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Baxdela (Generic Delafloxacin)

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WARNING

During therapy or for up to several months afterward, taking delafloxacin increases your risk of experiencing tendinitis (swelling of a fibrous tissue that joins a bone to a muscle) or a tendon rupture (tearing of a fibrous tissue that connects a bone to a muscle). These issues could impact the tendons in your shoulder, hand, ankle’s back, or other portions of your body. Any age can get tendinitis or a ruptured tendon, although adults over 60 have the highest risk. Inform your doctor if you have kidney disease, a joint or tendon disorder like rheumatoid arthritis (a condition in which the body attacks its own joints, resulting in pain, swelling, and loss of function), have undergone a kidney, heart, or lung transplant, or have ever done so, or if you engage in regular physical activity. If you are using oral or injectable steroids like dexamethasone, methylprednisolone (Medrol), or prednisone, let your doctor and pharmacist know (Rayos). Delafloxacin should be stopped immediately if you suffer any of the following tendinitis symptoms: pain, edoema, soreness, stiffness, or difficulty moving a muscle. Delafloxacin should be stopped immediately if you develop any of the following tendon rupture symptoms: hearing or feeling a snap or pop in a tendon area; bruising following an injury to a tendon area; or being unable to move or bear weight on an affected area.

Delafloxacin use may result in sensory abnormalities and nerve damage that can persist long after you stop taking the medication. Immediately after you start using delafloxacin, this harm could happen. If you have ever experienced peripheral neuropathy, let your doctor know (a type of nerve damage that causes tingling, numbness, and pain in the hands and feet). Call your doctor right away and stop taking delafloxacin if you have any of the following symptoms: inability to feel light touch, vibrations, pain, heat, or cold; or numbness, tingling, discomfort, burning, or weakness in the arms or legs.

Delafloxacin use may have negative consequences on the neurological system or brain. Following the initial dose of delafloxacin, this is possible. Inform your doctor if you currently have or previously had kidney illness, seizures, epilepsy, cerebral arteriosclerosis (narrowing of blood arteries in or around the brain that can cause a stroke or ministroke), stroke, or any other condition. Call your doctor right away and stop taking delafloxacin if you have any of the following symptoms: convulsions, tremors, lightheadedness, vertigo, persistent headaches (with or without impaired vision); nightmares, trouble falling or staying asleep, a lack of confidence in people, or the impression that people are out to get you; Feeling restless, worried, nervous, depressed, or confused; memory issues; or other changes in your mood or behaviour. Hallucinations (seeing objects or hearing voices that do not exist) or delusions (strange thoughts or beliefs that have no basis in reality).

Delafloxacin use may aggravate myasthenia gravis, a neurological system illness that causes significant muscle weakness, and result in serious breathing problems or even death. If you have myasthenia gravis, tell your doctor. You might be advised by your doctor not to take delafloxacin. If your doctor prescribes delafloxacin for your myasthenia gravis and you have muscle weakness or have trouble breathing while taking it, call your doctor right away.

Delafloxacin hazards should be discussed with your doctor.

When you start delafloxacin therapy, your doctor or pharmacist will give you the manufacturer’s patient information leaflet (Medication Guide). If you have any questions, carefully read the material and contact your doctor or pharmacist. To obtain the Medication Guide, you can also go to the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs) or the manufacturer’s website.

Why is this medication prescribed?

Adults with bacterial pneumonia (infection of the lungs) who have developed skin infections or specific forms of pneumonia are treated with delafloxacin. Delafloxacin belongs to the fluoroquinolone family of antibiotics. It functions by eradicating the infection-causing germs.

Colds, the flu, or other viral diseases cannot be treated with antibiotics like delafloxacin. Antibiotic overuse raises the likelihood that you’ll get an infection later on that is resistant to antibiotic therapy.

How should this medicine be used?

Delafloxacin is available as an oral tablet. It is often taken twice daily, with or without food (every 12 hours). Delafloxacin should be taken every day at roughly the same time. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Delafloxacin should be taken as prescribed. Never take it in larger or less amounts or more frequently than directed by your doctor.

During the first several days of delafloxacin therapy, you should start to feel better. Call your doctor if your symptoms don’t go away or get worse.

Despite feeling better, continue taking delafloxacin until the prescription is finished. If you suffer any of the significant adverse effects described in the IMPORTANT WARNING or SIDE EFFECTS sections, see your doctor before stopping taking delafloxacin. Delafloxacin may not entirely treat your infection if you stop taking it too soon or skip doses, and the bacteria may develop an antibiotic resistance.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking delafloxacin,

  • Inform your doctor and pharmacist if you have ever experienced a severe allergic reaction to any medication, including ciprofloxacin (Cipro), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), or any of the ingredients in delafloxacin tablets, or if you are allergic to any quinolone or fluoroquinolone antibiotic. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
  • Inform your doctor and pharmacist about all prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products that you are now taking or intend to use. Mention insulin as well as any of the diabetes-related drugs listed in the IMPORTANT WARNING section, including chlorpropamide, glimepiride (Amaryl, in Duetact), glipizide (Glucotrol), glyburide (DiaBeta), tolazamide, and tolbutamide. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • Take didanosine (Videx) solution, sucralfate (Carafate), or vitamin or mineral supplements that contain iron or zinc 6 hours before or 2 hours after you take delafloxacin if you are taking antacids that contain aluminium hydroxide or magnesium hydroxide (Maalox, Mylanta, or other brands).
  • Inform your doctor if you have or have ever had an aortic aneurysm (swelling of the large artery that transports blood from the heart to the body), high blood pressure, peripheral vascular disease (poor blood vessel circulation), Marfan syndrome (a genetic condition that can affect the heart, eyes, blood vessels, and bones), Ehlers-Danlos syndrome (a genetic condition that can affect skin, joints, or blood vessels), diabetes, or issues with low blood sugar.
  • Inform your physician if you are nursing a baby, intend to get pregnant, or are already pregnant. Call your doctor if you become pregnant while taking delafloxacin.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

If you miss a dosage, take it as soon as you recall. If your next dose is due in 8 hours or less, skip the missed dose and carry on with your normal dosing plan. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

Delafloxacin might have negative effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Nausea
  • Vomiting
  • Diarrhea
  • Headache

Some adverse effects can be very harmful. Delafloxacin should be stopped immediately if you suffer any of the symptoms listed below or those in the IMPORTANT WARNING section. You should also seek emergency medical attention.

  • Severe diarrhoea (bloody or watery stools), which may or may not be accompanied by fever and cramping (may occur up to 2 months or more after your treatment)
  • Hives, shortness of breath, tingling or swelling in the face or throat, or fainting. Rash, itching, and hives.
  • Intense hunger or thirst, pallor, trembling, a racing or fluttering heartbeat, excessive sweating, frequent urination, blurred vision, or unusual anxiety
  • Unexpected chest, stomach, or back pain

Other negative effects of delafloxacin are possible. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Store it away from excessive heat and moisture at room temperature (not in the bathroom).

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p for additional information.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

What other information should I know?

Keep all of your appointments with your physician and the lab. To monitor your body’s reaction to delafloxacin, your doctor could request specific lab tests. Your doctor might advise you to monitor your blood sugar more frequently while taking delafloxacin if you have diabetes.

No one else should take your medication. It’s likely that your prescription cannot be renewed. Call your doctor if you continue to experience infection symptoms after finishing the delafloxacin.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Baxdela®
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