Drug profile
Lactulose
Adult, child, renal, hepatic, pregnancy and breastfeeding information, with the source named on every line.
DRUG INFORMATION
ADULT
- DOSAGE & ADMINISTRATION Oral Adult: The usual adult, oral dosage is 2 to 3
tablespoonfuls (30 to 45 mL, containing 20 g to 30 g of lactulose) three or four
times daily.
Source: US FDA label for lactulose (Lactulose), section 'dosage and
administration', retrieved 2026-08-29
- Hourly doses of 30 to 45 mL of Lactulose may be used to induce the rapid laxation
indicated in the initial phase of the therapy of portal-systemic encephalopathy.
Source: US FDA label for lactulose (Lactulose), section 'dosage and
administration', retrieved 2026-08-29
- DOSAGE & ADMINISTRATION Oral Adult: The usual adult, oral dosage is 2 to 3
tablespoonfuls (30 to 45 mL, containing 20 g to 30 g of lactulose) three or four
times daily. The dosage may be adjusted every day or two to produce 2 or 3 soft
stools daily. Hourly doses of 30 to 45 mL of Lactulose may be used to induce the
rapid laxation indicated in the initial phase of the therapy of portal-systemic
encephalopathy.
Source: US FDA label for lactulose (Lactulose), section 'dosage and
administration', retrieved 2026-08-29
CHILD
- Very little information on the use of lactulose in pediatric patients has been
recorded. (See DOSAGE AND ADMINISTRATION.)
Source: US FDA label for lactulose (Lactulose), section 'pediatric use', retrieved
2026-08-29
- DOSAGE & ADMINISTRATION Oral Adult: The usual adult, oral dosage is 2 to 3
tablespoonfuls (30 to 45 mL, containing 20 g to 30 g of lactulose) three or four
times daily. The dosage may be adjusted every day or two to produce 2 or 3 soft
stools daily. Hourly doses of 30 to 45 mL of Lactulose may be used to induce the
rapid laxation indicated in the initial phase of the therapy of portal-systemic
encephalopathy.
Source: US FDA label for lactulose (Lactulose), section 'dosage and
administration', retrieved 2026-08-29
- On the basis of information available, the recommended initial daily oral dose in
infants is 2.5 to 10 mL in divided doses.
Source: US FDA label for lactulose (Lactulose), 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 lactulose (Lactulose),
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 lactulose (Lactulose),
retrieved 2026-08-29
PREGNANCY
- Teratogenic Effects Pregnancy category B .
Source: US FDA label for lactulose (Lactulose), section 'pregnancy', retrieved
2026-08-29
- Reproduction studies have been performed in mice, rats, and rabbits at doses up to
2 or 4 times the usual human oral dose and have revealed no evidence of impaired
fertility or harm to the fetus due to lactulose.
Source: US FDA label for lactulose (Lactulose), section 'pregnancy', retrieved
2026-08-29
- There are, however, no adequate and well-controlled studies in pregnant women.
Source: US FDA label for lactulose (Lactulose), 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 this drug is excreted in human milk.
Source: US FDA label for lactulose (Lactulose), section 'nursing mothers',
retrieved 2026-08-29
- Because many drugs are excreted in human milk, caution should be exercised when
lactulose solution is administered to a nursing woman.
Source: US FDA label for lactulose (Lactulose), section 'nursing mothers',
retrieved 2026-08-29
- Because animal reproduction studies are not always predictive of human response,
this drug should be used during pregnancy only if clearly needed. 8.3 Nursing
Mothers It is not known whether this drug is excreted in human milk.
Source: US FDA label for lactulose (Lactulose), section 'use in specific
populations', retrieved 2026-08-29