Product Details
INCRUSE ELLIPTA INH 30
Manufacturer: Glaxo Smith Kline
MFG#: 00173-0873-10
NDC: 00173-0873-10
PID: 320255
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Product Properties:
| Description | - |
|---|---|
| Description | S |
| Description | S |
| DESI Drug Ind | -; - |
| DESI Drug Ind | -; - |
| DESI Drug Ind | - |
| DESI2 Drug Ind | - |
| Drug Category | USES: Umeclidinium is used to control and prevent symptoms (such as wheezing, shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes bronchitis and emphysema). It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Umeclidinium belongs to a class of drugs known as anticholinergics. Controlling symptoms of breathing problems can decrease time lost from work or school. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden shortness of breath. If wheezing or sudden shortness of breath occurs, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed. |
| Drug Category | USES: Umeclidinium is used to control and prevent symptoms (such as wheezing, shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes bronchitis and emphysema). It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Umeclidinium belongs to a class of drugs known as anticholinergics. Controlling symptoms of breathing problems can decrease time lost from work or school. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden shortness of breath. If wheezing or sudden shortness of breath occurs, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed. |
| Drug Category | S |
| Drug Type Code | COMMON BRAND NAME(S): Incruse Ellipta |
| Drug Type Code | COMMON BRAND NAME(S): Incruse Ellipta |
| Drug Type Code | 1 |
| FDA Approval Date | 04/30/2014 |
| FDA Therap Equiv | NR |
| HCPCS | - |
| HCPCS | 1 |
| HCPCS | 1 |
| Market Entry Date | 01/12/2015 |
| Medical Coverage | - |
| Medical Coverage | - |
| Medical Coverage | - |
| Termination Date | (ue-ME-kli-DIN-ee-um) |
| Termination Date | (ue-ME-kli-DIN-ee-um) |
| Termination Date | - |
| Unit | EA |
| Units Per Pkg | 30 |
| Active Ingredients | 15345 umeclidinium bromide 869113097 |
| Active Ingredients | 15345 umeclidinium bromide 869113097 |
| Active Ingredients | 15345 umeclidinium bromide 869113097 |
| AHFS Class | 12080800 ANTIMUSCARINICS/ANTISPASMODICS; 48120800 ANTICHOLINERGIC AGENTS (RESPIR.TRACT) |
| AHFS Class | 12080800 ANTIMUSCARINICS/ANTISPASMODICS; 48120800 ANTICHOLINERGIC AGENTS (RESPIR.TRACT) |
| AHFS Class | 12080800 ANTIMUSCARINICS/ANTISPASMODICS; 48120800 ANTICHOLINERGIC AGENTS (RESPIR.TRACT) |
| DEA Class | NC |
| DEA Class | NC |
| DEA Class | NC |
| Dose Form | BLISTER, WITH INHALATION DEVICE |
| Dose Form | BLISTER, WITH INHALATION DEVICE |
| Dose Form | BLISTER, WITH INHALATION DEVICE |
| Fine Line Class | 850085008510 All Rx Products |
| Fine Line Class | 850085008510 All Rx Products |
| Fine Line Class | 850085008510 All Rx Products |
| Gen Code and Des | 72375 umeclidinium bromide INHALATION BLST W/DEV 62.5 MCG |
| Gen Code and Des | 72375 umeclidinium bromide INHALATION BLST W/DEV 62.5 MCG |
| Gen Code and Des | 72375 umeclidinium bromide INHALATION BLST W/DEV 62.5 MCG |
| Inactive Ingredients | 2432 lactose 64044515 |
| Inactive Ingredients | 2432 lactose 64044515 |
| Inactive Ingredients | 2432 lactose 64044515 |
| OMP Family | - |
| OMP Family | - |
| OMP Family | - |
| Product Category | RX Pharmaceuticals |
| Product Category | RX Pharmaceuticals |
| Product Category | RX Pharmaceuticals |
| Strength | - |
| Strength | - |
| Strength | - |
| Common Brand Name | - |
| Common Brand Name | - |
| Common Brand Name | COMMON BRAND NAME(S): Incruse Ellipta |
| 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. Some products that may interact with this drug include: other anticholinergics (such as ipratropium, atropine). |
| Drug Interaction | - |
| Drug Interaction | - |
| Allocation Period | Weekly |
| Allocation Period | Weekly |
| Allocation Period | Weekly |
| Case Quantity | 24 |
| Case Quantity | 24 |
| Case Quantity | 24 |
| Drug Form Pack Size | 30 |
| Drug Form Pack Size | 30 |
| Drug Form Pack Size | 30 |
| Form | INHALANT |
| Form | INHALANT |
| Form | INHALANT |
| Hazard Code | - |
| Hazard Code | - |
| Hazard Code | - |
| Listed Chemical | - |
| Listed Chemical | - |
| Listed Chemical | - |
| NIOSH Code | - |
| NIOSH Code | - |
| NIOSH Code | - |
| Orange Book | ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs. |
| Orange Book | ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs. |
| Orange Book | ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs. |
| Retail Pack Quantity | 1 |
| Retail Pack Quantity | 1 |
| Retail Pack Quantity | 1 |
| Returnable Status | Returnable |
