Clarithromycin

What is Clarithromycin?

• Clarithromycin (Biaxin) is a semisynthetic macrolide antibiotic used for a wide variety of mild-to-moderate bacterial infections.

Clarithromycin structure

Clarithromycin ball-and-stick

Clarithromycin skeletal

What are the uses of this medicine?

Clarithromycin (Biaxin) is used for mild to moderate infections caused by designated, susceptible bacteria in the following:

• Acute Bacterial Exacerbation of Chronic Bronchitis in Adults
• Acute Maxillary Sinusitis
• Community-Acquired Pneumonia
• Pharyngitis/Tonsillitis
• Uncomplicated Skin and Skin Structure Infections
• Acute Otitis Media in Pediatric Patients
• Treatment and Prophylaxis of Disseminated Mycobacterial Infections
• Helicobacter pylori Infection and Duodenal Ulcer Disease in Adults

Limitations of use: clarithromycin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. There is resistance to macrolides in certain bacterial infections caused by Streptococcus pneumoniae and Staphylococcus aureus. Susceptibility testing should be performed when clinically indicated.

How does this medicine work?

• Clarithromycin is a macrolide antimicrobial drug.
• Clarithromycin exerts its antibacterial action by binding to the 50S ribosomal subunit of susceptible bacteria resulting in inhibition of protein synthesis.
• Clarithromycin, like other macrolide antibiotics such such as eythromycin and azithromycin, is bacteriostatic against many gram positive bacteria including many strains of streptococci, staphylococci, clostridia, corynebacteria, listeria, haemophilus sp., moxicella, and Neisseria meningitidis.
• Clarithromycin is also active against Chlamydia pneumoniae, Helicobacter pylori, and several atypical mycobacteria.
• Macrolide antibiotics act by inhibiting protein synthesis of bacteria by binding to the 50S ribosomal element.
• Resistance occurs by several mechanisms.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with hypersensitivity to clarithromycin or any macrolide drug
• using cisapride and pimozide
• with History of cholestatic jaundice/hepatic dysfunction with use of clarithromycin
• using colchicine in renal or hepatic impairment
• using lomitapide, lovastatin, and simvastatin
• using ergot alkaloids (ergotamine or dihydroergotamine)

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• cisapride (Propulsid; not available in U.S.)
• colchicine (Colcrys, Mitigare) if you have kidney or liver disease, dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar, in Cafergot, in Migergot), lomitapide (Juxtapid), lovastatin (in Advicor), pimozide (Orap), or simvastatin (Flolipid, Zocor, in Vytorin)
• anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven)
• certain benzodiazepines such as alprazolam (Xanax), midazolam, and triazolam (Halcion)
• bromocriptine (Parlodel)
• calcium channel blockers such as amlodipine (Norvasc, in Caduet, in Lotrel), diltiazem (Cardizem, Cartia, Tiazac), nifedipine (Adalat, Afeditab CR), and verapamil (Calan, Verelan, in Tarka, others)
• carbamazepine (Epitol, Tegretol, Teril, others)
• colchicine (Colcrys, Mitigare)
• certain medications for HIV such as atazanavir (Reyataz), didanosine (Videx), efavirenz (Sustiva, in Atripla), etravirine (Intelence), nevirapine (Viramune), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), saquinavir (Invirase), and zidovudine (AZT, Retrovir)
• certain medications for irregular heartbeat such as amiodarone (Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), procainamide, quinidine (in Nuedexta), and sotalol (Betapace, Sorine)
• cholesterol-lowering medications (statins) such as atorvastatin (Lipitor, in Caduet), and pravastatin (Pravachol)
• cilostazol
• cyclosporine (Gengraf, Neoral, Sandimmune)
• darifenacin (Enablex)
• digoxin (Digitek, Lanoxin)
• erlotinib (Tarceva)
• eszopiclone (Lunesta)
• fluconazole (Diflucan)
• insulin
• itraconazole (Onmel, Sporanox)
• maraviroc (Selzentry)
• methylprednisolone (Medrol)
• omeprazole (Prilosec)
• oral medications for diabetes such as nateglinide (Starlix), pioglitazone (Actos, in Actoplus Met, in Duetact), repaglinide (Prandin, in Prandimet), and rosiglitazone (Avandia, in Avandamet, in Avandaryl)
• phenobarbital
• phenytoin (Dilantin, Phenytek)
• quetiapine (Seroquel)
• ranitidine (Zantac)
• rifabutin (Mycobutin)
• rifampin (Rifadin, Rimactane, in Rifater, in Rifamate)
• rifapentine (Priftin)
• sildenafil (Revatio, Viagra)
• tacrolimus (Astagraf, Prograf)
• theophylline (Elixophyllin, Theo-24, Theochron)
• tadalafil (Adcirca, Cialis)
• tolterodine (Detrol)
• valproate (Depacon)
• vardenafil (Levitra, Staxyn)
• vinblastine
• St. John's wort

Is this medicine FDA approved?

• Clarithromycin was approved for use in the United States in 1993, and currently more than 3 million prescriptions are filled yearly.
• Typical indications are for upper respiratory infections, bronchitis, sinusitis, community acquired pneumonia, and skin and tissue infections. Clarithromycin is also used for infections caused by Chlamydia pneumoniae, Helicobacter pylori and atypical mycobacteria.

How should this medicine be used?

Recommended dosage: In adults:

• clarithromycin tablets 250 mg or 500 mg every 12 hours for 7 to 14 days.

In H. pylori eradication (in combination with lansoprazole/amoxicillin, omeprazole/amoxicillin, or omeprazole):

• clarithromycin tablets 500 mg every 8 or 12 hours for 10 to 14 days.

