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  • CLASSES

    Enemas for Constipation
    Softeners, Emollients

    DEA CLASS

    OTC

    DESCRIPTION

    Anionic surfactant used to treat constipation
    Available as calcium salt or as the sodium salt; no apparent clinical difference between the two salts
    At recommended doses, exhibits little stimulatory actions and thus not considered a laxative; stool softening effects apparent after 1—3 days of therapy

    COMMON BRAND NAMES

    Colace, Colace Clear, Correctol, D.O.S., DC, Diocto, Doc-Q-Lace, Docu Liquid, DocuLace, Docusoft S, DocuSol, DOK, DOK Extra Strength, Dulcolax, Enemeez, Genasoft, Kao-Tin, Kaopectate Liqui-Gels, Phillips Stool Softener, Silace, Stool Softener, Stool Softner DC, Sur-Q-Lax, Surfak, Uni-Ease

    HOW SUPPLIED

    Colace/Colace Clear/Correctol/D.O.S./DC/Doc-Q-Lace/DocuLace/Docusate/Docusate Calcium/Docusate Sodium/Docusoft S/DOK/DOK Extra Strength/Dulcolax/Genasoft/Kaopectate Liqui-Gels/Kao-Tin/Phillips Stool Softener/Stool Softener/Stool Softner DC/Surfak/Sur-Q-Lax/Uni-Ease Oral Cap: 50mg, 100mg, 240mg, 250mg
    Colace/Diocto/Doc-Q-Lace/Docusate/Docusate Sodium/Silace Oral Syrup: 15mL, 60mg
    Colace/Diocto/Docu Liquid/Docusate/Docusate Sodium/Fleet/Silace Oral Liq: 1mL, 5mL, 10mg, 50mg
    Diocto/Docu Liquid/Docusate/Docusate Sodium/Fleet Oral Sol: 5mL, 15mL, 50mg
    Docusate/Docusate Sodium Oral Susp: 5mL, 50mg
    Docusate/Docusate Sodium/DocuSol/Enemeez/VACUANT Rectal Enema: 100mg, 283mg
    Docusate/Docusate Sodium/DOK/Stool Softener Oral Tab: 100mg

    DOSAGE & INDICATIONS

    For the prevention or treatment of constipation.
    Oral dosage (oral liquid-filled capsules, soft-gels, or tablets containing docusate sodium)
    Adults, Adolescents, and Children 12 years and older

    50 to 300 mg/day PO given in single or divided doses.

    Children 2 to 11 years

    50 to 150 mg/day PO given in single or divided doses.

    Oral dosage (capsules containing docusate calcium)
    Adults, Adolescents, and Children 12 years and older

    240 mg/day PO.

    Oral dosage (oral solution containing 10 mg/mL docusate sodium)
    Adults, Adolescents, and Children 12 years and older

    50 to 200 mg/day PO given in single or divided doses. Up to 500 mg/day PO in divided doses recommended per treatment guidelines for idiopathic childhood constipation.

    Children 2 to 11 years

    25 to 100 mg/day PO given in single or divided doses. Per treatment guidelines for idiopathic childhood constipation, 12.5 to 25 mg PO 3 times daily has been recommended.

    Infants and Children 6 months to 1 year†

    12.5 mg PO 3 times daily, recommended per treatment guidelines for idiopathic childhood constipation. In clinical practice, 10 to 40 mg/day PO given in single or divided doses has also been used effectively. Use only under medical supervision.

    Oral dosage (oral syrup containing 60 mg/15 mL docusate sodium)
    Adults, Adolescents, and Children 12 years and older

    60 to 360 mg/day (15 to 90 mL/day) PO given in single or divided doses.

    Children 2 to 11 years

    60 to 150 mg/day (15 to 37.5 mL/day) PO given in single or divided doses.

    Rectal dosage (283 mg enema; e.g., Enemeez)
    Adults, Adolescents, and Children 12 years and older

    1 to 3 rectal enemas daily as needed. A bowel movement is generally produced within 2 to 15 minutes of administration. Do not use product for longer than 1 week unless under the supervision of a physician.

    Children 2 to 11 years

    1 enema (283 mg) per rectum daily as needed; only use after consultation with a physician. A bowel movement is generally produced within 2 to 15 minutes of administration. Do not use product for longer than 1 week unless under the supervision of a physician.

    Rectal dosage (283 mg enema; e.g., Docusol)
    Adults, Adolescents, and Children 12 years and older

    1 to 3 rectal enemas daily as needed. A bowel movement is generally produced within 2 to 15 minutes of administration. Do not use product for longer than 1 week unless under the supervision of a physician.

    Rectal dosage (100 mg enema; e.g., Docusol Kids)
    Children 2 to 11 years

    1 enema (100 mg) per rectum daily as needed. A bowel movement is generally produced within 2 to 15 minutes of administration. Do not use product for longer than 1 week unless under the supervision of a physician.

