Pronunciation:

kla-rith-roe-MYE-sin

Brand Names:

• Biaxin
• Biaxin Filmtab
• Biaxin XL

Dosage Forms:

• Tablet, Extended Release
• Tablet
• Powder for Suspension

Classifications:

Therapeutic—

Antibiotic

Chemical—

Macrolide

Uses of This Medicine:

Clarithromycin is used to treat bacterial infections in many different parts of the body. It is also used in combination with other medicines to treat duodenal ulcers caused by H. pylori. This medicine is also used to prevent and treat Mycobacterium avium complex (MAC) infection.

Clarithromycin belongs to the class of medicines, known as macrolide 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.

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of clarithromycin to treat bacterial infections in children younger than 6 months of age, and to prevent and treat Mycobacterium avium complex in children younger than 20 months of age. Safety and efficacy have not been established in these age groups.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of clarithromycin in the elderly. However, elderly patients are more likely to have severe kidney problems and heart rhythm problems, which may require caution and an adjustment in the dose for patients receiving clarithromycin.

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.

Other 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.

• Alfuzosin
• Alprazolam
• Astemizole
• Bepridil
• Cisapride
• Colchicine
• Conivaptan
• Dihydroergotamine
• Domperidone
• Dronedarone
• Eletriptan
• Eliglustat
• Eplerenone
• Ergotamine
• Finerenone
• Flibanserin
• Fluconazole
• Gepirone
• Isavuconazonium Sulfate
• Ivabradine
• Ketoconazole
• Levoketoconazole
• Lomitapide
• Lovastatin
• Lurasidone
• Maraviroc
• Mavacamten
• Mesoridazine
• Naloxegol
• Nelfinavir
• Nimodipine
• Pacritinib
• Pimozide
• Piperaquine
• Posaconazole
• Ranolazine
• Saquinavir
• Silodosin
• Simvastatin
• Sparfloxacin
• Terfenadine
• Thioridazine
• Tolvaptan
• Ubrogepant
• Venetoclax
• Voclosporin
• Ziprasidone

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.

