Klaryz

Clarithromycin.

Film-coated tablet: Each film-coated tablet contains: Clarithromycin, USP 500 mg.
Granules for oral suspension: Each 5 mL (1 teaspoonful) suspension contains: Clarithromycin, USP 125 mg.

Pharmacology: Clarithromycin is rapidly absorbed from the gastrointestinal tract following oral administration and undergoes first-pass metabolism; the bioavailability of the parent drug is about 55%. The extent of absorption is relatively unaffected by the presence of food. Peak concentrations of clarithromycin and its principal active metabolite 14-hydroxyclarithromycin are reported to be about 0.6 and 0.7 g per mL respectively following a single 250 mg dose by mouth; at steady state the same dosage given every 12 hours as tablets produces peak concentrations of clarithromycin of about 1 g per mL. The same dose given as a suspension produces a steady state plasma concentration of about 2 g per mL.
The pharmacokinetics of clarithromycin is nonlinear and dose dependent; high doses may produce disproportionate increase in peak concentration of the parent drug, due to saturation of the metabolic pathways.
The drug and its principal metabolite are widely distributed and tissue concentrations exceed those in serum, in part because of intracellular uptake. Clarithromycin has been detected in breast milk. It is extensively metabolized in the liver and excreted in feces via the bile. Substantial amount are excreted in urine; at a steady state about 20% and 30%, respectively of a 250 mg or 500 mg dose is excreted in this way, as unchanged drug. 14-hydroxyclarithromycin as well as other metabolites are also excreted in the urine accounting for 10 to 15% of the dose. The terminal half-life of Clarithromycin is reportedly about 3 to 4 hours in patients receiving 250 mg doses twice daily and about 5 to 7 hours in those receiving 500 mg twice daily. The half-life is prolonged in renal impairment.

Clarithromycin is given in the treatment of respiratory tract infections (including otitis media) and in skin and soft tissue infections. It is also used for prophylaxis treatment of opportunistic mycobacterial infections and for the treatment of leprosy.
Clarithromycin may be given to eradicate Helicobacter pylori in treatment regimens for peptic ulcer diseases.

Film-coated tablet: Usual dose in adult is 250 mg twice daily for 7 to 14 days, increased to 500 mg twice daily if necessary in severe infections.
For disseminated infection due to Mycobacterium complex, clarithromycin may be given 500 mg twice daily in conjunction with other anti-mycobacterials.
Granules for oral suspension: The recommended daily dosage of Clarithromycin Pediatric Suspension (125 mg/5 mL) in children is 7.5 mg/kg twice a day up to a maximum dose of 500 mg twice daily for non-mycobacterial infections. The usual duration of treatment is for 5 to 10 days depending on the pathogen involved and the severity of the condition. The prepared suspension can be taken with or without meals and can be taken with milk. Or as prescribed by the physician.
In children with creatinine clearance less than 30 mL/min, the dosage of Clarithromycin should be reduced by one-half, i.e. up to 250 mg once daily, or 250 mg twice daily in more severe infections. Dosage should not be continued beyond 14 days in these patients. Or as prescribed by the physician.

Film-coated tablet: Overdose symptoms may include severe stomach pain, nausea, vomiting, or diarrhea. Seek emergency medical attention immediately.
Granules for oral suspension: Reports indicate that the ingestion of large amounts of Clarithromycin can be expected to produce gastrointestinal symptoms. One patient who had a history of bipolar disorder ingested eight grams of Clarithromycin and showed altered mental status, paranoid behavior and hypokalemia. Adverse reactions accompanying overdosage should be treated by the prompt elimination of unabsorbed drug and supportive measures. As with other macrolides, Clarithromycin serum levels are not expected to be appreciably affected by hemodialysis or peritoneal dialysis.

Clarithromycin film-coated tablets and granules for oral suspension is contraindicated in patients with known hypersensitivity to macrolide antibiotic drugs.
Concomitant administration of Clarithromycin and any of the following drugs is contraindicated: astemizole, cisapride, pimozide and terfenadine.

If Clarithromycin film-coated tablet and suspension is considered for patients of post-pubertal age, the physician should carefully weigh the benefits against the risk when pregnancy is either suspected or confirmed.
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including macrolides and may range from mild to life threatening.

The liver excretes Clarithromycin. Therefore, caution should be exercised in administering the antibiotic to patients with impaired hepatic function and with moderate to severe renal failure.
Attention should be paid to the possibility of cross-resistance between Clarithromycin and other macrolide drugs, as well as lincomycin and clindamycin.
Clarithromycin should not be used during pregnancy if possible. High doses have been associated with embryo toxicity in animal studies.

If Clarithromycin film-coated tablet and suspension is considered for patients of post-pubertal age, the physician should carefully weigh the benefits against the risk when pregnancy is either suspected or confirmed.
Clarithromycin should not be used during pregnancy if possible. High doses have been associated with embryo toxicity in animal studies.
Film-coated tablet: Clarithromycin should not be used during pregnancy unless there are no alternatives and the benefit outweighs the risk. Clarithromycin can pass into breast milk and may harm a nursing baby. Tell the doctor if the patient is breast-feeding a baby.

Film-coated tablet: Reports indicate that the ingestion of large amounts of Clarithromycin can be expected to produce gastrointestinal symptoms. One patient who had a history of bipolar disorder ingested eight grams of Clarithromycin and showed altered mental status, paranoid behavior and hypokalemia. Adverse reactions accompanying overdosage should be treated by the prompt elimination of unabsorbed drug and supportive measures. As with other macrolides, Clarithromycin serum levels are not expected to be appreciably affected by hemodialysis or peritoneal dialysis.

Increased Rifabutin toxicity has been reported in patients receiving Clarithromycin and Rifabutin and there has been a report of delirium following concurrent use with Fluoxetine.

Store at temperatures not exceeding 30°C.
Granules for oral suspension: Do not refrigerate the reconstituted suspension.

Macrolides

J01FA09 - clarithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.

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