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Drug overview for KRISTALOSE (lactulose):
Generic name: LACTULOSE (LACK-tew-lohss)
Drug class: Laxatives
Therapeutic class: Gastrointestinal Therapy Agents
Lactulose, a synthetic derivative of lactose, is an ammonia detoxicant.
No enhanced Uses information available for this drug.
Generic name: LACTULOSE (LACK-tew-lohss)
Drug class: Laxatives
Therapeutic class: Gastrointestinal Therapy Agents
Lactulose, a synthetic derivative of lactose, is an ammonia detoxicant.
No enhanced Uses information available for this drug.
DRUG IMAGES
KRISTALOSE 10 GM PACKET
KRISTALOSE 20 GM PACKET
The following indications for KRISTALOSE (lactulose) have been approved by the FDA:
Indications:
Constipation
Hepatic encephalopathy
Hyperammonemia
Professional Synonyms:
Abnormally elevated blood ammonia
Ammonemia
Portal systemic encephalopathy
Indications:
Constipation
Hepatic encephalopathy
Hyperammonemia
Professional Synonyms:
Abnormally elevated blood ammonia
Ammonemia
Portal systemic encephalopathy
The following dosing information is available for KRISTALOSE (lactulose):
Each 15 mL of commercially available lactulose solution provides approximately 10 g of the drug; corresponding doses provided by 2.5, 5, 7.5, 10, 30, 40, 45, 90, 150, and 300 mL of the commercial solution are approximately 1.67,
3.3, 5, 6.67, 20, 27, 30, 60, 100, and 200 g, respectively. Following reconstitution of the oral powder as directed, a 10 or 20 g dose is provided by the total volume.
3.3, 5, 6.67, 20, 27, 30, 60, 100, and 200 g, respectively. Following reconstitution of the oral powder as directed, a 10 or 20 g dose is provided by the total volume.
No enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| KRISTALOSE 10 GM PACKET | Maintenance | Adults take 1 packet (10 gram) dissolved in 4 ounces of water by oral route once daily |
| KRISTALOSE 20 GM PACKET | Maintenance | Adults take 1 packet (20 gram) dissolved in 4 ounces of water by oral route once daily |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| LACTULOSE 10 GM PACKET | Maintenance | Adults take 1 packet (10 gram) dissolved in 4 ounces of water by oral route once daily |
| LACTULOSE 20 GM PACKET | Maintenance | Adults take 1 packet (20 gram) dissolved in 4 ounces of water by oral route once daily |
The following drug interaction information is available for KRISTALOSE (lactulose):
There are 0 contraindications.
There are 2 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Trofinetide/Laxatives SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Trofinetide commonly causes diarrhea of mild to moderate severity. Laxatives may increase the incidence or severity of diarrhea.(1) CLINICAL EFFECTS: Concurrent use of laxatives with trofinetide may increase the risk of severe diarrhea.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Patients should stop laxatives before starting trofinetide. If diarrhea occurs, consider anti-diarrheal treatment and monitor hydration status. If severe diarrhea or dehydration occurs, interrupt, reduce dose, or discontinue trofinetide.(1) DISCUSSION: In clinical trials, 85% of patients on trofinetide developed diarrhea. Concurrent use of laxatives may increase this risk.(1) |
DAYBUE |
| Tenapanor/Laxatives; Stool Softeners SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Tenapanor commonly causes diarrhea of mild to moderate severity. Laxatives and stool softeners may increase the incidence or severity of diarrhea.(1) CLINICAL EFFECTS: Concurrent use of laxatives or stool softeners with tenapanor may increase the risk of severe diarrhea.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of tenapanor states that patients should be instructed to avoid stool softeners and laxatives with tenapanor. If severe diarrhea occurs, tenapanor should be discontinued.(1) DISCUSSION: In clinical trials, 43-53% of CKD patients on dialysis treated with tenapanor developed diarrhea. Diarrhea usually occurred soon after treatment initiation and was severe in 5% of patients.(1) |
XPHOZAH |
There are 0 moderate interactions.
The following contraindication information is available for KRISTALOSE (lactulose):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 4 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Appendicitis |
| Galactosemia |
| Gastrointestinal obstruction |
| Glucose-galactose malabsorption |
There are 0 severe contraindications.
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Diabetes mellitus |
The following adverse reaction information is available for KRISTALOSE (lactulose):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 0 severe adverse reactions.
There are 4 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Abdominal pain with cramps Diarrhea Flatulence Polydipsia |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for KRISTALOSE (lactulose):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Use of lactulose during pregnancy has not been studied in humans. Reproduction studies in rats, mice, and rabbits receiving oral lactulose doses up to 6 times the usual human oral dose have not revealed evidence of harm to the fetus. Lactulose should be used during pregnancy only when clearly needed.
It is not known if lactulose is distributed into milk. The drug should be used with caution in nursing women.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for KRISTALOSE (lactulose):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for KRISTALOSE (lactulose)'s list of indications:
| Constipation | |
| K59.0 | Constipation |
| K59.00 | Constipation, unspecified |
| K59.01 | Slow transit constipation |
| K59.03 | Drug induced constipation |
| K59.04 | Chronic idiopathic constipation |
| K59.09 | Other constipation |
| Hepatic encephalopathy | |
| B15.0 | Hepatitis A with hepatic coma |
| B16.0 | Acute hepatitis B with delta-agent with hepatic coma |
| B16.2 | Acute hepatitis B without delta-agent with hepatic coma |
| B17.11 | Acute hepatitis C with hepatic coma |
| B19.0 | Unspecified viral hepatitis with hepatic coma |
| B19.11 | Unspecified viral hepatitis B with hepatic coma |
| B19.21 | Unspecified viral hepatitis C with hepatic coma |
| K70.41 | Alcoholic hepatic failure with coma |
| K71.11 | Toxic liver disease with hepatic necrosis, with coma |
| K72.01 | Acute and subacute hepatic failure with coma |
| K72.11 | Chronic hepatic failure with coma |
| K72.90 | Hepatic failure, unspecified without coma |
| K72.91 | Hepatic failure, unspecified with coma |
| K76.82 | Hepatic encephalopathy |
| Hyperammonemia | |
| B15.0 | Hepatitis A with hepatic coma |
| B16.0 | Acute hepatitis B with delta-agent with hepatic coma |
| B16.2 | Acute hepatitis B without delta-agent with hepatic coma |
| B17.11 | Acute hepatitis C with hepatic coma |
| B19.0 | Unspecified viral hepatitis with hepatic coma |
| B19.11 | Unspecified viral hepatitis B with hepatic coma |
| B19.21 | Unspecified viral hepatitis C with hepatic coma |
| D81.810 | Biotinidase deficiency |
| E71.110 | Isovaleric acidemia |
| E71.121 | Propionic acidemia |
| E72.20 | Disorder of urea cycle metabolism, unspecified |
| E72.21 | Argininemia |
| E72.22 | Arginosuccinic aciduria |
| E72.23 | Citrullinemia |
| E72.29 | Other disorders of urea cycle metabolism |
| E72.4 | Disorders of ornithine metabolism |
| K72.91 | Hepatic failure, unspecified with coma |
| P74.6 | Transitory hyperammonemia of newborn |
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