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Lactitol (United States and Canada: Not available): Drug information

Lactitol (United States and Canada: Not available): Drug information
(For additional information see "Lactitol (United States and Canada: Not available): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Pharmacologic Category
  • Ammonium Detoxicant;
  • Laxative, Osmotic
Dosing: Adult
Chronic idiopathic constipation

Chronic idiopathic constipation: Oral: 20 g once daily; may reduce dose to 10 g once daily for persistent loose stools.

Hepatic encephalopathy

Hepatic encephalopathy (off-label use):

Prevention:

Note: May consider as chronic therapy for the prevention of recurrent hepatic encephalopathy with or without other therapies (Ferenci 2021).

Oral: 30 to 60 g/day in 2 to 4 divided doses; adjust dose to achieve 2 to 3 soft stools per day (Ferenci 2021).

Treatment:

Note: Identify and treat precipitating factors. May use as monotherapy for initial treatment or in combination with other therapies when initial monotherapy is unsuccessful. Not recommended for routine treatment of minimal hepatic encephalopathy; may consider on a case-by-case basis in patients with decreased quality of life (AASLD [Vilstrup 2014]; Ferenci 2021; Prasad 2007).

Oral: 30 to 60 g/day in 2 to 4 divided doses; adjust dose to achieve 2 to 3 soft stools per day (AASLD [Vilstrup 2014]; Ferenci 2021; Heredia 1988; Mas 2003).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Product Availability

Pizensy: FDA approved February 2020; anticipated availability is currently unknown.

Administration: Adult

Oral: Administration with meals is preferred; drink entire contents of glass. Administer oral medications at least 2 hours before or 2 hours after lactitol.

Use: Labeled Indications

Chronic idiopathic constipation: Treatment of chronic idiopathic constipation (CIC) in adult patients.

Use: Off-Label: Adult

Hepatic encephalopathy, prevention; Hepatic encephalopathy, treatment

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%:

Cardiovascular: Increased blood pressure (3%)

Gastrointestinal: Flatulence (8%), diarrhea (4%), abdominal distention (3%), abdominal pain (3%), severe diarrhea (1%)

Genitourinary: Urinary tract infection (5%)

Neuromuscular & skeletal: Increased creatine phosphokinase in blood specimen (4%)

Respiratory: Upper respiratory tract infection (9%)

Postmarketing: Hypersensitivity reaction, pruritus, skin rash

Contraindications

Mechanical GI obstruction (known or suspected); galactosemia

Warnings/Precautions

Concurrent drug therapy issues:

• Absorption: May reduce the absorption of concomitantly administered oral medications. Administer oral medications at least 2 hours before or 2 hours after lactitol.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Dichlorphenamide: Laxatives may enhance the hypokalemic effect of Dichlorphenamide. Risk C: Monitor therapy

Pregnancy Considerations

Lactitol has minimal systemic absorption.

Treatment of constipation in pregnant women is similar to that of nonpregnant patients, and medications may be used when diet and lifestyle modifications are not effective. In general, osmotic laxatives are not initial therapy and should be used with caution and only for short durations in pregnancy due to the risk of electrolyte abnormalities (Body 2016).

Breastfeeding Considerations

It is not known if lactitol is present in breast milk; however, lactitol has minimal systemic absorption.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.

Monitoring Parameters

Bowel movement frequency, serum ammonia in patients with hepatic encephalopathy (as clinically indicated) (AASLD [Vilstrup 2014]).

Mechanism of Action

Simple monosaccharide sugar; produces laxative effect in colon by causing water influx into small intestine.

Pharmacokinetics

Absorption: Minimal.

Half-life elimination: 2.4 hours.

Excretion: Feces (minimal).

