lactitol (Rx)

1-10%

Upper respiratory tract infection (9%)

Flatulence (8%)

Urinary tract infection (5%)

Diarrhea (4%)

Increased blood creatinine phosphokinase (4%)

Abdominal distension (3%)

Abdominal pain (3%)

Increased blood pressure (3%)

Severe diarrhea (1%)

Elevated creatinine kinase (1%)

Postmarketing Reports

Hypersensitivity reactions (eg, rash, pruritus)

Contraindications

Known or suspected mechanical gastrointestinal obstruction

Galactosemia

Cautions

Drug interaction overview

• May reduce absorption of coadministered oral medications; administer oral medications at least 2 hr before or after lactitol

Pregnancy

Unknown whether maternal use will result in fetal exposure to drug

Insufficient data available from case reports on use in pregnant women to evaluate for any drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

Lactation

No data available on the presence of lactitol in human or animal milk, effects on breastfed infants, or effects on milk production

Unknown whether minimal systemic absorption of lactitol by adults will result in a clinically relevant exposure to breastfed infants

Consider developmental and health benefits of breastfeeding along with the mother’s clinical need for lactitol and any potential adverse effects on the breastfed infant from lactitol or from the underlying maternal condition

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Osmotic laxative; exerts an osmotic effect ,causing an influx of water into the small intestine and resulting in a laxative effect in the colon

Absorption

Minimally absorbed systemically after oral administration

Peak plasma concentration: 776 ng/mL

Peak plasma time: 3.6 hr

AUC: 6,019 ng⋅hr/mL

Effect of food

• Peak plasma concentration and AUC values increase greater than 2-fold under fasted conditions compared with fed conditions

Elimination

Half-life: 2.4 hr

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

Oral Preparation

Multidose bottle

• Bottle top measures 10 grams of powder
• 10-gram dose: Fill measuring cap once
• 20-gram dose: Fill measuring cap twice
• Pour measured powder into an empty glass
• Add 4-8 ounces of water, juice, or other common beverages (eg, coffee, tea, soda) to glass containing the powder; stir thoroughly to dissolve
• Drink entire contents of glass

Unit-dose packets

• Pour contents of 1-2 unit-dose packets, as prescribed, into an empty 8-ounce glass.
• Add 4-8 ounces of water, juice, or other common beverages (eg, coffee, tea, soda) to the glass containing the powder; stir thoroughly to dissolve
• Drink entire contents of the glass

Oral Administration

Preferably taken with meals

Administer oral medications at least 2 hr before or after dose

Storage

Store at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59- 86ºF)