Diltiazem

DRUG INFORMATION

  ADULT
    - ( 2 ) Hypertension: Initial adult dose is 180 to 240 mg once daily.
      Source: US FDA label for diltiazem (DILTIAZEM HYDROCHLORIDE), section 'dosage and
      administration', retrieved 2026-08-29
    - Adjust dose according to blood pressure response to a maximum of 540 mg daily (
      2.1 ) Angina: Initial adult dose is 180 mg once daily.
      Source: US FDA label for diltiazem (DILTIAZEM HYDROCHLORIDE), section 'dosage and
      administration', retrieved 2026-08-29
    - Adjust dose according to response to a maximum of 360 mg.
      Source: US FDA label for diltiazem (DILTIAZEM HYDROCHLORIDE), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - Safety and effectiveness in pediatric patients have not been established.
      Source: US FDA label for diltiazem (DILTIAZEM HYDROCHLORIDE), section 'pediatric
      use', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - In general, dose selection for an elderly patient should be cautious, usually
      starting at the low end of the dosing range, reflecting the greater frequency of
      decreased hepatic, renal, or cardiac function, and of concomitant disease or other
      drug therapy. 8.6 Use in Renal Impairment No dose adjustment is necessary. 8.7 Use
      in Hepatic Impairment No dose adjustment is likely to be needed for mild-moderate
      hepatic impairment.
      Source: US FDA label for diltiazem (DILTIAZEM HYDROCHLORIDE), section 'use in
      specific populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - In general, dose selection for an elderly patient should be cautious, usually
      starting at the low end of the dosing range, reflecting the greater frequency of
      decreased hepatic, renal, or cardiac function, and of concomitant disease or other
      drug therapy. 8.6 Use in Renal Impairment No dose adjustment is necessary. 8.7 Use
      in Hepatic Impairment No dose adjustment is likely to be needed for mild-moderate
      hepatic impairment.
      Source: US FDA label for diltiazem (DILTIAZEM HYDROCHLORIDE), section 'use in
      specific populations', retrieved 2026-08-29

  PREGNANCY
    - Risk Summary The available data from the published literature over decades of use
      with diltiazem during pregnancy have not identified a drug associated risk of
      major birth defects, miscarriage, or adverse maternal or fetal outcomes.
      Source: US FDA label for diltiazem (DILTIAZEM HYDROCHLORIDE), section 'pregnancy',
      retrieved 2026-08-29
    - In animal reproduction studies in rats and rabbits, administration of diltiazem to
      pregnant animals during organogenesis at oral doses approximately 1 and 4 times
      the Maximum Recommended Human Dose (MRHD) of diltiazem hydrochloride extended-
      release tablets produced embryofetal deaths and increased incidence of skeletal
      abnormalities.
      Source: US FDA label for diltiazem (DILTIAZEM HYDROCHLORIDE), section 'pregnancy',
      retrieved 2026-08-29
    - An increased incidence of stillbirths was noted at diltiazem doses approximately 2
      times the MRHD of diltiazem hydrochloride extended-release tablets.
      Source: US FDA label for diltiazem (DILTIAZEM HYDROCHLORIDE), section 'pregnancy',
      retrieved 2026-08-29

  BREASTFEEDING
    - In an oral perinatal/postnatal study in rats with diltiazem at 0, 50, 100, 200 and
      400 mg/kg/day from gestation day 15 to lactation/post-partum day 20, there was an
      increased incidence of stillbirths at 100 mg/kg/day, approximately 2 times (on a
      mg/m 2 basis) the MRHD of diltiazem hydrochloride extended-release tablets. 8.2
      Lactation Risk Summary Diltiazem is excreted in human milk.
      Source: US FDA label for diltiazem (DILTIAZEM HYDROCHLORIDE), section 'use in
      specific populations', retrieved 2026-08-29
    - One report suggests that concentrations in breast milk may approximate serum
      levels.
      Source: US FDA label for diltiazem (DILTIAZEM HYDROCHLORIDE), section 'use in
      specific populations', retrieved 2026-08-29
    - Because of the potential for serious adverse reactions in nursing infants from
      diltiazem, a decision should be made whether to discontinue nursing or to
      discontinue the drug, taking into account the importance of the drug to the
      mother.
      Source: US FDA label for diltiazem (DILTIAZEM HYDROCHLORIDE), section 'use in
      specific populations', retrieved 2026-08-29