Lactitol

What is Lactitol?

• Lactitol (PIZENSY) is an osmotic laxative.

What are the uses of this medicine?

• This medicine is indicated for chronic idiopathic constipation (CIC) in adults.

How does this medicine work?

• Lactitol exerts an osmotic effect, causing the influx of water into the small intestine leading to a laxative effect in the colon.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• known or suspected mechanical gastrointestinal obstruction
• galactosemia

What drug interactions can this medicine cause?

• PIZENSY may reduce the absorption of concomitantly administered oral medications.
• Administer oral medications at least 2 hours before or 2 hours after PIZENSY.

Is this medicine FDA approved?

• It was approved for use in the United States in 2020.

How should this medicine be used?

Recommended Dosage

• The recommended adult dosage of PIZENSY is 20 grams orally once daily, preferably with meals.
• Reduce the dosage to 10 grams once daily for persistent loose stools.
• Administer oral medications at least 2 hours before or 2 hours after PIZENSY.

Administration

PIZENSY Multi-dose bottle

• The multi-dose bottles are equipped with a measuring cap marked to contain 10 grams of powder when filled to the top of white section in cap.
• Pour the measured dose into an empty 8-ounce glass.
• Add 4 ounces to 8 ounces of water, juice or other common beverages (coffee, tea, soda) and stir to dissolve.
• Drink the entire contents of the glass.

PIZENSY Unit-dose packets

• The unit-dose packets contain 10 grams of PIZENSY each.
• Pour the contents of one or two unit-dose packets, as prescribed, into an empty 8-ounce glass.
• Add 4 ounces to 8 ounces of water, juice or other common beverages (coffee, tea, soda) to the glass containing the powder and stir thoroughly to dissolve.
• Drink the entire contents of the glass.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

As Oral Solution:

• 280 grams of lactitol in multi-dose bottles
• 560 grams of lactitol in multi-dose bottles
• 10 grams of lactitol in unit-dose packets

This medicine is available in fallowing brand namesː

• PIZENSY

What side effects can this medication cause?

The most common side effects of this medicine include:

• upper respiratory tract infection
• flatulence
• diarrhea
• increased blood creatinine phosphokinase
• abdominal distention
• increased blood pressure

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Available data from case reports on lactitol use in pregnant women are insufficient to evaluate for any drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Can this medicine be used in children?

• The safety and effectiveness of PIZENSY have not been established in pediatric patients.

What should I know about storage and disposal of this medication?

• Store at 20°C to 25°C (68° to 77°F). Excursions permitted between 15° to 30°C (59° to 86°F).
• Each bottle contains a white desiccant packet printed “Do Not Eat.”

• Dailymed label info on Lactitol
• FDA Lactitol

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