Clarithromycin

DRUG INFORMATION

  ADULT
    - Adults : Clarithromycin tablets 250 mg or 500 mg every 12 hours for 7 to 14 days (
      2.2 ) 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.
      Source: US FDA label for clarithromycin (Clarithromycin), section 'dosage and
      administration', retrieved 2026-08-29
    - Clarithromycin tablets can be discontinued when the patient is considered at low
      risk of disseminated infection. 2.3 Combination Dosing Regimens for H. pylori
      Infection Triple therapy: Clarithromycin tablets/lansoprazole/amoxicillin The
      recommended adult dosage is 500 mg clarithromycin tablets, 30 mg lansoprazole, and
      1 gram amoxicillin, all given every 12 hours for 10 or 14 days [see Indications
      and Usage (1.8) and Clinical Studies (14.3) ] .
      Source: US FDA label for clarithromycin (Clarithromycin), section 'dosage and
      administration', retrieved 2026-08-29
    - Triple therapy: Clarithromycin tablets/omeprazole/amoxicillin The recommended
      adult dosage is 500 mg clarithromycin tablets, 20 mg omeprazole, and 1 gram
      amoxicillin; all given every 12 hours for 10 days.
      Source: US FDA label for clarithromycin (Clarithromycin), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - Adults : Clarithromycin tablets 250 mg or 500 mg every 12 hours for 7 to 14 days (
      2.2 ) 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. See full prescribing information (FPI) for additional
      information.
      Source: US FDA label for clarithromycin (Clarithromycin), section 'dosage and
      administration', retrieved 2026-08-29
    - An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer
      healing and symptom relief [see Indications and Usage (1.8) and Clinical Studies
      (14.3) ]. 2.4 Pediatric Dosage The recommended daily dosage is 15 mg/kg/day
      divided every 12 hours for 10 days (up to the adult dose).
      Source: US FDA label for clarithromycin (Clarithromycin), section 'dosage and
      administration', retrieved 2026-08-29
    - Pediatric Patients For treatment and prophylaxis of mycobacterial infections in
      pediatric patients, the recommended dose is 7.5 mg/kg every 12 hours up to 500 mg
      every 12 hours. [See Use in Specific Populations (8.4) and Clinical Studies (14.1)
      ] .
      Source: US FDA label for clarithromycin (Clarithromycin), section 'dosage and
      administration', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - Clarithromycin tablets can be discontinued when the patient is considered at low
      risk of disseminated infection. 2.6 Dosage Adjustment in Patients with Renal
      Impairment See Table 2 for dosage adjustment in patients with moderate or severe
      renal impairment with or without concomitant atazanavir or ritonavir-containing
      regimens [see Drug Interactions (7) ] .
      Source: This line points to a numbered table that this card does not show - read
      that table in the label before you dose. US FDA label for clarithromycin
      (Clarithromycin), section 'dosage and administration', retrieved 2026-08-29
    - Consider dosage adjustment in elderly patients with severe renal impairment.
      Source: US FDA label for clarithromycin (Clarithromycin), section 'use in specific
      populations', retrieved 2026-08-29
    - Especially in elderly patients, there have been reports of colchicine toxicity
      with concomitant use of clarithromycin and colchicine, some of which occurred in
      patients with renal insufficiency.
      Source: US FDA label for clarithromycin (Clarithromycin), section 'use in specific
      populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - Deaths have been reported in some patients [see Contraindications (4.4) and
      Warnings and Precautions (5.4) ] . 8.6 Renal and Hepatic Impairment Clarithromycin
      is principally excreted via the liver and kidney.
      Source: US FDA label for clarithromycin (Clarithromycin), section 'use in specific
      populations', retrieved 2026-08-29
    - Clarithromycin may be administered without dosage adjustment to patients with
      hepatic impairment and normal renal function.
      Source: US FDA label for clarithromycin (Clarithromycin), section 'use in specific
      populations', retrieved 2026-08-29
    - However, in the presence of severe renal impairment with or without coexisting
      hepatic impairment, decreased dosage or prolonged dosing intervals may be
      appropriate [see Dosage and Administration (2.6) ] .
      Source: US FDA label for clarithromycin (Clarithromycin), section 'use in specific
      populations', retrieved 2026-08-29

  PREGNANCY
    - Risk Summary Based on findings from animal studies, clarithromycin is not
      recommended for use in pregnant women except in clinical circumstances where no
      alternative therapy is appropriate.
      Source: US FDA label for clarithromycin (Clarithromycin), section 'pregnancy',
      retrieved 2026-08-29
    - If pregnancy occurs while taking clarithromycin, the patient should be apprised of
      the potential hazard to the fetus [see Warnings and Precautions (5.7) ].
      Source: US FDA label for clarithromycin (Clarithromycin), section 'pregnancy',
      retrieved 2026-08-29
    - Limited data from a small number of published human studies with clarithromycin
      use during pregnancy are insufficient to inform drug-associated risks of major
      birth defects, miscarriage, or adverse maternal or fetal outcomes.
      Source: US FDA label for clarithromycin (Clarithromycin), section 'pregnancy',
      retrieved 2026-08-29

  BREASTFEEDING
    - Males Administration of clarithromycin resulted in testicular atrophy in rats,
      dogs and monkeys [see Nonclinical Toxicology (13.1) ] .
      Source: US FDA label for clarithromycin (Clarithromycin), section 'nursing
      mothers', retrieved 2026-08-29
    - In a reproductive toxicology study in rats administered oral clarithromycin late
      in gestation through lactation (GD 17 to post-natal day 21) at doses of 10, 40, or
      160 mg/kg/day (≤ 1 times MRHD based on body surface area comparison), reductions
      in maternal body weight and food consumption were observed at 160 mg/kg/day.
      Source: US FDA label for clarithromycin (Clarithromycin), section 'use in specific
      populations', retrieved 2026-08-29
    - No adverse developmental effects were observed with clarithromycin at any dose
      tested. 8.2 Lactation Risk Summary Based on limited human data, clarithromycin and
      its active metabolite 14-OH clarithromycin are present in human milk at less than
      2% of the maternal weight-adjusted dose (see Data).
      Source: US FDA label for clarithromycin (Clarithromycin), section 'use in specific
      populations', retrieved 2026-08-29