Product Details
ROFLUMILAST 500 MCG TAB 30
Manufacturer: NOVADOZ PHARMACEUTICALS LLC
MFG#: 72205-0200-30
NDC: 72205-0200-30
PID: 306452
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Product Properties:
| Description | - |
|---|---|
| DESI Drug Ind | - |
| DESI2 Drug Ind | - |
| Drug Category | N |
| Drug Type Code | 1 |
| FDA Approval Date | 09/07/2022 |
| FDA Therap Equiv | AB |
| HCPCS | - |
| Market Entry Date | 10/19/2022 |
| Medical Coverage | - |
| Termination Date | - |
| Unit | TAB |
| Units Per Pkg | 30 |
| Active Ingredients | 13499 roflumilast 162401323 |
| AHFS Class | 48320000 PHOSPHODIESTERASE TYPE 4 INHIBITORS |
| DEA Class | NC |
| Dose Form | TABLET |
| Fine Line Class | 850085008510 All Rx Products |
| Gen Code and Des | 66612 roflumilast ORAL TABLET 500 MCG |
| Inactive Ingredients | 2432 lactose 64044515 |
| OMP Family | - |
| Product Category | RX Pharmaceuticals |
| Strength | 500MCG |
| Common Brand Name | COMMON BRAND NAME(S): Daliresp |
| 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 medications can affect the removal of roflumilast from your body, which may affect how this product works. Examples include rifamycins (such as rifampicin), drugs used to treat seizures (such as carbamazepine, phenytoin), among others. |
| Allocation Period | - |
| Case Quantity | 48 |
| Drug Form Pack Size | 30 |
| Form | TABLET |
| Hazard Code | - |
| Listed Chemical | - |
| NIOSH Code | - |
| Orange Book | AB Products meeting necessary bioequivalence requirements. |
| Retail Pack Quantity | 1 |
| Returnable Status | Returnable |
| Special Storage Cond | 00 None |
| Temp Zone | 10 Room Temperature |
| Unit | EA |
| Unit Size | 30 |
| How to Use | HOW TO USE: Read the Medication Guide and, if available, the Patient Information Leaflet from your pharmacist before you start taking roflumilast and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor, usually once daily. Use this medication regularly in order 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 time each day. Do not increase your dose, use this medication more frequently, or stop using it without first consulting your doctor. Tell your doctor if your condition does not improve or if it worsens. |
| Missed Dose | MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take 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, weight) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details. |
| 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. Symptoms of overdose may include: severe dizziness, fast/pounding heartbeat. |
| Phonetic Pronunciation | (roe-FLUE-mi-last) |
| Precautions | PRECAUTIONS: Before taking roflumilast, 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: liver disease, cancer, heart disease (such as heart failure), current/past infections (such as tuberculosis, herpes), mental/mood disorders (depression, thoughts of suicide), unexplained/extreme weight loss, immune system disorders (such as lupus, HIV). This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). 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. |
| Side Effects | SIDE EFFECTS: Diarrhea, weight loss, stomach/abdominal pain, nausea, loss of appetite, headache, or dizziness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Check your weight regularly while taking this medication. Tell your doctor right away of any unusual or extreme weight loss. 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: mental/mood changes (such as nervousness, depression, thoughts of suicide), trouble sleeping, shaking (tremors), fast/irregular heartbeat. A very serious allergic reaction to this product 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 away from light and moisture. Do not store in the bathroom. 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: Roflumilast is used to control and prevent symptoms (wheezing and shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD which includes bronchitis). It should be used along with other medications (bronchodilators such as salmeterol, ipratropium) to treat COPD. It works by reducing the irritation and swelling of the airways. 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 or wheezing. If sudden breathing problems occur, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed. |
Frequently Asked Questions (FAQs)
The cost of ROFLUMILAST 500 MCG TAB 30 is $available for registerd members only
ROFLUMILAST 500 MCG TAB 30 is manufactured by NOVADOZ PHARMACEUTICALS LLC.
You can purchase ROFLUMILAST 500 MCG TAB 30 on our website at https://supplies.pipelinemedical.com/product/detail/roflumilast-500-mcg-tab-30-306452