Dosing & Uses
Dosage Forms & Strengths
unit-dose packet, oral powder
- 10g/packet
multidose bottle, oral powder
- 280g/bottle
- 560g/bottle
Chronic Idiopathic Constipation
Indicated for chronic idiopathic constipation (CIC)
20 g PO qDay
Reduce to 10 g PO qDay for persistent loose stools
Safety and efficacy not established
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Contraindicated (0)
Serious - Use Alternative (0)
Monitor Closely (0)
Minor (0)
Adverse Effects
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)
Warnings
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 & Lactation
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.Pharmacology
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
Administration
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)
Images
Formulary
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