    Rectal dosage (oral solution)
    Adults

    50 to 100 mg PR of docusate liquid in saline or water as a retention enema.

    Oral dosage (oral solution containing 50 mg/15 mL docusate sodium)
    Children 2 to 11 years

    50 to 150 mg/day (15 to 45 mL/day) PO given in single or divided doses.

    MAXIMUM DOSAGE

    NOTE: Do not exceed recommended dosage limits for the specific product; specific OTC products, for example, may specify slightly different recommendations from other products on the product label.

    Adults

    240 mg/day PO for docusate calcium; 360 mg/day PO for docusate sodium; 849 mg/day (three 283 mg enemas) PR docusate sodium.

    Geriatric

    240 mg/day PO for docusate calcium; 360 mg/day PO for docusate sodium; 849 mg/day (three 283 mg enemas) PR docusate sodium.

    Adolescents

    240 mg/day PO for docusate calcium; 360 mg/day PO for docusate sodium; 849 mg/day (three 283 mg enemas) PR docusate sodium.

    Children

    >= 12 years: 240 mg/day PO for docusate calcium; 360 mg/day PO for docusate sodium; 849 mg/day (three 283 mg enemas) PR docusate sodium.
    2 to 11 years: 150 mg/day PO for docusate sodium; 283 mg/day PR for docusate sodium.
    < 2 years of age: Safety and efficacy have not been established; however, 40 mg/day PO of docusate sodium has been used.

    Infants

    Safety and efficacy have not been established; however, 40 mg/day PO of docusate sodium has been used.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

    Renal Impairment

    Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

    ADMINISTRATION

    Oral Administration
    Oral Solid Formulations

    Give tablets or soft-gel capsules with full glass of water.

    Oral Liquid Formulations

    Oral solution: Measure the dose to be administered using a calibrated measuring device to ensure accurate dosing. Solution should be mixed with 6–8 ounces of milk, fruit juice, or infant formula to mask the bitter taste and prevent throat irritation.

    Rectal Administration

    Rectal mini enema: The patient should lay on their left side with top knee bent and arms resting comfortably. Alternatively, the patient may kneel, then lower their head and chest forward until left side of the face is resting on a surface with arms folded comfortably. Open tube by twisting off and removing tip. Moisten the shaft of the tube with water or a few drops of the medication. Applying lubricant to the anal area is recommended before inserting enema. With steady pressure, carefully insert the tube shaft into the rectum. Squeeze tube to empty contents and keep the tube squeezed until completely removed from the rectum. Discard empty tube.

    STORAGE

    Generic:
    - Store at room temperature (between 59 to 86 degrees F)
    Colace:
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Colace Clear:
    - Store at room temperature (between 59 to 86 degrees F)
    Correctol:
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    D.O.S.:
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    DC:
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    Diocto:
    - Store at room temperature (between 59 to 86 degrees F)
    Doc-Q-Lace:
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Docu Liquid:
    - Store at room temperature (between 59 to 86 degrees F)
    DocuLace:
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Docusoft S:
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    DocuSol:
    - Store at room temperature (between 59 to 86 degrees F)
    DOK:
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    DOK Extra Strength:
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    Dulcolax:
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Enemeez:
    - Protect from freezing
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Genasoft:
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Kaopectate Liqui-Gels:
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    Kao-Tin :
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    Phillips Stool Softener:
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Silace:
    - Protect from freezing
    - Store at room temperature (between 59 to 86 degrees F)
    Stool Softener :
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Stool Softner DC :
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    Sulfolax:
    - Protect from moisture
    - Store at room temperature (between 59 to 86 degrees F)
    Surfak:
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    Sur-Q-Lax :
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    Uni-Ease :
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    VACUANT:
    - Protect from freezing
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    There are few absolute contraindications to the use of docusate; do not use docusate in patients with a known hypersensitivity to the drug or any of the product components.

    Abdominal pain, GI bleeding, vomiting

    Before self-treatment with a docusate laxative, patients should be advised to consult their health care professional if they notice a sudden change in bowel habits that persists for two weeks. Patients should not use this product for a period >= 1 week without health care provider consultation. Patients should not use this product if they are experiencing abdominal pain, nausea, and/or vomiting. In addition, if the product fails to produce a bowel movement after use or if rectal GI bleeding occurs, patients should be instructed to discontinue use of laxative and consult their physician as this may indicate a serious condition. If a patient is using a rectal formulation, the patient should be encouraged to follow proper administration techniques; forcing the enema may result in injury and damage to the rectum. For patients with impaired rectal function, including loss of sensation, occasional rectal examinations are warranted.