• Abametapir
• Abiraterone Acetate
• Acalabrutinib
• Acecainide
• Adagrasib
• Ado-Trastuzumab Emtansine
• Afatinib
• Ajmaline
• Alfentanil
• Amiodarone
• Amisulpride
• Amitriptyline
• Amlodipine
• Amprenavir
• Anagrelide
• Apalutamide
• Apixaban
• Apomorphine
• Aprepitant
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Artemether
• Asciminib
• Asenapine
• Atazanavir
• Atogepant
• Atorvastatin
• Avacopan
• Avanafil
• Avapritinib
• Avatrombopag
• Axitinib
• Azithromycin
• Bedaquiline
• Belumosudil
• Benzhydrocodone
• Betrixaban
• Bictegravir
• Boceprevir
• Bosentan
• Bosutinib
• Bretylium
• Brexpiprazole
• Brigatinib
• Bromocriptine
• Budesonide
• Buprenorphine
• Buserelin
• Buspirone
• Cabazitaxel
• Cabozantinib
• Calcifediol
• Cannabidiol
• Capivasertib
• Capmatinib
• Carbamazepine
• Cariprazine
• Cenobamate
• Ceritinib
• Chloroquine
• Chlorpromazine
• Cholera Vaccine, Live
• Cilostazol
• Cinacalcet
• Ciprofloxacin
• Citalopram
• Clindamycin
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Cobicistat
• Cobimetinib
• Codeine
• Copanlisib
• Crizotinib
• Cyclobenzaprine
• Cyclosporine
• Dabigatran Etexilate
• Dabrafenib
• Daclatasvir
• Daridorexant
• Darifenacin
• Darolutamide
• Darunavir
• Dasatinib
• Deflazacort
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexamethasone
• Dexmedetomidine
• Diazepam
• Dienogest
• Digoxin
• Dihydrocodeine
• Diltiazem
• Dipyrone
• Disopyramide
• Docetaxel
• Dofetilide
• Dolasetron
• Dolutegravir
• Donepezil
• Doravirine
• Doxepin
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Droperidol
• Drospirenone
• Duvelisib
• Ebastine
• Edoxaban
• Efavirenz
• Elacestrant
• Elagolix
• Elbasvir
• Elexacaftor
• Encorafenib
• Entrectinib
• Enzalutamide
• Eravacycline
• Erdafitinib
• Eribulin
• Erlotinib
• Erythromycin
• Escitalopram
• Estradiol
• Eszopiclone
• Etrasimod
• Etravirine
• Everolimus
• Famotidine
• Fedratinib
• Felbamate
• Felodipine
• Fentanyl
• Fesoterodine
• Fexinidazole
• Fingolimod
• Flecainide
• Fluoxetine
• Fluticasone
• Formoterol
• Fosamprenavir
• Fosaprepitant
• Foscarnet
• Fosnetupitant
• Fosphenytoin
• Fostamatinib
• Fostemsavir
• Futibatinib
• Galantamine
• Ganaxolone
• Gatifloxacin
• Gemifloxacin
• Gilteritinib
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Grazoprevir
• Halofantrine
• Haloperidol
• Halothane
• Histrelin
• Hydrocodone
• Hydrocortisone
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibrexafungerp
• Ibrutinib
• Ibutilide
• Idelalisib
• Ifosfamide
• Iloperidone
• Imatinib
• Imipramine
• Indinavir
• Infigratinib
• Inotuzumab Ozogamicin
• Irinotecan
• Irinotecan Liposome
• Isoflurane
• Istradefylline
• Itraconazole
• Ivacaftor
• Ivosidenib
• Ixabepilone
• Ixazomib
• Lapatinib
• Larotrectinib
• Lefamulin
• Lemborexant
• Lenacapavir
• Leniolisib
• Lenvatinib
• Lercanidipine
• Lesinurad
• Leuprolide
• Levamlodipine
• Levofloxacin
• Levomethadyl
• Levomilnacipran
• Linagliptin
• Lofexidine
• Loperamide
• Lopinavir
• Loratadine
• Lorlatinib
• Lumacaftor
• Lumateperone
• Lumefantrine
• Lurbinectedin
• Macimorelin
• Macitentan
• Manidipine
• Mefloquine
• Meperidine
• Methadone
• Methotrexate
• Methotrimeprazine
• Methylprednisolone
• Metronidazole
• Midazolam
• Midostaurin
• Mifepristone
• Mirtazapine
• Mirvetuximab Soravtansine-gynx
• Mitapivat
• Mitotane
• Mizolastine
• Mobocertinib
• Modafinil
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nafarelin
• Nafcillin
• Naldemedine
• Neratinib
• Netupitant
• Nifedipine
• Nilotinib
• Nintedanib
• Nirmatrelvir
• Nirogacestat
• Nisoldipine
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Olaparib
• Oliceridine
• Omaveloxolone
• Omeprazole
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxycodone
• Ozanimod
• Palbociclib
• Paliperidone
• Palovarotene
• Panobinostat
• Papaverine
• Paritaprevir
• Paroxetine
• Pasireotide
• Pazopanib
• Pemigatinib
• Pentamidine
• Pentazocine
• Perphenazine
• Pexidartinib
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pipamperone
• Pirtobrutinib
• Pitolisant
• Pixantrone
• Ponatinib
• Ponesimod
• Prajmaline
• Pralsetinib
• Pravastatin
• Praziquantel
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Progesterone
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Reboxetine
• Regorafenib
• Relugolix
• Repotrectinib
• Retapamulin
• Ribociclib
• Rifabutin
• Rifampin
• Rifapentine
• Rilpivirine
• Rimegepant
• Riociguat
• Risperidone
• Ritonavir
• Rivaroxaban
• Roflumilast
• Rolapitant
• Romidepsin
• Ruxolitinib
• Salmeterol
• Samidorphan
• Selpercatinib
• Selumetinib
• Sertindole
• Sertraline
• Sevoflurane
• Sibutramine
• Sildenafil
• Simeprevir
• Siponimod
• Sirolimus
• Sirolimus Protein-Bound
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sonidegib
• Sorafenib
• Sotalol
• Sparsentan
• Sparteine
• Spiramycin
• St John's Wort
• Sufentanil
• Sulfamethoxazole
• Sulpiride
• Sultopride
• Sunitinib
• Suvorexant
• Tacrolimus
• Tadalafil
• Talazoparib
• Tamoxifen
• Tamsulosin
• Tazemetostat
• Tedisamil
• Telaprevir
• Telavancin
• Telithromycin
• Telotristat Ethyl
• Temsirolimus
• Tenofovir Alafenamide
• Tepotinib
• Tetrabenazine
• Tezacaftor
• Theophylline
• Thiotepa
• Ticagrelor
• Tivozanib
• Tolterodine
• Topotecan
• Toremifene
• Trabectedin
• Tramadol
• Trazodone
• Tretinoin
• Triazolam
• Triclabendazole
• Trimethoprim
• Trimipramine
• Triptorelin
• Tucatinib
• Ulipristal
• Upadacitinib
• Valbenazine
• Valproic Acid
• Vamorolone
• Vandetanib
• Vardenafil
• Velpatasvir
• Vemurafenib
• Venlafaxine
• Verapamil
• Vilanterol
• Vilazodone
• Vinblastine
• Vincristine
• Vincristine Sulfate Liposome
• Vinflunine
• Vinorelbine
• Vorapaxar
• Voriconazole
• Vorinostat
• Voxelotor
• Voxilaprevir
• Warfarin
• Zanubrutinib
• Zidovudine
• Zolpidem
• Zotepine
• Zuclopenthixol
• Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol
• Delavirdine
• Glipizide
• Glyburide
• Linezolid
• Nevirapine
• Prednisone
• Repaglinide
• Tipranavir

