Insulin Glargine

DRUG INFORMATION

  ADULT
    - It delivers doses in 1-unit increments and can deliver up to 80 units in a single
      injection.
      Source: US FDA label for insulin glargine (Insulin glargine U-300 Max), section
      'dosage and administration', retrieved 2026-08-29
    - It delivers doses in 2-unit increments and can deliver up to 160 units in a single
      injection.
      Source: US FDA label for insulin glargine (Insulin glargine U-300 Max), section
      'dosage and administration', retrieved 2026-08-29
    - It is recommended for patients requiring at least 20 units per day.
      Source: US FDA label for insulin glargine (Insulin glargine U-300 Max), section
      'dosage and administration', retrieved 2026-08-29

  CHILD
    - Individualize dose based on type of diabetes, metabolic needs, blood glucose
      monitoring results and glycemic control goal. ( 2.2 ) Administer subcutaneously
      into the abdominal area, thigh, or deltoid once daily at any time during the day,
      at the same time every day. ( 2.1 ) Rotate injection sites to reduce risk of
      lipodystrophy and localized cutaneous amyloidosis. ( 2.1 ) Do not dilute or mix
      with any other insulin or solution.
      Source: US FDA label for insulin glargine (Insulin glargine U-300 Max), section
      'dosage and administration', retrieved 2026-08-29
    - Recommended Starting Dosage in Patients with Type 2 Diabetes The recommended
      starting dose of Insulin Glargine, U-300 in insulin-naive patients with type 2
      diabetes is 0.2 units per kilogram of body weight once daily.
      Source: US FDA label for insulin glargine (Insulin glargine U-300 Max), section
      'dosage and administration', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - In geriatric patients with diabetes, the initial dosing, dose increments, and
      maintenance dosage should be conservative to avoid hypoglycemia [see Warnings and
      Precautions (5.3) , Adverse Reactions (6) , and Clinical Studies (14) ] . 8.6
      Renal Impairment The effect of kidney impairment on the pharmacokinetics of
      Insulin Glargine, U-300 has not been studied.
      Source: US FDA label for insulin glargine (Insulin glargine U-300 Max), section
      'use in specific populations', retrieved 2026-08-29
    - Some studies with human insulin have shown increased circulating levels of insulin
      in patients with kidney failure.
      Source: US FDA label for insulin glargine (Insulin glargine U-300 Max), section
      'use in specific populations', retrieved 2026-08-29
    - Frequent glucose monitoring and dose adjustment may be necessary for Insulin
      Glargine, U-300 in patients with kidney impairment [see Warnings and Precautions
      (5.3) ] . 8.7 Hepatic Impairment The effect of hepatic impairment on the
      pharmacokinetics of Insulin Glargine, U-300 has not been studied.
      Source: US FDA label for insulin glargine (Insulin glargine U-300 Max), section
      'use in specific populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - Frequent glucose monitoring and dose adjustment may be necessary for Insulin
      Glargine, U-300 in patients with kidney impairment [see Warnings and Precautions
      (5.3) ] . 8.7 Hepatic Impairment The effect of hepatic impairment on the
      pharmacokinetics of Insulin Glargine, U-300 has not been studied.
      Source: US FDA label for insulin glargine (Insulin glargine U-300 Max), section
      'use in specific populations', retrieved 2026-08-29
    - Frequent glucose monitoring and dose adjustment may be necessary for Insulin
      Glargine, U-300 in patients with hepatic impairment [see Warnings and Precautions
      (5.3) ] .
      Source: US FDA label for insulin glargine (Insulin glargine U-300 Max), section
      'use in specific populations', retrieved 2026-08-29
    - Increase frequency of glucose monitoring with changes to: insulin dosage,
      concomitant drugs, meal pattern, physical activity, and in patients with renal
      impairment or hepatic impairment or hypoglycemia unawareness.
      Source: US FDA label for insulin glargine (Insulin glargine U-300 Max), section
      'warnings and cautions', retrieved 2026-08-29

  PREGNANCY
    - Risk Summary Published studies with use of insulin glargine during pregnancy have
      not reported a clear association with insulin glargine and adverse developmental
      outcomes (see Data ) .
      Source: US FDA label for insulin glargine (Insulin glargine U-300 Max), section
      'pregnancy', retrieved 2026-08-29
    - There are risks to the mother and fetus associated with poorly controlled diabetes
      in pregnancy (see Clinical Considerations ) .
      Source: US FDA label for insulin glargine (Insulin glargine U-300 Max), section
      'pregnancy', retrieved 2026-08-29
    - Rats and rabbits were exposed to insulin glargine in animal reproduction studies
      during organogenesis, respectively 50 times and 10 times the human subcutaneous
      dose of 0.2 unit/kg/day.
      Source: US FDA label for insulin glargine (Insulin glargine U-300 Max), section
      'pregnancy', retrieved 2026-08-29

  BREASTFEEDING
    - Fertility and early embryonic development appeared normal. 8.2 Lactation Risk
      Summary There are either no or only limited data on the presence of insulin
      glargine in human milk, the effects on breastfed infant, or the effects on milk
      production.
      Source: US FDA label for insulin glargine (Insulin glargine U-300 Max), section
      'use in specific populations', retrieved 2026-08-29
    - Endogenous insulin is present in human milk.
      Source: US FDA label for insulin glargine (Insulin glargine U-300 Max), section
      'use in specific populations', retrieved 2026-08-29
    - The developmental and health benefits of breastfeeding should be considered along
      with the mother's clinical need for Insulin Glargine, U-300, and any potential
      adverse effects on the breastfed child from Insulin Glargine, U-300 or from the
      underlying maternal condition.
      Source: US FDA label for insulin glargine (Insulin glargine U-300 Max), section
      'use in specific populations', retrieved 2026-08-29