DRUG INTERACTIONS

1. 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           

U.S. FDA APPROVED  DRUGS DURING 2020

Sr.No-  4

ADVERSE REACTIONS

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

 CONTRAINDICATIONS                                                                                           PIZENSY is contraindicated in patients with:                                                                         • known or suspected mechanical gastrointestinal obstruction                                              • galactosemia 

 HOW SUPPLIED/STORAGE AND HANDLING

PIZENSY is supplied in a white to off-white crystalline powder form, for oral administration following reconstitution.

PIZENSY is available in three sizes:

• 280 grams of lactitol in multi-dose bottles 

• 560 grams of lactitol in multi-dose bottles 

• carton of 28 unit-dose packets each containing 10 grams of lactitol 

The measuring cap on each multi-dose bottle is marked to contain 10 grams of powder when filled to the top of white section in cap and may be used to measure the appropriate PIZENSY dose.

Each bottle contains a white desiccant packet printed “Do Not Eat.”

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.

 PATIENT COUNSELING INFORMATION

Persistent Loose Stools Advise patients to stop PIZENSY and contact their healthcare provider if they experience persistent loose stools.

Distributed by Braintree Laboratories, Inc. Braintree, MA 02185

 CLINICAL PHARMACOLOGY

1. 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. 

2.Pharmacodynamics                                                                                                 No formal pharmacodynamic studies have been conducted with PIZENSY.

3. Pharmacokinetics                                                                                          Following a single oral dose of 20-gram PIZENSY in healthy adult subjects under fed conditions, the mean ± SD peak serum concentration (Cmax) is 776 ± 253 ng/mL, and the mean ± SD area under the curve (AUC) is 6,019 ± 1,771 ng*hr/mL. 

Absorption                                                                                                             Lactitol is minimally absorbed systemically following oral administration. The mean ± SD time to reach peak serum concentration (Tmax) is 3.6 ± 1.2 hours following a single oral dose of 20-gram PIZENSY in healthy adult subjects under fed conditions.

Effect of Food                                                                                                          Cmax and AUC values increase greater than 2-fold under fasted conditions compared to fed conditions. 

Elimination                                                                                                                 The mean half-life of lactitol is 2.4 hours. 

Excretion                                                                                                                Lactitol is minimally absorbed in the small intestine. Unabsorbed lactitol is expected to be degraded into organic acids in the colon and is minimally excreted in the feces. 

 USE IN SPECIFIC POPULATIONS

1. Pregnancy Risk Summary

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.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the United States general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

2. Lactation Risk Summary                                                                                   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.

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

4. 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.