Other interactions—

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.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cholestatic jaundice, history of or
• Liver disease, history of—Should not be used in patients with these conditions caused by clarithromycin.

• Bradycardia (slow heartbeat) or
• Heart rhythm problems (eg, QT prolongation, torsades de pointes, ventricular arrhythmia), history of or
• Hypokalemia (low potassium in the blood), uncorrected or
• Hypomagnesemia (low magnesium in the blood), uncorrected—Use is not recommended in patients with these conditions.

• Decreased kidney function or
• Porphyria (enzyme problem), history of—Clarithromycin together with ranitidine bismuth citrate should not be used in patients with these conditions.

• Diarrhea or
• Heart disease or
• Liver disease or
• Myasthenia gravis (severe muscle weakness)—Use with caution. May make these conditions worse.

• Kidney disease or
• Liver disease—Clarithromycin together with colchicine should not be used in patients with these conditions.

• Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

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.

You may take this medicine with meals or milk or on an empty stomach. However, clarithromycin extended release tablets should be taken with food.

If you are using the extended-release tablets:

• Swallow the tablet whole. Do not break, crush, or chew it.
• While taking the extended-release form of this medicine, a part of the tablet may pass into your stools. This is normal and is nothing to worry about.

Measure the oral liquid with a marked measuring spoon, syringe, or cup. The average household teaspoon may not hold the right amount of liquid. Shake the bottle well before each use.

If you are taking clarithromycin and zidovudine, these medicines should be taken at least 2 hours apart.

Keep using this medicine for the full time of treatment, even if you or your child begin to feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

