Clarithromycin

Clarithromycin is a prescription drug used to treat a wide variety of bacterial infections. This medication can also be used in combination with anti-ulcer medications to treat certain types of stomach ulcers. It may also be used to prevent certain bacterial infections. Clarithromycin is known as a macrolide antibiotic. It works by stopping the growth of bacteria.

Clarithromycin is available under the following different brand names: Biaxin, and Biaxin XL.

Dosage of Clarithromycin:

Adult and pediatric dosages:

Oral suspension

• 125 mg/5 ml
• 250 mg/5 ml

Tablet

• 250 mg
• 500 mg

Tablet, extended-release (adult dosage only, safety and efficacy not established in children)

• 500 mg

Dosing Considerations – Should be Given as Follows:

Acute Exacerbation of Chronic Bronchitis

Adults:

• 250-500 mg orally every 12 hours for 7-14 days
• Extended-release: 1,000 mg orally once daily for 7 days

Pediatric:

• 15 mg/kg/day orally divided every 12 hours for 10 days

Acute Maxillary Sinusitis

Adult Dosage:

• 500 mg orally every 12 hours for 14 days
• Extended-release: 1,000 mg orally once daily for 14 days

Pediatric Dosage:

• 15 mg/kg/day orally divided every 12 hours for 10 days

Mycobacterial Infection

Adult Dosage:

• 500 mg orally every 12 hours for 7-14 days
• Use with antimycobacterial drugs such as rifampin and ethambutol

Pediatric Dosage:

Prophylaxis and treatment

• 7.5 mg/kg orally divided every 12 hours; individual dose not to exceed 500 mg
• Children under 20 months: safety of clarithromycin for mycobacterium avium complex not studied

Peptic Ulcer Disease

Adult Dosage:

• 500 mg orally every 8-12 hours for 10-14 days
• Administer as part of 2- or 3-drug combination regimen with bismuth subsalicylate, amoxicillin, H2 receptor antagonist, or proton pump inhibitor

Pharyngitis, Tonsillitis

• 250 mg orally every 12 hours for 10 days

Streptococcal Pharyngitis

Pediatric Dosage:

• 7 mg/kg orally every 12 hours for 10 days; individual dose not to exceed 500 mg

Community-Acquired Pneumonia

Adult Dosage:

• 250 mg orally every 12 hours for 7-14 days
• Extended-release: 1,000 mg orally once daily for 7 days

Pediatric Dosage:

• 15 mg/kg/day orally divided every 12 hours for 10 days

Pertussis (off-label)

Adult dosage:

• 500 mg orally twice daily for 7 days

Pediatric Dosage:

• Infants under 1 month: safety and efficacy not established
• Infants 1-6 months: 7.5 mg/kg/dose orally every 12 hours for 7 days
• Infants over 6 months: 7.5 mg/kg/dose orally every 12 hours for 7 days

Skin/Skin Suture Infection

Adult Dosage:

• 250 mg orally for every 12 hours for 7-14 days

Pediatric Dosage:

• 15 mg/kg/day orally divided every 12 hours for 10 days

Endocarditis

Adult Dosage:

Prophylaxis

• 500 mg orally 30-60 minutes before surgical procedure

Pediatric Dosage:

Prophylaxis

• 15 mg/kg orally 30-60 minutes before the surgical procedure; individual dose not to exceed 500 mg

Dosing Modifications

• Renal impairment (creatinine clearance under 30 ml/min): reduce normal dosage by 50%
• In combination with atazanavir: creatinine clearance 30-60 ml/min decrease dose by 50%; creatinine clearance under 30 ml/min, decrease dose by 75%

Dosing Considerations

Susceptible organisms:

