{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "bisoprolol",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "The usual starting dose is 5 mg once daily.",
        "source": "US FDA label for bisoprolol (Bisoprolol fumarate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/bisoprolol.json",
        "verbatim": true
      },
      {
        "text": "In some patients, 2.5 mg may be an appropriate starting dose (see Bronchospastic Disease in WARNINGS ).",
        "source": "US FDA label for bisoprolol (Bisoprolol fumarate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/bisoprolol.json",
        "verbatim": true
      },
      {
        "text": "If the antihypertensive effect of 5 mg is inadequate, the dose may be increased to 10 mg and then, if necessary, to 20 mg once daily.",
        "source": "US FDA label for bisoprolol (Bisoprolol fumarate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/bisoprolol.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Safety and effectiveness in pediatric patients have not been established.",
        "source": "US FDA label for bisoprolol (Bisoprolol fumarate), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/bisoprolol.json",
        "verbatim": true
      },
      {
        "text": "The dose of bisoprolol fumarate tablets must be individualized to the needs of the patient. The usual starting dose is 5 mg once daily. In some patients, 2.5 mg may be an appropriate starting dose (see Bronchospastic Disease in WARNINGS ). If the antihypertensive effect of 5 mg is inadequate, the dose may be increased to 10 mg and then, if necessary, to 20 mg once daily.",
        "source": "US FDA label for bisoprolol (Bisoprolol fumarate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/bisoprolol.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "Patients with Renal or Hepatic Impairment In patients with hepatic impairment (hepatitis or cirrhosis) or renal dysfunction (creatinine clearance less than 40 mL/min), the initial daily dose should be 2.5 mg and caution should be used in dose-titration.",
        "source": "US FDA label for bisoprolol (Bisoprolol fumarate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/bisoprolol.json",
        "verbatim": true
      },
      {
        "text": "Since limited data suggest that bisoprolol fumarate is not dialyzable, drug replacement is not necessary in patients undergoing dialysis.",
        "source": "US FDA label for bisoprolol (Bisoprolol fumarate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/bisoprolol.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "Patients with Renal or Hepatic Impairment In patients with hepatic impairment (hepatitis or cirrhosis) or renal dysfunction (creatinine clearance less than 40 mL/min), the initial daily dose should be 2.5 mg and caution should be used in dose-titration.",
        "source": "US FDA label for bisoprolol (Bisoprolol fumarate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/bisoprolol.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "In rats, bisoprolol fumarate was not teratogenic at doses up to 150 mg/kg/day which is 375 and 77 times the MRHD on the basis of body weight and body surface area, respectively.",
        "source": "US FDA label for bisoprolol (Bisoprolol fumarate), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/bisoprolol.json",
        "verbatim": true
      },
      {
        "text": "Bisoprolol fumarate was fetotoxic (increased late resorptions) at 50 mg/kg/day and maternotoxic (decreased food intake and body weight gain) at 150 mg/kg/day.",
        "source": "US FDA label for bisoprolol (Bisoprolol fumarate), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/bisoprolol.json",
        "verbatim": true
      },
      {
        "text": "The fetotoxicity in rats occurred at 125 times the MRHD on a body weight basis and 26 times the MRHD on the basis of body surface area.",
        "source": "US FDA label for bisoprolol (Bisoprolol fumarate), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/bisoprolol.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Small amounts of bisoprolol fumarate (< 2% of the dose) have been detected in the milk of lactating rats.",
        "source": "US FDA label for bisoprolol (Bisoprolol fumarate), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/bisoprolol.json",
        "verbatim": true
      },
      {
        "text": "It is not known whether this drug is excreted in human milk.",
        "source": "US FDA label for bisoprolol (Bisoprolol fumarate), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/bisoprolol.json",
        "verbatim": true
      },
      {
        "text": "Because many drugs are excreted in human milk caution should be exercised when bisoprolol fumarate is administered to nursing women.",
        "source": "US FDA label for bisoprolol (Bisoprolol fumarate), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/bisoprolol.json",
        "verbatim": true
      }
    ]
  }
}