lactitol (Rx)

Brand and Other Names:Pizensy
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Dosing & Uses

AdultPediatric

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

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Interactions

Interaction Checker

and lactitol

No Results

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Contraindicated (0)

              Serious - Use Alternative (0)

                Monitor Closely (0)

                  Minor (0)

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                    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)

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                    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
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                    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.

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                    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

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                    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)

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                    Images

                    No images available for this drug.
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                    Patient Handout

                    A Patient Handout is not currently available for this monograph.
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                    Formulary

                    FormularyPatient Discounts

                    Adding plans allows you to compare formulary status to other drugs in the same class.

                    To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                    Adding plans allows you to:

                    • View the formulary and any restrictions for each plan.
                    • Manage and view all your plans together – even plans in different states.
                    • Compare formulary status to other drugs in the same class.
                    • Access your plan list on any device – mobile or desktop.

                    The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                    Tier Description
                    1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                    2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                    3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                    4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                    5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                    6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                    NC NOT COVERED – Drugs that are not covered by the plan.
                    Code Definition
                    PA Prior Authorization
                    Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                    QL Quantity Limits
                    Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                    ST Step Therapy
                    Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                    OR Other Restrictions
                    Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                    Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.