| Returnable Status | Returnable |
| Returnable Status | Returnable |
| Special Storage Cond | 00 None |
| Special Storage Cond | 00 None |
| Special Storage Cond | 00 None |
| Temp Zone | 10 Room Temperature |
| Temp Zone | 10 Room Temperature |
| Temp Zone | 10 Room Temperature |
| Unit | EA |
| Unit | EA |
| Unit | EA |
| Unit Size | 30 |
| Unit Size | 30 |
| Unit Size | 30 |
| How to Use | - |
| How to Use | HOW TO USE: Read the Patient Information Leaflet and Instructions for Use Leaflet for directions on the proper use of this medication. If you have any questions, ask your doctor or pharmacist. Inhale this medication by mouth as directed by your doctor, usually once daily. Do not open the cover of the inhaler until you are ready to use it. Each time you open the cover, you prepare a dose of the medication. If you open and close the cover without inhaling the medication, you will lose the dose. To avoid wasting a dose, do not close the cover until after you have inhaled the medication. You may or may not taste/feel the drug when you inhale. Do not exhale into the device. Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time every day. Do not use it more than one time each day. Do not increase your dose, use this medication more often, or stop using it without first consulting your doctor. Your condition will not improve any faster, and your risk of side effects will increase. If you are using other inhalers at the same time, wait at least 1 minute between the use of each medication. Learn which of your inhalers you should use every day 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, waking up at night with trouble breathing, if you use your quick-relief inhaler more often, 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. Tell your doctor if your condition does not improve or if it worsens. |
| How to Use | - |
| Missed Dose | 30 |
| Missed Dose | 30 |
| 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. Do not use more than one dose each day. |
| Notes | NOTES: Do not share this medication with others. Avoid smoking and other things that can worsen breathing problems. Because the flu virus can also worsen breathing problems, ask your doctor or pharmacist if you should have a flu shot every year. |
| Notes | EA |
| Notes | EA |
| Overdose | NR |
| Overdose | NR |
| 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 | - |
| Phonetic Pronunciation | - |
| Phonetic Pronunciation | (ue-ME-kli-DIN-ee-um) |
| Precautions | - |
| Precautions | PRECAUTIONS: Before using umeclidinium, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as milk proteins), 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: personal or family history of glaucoma (angle-closure type), difficulty urinating (such as due to an enlarged prostate). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding. |
| Precautions | - |
| Side Effects | - |
| Side Effects | - |
| Side Effects | SIDE EFFECTS: 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: difficult/painful urination. Rarely, this medication may cause sudden severe wheezing/trouble breathing right after use. If this occurs, use your quick-relief inhaler and get medical help right away. Get medical help right away if you have any very serious side effects, including: eye pain/swelling/redness, vision changes (such as seeing rainbows around lights at night, blurred vision). 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 | 04/30/2014 |
| Storage | 04/30/2014 |
| Storage | STORAGE: Store at room temperature away from light, heat, and moisture. Do not store in the bathroom. Do not open the sealed tray that the inhaler comes in until you are ready to use the new inhaler. Throw away the inhaler 6 weeks after first removing it from the tray or when the dose counter reads zero, whichever comes first. 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 | - |
| Uses | USES: Umeclidinium is used to control and prevent symptoms (such as wheezing, shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes bronchitis and emphysema). It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Umeclidinium belongs to a class of drugs known as anticholinergics. Controlling symptoms of breathing problems can decrease time lost from work or school. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden shortness of breath. If wheezing or sudden shortness of breath 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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INCRUSE ELLIPTA INH 30 is manufactured by Glaxo Smith Kline.
You can purchase INCRUSE ELLIPTA INH 30 on our website at https://supplies.pipelinemedical.com/product/detail/incruse-ellipta-inh-30-320255