourage children to exercise and eat a healthy diet (including calcium). |
| Overdose | OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. |
| Phonetic Pronunciation | (floo-TIK-a-sone) |
| Precautions | PRECAUTIONS: Before using fluticasone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: current/past infections (such as tuberculosis, herpes), certain eye problems (cataracts, glaucoma, herpes infection of the eye), bone loss (osteoporosis), liver disease. This medication may mask signs of infection. It can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details. If you have switched from a corticosteroid taken by mouth (such as prednisone tablets) to this inhaler within the past 12 months, or if you have been using this product in higher-than-usual doses for a long time, it may be more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used a corticosteroid taken by mouth within the past 12 months. Tell your doctor right away if you develop unusual/extreme tiredness or weight loss. Carry a warning card or medical ID bracelet that says you use (or have used) corticosteroid medications. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). This medication may temporarily slow down a child's growth if used for a long time. However, poorly controlled asthma can also slow down growth. See the doctor regularly so your child's height can be checked. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding. |
| Side Effects | SIDE EFFECTS: Hoarseness or throat irritation may occur. If either of these effects lasts or gets worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: white patches in your mouth/on your tongue, signs of infection (such as sore throat that doesn't go away, fever, chills, cough), vision problems, increased thirst/urination, easy bruising/bleeding, mental/mood changes (such as depression, mood swings, agitation), bone pain. Rarely, this medication may cause sudden severe wheezing/trouble breathing immediately after you use it. If this occurs, use your quick-relief inhaler and get medical help right away. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. |
| Storage | STORAGE: Store at room temperature. Do not puncture or expose this medication to high heat or open flame. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company. |
| Uses | USES: Fluticasone is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by asthma. It works by reducing swelling (inflammation) of the airways in the lungs to make breathing easier. Controlling symptoms of asthma helps you maintain your normal activities and decreases time lost from work or school. Fluticasone belongs to a class of drugs known as corticosteroids. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks. If an asthma attack occurs, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed. |
Frequently Asked Questions (FAQs)
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FLOVENT HFA 44 MCG INH 10.6 GM is manufactured by Glaxo Smith Kline.
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