Drug profile
Glimepiride
Adult, child, renal, hepatic, pregnancy and breastfeeding information, with the source named on every line.
DRUG INFORMATION
ADULT
- Recommended starting dose is 1 or 2 mg once daily.
Source: US FDA label for glimepiride (Glimepiride), section 'dosage and
administration', retrieved 2026-08-29
- Increase in 1 or 2 mg increments no more frequently than every 1 to 2 weeks based
on glycemic response.
Source: US FDA label for glimepiride (Glimepiride), section 'dosage and
administration', retrieved 2026-08-29
- Maximum recommended dose is 8 mg once daily ( 2.1 ).
Source: US FDA label for glimepiride (Glimepiride), section 'dosage and
administration', retrieved 2026-08-29
CHILD
- The pharmacokinetics, efficacy and safety of glimepiride have been evaluated in
pediatric patients with type 2 diabetes as described below. Glimepiride tablets
are not recommended in pediatric patients because of its adverse effects on body
weight and hypoglycemia. The pharmacokinetics of a 1 mg single dose of glimepiride
was evaluated in 30 patients with type 2 diabetes (male = 7; female = 23) between
ages 10 and 17 years.
Source: US FDA label for glimepiride (Glimepiride), section 'pediatric use',
retrieved 2026-08-29
RENAL IMPAIRMENT
- Use 1 mg starting dose and titrate slowly in patients at increased risk for
hypoglycemia (e.g., elderly, patients with renal impairment) ( 2.1 ). 2.1
Recommended Dosing Glimepiride tablets should be administered with breakfast or
the first main meal of the day.
Source: US FDA label for glimepiride (Glimepiride), section 'dosage and
administration', retrieved 2026-08-29
- Patients at increased risk for hypoglycemia (e.g., the elderly or patients with
renal impairment) should be started on 1 mg once daily [see Warnings and
Precautions ( 5.1 ) and Use in Specific Populations ( 8.5 , 8.6 ) ].
Source: US FDA label for glimepiride (Glimepiride), section 'dosage and
administration', retrieved 2026-08-29
- Elderly patients are more likely to have renal impairment.
Source: US FDA label for glimepiride (Glimepiride), section 'use in specific
populations', retrieved 2026-08-29
HEPATIC IMPAIRMENT
- Debilitated or malnourished patients, and those with adrenal, pituitary, or
hepatic impairment are particularly susceptible to the hypoglycemic action of
glucose-lowering medications.
Source: US FDA label for glimepiride (Glimepiride), section 'warnings and
cautions', retrieved 2026-08-29
PREGNANCY
- Pregnancy Category C There are no adequate and well-controlled studies of
glimepiride in pregnant women.
Source: US FDA label for glimepiride (Glimepiride), section 'pregnancy', retrieved
2026-08-29
- In animal studies there was no increase in congenital anomalies, but an increase
in fetal deaths occurred in rats and rabbits at glimepiride doses 50 times (rats)
and 0.1 times (rabbits) the maximum recommended human dose (based on body surface
area).
Source: US FDA label for glimepiride (Glimepiride), section 'pregnancy', retrieved
2026-08-29
- This fetotoxicity, observed only at doses inducing maternal hypoglycemia, is
believed to be directly related to the pharmacologic (hypoglycemic) action of
glimepiride and has been similarly noted with other sulfonylureas.
Source: US FDA label for glimepiride (Glimepiride), section 'pregnancy', retrieved
2026-08-29
BREASTFEEDING
- It is not known whether glimepiride tablets are excreted in human milk.
Source: US FDA label for glimepiride (Glimepiride), section 'nursing mothers',
retrieved 2026-08-29
- During pre- and post-natal studies in rats, significant concentrations of
glimepiride were present in breast milk and the serum of the pups.
Source: US FDA label for glimepiride (Glimepiride), section 'nursing mothers',
retrieved 2026-08-29
- Offspring of rats exposed to high levels of glimepiride during pregnancy and
lactation developed skeletal deformities consisting of shortening, thickening, and
bending of the humerus during the postnatal period.
Source: US FDA label for glimepiride (Glimepiride), section 'nursing mothers',
retrieved 2026-08-29