In Pediatric Patients:

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

For Mycobacterial Infections:

• clarithromycin tablets 500 mg every 12 hours; clarithromycin tablets 7.5 mg/kg up to 500 mg every 12 hours in pediatric patients.

• Reduce dose in moderate renal impairment with concomitant atazanavir or ritonavir-containing regimens and in severe renal impairment.

Administration:

• Clarithromycin comes as a tablet, an extended-release (long-acting) tablet, and a suspension (liquid) to take by mouth.
• The regular tablet and liquid are usually taken with or without food every 8 (three times a day) to 12 hours (twice a day) for 7 to 14 days.
• The extended-release tablet is usually taken with food every 24 hours (once a day) for 7 to 14 days.
• Advise patients that clarithromycin tablets can be taken with or without food and can be taken with milk.
• Your doctor may tell you to take clarithromycin for a longer time depending on your condition.
• Take clarithromycin at around the same time every day.
• Shake the suspension well before each use to mix the medication evenly.
• Swallow the long-acting tablets whole; do not split, chew, or crush them.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 250 mg and 500 mg

This medicine is available in fallowing brand namesː

• Biaxin Filmtab
• Biaxin Granules
• Biaxin XL Filmtab
• Biaxin XL Pac
• Claripen
• Clacid

What side effects can this medication cause?

The most common side effects of this medicine include:

• abdominal pain
• diarrhea
• nausea
• vomiting
• dysgeusia
• Headache
• Flatulence
• Rash
• Taste Perversion

The following serious adverse reactions are described below:

• Acute Hypersensitivity Reactions
• QT Prolongation
• Hepatotoxicity
• Serious Adverse Reactions Due to Concomitant Use with Other Drugs
• Clostridium difficile Associated Diarrhea
• Exacerbation of Myasthenia Gravis

What special precautions should I follow?

• In the event of severe acute hypersensitivity reactions, such as anaphylaxis, Stevens-Johnson Syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), Henoch-Schonlein purpura, and acute generalized exanthematous pustulosis, discontinue clarithromycin tablets therapy immediately and institute appropriate treatment.
• Clarithromycin tablets have been associated with prolongation of the QT interval. Avoid clarithromycin tablets in patients with known QT prolongation or receiving drugs known to prolong the QT interval, ventricular arrhythmia (torsades de pointes), hypokalemia/hypomagnesemia, significant bradycardia, or taking Class IA or III antiarrhythmics.
• Hepatic dysfunction, including increased liver enzymes, and hepatocellular and/or cholestatic hepatitis, with or without jaundice, has been reported with clarithromycin. Discontinue if signs and symptoms of hepatitis occur.
• Serious adverse reactions can occur due to drug interactions of clarithromycin tablets with colchicine, some lipid-lowering agents, some calcium channel blockers, and other drugs.
• Risk of all-cause mortality one year or more after the end of treatment in patients with coronary artery disease. Balance this potential risk with the treatment benefits when prescribing clarithromycin tablets in these patients.
• Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clarithromycin tablets, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. Evaluate if diarrhea occurs.
• Based on animal findings, clarithromycin tablets is not recommended for use in pregnant women except in clinical circumstances where no alternative therapy is appropriate.
• Exacerbation of myasthenia gravis has been reported in patients receiving clarithromycin tablets therapy.
• Prescribing clarithromycin tablets in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
• You should know that clarithromycin may make you dizzy, confused, or disoriented. Do not drive a car or operate machinery until you know how this medication affects you.
• Clarithromycin has been linked to rare instances of acute liver injury that can be severe and even fatal.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• gastrointestinal symptoms such as abdominal pain, vomiting, nausea, and diarrhea

Management of overdosage:

• Treat adverse reactions accompanying overdosage by the prompt elimination of unabsorbed drug and supportive measures.
• As with othermacrolides, clarithromycin serum concentrations are not expected to be appreciably affected by hemodialysis or peritoneal dialysis.

Can this medicine be used in pregnancy?

• Based on findings from animal studies, clarithromycin tablets are not recommended for use in pregnant women except in clinical circumstances where no alternative therapy is appropriate.
• If pregnancy occurs while taking clarithromycin tablets, the patient should be apprised of the potential hazard to the fetus.

Can this medicine be used in children?

• Safety and effectiveness of clarithromycin in pediatric patients under 6 months of age have not been established.
• The safety and effectiveness of clarithromycin tablets have been established for the treatment of the following conditions or diseases in pediatric patients 6 months and older:
• Pharyngitis/Tonsillitis
• Community-Acquired Pneumonia
• Acute maxillary sinusitis
• Acute otitis media
• Uncomplicated skin and skin structure infections

What are the active and inactive ingredients in this medicine?

Active ingredient:

• CLARITHROMYCIN

Inactive ingredients:

• MICROCRYSTALLINE CELLULOSE
• CROSCARMELLOSE SODIUM
• HYPROMELLOSE 2910
• HYPROMELLOSE 2910
• MAGNESIUM STEARATE
• POLYETHYLENE GLYCOL 400
• POLYSORBATE 80
• POVIDONE, UNSPECIFIED
• TALC
• TITANIUM DIOXIDE

Who manufactures and distributes this medicine?

• Manufactured in Romania by S.C. Sandoz S.R.L. for
• Sandoz Inc., Princeton, NJ

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

• Store at 20° to 25°C (68° to 77°F).
• Dispense in a tight container as described in the USP.
• Protect from light.

The following are macrolides

• Azithromycin
• Clarithromycin
• Erythromycin
• Fidaxomicin
• Telithromycin

• Dailymed label info on Clarithromycin
• FDA Clarithromycin

Clarithromycin Resources
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