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 (extended-release tablets):
  • For bacterial infections:
    • Adults—1000 milligrams (mg) once a day for 7 to 14 days.
    • Children—Use and dose must be determined by your doctor.
  • For community-acquired pneumonia:
    • Adults—1000 milligrams (mg) once a day for 7 days.
    • Children—Use and dose must be determined by your doctor.
• For oral dosage forms (suspension and tablets):
  • For bacterial infections:
    • Adults—250 to 500 milligrams (mg) every 12 hours for 7 to 14 days.
    • Children 6 months of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 7.5 milligrams (mg) per kilogram (kg) of body weight every 12 hours for 10 days.
    • Infants younger than 6 months of age—Use and dose must be determined by your doctor.
  • For community-acquired pneumonia:
    • Adults—250 milligrams (mg) every 12 hours for 7 to 14 days.
    • Children 6 months of age and older—Dose is based on body weight and must be determined by your doctor.
    • Infants younger than 6 months of age—Use and dose must be determined by your doctor.
  • For prevention or treatment of Mycobacterium avium complex (MAC) infection:
    • Adults—500 milligrams (mg) 2 times a day.
    • Children 20 months of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 7.5 milligrams (mg) per kilogram (kg) of body weight, up to 500 mg, 2 times a day.
    • Children younger than 20 months of age—Use and dose must be determined by your doctor.
  • For treatment of ulcers associated with H. pylori:
    • Adults—500 milligrams (mg) every 8 hours for 14 days in combination with omeprazole, 500 mg every 12 hours in combination with amoxicillin and lansoprazole for 10 or 14 days, or 500 mg every 12 hours in combination with amoxicillin and omeprazole for 10 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.

Storage—

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.

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

Do not refrigerate or freeze the oral liquid. Throw away any unused mixed medicine after 14 days.

Precautions While Using This Medicine:

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

Do not use this medicine if you or your child are also using astemizole (Hismanal®), cisapride (Propulsid®), lomitapide (Juxtapid®), lovastatin (Mevacor®), pimozide (Orap®), simvastatin (Zocor®), terfenadine (Seldane®), or certain ergot medicines (eg, dihydroergotamine, ergotamine, D.H.E. 45®, Ergomar®, Ergostat®, or Migranal®). If you have kidney or liver disease, do not take this medicine together with colchicine (Colcrys®). Using these medicines together may increase the risk for more serious side effects.

If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

Make sure your doctor knows if you are pregnant or planning to become pregnant. If you become pregnant while using this medicine, tell your doctor right away.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have a rash, itching, hoarseness, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat while you or your child are using this medicine.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you or your child have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you or your child are using this medicine.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

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.

Clarithromycin may increase the risk for heart and blood vessel problems in patients with these conditions. It may occur a year or 10 years after the use of this medicine. Talk to your doctor if you have concerns about this risk.

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

This medicine may make you dizzy or confused. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

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.

Side Effects of This Medicine:

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

Chills

cough

fever

hoarseness

lower back or side pain

painful or difficult urination

Rare

Fever with or without chills

itching, skin rash

nausea

severe stomach cramps and pain

stomach tenderness

unusual bleeding or bruising

vomiting

watery and severe diarrhea, which may also be bloody

yellow eyes or skin

Incidence not known

Anxiety

black, tarry stools

blistering, peeling, or loosening of the skin

blurred vision

chest pain or discomfort

clay-colored stools

confusion about identity, place, and time

cool, pale skin

dark urine

depression

difficulty with swallowing

dizziness

fainting

fast, slow, pounding, or irregular heartbeat or pulse

feeling of unreality

feeling that others are watching you or controlling your behavior

feeling that others can hear your thoughts

feeling, seeing, or hearing things that are not there

hives

increased hunger

joint or muscle pain

light-colored stools

loss of appetite

nightmares

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

recurrent fainting

red skin lesions, often with a purple center

red, irritated eyes

redness, swelling, or soreness of the tongue

seizures

sense of detachment from self or body

severe mood or mental changes

shakiness

skin eruptions

slurred speech

sore throat

sores, ulcers, or white spots in the mouth or on the lips

stomach pain

swollen glands

tightness in the chest

unpleasant breath odor

unusual behavior

unusual tiredness or weakness

vomiting of blood

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

Belching

bloated or full feeling

change in sensation of taste

excess air or gas in the stomach or bowels

headache

heartburn

indigestion

mild diarrhea

passing gas

Incidence not known

Change in sense of smell

continuing ringing or buzzing or other unexplained noise in the ears

feeling of constant movement of self or surroundings

hearing loss

lightheadedness

loss of taste

mood or mental changes

sensation of spinning

shakiness in the legs, arms, hands, or feet

sore mouth or tongue

swelling or inflammation of the mouth

tongue discoloration

tooth discoloration

trouble sleeping

weight loss

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.