Lefamulin - Oral

Pronunciation: le-FAM-ue-lin

Important: How To Use This Information

This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Uses

This medication is used to treat a wide variety of bacterial infections. 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.

How To Use

Take this medication by mouth on an empty stomach (at least 1 hour before or 2 hours after a meal) with a glass of water (6 to 8 ounces/180 to 240 milliliters) as directed by your doctor, usually twice daily (12 hours apart). The manufacturer directs not to split or crush the tablet before taking it. However, many similar drugs (immediate-release tablets) can be split or crushed. Follow your doctor's directions on how to take this medication. The dosage is 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.

Side Effects

Nausea, vomiting, or diarrhea may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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.

Get medical help right away if you have any very serious side effects, including:

  • fast/irregular heartbeat
  • severe dizziness
  • fainting

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. 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

Do not use anti-diarrhea or opioid medications if you have any of these symptoms because these products may make them 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.

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.

Precautions

Before taking lefamulin, 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 problems

Lefamulin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using lefamulin, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions:

  • certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG)
  • family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death)

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using lefamulin safely.

Lefamulin may cause live bacterial vaccines (such as typhoid vaccine) to not work as well. Do not have any immunizations/vaccinations while using this medication unless your doctor tells you to.

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 more sensitive to the side effects of this drug, especially QT prolongation (see above).

Tell your doctor if you are pregnant or plan to become pregnant. Women of childbearing age should have a pregnancy test before starting treatment. You should not become pregnant while using lefamulin. Lefamulin may harm an unborn baby. Ask about reliable forms of birth control while using this medication and for 2 days after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug and for 2 days after the last dose is not recommended. Consult your doctor before breast-feeding.

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 lefamulin from your body, which may affect how lefamulin works. Examples include azole antifungals (such as fluconazole, itraconazole), HIV protease inhibitors (such as indinavir, nelfinavir, ritonavir), rifamycins (such as rifabutin, rifampin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

Many drugs besides lefamulin may affect the heart rhythm (QT prolongation), including pimozide, among others.

This medication can slow down the removal of other medications from your body, which may affect how they work. An example of an affected drug is lomitapide, among others.

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.

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.

Missed Dose

If you miss a dose, take it as soon as you remember if it is at least 8 hours before the next dose. If it is less than 8 hours before the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

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.

Is it an emergency?

If you or someone in your care has chest pains, difficulty breathing, or severe bleeding, it could be a life-threatening emergency. Call 9-1-1 or the local emergency number immediately.
If you are concerned about a possible poisoning or exposure to a toxic substance, call Poison Control now at 1-800-567-8911.

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