Lefamulin (Oral)

Generic name: Lefamulin
Drug class: Miscellaneous antibiotics

Usage of Lefamulin (Oral)

Lefamulin is used to treat community-acquired bacterial pneumonia (CABP).

Lefamulin belongs to the class of medicines known as pleuromutilin antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

This medicine is available only with your doctor's prescription.

Lefamulin (Oral) side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Convulsions

decreased urine

dry mouth

increased thirst

irregular heartbeat

loss of appetite

mood changes

muscle pain or cramps

nausea or vomiting

numbness or tingling in the hands, feet, or lips

trouble breathing

unusual tiredness or weakness

Incidence not known

Abdominal or stomach tenderness

chest pain or discomfort

fainting

fever

irregular or slow heart rate

severe abdominal or stomach cramps and pain

watery and severe diarrhea, which may also be bloody

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Headache

trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking Lefamulin (Oral)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of lefamulin in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lefamulin in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Dasatinib

Dofetilide

Dronedarone

Ivabradine

Levoketoconazole

Pimavanserin

Pimozide

Quetiapine

Quinidine

Tacrolimus

Vardenafil

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acalabrutinib

Acecainide

Adagrasib

Alfentanil

Alfuzosin

Amiodarone

Amitriptyline

Anagrelide

Apalutamide

Apomorphine

Aprepitant

Aripiprazole

Aripiprazole Lauroxil

Arsenic Trioxide

Asenapine

Astemizole

Atazanavir

Avanafil

Azithromycin

Bedaquiline

Bepridil

Boceprevir

Bosentan

Bosutinib

Bretylium

Budesonide

Buprenorphine

Buserelin

Buspirone

Carbamazepine

Carvedilol

Ceritinib

Chloroquine

Chlorpromazine

Ciprofloxacin

Cisapride

Citalopram

Clarithromycin

Clofazimine

Clomipramine

Clothiapine

Clozapine

Cobicistat

Cobimetinib

Conivaptan

Crizotinib

Cyclobenzaprine

Cyclosporine

Dabrafenib

Darifenacin

Darunavir

Degarelix

Delamanid

Desipramine

Deslorelin

Deutetrabenazine

Dexmedetomidine

Dihydroergotamine

Disopyramide

Dolasetron

Domperidone

Donepezil

Doxepin

Droperidol

Ebastine

Efavirenz

Eletriptan

Encorafenib

Enzalutamide

Eplerenone

Ergotamine

Eribulin

Erythromycin

Escitalopram

Etrasimod

Etravirine

Everolimus

Famotidine

Felbamate

Felodipine

Fentanyl

Fexinidazole

Fingolimod

Flecainide

Flibanserin

Fluconazole

Fluoxetine

Fluticasone

Formoterol

Fosaprepitant

Foscarnet

Fosphenytoin

Galantamine

Gatifloxacin

Gemifloxacin

Gepirone

Glasdegib

Gonadorelin

Goserelin

Granisetron

Halofantrine

Haloperidol

Histrelin

Hydroquinidine

Hydroxychloroquine

Hydroxyzine

Ibrutinib

Ibutilide

Idelalisib

Iloperidone

Imipramine

Indinavir

Inotuzumab Ozogamicin

Itraconazole

Ivacaftor

Ivosidenib

Ketoconazole

Lapatinib

Lenvatinib

Leuprolide

Levofloxacin

Lofexidine

Lomitapide

Lopinavir

Lorlatinib

Lovastatin

Lumacaftor

Lumefantrine

Lurasidone

Macimorelin

Maraviroc

Mefloquine

Mesoridazine

Methadone

Methotrimeprazine

Metronidazole

Midazolam

Mifepristone

Mitotane

Mizolastine

Mobocertinib

Modafinil

Moricizine

Moxifloxacin

Nafarelin

Nafcillin

Naloxegol

Nefazodone

Nelfinavir

Nilotinib

Norfloxacin

Octreotide

Ofloxacin

Olanzapine

Ondansetron

Osimertinib

Oxycodone

Pacritinib

Paliperidone

Panobinostat

Papaverine

Paroxetine

Pasireotide

Pazopanib

Pentamidine

Perphenazine

Phenobarbital

Phenytoin

Pipamperone

Piperaquine

Pitolisant

Posaconazole

Primidone

Probucol

Procainamide

Prochlorperazine

Promethazine

Propafenone

Protriptyline

Quinine

Quizartinib

Ranolazine

Relugolix

Ribociclib

Rifabutin

Rifampin

Risperidone

Ritonavir

Saquinavir

Sertindole

Sertraline

Sevoflurane

Sildenafil

Simvastatin

Sirolimus

Sodium Phosphate

Sodium Phosphate, Dibasic

Sodium Phosphate, Monobasic

Solifenacin

Sorafenib

Sotalol

Sparfloxacin

St John's Wort

Sulpiride

Sultopride

Sunitinib

Tamoxifen

Terfenadine

Tetrabenazine

Thioridazine

Ticagrelor

Tipranavir

Tolterodine

Tolvaptan

Toremifene

Trazodone

Triazolam

Triclabendazole

Trimipramine

Triptorelin

Vandetanib

Vemurafenib

Venetoclax

Venlafaxine

Verapamil

Vernakalant

Vilanterol

Vinflunine

Voriconazole

Vorinostat

Ziprasidone

Zotepine

Zuclopenthixol

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Relate drugs

How to use Lefamulin (Oral)

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Swallow the tablet whole with water. Do not break, crush, or divide it.

Take this medicine at least 1 hour before or 2 hours after a meal.

Keep using this medicine for the full time of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon, your infection may not clear up.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take Depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):

For community-acquired bacterial pneumonia:

Adults—600 milligrams (mg) every 12 hours, to be taken for 5 days.

Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If your next regular dose is less than 8 hours away, wait until then to use the medicine and skip the missed dose.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Warnings

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 2 days after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

Do not use this medicine if you are also using erythromycin (Ery-Tab®), moxifloxacin (Avelox®), medicine to treat heart rhythm problems (eg, amiodarone, quinidine, procainamide, sotalol, Betapace®, Cordarone®), medicine to treat mental illness (eg, pimozide, Orap®), or tricyclic antidepressants. Using these medicines together with lefamulin may cause unwanted serious side effects.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.

Lefamulin may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop taking this medicine. Do not take any medicine to treat diarrhea without checking first with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

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