Kristalose

• Cumberland Pharmaceuticals, Inc.

• Mylan Bertek Pharmaceuticals Inc.

• Stat Rx Usa Llc

Lactulose is a type of sugar. It is broken down in the large intestine into mild acids that draw water into the colon, which helps soften the stools.

Lactulose is used to treat chronic constipation.

Lactulose is sometimes used to treat or prevent certain conditions of the brain that are caused by liver failure, which can lead to confusion, problems with memory or thinking, behavior changes, tremors, feeling irritable, sleep problems, loss of coordination, and loss of consciousness.

Lactulose may also be used for purposes not listed in this medication guide.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, and muscle weakness or limp feeling.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using lactulose and call your doctor at once if you have severe or ongoing diarrhea.

Less serious side effects may include:

• bloating, gas;

• stomach pain;

• diarrhea; or

• nausea, vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

There may be other drugs that can interact with lactulose. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Burping.
• Stomach cramps.
• Gas.
• Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Kristalose® (LACTULOSE) For Oral Solution is indicated for the treatment of constipation. In patients with a history of chronic constipation, lactulose therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.

The usual adult dosage is 10 g to 20 g of lactulose daily. The dose may be increased to 40 g daily if necessary. Twenty-four to 48 hours may be required to produce a normal bowel movement.

Dissolve contents of packet in half a glass (4 ounces) of water.

When Lactulose For Oral Solution is dissolved in water, the resulting solution may be colorless to a slightly pale yellow color.

Applies to lactulose: compounding solution, oral powder for reconstitution, oral solution, oral syrup, oral and rectal liquid

Gastrointestinal

Diarrhea is an indication of overdose. Severe diarrhea may lead to hypovolemia, hypokalemia, and hypernatremia, especially in elderly or acutely ill patients. If diarrhea develops, the dosage should be reduced.

Pneumatosis cystoides intestinalis may occur with lactulose (the active ingredient contained in Kristalose) therapy as a result of increased intracolonic pressure caused by ammonia sequestration in the bowel, and particularly when there is a concomitant breach of intestinal mucosal integrity.[Ref]

Gastrointestinal side effects have included abdominal cramps, gaseous distention, flatulence, belching, bowel distention, cramping, nausea and vomiting, and with excessive doses, diarrhea. Colonic dilatation has been reported in elderly patients. Rare cases of pneumatosis cystoides intestinalis have been reported.[Ref]

Metabolic

Metabolic side effects have included hypernatremia, hypokalemia and hyperchloremic metabolic acidosis. An isolated case of severe and intractable lactic acidosis has been reported.[Ref]

Fluid and electrolyte disturbances, including severe hypokalemia, hypernatremia and hyperchloremic metabolic acidosis, typically occur as a result of severe diarrhea and subsequent fluid loss. A case of fatal lactulose-induced lactic acidosis in the absence of diarrhea has also been reported. Elderly and/or acutely ill patients may be at increased risk for adverse metabolic effects with lactulose.[Ref]

Some side effects of Kristalose may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.