Biaxin, Biaxin XL

Clarithromycin is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6-0methylerythromycin. The molecular formula is C38H69NO13, and the molecular weight is 747.96. The structural formula is:

Figure 1: Structure of Clarithromycin

Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in methanol, ethanol, and acetonitrile, and practically insoluble in water.

BIAXIN is available as immediate-release tablets, extended-release tablets, and granules for oral suspension.

Each yellow oval film-coated immediate-release BIAXIN Filmtab tablet (clarithromycin tablets, USP) contains 250 mg or 500 mg of clarithromycin and the following inactive ingredients:

• 250 mg tablets: hypromellose, hydroxypropyl cellulose, croscarmellose sodium, D&C Yellow No. 10, FD&C Blue No. 1, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, silicon dioxide, sorbic acid, sorbitan monooleate, stearic acid, talc, titanium dioxide, and vanillin.
• 500 mg tablets: hypromellose, hydroxypropyl cellulose, colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10, magnesium stearate, microcrystalline cellulose, povidone, propylene glycol, sorbic acid, sorbitan monooleate, titanium dioxide, and vanillin.

Each yellow oval film-coated BIAXIN XL Filmtab tablet (clarithromycin extended-release tablets) contains 500 mg of clarithromycin and the following inactive ingredients: cellulosic polymers, D&C Yellow No. 10, lactose monohydrate, magnesium stearate, propylene glycol, sorbic acid, sorbitan monooleate, talc, titanium dioxide, and vanillin.

Each 5 mL of BIAXIN reconstituted suspension (clarithromycin for oral suspension, USP) contains 125 mg or 250 mg of clarithromycin. Each bottle of BIAXIN granules contains 1250 mg (50 mL size), 2500 mg (50 and 100 mL sizes) or 5000 mg (100 mL size) of clarithromycin and the following inactive ingredients: carbomer, castor oil, citric acid, hypromellose phthalate, maltodextrin, potassium sorbate, povidone, silicon dioxide, sucrose, xanthan gum, titanium dioxide and fruit punch flavor.

Dosage Forms And Strengths

BIAXIN is available as:

• BIAXIN Filmtab (yellow oval film-coated tablet):
  • 250 mg: imprinted in blue with the “a” logo and KT
  • 500 mg: debossed with the “a” logo on one side and KL on the opposite side
• BIAXIN XL Filmtab (yellow oval film-coated extended-release tablet):
  • 500 mg: debossed with the “a” logo and KJ
• BIAXIN Granules (white to off-white granules before reconstitution; white to off-white opaque suspension after reconstitution):
  • 125 mg/5 mL concentration available in 50 mL and 100 mL bottles
  • 250 mg/5 mL concentration available in 50 mL and 100 mL bottles

Storage And Handling

BIAXIN Filmtab (clarithromycin tablets, USP) is supplied as yellow oval film-coated tablets in the following packaging sizes:

250 mg tablets: (imprinted in blue with the “a” logo and KT)

Bottles of 60 (NDC 0074-3368-60) and unit dose strip packages of 100 (NDC 0074-3368-11).

Store BIAXIN Filmtab 250 mg at controlled room temperature 15° to 30°C (59° to 86°F) in a well-closed container. Protect from light.

500 mg tablets: (debossed with the “a” logo on one side and KL on the opposite side)

Bottles of 60 (NDC 0074-2586-60) and unit dose strip packages of 100 (NDC 0074-2586-11).

Store BIAXIN Filmtab 500 mg at controlled room temperature 20° to 25°C (68° to 77°F) in a well-closed container.

BIAXIN XL Filmtab (clarithromycin extended-release tablets) is supplied as yellow oval film-coated tablets in the following packaging sizes:

500 mg tablets: (debossed with the “a” logo and KJ)

Bottles of 60 (NDC 0074-3165-60), unit dose strip packages of 100 (NDC 0074-3165-11), and BIAXIN XL PAC carton of 4 blister packages 14 tablets each (NDC 0074-3165-41).

Store BIAXIN XL Filmtab at 20° to 25°C (68° to 77°F). Excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]

BIAXIN Granules (clarithromycin for oral suspension, USP) is supplied as white to off-white granules in the following strengths and sizes:

Store BIAXIN Granules below 25°C (77°F) in a well-closed container. Do not refrigerate the reconstituted BIAXIN granules.

BIAXIN Filmtab 250 mg and 500 mg and BIAXIN XL Filmtab 500 mg. Mfd. by AbbVie LTD, Barceloneta, PR 00617. BIAXIN Granules, 125 mg/5 mL and 250 mg/5 Ml. Mfd. by AbbVie Inc., North Chicago, IL 60064. For AbbVie Inc., North Chicago, IL 60064, U.S.A. Revised: June, 2017

You should not use this medication if you are allergic to clarithromycin, or to similar medicines such as azithromycin (Zithromax), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), or telithromycin (Ketek).

You should not use this medication if you have a life-threatening heart rhythm disorder, a history of Long QT syndrome, if you have ever had jaundice or liver problems caused by taking clarithromycin, or if you have liver or kidney disease and are also taking colchicine (Colcrys).

Do not use clarithromycin if you are also using any of the drugs listed below. They can interact with clarithromycin and cause serious or life-threatening side effects:

• cisapride (Propulsid);
• pimozide (Orap);
• lovastatin (Mevacor, Altoprev, Advicor) or simvastatin (Zocor, Simcor, Vytorin); or
• ergot medicine such as ergotamine (Ergomar, Ergostat, Cafergot, Ercaf, Wigraine), or dihydroergotamine (D.H.E. 45, Migranal Nasal Spray).

Take this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Clarithromycin will not treat a viral infection such as the common cold or flu.