Product Details
BAXDELA 450MG TAB 20
Manufacturer: MELINTA THERAPEUTICS INC
MFG#: 70842-0101-01
NDC: 70842-0101-01
PID: 240706
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Product Properties:
| Description | - |
|---|---|
| Description | S |
| DESI Drug Ind | -; - |
| DESI Drug Ind | - |
| DESI2 Drug Ind | NR |
| Drug Category | - |
| Drug Category | USES: Delafloxacin is used to treat a variety of bacterial infections. This medication belongs to a class of drugs known as quinolone antibiotics. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections. |
| Drug Type Code | COMMON BRAND NAME(S): Baxdela |
| Drug Type Code | S |
| FDA Approval Date | 01/02/2018 |
| FDA Therap Equiv | TAB |
| HCPCS | - |
| HCPCS | 1 |
| Market Entry Date | - |
| Medical Coverage | - |
| Medical Coverage | - |
| Termination Date | (DEL-a-FLOX-a-sin) |
| Termination Date | 1 |
| Unit | 20 |
| Units Per Pkg | 06/19/2017 |
| Active Ingredients | 17250 delafloxacin meglumine 352458378 |
| Active Ingredients | 17250 delafloxacin meglumine 352458378 |
| AHFS Class | 8121800 QUINOLONE ANTIBIOTICS |
| AHFS Class | 8121800 QUINOLONE ANTIBIOTICS |
| DEA Class | NC |
| DEA Class | NC |
| Dose Form | TABLET |
| Dose Form | TABLET |
| Fine Line Class | 850085008510 All Rx Products |
| Fine Line Class | 850085008510 All Rx Products |
| Gen Code and Des | 77492 delafloxacin meglumine ORAL TABLET 450 MG |
| Gen Code and Des | 77492 delafloxacin meglumine ORAL TABLET 450 MG |
| Inactive Ingredients | 11039 sodium bicarbonate 144558; 2537 povidone 9003398 |
| Inactive Ingredients | 11039 sodium bicarbonate 144558; 2537 povidone 9003398 |
| OMP Family | - |
| OMP Family | - |
| Product Category | RX Pharmaceuticals |
| Product Category | RX Pharmaceuticals |
| Strength | 450MG |
| Strength | 450MG |
| Common Brand Name | - |
| Common Brand Name | COMMON BRAND NAME(S): Baxdela |
| Drug Interaction | DRUG INTERACTIONS: See also How to Use section. 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. A product that may interact with this drug is: strontium. |
| Drug Interaction | - |
| Allocation Period | - |
| Allocation Period | - |
| Case Quantity | 12 |
| Case Quantity | 12 |
| Drug Form Pack Size | 20 |
| Drug Form Pack Size | 20 |
| Form | TABLET |
| Form | TABLET |
| Hazard Code | - |
| Hazard Code | - |
| Listed Chemical | - |
| Listed Chemical | - |
| 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. |
| Retail Pack Quantity | 1 |
| Retail Pack Quantity | 1 |
| Returnable Status | Returnable |
| Returnable Status | Returnable |
| Special Storage Cond | 00 None |
| Special Storage Cond | 00 None |
| Temp Zone | 10 Room Temperature |
| Temp Zone | 10 Room Temperature |
| Unit | EA |
| Unit | EA |
| Unit Size | 20 |
| Unit Size | 20 |
| How to Use | - |
| How to Use | HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking delafloxacin 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 every 12 hours. Drink plenty of fluids while taking this medication unless otherwise directed by your doctor. Take this medication at least 2 hours before or 6 hours after taking other products that may make it work less well. Examples include quinapril, sucralfate, vitamins/minerals (including iron, zinc), and products that contain magnesium, aluminum, or calcium (such as antacids, didanosine solution, calcium-enriched juice), among others. Ask your pharmacist about all the products you take. The dosage and length of treatment are based on your medical condition and response to treatment. For the best effect, take this antibiotic at evenly spaced times. To help you remember, take this medication at the same times every day. Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection. Tell your doctor if your condition lasts or gets worse. |
| Missed Dose | 20 |
| Missed Dose | MISSED DOSE: If you miss a dose and it has been less than 4 hours, take it as soon as you remember. If you miss a dose and it has been more than 4 hours, 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. This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor tells you to. Lab tests (such as kidney function, complete blood count, cultures) may be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. |
| Notes | TAB |
| 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 | (DEL-a-FLOX-a-sin) |
| Phonetic Pronunciation | - |
| Precautions | - |
| Precautions | PRECAUTIONS: Before taking delafloxacin, tell your doctor or pharmacist if you are allergic to it; or to other quinolone antibiotics (such as ciprofloxacin, moxifloxacin, ofloxacin); 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: joint/tendon problems (such as tendonitis, bursitis), kidney disease, mental/mood disorders (such as depression), a certain muscle condition (myasthenia gravis), nerve problems (such as peripheral neuropathy), seizures, blood vessel problems (such as aneurysm or blockage of the aorta or other blood vessels, hardening of the arteries), high blood pressure, certain genetic conditions (Marfan syndrome, Ehlers-Danlos syndrome). This medication may rarely cause serious changes in blood sugar, especially if you have diabetes. Check your blood sugar regularly as directed and share the results with your doctor. Watch for symptoms of high blood sugar, such as increased thirst/urination. Also watch for symptoms of low blood sugar such as sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or by drinking fruit juice or non-diet soda. Tell your doctor right away about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Your doctor may need to switch you to another antibiotic or adjust your diabetes medications if any reaction occurs. This drug may make you dizzy or lightheaded. 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). Delafloxacin may cause live bacterial vaccines (such as typhoid vaccine) to not work well. Tell your health care professional that you are using delafloxacin before having any immunizations/vaccinations. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Older adults may be at greater risk for tendon problems (especially if they are also taking corticosteroids such as prednisone or hydrocortisone) and a sudden tear/break in the main blood vessel (aorta). 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 | SIDE EFFECTS: See also Warning section. Nausea, diarrhea, dizziness, or lightheadedness may occur. If any of these effects last or get 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. This medication may rarely cause a severe intestinal condition due to a bacteria called C. difficile. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: diarrhea that doesn't stop, abdominal or stomach pain/cramping, blood/mucus in your stool. If you have these symptoms, do not use anti-diarrhea or opioid products because they may make symptoms worse. Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms. Get medical help right away if you have any very serious side effects, including: signs of a tear/break in the main blood vessel called the aorta (such as sudden/severe pain in the stomach/chest/back, shortness of breath). 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 | 06/19/2017 |
| 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 | USES: Delafloxacin is used to treat a variety of bacterial infections. This medication belongs to a class of drugs known as quinolone antibiotics. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections. |
Frequently Asked Questions (FAQs)
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BAXDELA 450MG TAB 20 is manufactured by MELINTA THERAPEUTICS INC.
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