• Actinobacillus actinomycetemcomitans, Actinomyces israelii, Actinomyces naeslundii, Actinomyces odontolyticus, Afipia felis, Arachnia propionica, Bartonella henselae, Bartonella quintana, Chlamydia pneumoniae (TWAR agent), Bordetella pertussis, Borrelia recurrentis, Calymmatobacterium granulomatis, Campylobacter jejuni, Chlamydia spp, Haemophilus ducreyi, Haemophilus influenzae, Helicobacter pylori, Legionella pneumophila, Mycobacterium avium complex (MAC), Mycobacterium chelonae, Mycobacterium fortuitum, Mycobacterium genavense, Mycobacterium gordonae, Mycobacterium kansasii, Mycobacterium leprae, Mycobacterium marinum, Mycobacterium scrofulaceum, Mycobacterium simiae, Mycobacterium szulgai, Mycobacterium ulcerans, Mycobacterium xenopi, Mycoplasma pneumoniae, Moraxella (Branhamella) catarrhalis, Staphylococcus aureus, Streptococcus (group C, G), Streptococcus agalactiae (group B), Streptococcus bovis (group D), Streptococcus intermedius group (Streptococcus anginosus, Streptococcus intermedius, Streptococcus constellatus), Streptococcus pneumoniae (penicillin sensitive; minimal inhibitory concentration [MIC] under 0.1 mcg/mL), Streptococcus pyogenes (group A), viridans streptococci, Ureaplasma urealyticum
• H. pylori (with lansoprazole and amoxicillin)
• First-line: A felis, B henselae, B quintana, B pertussis, C jejuni, C pneumoniae, H ducreyi, H pylori, Legionella spp, Mycobacterium avium complex (MAC), M chelonae, M fortuitum, M genavense, M gordonae, M marinum, M scrofulaceum, M simiae, M xenopi; no unanimity on others (H influenzae)

Common Side effects of Clarithromycin include:

• gastrointestinal (GI) effects, general
• abnormal taste
• diarrhea
• nausea
• vomiting
• elevated blood urea nitrogen (BUN)
• abdominal pain
• rash
• indigestion
• heartburn
• headache
• longer time for blood to clot
• severe allergic reaction (anaphylaxis)
• loss of appetite
• anxiety
• Clostridium difficile colitis (fever, diarrhea, abdominal cramps)
• dizziness
• difficulty breathing
• elevated liver function tests
• swelling of the tongue
• hallucinations
• liver dysfunction
• inflammation of the liver (hepatitis)
• low blood sugar (hypoglycemia)
• increased alkaline phosphatase (ALP) levels in the blood
• increased aspartate aminotransferase (AST) levels in the blood
• increased bilirubin levels in the blood
• increased serum creatinine levels in the blood
• yellowing of skin and eyes (jaundice)
• decreased amount of white cells in the blood (leukopenia)
• manic behavior
• neuromuscular blockage
• decreased white blood cells to fight infection (neutropenia)
• pancreatitis
• psychosis
• heart rhythm disorder (QT prolongation)
• seizures
• Stevens-Johnson syndrome (flu-like symptoms, followed by a blistering rash)
• low levels of platelets (thrombocytopenia)
• gas (flatulence)

Postmarketing side effects of Clarithromycin reported include:

• blood and lymphatic system disorders: low levels of platelets (thrombocytopenia), decreased white blood cells to fight infection (agranulocytosis)
• cardiac disorders: rapid and irregular heartbeat (torsades de pointes), fast heart rhythm (ventricular tachycardia), abnormal rapid heart rhythms (ventricular arrhythmia)
• ear and labyrinth disorders: spinning sensation (vertigo), ringing in the ears (tinnitus), deafness was reported chiefly in elderly women and was usually reversible
• gastrointestinal disorders: pancreatitis acute, tongue discoloration, tooth discoloration, burping
• hepatobiliary disorders: severe allergic reaction (anaphylactic reaction)
• immune system disorders: severe allergic reaction, rapid swelling (angioedema)
• infections and infestations: colitis due to recent use of antibiotics (pseudomembranous colitis), bacterial infection of the skin (cellulitis), infection, vaginal infection
• investigations: slow blood clotting time (prothrombin time prolonged), white blood cell count decreased, international normalized ratio increased; abnormal urine color has been reported, associated with liver (hepatic) failure
• metabolism and nutrition disorders: low blood sugar has been reported in patients taking oral hypoglycemic agents or insulin
• musculoskeletal and connective tissue disorders: disease of muscle tissue (myopathy), destruction of muscle tissue (rhabdomyolysis) was reported and in some of the reports, clarithromycin was administrated concomitantly with statins, fibrates, colchicine or allopurinol, muscle spasm, impaired neck flexion (nuchal rigidity)
• nervous system disorders: convulsions, inability to taste (ageusia), abnormal sense of smell (parosmia), loss of sense of smell (anosmia), numbness and tingling, tremors, sleepiness, loss of consciousness, involuntary movement (dyskinesia)
• psychotic disorders: psychotic disorder, confusional state, depersonalization, depression, disorientation, manic behavior, hallucination, abnormal behavior, abnormal dreams
• renal and urinary disorders: inflammation in the kidney (nephritis interstitial), kidney (renal) failure
• skin and subcutaneous tissue disorders: Steven-Johnson syndrome (flu-like symptoms, followed by a blistering rash), dermatologic disorder (toxic epidermal necrolysis or TEN), drug rash with eosinophilia and systemic symptoms (DRESS), Henoch-Schonlein purpura (inflammation of small blood vessels), acne, blistering eruptions (dermatitis bullous), excessive sweating, flat, red area with small bumps (maculo-papular rash)
• vascular disorders: bleeding (hemorrhage)
• other: reports of colchicine toxicity, some resulting in death, with concomitant use of clarithromycin and colchicine, especially in the elderly, some of which occurred in patients with kidney (renal) insufficiency, asthma, nose bleed, blood clot in the lung (pulmonary embolism)

