{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "clarithromycin",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "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",
        "cached_file": "labels/clarithromycin.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/clarithromycin.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/clarithromycin.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "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",
        "cached_file": "labels/clarithromycin.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/clarithromycin.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/clarithromycin.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "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",
        "cached_file": "labels/clarithromycin.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/clarithromycin.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/clarithromycin.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "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",
        "cached_file": "labels/clarithromycin.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/clarithromycin.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/clarithromycin.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "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",
        "cached_file": "labels/clarithromycin.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/clarithromycin.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/clarithromycin.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "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",
        "cached_file": "labels/clarithromycin.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/clarithromycin.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/clarithromycin.json",
        "verbatim": true
      }
    ]
  }
}