PIZENSY (lactitol) for oral solution

PIZENSY (lactitol) for oral solution

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PIZENSY (lactitol) for oral solution

Lactitol is an osmotic laxative for oral use. Lactitol is a simple monosaccharide sugar alcohol. It is a dry, free flowing, white to off-white powder, readily soluble in aqueous solutions. As shown by the structure diagrams, it is an analog of the disaccharide lactulose. Its chemical name is 4-O-β-d-Galactopyranosyl-d-glucitol lactitol.

Molecular Formula: C12H24O11

Molecular Weight: 344.31

PIZENSY (lactitol) for oral solution is available in unit-dose packets and multi-dose bottles. There are no inactive ingredients.

Indications and usage

PIZENSY is indicated for chronic idiopathic constipation (CIC) in adults.

Mechanism of Action

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

Dosage and administration

  • 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

Contraindications

PIZENSY is contraindicated in patients with:

  • known or suspected mechanical gastrointestinal obstruction
  • galactosemia

Adverse reactions

Most common adverse reactions (> 3%) are upper respiratory tract infection, flatulence, diarrhea, increased blood creatinine phosphokinase, abdominal distension, and increased blood pressure.

Drug interactions

Reduced Absorption of Other Oral Medications: PIZENSY may reduce the absorption of concomitantly administered oral medications. Administer oral medications at least 2 hours before or 2 hours after PIZENSY.

Use in specific populations

Pregnancy: Lactitol is minimally absorbed systemically following oral administration, and it is unknown whether maternal use will result in fetal exposure to the drug. 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.

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Lactation: There are no data on the presence of lactitol in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Lactitol is minimally absorbed systemically following oral administration. It is unknown whether the minimal systemic absorption of lactitol by adults will result in a clinically relevant exposure to breastfed infants. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for PIZENSY and any potential adverse effects on the breastfed infant from PIZENSY or from the underlying maternal condition.

Pediatric Use: The safety and effectiveness of PIZENSY have not been established in pediatric patients.

Geriatric Use: Of the 807 patients who received PIZENSY in clinical trials, 202 (25%) were 65 years of age or older, and 59 (7%) were 75 years of age or older. No overall differences in safety or effectiveness of PIZENSY were observed between geriatric patients and younger patients.

Storage

Store at 20°C to 25°C (68° to 77°F). Excursions permitted between 15° to 30°C (59° to 86°F). See USP controlled room temperature.

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