Lactulose

Pronunciation
(LAK tyoo lose)

Dosage Forms
Excipient information presented when available (limited, particularly for
generics); consult specific product labeling.
Packet, Oral:
Kristalose: 10 g (30 ea); 20 g (30 ea)
Solution, Oral:
Constulose: 10 g/15 mL (237 mL, 946 mL) [unflavored flavor]
Enulose: 10 g/15 mL (473 mL) [unflavored flavor]
Generlac: 10 g/15 mL (473 mL, 1892 mL) [unflavored flavor]
Generic: 10 g/15 mL (15 mL, 30 mL, 236 mL, 237 mL, 473 mL, 500 mL, 946
mL, 1892 mL); 20 g/30 mL (30 mL)

Brand Names: U.S.

Constulose

Enulose

Generlac

Kristalose

Pharmacologic Category

Ammonium Detoxicant

Laxative, Osmotic

Pharmacology
The bacterial degradation of lactulose resulting in an acidic pH inhibits the
diffusion of NH3 into the blood by causing the conversion of NH3 to NH4+; also
enhances the diffusion of NH3 from the blood into the gut where conversion
to NH4+ occurs; produces an osmotic effect in the colon with resultant
distention promoting peristalsis; reduces blood ammonia concentration to
reduce the degree of portal systemic encephalopathy
Absorption

Poor
Metabolism

Via colonic flora to lactic acid and acetic acid; requires colonic flora for drug
activation
Excretion

Primarily feces; urine (3%)

Onset of Action
Constipation: Up to 24 to 48 hours to produce a normal bowel movement
Encephalopathy: At least 24 to 48 hours

Use: Labeled Indications

Constipation (Constulose, Kristalose): Treatment of constipation
Portal systemic encephalopathy (Enulose, Generlac): Prevention and
treatment of portal-systemic encephalopathy (including hepatic precoma and
coma)

Contraindications
Patients requiring a low galactose diet

Dosing: Adult
Constipation: Oral: 10 to 20 g (15 to 30 mL or 1 to 2 packets) daily; may
increase to 40 g (60 mL or 2 to 4 packets) daily if necessary
Portal systemic encephalopathy (PSE), prevention: Oral: 20 to 30 g (30
to 45 mL) 3 to 4 times daily; adjust dose every 1 to 2 days to produce 2 to 3
soft stools/day
PSE treatment:
Oral: 20 to 30 g (30 to 45 mL) every 1 hour to induce rapid laxation; reduce
to 20 to 30 g (30 to 45 mL) 3 to 4 times daily after laxation is achieved to
produce 2 to 3 soft stools/day
Rectal administration (retention enema): 200 g (300 mL) via rectal balloon
catheter; retain for 30 to 60 minutes; may repeat every 4 to 6 hours;
transition to oral treatment prior to discontinuing rectal administration
Overt hepatic encephalopathy (OHE) episodes, treatment: Route not
specified: 16.7 g (25 mL) every 1 to 2 hours until at least 2 soft or loose
bowel movements are produced daily; titrate to maintain 2 to 3 bowel
movements daily (AASLD [Vilstrup 2014]).

Dosing: Geriatric
Refer to adult dosing.

Dosing: Pediatric
Note: Doses in pediatric patients may be expressed in volume (mL) or
weight (g); use extra precaution.
Portal systemic encephalopathy (PSE), prevention: Oral:
Infants: 1.7 to 6.7 g/day (2.5 to 10 mL/day) in divided doses; adjust dosage
to produce 2 to 3 stools/day
Children and Adolescents: 26.7 to 60 g/day (40 to 90 mL/day) in divided
doses; adjust dosage to produce 2 to 3 stools/day

Constipation (off-label dose): Infants, Children, and Adolescents: Oral:1 to

2 g/kg/day (1.5 to 3 mL/kg/day) once daily or in 2 divided doses (NASPGHAN
[Tabbers 2014]); maximum daily dose: 60 mL/day in adults.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturers labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturers labeling.

Administration
Oral solution: May mix with fruit juice, water or milk.
Crystals for oral solution: Dissolve contents of packet in 120 mL water.
Rectal: Dilute with 700 mL of water or NS; administer as retention enema
using a rectal balloon catheter; retain for 30 to 60 minutes. May repeat
enema immediately if inadvertently evacuated too promptly. Cleansing
enemas containing soapsuds or other alkaline agents should not be used.

Dietary Considerations
Contraindicated in patients on galactose-restricted diet.

Storage
Store at room temperature; do not freeze. Protect from light. Discard solution
if cloudy or very dark. Prolonged exposure to cold temperatures will cause
thickening which will return to normal upon warming to room temperature.

Drug Interactions
Glutamine: May diminish the therapeutic effect of Lactulose. Specifically,
glutamine may diminish the ammonia-lowering effects of lactulose. Monitor
therapy

Adverse Reactions
Frequency not defined.
Endocrine & metabolic: Dehydration, hypernatremia, hypokalemia
Gastrointestinal: Abdominal cramps, abdominal distention, abdominal
distress, diarrhea (excessive dose), eructation, flatulence, nausea, vomiting

Warnings/Precautions
Concerns related to adverse effects:
Electrolyte imbalance: Monitor periodically for electrolyte imbalance when
lactulose is used >6 months or in patients predisposed to electrolyte
abnormalities (eg, elderly, debilitated patients). Hepatic disease may
predispose patients to electrolyte imbalance. Infants receiving lactulose may
develop hyponatremia and dehydration.
Disease-related concerns:
Diabetes: Use with caution in patients with diabetes mellitus; solution
contains galactose and lactose.
Other warnings/precautions:
Electrocautery procedures: During proctoscopy or colonoscopy procedures
involving electrocautery, a theoretical risk of reaction between H2 gas
accumulation and electrical spark may exist; thorough bowel cleansing with
a nonfermentable solution is recommended.

Monitoring Parameters
Blood pressure, standing/supine; serum electrolytes, serum ammonia; bowel
movement patterns, fluid status

Pregnancy Risk Factor

B

Pregnancy Considerations
Adverse events have not been observed in animal reproduction studies.
Lactulose is poorly absorbed following oral administration. Use of dietary
fiber or bulk-forming laxatives along with increased fluid intake is generally
considered first line therapy for treating constipation in pregnant women.
Short-term use of lactulose is also considered to be safe/low risk when
therapy is needed; however, side effects may limit its use (Cullen, 2007;
Mahadevan, 2006; Prather, 2004; Wald, 2003).

Patient Education
Discuss specific use of drug and side effects with patient as it relates to
treatment. (HCAHPS: During this hospital stay, were you given any medicine
that you had not taken before? Before giving you any new medicine, how
often did hospital staff tell you what the medicine was for? How often did
hospital staff describe possible side effects in a way you could understand?)
Patient may experience burping, abdominal cramps, flatulence, vomiting,
or nausea. Have patient report immediately to prescriber signs of high blood
sugar (confusion, feeling sleepy, more thirst, hunger, passing urine more
often, flushing, fast breathing, or breath that smells like fruit), diarrhea,
severe dizziness, passing out, or severe abdominal pain (HCAHPS).
Educate patient about signs of a significant reaction (eg, wheezing; chest
tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of
face, lips, tongue, or throat). Note: This is not a comprehensive list of all
side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients.
This information is intended to serve as a concise initial reference for
healthcare professionals to use when discussing medications with a patient.
You must ultimately rely on your own discretion, experience and judgment in
diagnosing, treating and advising patients.