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Clarithromycin has severe interactions with at least 25 different drugs.
• Clarithromycin has serious interactions with at least 215 different drugs.
• Clarithromycin has moderate interactions with at least 238 different drugs.
• Clarithromycin has minor interactions with at least 98 different drugs.

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns, or for more information about this medicine.

Warnings

• Discontinue clarithromycin immediately if signs and symptoms of hepatitis occur (loss of appetite, jaundice, dark urine, pruritus, or tender abdomen)
• This medication contains clarithromycin. Do not take Biaxin or Biaxin XL if you are allergic to clarithromycin or any ingredients contained in this drug
• In case of overdose, get medical help or contact a Poison Control Center immediately

Contraindications

• Documented hypersensitivity
• Coadministration with pimozide, cisapride, ergotamine, and dihydroergotamine
• History of cholestatic jaundice or hepatic dysfunction associated with previous use of clarithromycin
• Coadministration with colchicine in patients with kidney (renal) or liver (hepatic) impairment
• Coadministration with HMG-CoA reductase inhibitors (statins) that are extensively metabolized by CYP3A4 (lovastatin, simvastatin), due to the increased risk of muscle disease (myopathy), including destruction of muscle tissue (rhabdomyolysis)

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Clarithromycin?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Clarithromycin?"

Cautions

• Severe kidney (renal) impairment
• Oral solution must not be refrigerated
• Not for use in pregnancy, except when there is no alternative therapy; apprise patient about potential hazard to fetus if pregnancy occurs while in therapy
• Use for endocarditis prophylaxis is appropriate only for high-risk patients, per American Heart Association (AHA) guidelines
• Associated with heart rhythm disorder (QT interval prolongation) and infrequent cases of arrhythmias, including torsade de pointes; avoid using with ongoing proarrhythmic conditions (uncorrected low blood levels of potassium or low blood levels of magnesium), clinically significant slow heart rate; do not coadminister with class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmics
• Elderly patients may be more susceptible to drug-associated hear rate disorder (QT prolongation)
• Use caution in patients with coronary artery disease; postmarketing trials suggest increased risk of cardiovascular mortality
• Discontinue immediately if severe hypersensitivity reactions occur (severe allergic reaction (anaphylaxis), Stevens-Johnson syndrome, TEN, drug reaction with eosinophilia and systemic symptoms [DRESS] syndrome, Henoch-Schonlein purpura)
• Clostridium difficile associated diarrhea reported with use of nearly all antibacterial agents, including clarithromycin
• May cause kidney injury when administered concomitantly with calcium channel blockers metabolized by CYP3A4
• Do not coadminister with ranitidine/bismuth citrate with history of acute porphyria or if Creatinine Clearance under 25 mL/min
• Coadministration with quetiapine may result in quetiapine related toxicities including neuroleptic malignant syndrome, heart rhythm disorder (QT prolongation), sleepiness, dizziness upon standing, altered state of consciousness
• Exacerbation of myasthenia gravis or new onset of symptoms reported
• Hepatic dysfunction
• Increased liver enzyme activity and hepatocellular or cholestatic hepatitis, with or without jaundice, have been reported; this may be severe and is usually reversible
• In some instances, hepatic failure with fatal outcome has been reported, generally in association with serious underlying diseases or concomitant medications
• Discontinue clarithromycin immediately if signs and symptoms of hepatitis occur (anorexia, jaundice, dark urine, pruritus, or tender abdomen)

Pregnancy and Lactation

• Use clarithromycin during pregnancy with caution if benefits outweigh risks. Animal studies show risk and human studies are not available, or neither animal nor human studies were done
• Clarithromycin is excreted in breast milk; use with caution if breastfeeding. Consult your doctor