Isosorbide-5-Mononitrate

DRUG INFORMATION

  ADULT
    - The recommended regimen of isosorbide mononitrate tablets is 20 mg twice daily,
      with the doses seven hours apart.
      Source: US FDA label for isosorbide mononitrate (Isosorbide Mononitrate), section
      'dosage and administration', retrieved 2026-08-29
    - A starting dose of 5 mg (½ tablet of the 10 mg dosing strength) might be
      appropriate for persons of particularly small stature but should be increased to
      at least 10 mg by the second or third day of therapy.
      Source: US FDA label for isosorbide mononitrate (Isosorbide Mononitrate), section
      'dosage and administration', retrieved 2026-08-29
    - Doses above 20 mg twice a day (with the doses seven hours apart) have not been
      adequately studied.
      Source: US FDA label for isosorbide mononitrate (Isosorbide Mononitrate), section
      'dosage and administration', retrieved 2026-08-29

  CHILD
    - Safety and effectiveness of isosorbide mononitrate in pediatric patients have not
      been established.
      Source: US FDA label for isosorbide mononitrate (Isosorbide Mononitrate), section
      'pediatric use', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - No kidney-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for isosorbide mononitrate
      (Isosorbide Mononitrate), retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - No liver-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for isosorbide mononitrate
      (Isosorbide Mononitrate), retrieved 2026-08-29

  PREGNANCY   [ CAUTION ]
    The label allows it only when the benefit is judged to outweigh the risk. Read the
      quote below.
    - Teratogenic Effects Reproduction studies performed in rats and rabbits at doses of
      up to 540 and 810 mg/kg/day, respectively, have revealed no evidence of harm to
      the fetus due to isosorbide mononitrate.
      Source: US FDA label for isosorbide mononitrate (Isosorbide Mononitrate), section
      'pregnancy', retrieved 2026-08-29
    - There are, however, no adequate and well-controlled studies in pregnant women.
      Source: US FDA label for isosorbide mononitrate (Isosorbide Mononitrate), section
      'pregnancy', retrieved 2026-08-29
    - Because animal reproduction studies are not always predictive of human response,
      isosorbide mononitrate should be used during pregnancy only if clearly needed.
      Source: US FDA label for isosorbide mononitrate (Isosorbide Mononitrate), section
      'pregnancy', retrieved 2026-08-29

  BREASTFEEDING   [ CAUTION ]
    The label allows it only when the benefit is judged to outweigh the risk. Read the
      quote below.
    - It is not known whether isosorbide mononitrate is excreted in human milk.
      Source: US FDA label for isosorbide mononitrate (Isosorbide Mononitrate), section
      'nursing mothers', retrieved 2026-08-29
    - Because many drugs are excreted in human milk, caution should be exercised when
      isosorbide mononitrate is administered to a nursing woman.
      Source: US FDA label for isosorbide mononitrate (Isosorbide Mononitrate), section
      'nursing mothers', retrieved 2026-08-29