Brand Names: International
  • Emportal (ES);
  • Encelax (IN);
  • Exportale (RU);
  • Importal (AT, BE, CH, CY, DE, FR, GR, LU, NL, PT, RU, SE, SI, VN);
  • Kang Xin (CN);
  • Latitol (KR);
  • Lotical Powder (TW);
  • Novolax (IL);
  • Opanaf (ES);
  • Osmolac (BR);
  • Oxatil (BD);
  • Paxitol (BD);
  • Portolac (IT, JP);
  • Potalac (KR);
  • Sigmalac (BR);
  • Sinalax (BD, VN);
  • Speedon Powder (TW);
  • Titolac (BD)


For country abbreviations used in Lexicomp (show table)
  1. Body C, Christie JA. Gastrointestinal diseases in pregnancy: nausea, vomiting, hyperemesis gravidarum, gastroesophageal reflux disease, constipation, and diarrhea. Gastroenterol Clin North Am. 2016;45(2):267-283. doi:10.1016/j.gtc.2016.02.005 [PubMed 27261898]
  2. Ferenci P. Hepatic encephalopathy in adults: treatment. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed September 2, 2021.
  3. Gluud LL, Vilstrup H, Morgan MY. Non-absorbable disaccharides versus placebo/no intervention and lactulose versus lactitol for the prevention and treatment of hepatic encephalopathy in people with cirrhosis. Cochrane Database Syst Rev. 2016;4:CD003044. doi:10.1002/14651858.CD003044.pub3 [PubMed 27089005]
  4. Heredia D, Terés J, Orteu N, Rodés J. Lactitol vs. lactulose in the treatment of chronic recurrent portal-systemic encephalopathy. J Hepatol. 1988;7(1):106-110. doi:10.1016/s0168-8278(88)80513-0 [PubMed 3053887]
  5. Mas A, Rodés J, Sunyer L, et al. Comparison of rifaximin and lactitol in the treatment of acute hepatic encephalopathy: results of a randomized, double-blind, double-dummy, controlled clinical trial. J Hepatol. 2003;38(1):51-58. doi:10.1016/s0168-8278(02)00350-1 [PubMed 12480560]
  6. Morgan MY, Hawley KE. Lactitol vs. lactulose in the treatment of acute hepatic encephalopathy in cirrhotic patients: a double-blind, randomized trial. Hepatology. 1987a;7(6):1278-1284. doi:10.1002/hep.1840070617 [PubMed 3315932]
  7. Morgan MY, Hawley KE, Stambuk D. Lactitol versus lactulose in the treatment of chronic hepatic encephalopathy. A double-blind, randomised, cross-over study. J Hepatol. 1987b;4(2):236-244. doi:10.1016/s0168-8278(87)80086-7 [PubMed 3295020]
  8. Morgan MY, Alonso M, Stanger LC. Lactitol and lactulose for the treatment of subclinical hepatic encephalopathy in cirrhotic patients. A randomised, cross-over study. J Hepatol. 1989;8(2):208-217. doi:10.1016/0168-8278(89)90009-3 [PubMed 2654285]
  9. Pizensy (lactitol) [prescribing information]. Braintree, MA: Braintree Laboratories Inc; August 2021.
  10. Prasad S, Dhiman RK, Duseja A, Chawla YK, Sharma A, Agarwal R. Lactulose improves cognitive functions and health-related quality of life in patients with cirrhosis who have minimal hepatic encephalopathy. Hepatology. 2007;45(3):549-559. doi:10.1002/hep.21533 [PubMed 17326150]
  11. Riggio O, Balducci G, Ariosto F, et al. Lactitol in prevention of recurrent episodes of hepatic encephalopathy in cirrhotic patients with portal-systemic shunt. Dig Dis Sci. 1989;34(6):823-829. doi:10.1007/BF01540265 [PubMed 2656134]
  12. Salerno F, Moser P, Maggi A, Vitaliani G, Benetti G. Effects of long-term administration of low-dose lactitol in patients with cirrhosis but without overt encephalopathy. J Hepatol. 1994;21(6):1092-1096. doi:10.1016/s0168-8278(05)80623-3 [PubMed 7699233]
  13. Vilstrup H, Amodio P, Bajaj J, et al; American Association for the Study of Liver Diseases. Hepatic encephalopathy in chronic liver disease: 2014 practice guideline by AASLD and EASL. https://www.aasld.org/sites/default/files/2019-06/141022_AASLD_Guideline_Encephalopathy_4UFd_2015.pdf. Accessed March 10, 2020.
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