Drug profile
Atropine
Adult, child, renal, hepatic, pregnancy and breastfeeding information, with the source named on every line.
DRUG INFORMATION
ADULT
- 2. DOSAGE AND ADMINISTRATION In individuals from three (3) months of age or
greater, 1 drop topically to the cul-de-sac of the conjunctiva, forty minutes
prior to the intended maximal dilation time ( 2.1 ) In individuals 3 years of age
or greater, doses may be repeated up to twice daily as needed.
Source: US FDA label for atropine (Atropine), section 'dosage and administration',
retrieved 2026-08-29
CHILD
- Due to the potential for systemic absorption of atropine sulfate ophthalmic
solution, the use of atropine sulfate ophthalmic solution, 1% in children under
the age of 3 months is not recommended and the use in children under 3 years of
age should be limited to no more than one drop per eye per day.
Source: US FDA label for atropine (Atropine), section 'pediatric use', retrieved
2026-08-29
- 2. DOSAGE AND ADMINISTRATION In individuals from three (3) months of age or
greater, 1 drop topically to the cul-de-sac of the conjunctiva, forty minutes
prior to the intended maximal dilation time ( 2.1 ) In individuals 3 years of age
or greater, doses may be repeated up to twice daily as needed.
Source: US FDA label for atropine (Atropine), section 'dosage and administration',
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 atropine (Atropine), 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 atropine (Atropine), retrieved
2026-08-29
PREGNANCY
- Pregnancy Category C: There are no adequate and well-controlled studies of
atropine sulfate in pregnant women.
Source: US FDA label for atropine (Atropine), section 'pregnancy', retrieved
2026-08-29
- Animal development and reproduction studies have not been conducted with atropine
sulfate.
Source: US FDA label for atropine (Atropine), section 'pregnancy', retrieved
2026-08-29
- Since it is not known whether topically administered atropine sulfate can cause
fetal harm, atropine sulfate ophthalmic solution, 1% should only be used during
pregnancy if the potential benefit justifies the potential risk to the fetus.
Source: US FDA label for atropine (Atropine), section 'pregnancy', retrieved
2026-08-29
BREASTFEEDING
- Traces of atropine have been found in human milk following administration of
atropine solution for injection.
Source: US FDA label for atropine (Atropine), section 'nursing mothers', retrieved
2026-08-29
- Because some systemic absorption occurs from topical administration, caution
should be exercised when atropine sulfate ophthalmic solution, 1% is administered
to a nursing woman.
Source: US FDA label for atropine (Atropine), section 'nursing mothers', retrieved
2026-08-29
- Since it is not known whether topically administered atropine sulfate can cause
fetal harm, atropine sulfate ophthalmic solution, 1% should only be used during
pregnancy if the potential benefit justifies the potential risk to the fetus. 8.3
Nursing Mothers Traces of atropine have been found in human milk following
administration of atropine solution for injection.
Source: US FDA label for atropine (Atropine), section 'use in specific
populations', retrieved 2026-08-29