Pizensy

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 11/30/2021
Pizensy Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Pizensy?

Pizensy (lactitol) is an osmotic laxative used to treat chronic idiopathic constipation (CIC) in adults.

What Are Side Effects of Pizensy?

Side effects of Pizensy include:

  • upper respiratory tract infection,
  • gas (flatulence),
  • diarrhea,
  • increased blood creatinine phosphokinase,
  • abdominal distension, and
  • increased blood pressure

Dosage for Pizensy

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.

Pizensy In Children

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

What Drugs, Substances, or Supplements Interact with Pizensy?

Pizensy may interact with other medicines such as:

  • other oral medications taken at the same time

Tell your doctor all medications and supplements you use.

Pizensy During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Pizensy; it is unknown how it would affect a fetus. Pizensy is minimally absorbed systemically following oral administration. It is unknown whether the minimal systemic absorption of Pizensy by adults will result in a clinically relevant exposure to breastfed infants. Consult your doctor before breastfeeding.

Additional Information

Our Pizensy (lactitol) for Oral Solution Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

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.

QUESTION

You are constipated if you don't have a bowel movement every day. See Answer
Pizensy Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to PIZENSY in 807 patients with CIC in a six-month placebo-controlled trial (Study 1), a three-month active-controlled trial (Study 2) [see Clinical Studies], and a one-year uncontrolled safety study (NCT02819310). Of the 298 patients in the one-year uncontrolled study, 55 patients were enrolled from Study 1 or Study 2.

Most Common Adverse Reactions

Table 1 provides the incidence of adverse reactions in Study 1 reported in at least 3% of patients in the PIZENSY treatment group and at higher incidence than placebo.

Table 1: Common Adverse Reactions1 Reported in Adult Patients with CIC in Study 1

PIZENSY2
N=291 (%)
Placebo
N=302 (%)
Upper Respiratory Tract Infection396
Flatulence83
Diarrhea43
Increased blood creatinine phosphokinase443
Abdominal Distension31
Increased blood pressure531
1 reported in at least 3% of patients and greater than placebo
2 74 of 291 patients in the PIZENSY group at least temporarily reduced their dose
3 Upper respiratory tract infection includes the terms viral upper respiratory tract infection and nasopharyngitis.
4 Increased blood creatinine phosphokinase includes the term blood creatinine phosphokinase myocardial band (MB) increased.5 Increased blood pressure includes the term Hypertension

In Study 2, the safety profile of PIZENSY was similar to Study 1.

In the 1-year uncontrolled safety study, adverse reactions reported in patients receiving PIZENSY (N=298) with an incidence of at least 3% that are not represented in Table 1 include urinary tract infection (5%) and abdominal pain (3%).

Adverse Reaction Of Special Interest - Severe Diarrhea

In Study 1, severe diarrhea was reported in 2 (1%) PIZENSY-treated patients compared to no patients in the placebo group.

Adverse Reactions Leading To Discontinuation

In Study 1, 11/291 (4%) PIZENSY-treated patients discontinued due to adverse reactions, compared to 10/302 (3%) of patients in the placebo group. The most common adverse reactions leading to discontinuation in PIZENSY-treated patients (1% each) were elevated creatinine kinase, flatulence, diarrhea and increased blood pressure.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of lactitol outside of the United States. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • hypersensitivity reactions, including rash and pruritus

Read the entire FDA prescribing information for Pizensy (Lactitol Tablets)

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© Pizensy Patient Information is supplied by Cerner Multum, Inc. and Pizensy Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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