    Pregnancy

    Docusate salts are generally considered to be low risk in pregnancy, due to their lack of systemic absorption and lack of adverse effects on hydration and nutritional status of the pregnant mother. No reports linking the use of docusate salts to congenital defects in humans have been published and epidemiologic data do not support an association between the drug and congenital defects. Docusate salts are sometimes found within the formulations of prescription prenatal vitamins to help prevent constipation from iron or other minerals. As with all medications, the pregnant patient should consult her qualified health care professional prior to the use of non-prescription stool softeners like docusate, and should follow recommendations on the duration of use. The safest first-line treatments to use for constipation during pregnancy are those that are not absorbed systemically (e.g., fiber, bulk-forming laxatives) in order to minimize drug exposure to the fetus.

    Breast-feeding

    There appear to be no precautions for the use of docusate salts during breast-feeding. In general, stool-softeners are not significantly absorbed systemically and thus should not appear in breast milk in amounts that would generate clinical concern. Agents that are non-absorbed or poorly absorbed (e.g., bulk-forming laxatives or stool softeners) are often the preferred drugs for use in the lactating female when such therapy is necessary.

    Geriatric

    The federal Omnibus Budget Reconciliation Act (OBRA) regulates the use of medications in residents (e.g., geriatric adults) of long-term care facilities. The OBRA guidelines caution that stool softeners, such as docusate, may cause accumulation of stool and possible bowel obstruction if not used with a sufficient amount of fluid or in patients with other causes of impaired bowel motility.

    ADVERSE REACTIONS

    Mild

    throat irritation / Early / 0-1.0
    diarrhea / Early / 0-1.0
    rash / Early / 0-1.0

    DRUG INTERACTIONS

    Calcium Phosphate, Supersaturated: (Moderate) Patients should be instructed not to administer additional laxatives or purgative agents during treatment with sodium phosphate monobasic monohydrate; sodium phosphate dibasic anhydrous.
    Dichlorphenamide: (Moderate) Use dichlorphenamide and docusate together with caution. Dichlorphenamide increases potassium excretion and can cause hypokalemia and should be used cautiously with other drugs that may cause hypokalemia including laxatives. Measure potassium concentrations at baseline and periodically during dichlorphenamide treatment. If hypokalemia occurs or persists, consider reducing the dichlorphenamide dose or discontinuing dichlorphenamide therapy.
    Loop diuretics: (Moderate) Loop diuretics may increase the risk of hypokalemia especially in patients receiving prolonged therapy with laxatives. Monitor serum potassium levels to determine the need for potassium supplementation and/or alteration in drug therapy.
    Mineral Oil: (Major) The concurrent use of docusate salts with mineral oil to relieve constipation is not recommended because docusate can increase the systemic absorption of mineral oil. Inflammation of the intestinal mucosa, liver, spleen and lymph nodes may occur due to a foreign body reaction. Mineral oil deposition has been detected at these sites.
    Sodium Phosphate Monobasic Monohydrate; Sodium Phosphate Dibasic Anhydrous: (Moderate) Patients should be instructed not to administer additional laxatives or purgative agents during treatment with sodium phosphate monobasic monohydrate; sodium phosphate dibasic anhydrous.

    PREGNANCY AND LACTATION

    Pregnancy

    Docusate salts are generally considered to be low risk in pregnancy, due to their lack of systemic absorption and lack of adverse effects on hydration and nutritional status of the pregnant mother. No reports linking the use of docusate salts to congenital defects in humans have been published and epidemiologic data do not support an association between the drug and congenital defects. Docusate salts are sometimes found within the formulations of prescription prenatal vitamins to help prevent constipation from iron or other minerals. As with all medications, the pregnant patient should consult her qualified health care professional prior to the use of non-prescription stool softeners like docusate, and should follow recommendations on the duration of use. The safest first-line treatments to use for constipation during pregnancy are those that are not absorbed systemically (e.g., fiber, bulk-forming laxatives) in order to minimize drug exposure to the fetus.

    There appear to be no precautions for the use of docusate salts during breast-feeding. In general, stool-softeners are not significantly absorbed systemically and thus should not appear in breast milk in amounts that would generate clinical concern. Agents that are non-absorbed or poorly absorbed (e.g., bulk-forming laxatives or stool softeners) are often the preferred drugs for use in the lactating female when such therapy is necessary.

    MECHANISM OF ACTION

    Docusate is an anionic surfactant (i.e., a surface-active agent). It lowers the surface tension at the oil-water interface of the feces, allowing water and lipids to penetrate the stool. This helps to hydrate and soften the fecal material, facilitating natural defecation. At usual recommended doses, docusate exhibits little intrinsic stimulatory actions and thus cannot be considered a laxative. Docusate has a delayed onset of action, with softening of the stool becoming apparent after 1—3 days of therapy.

    PHARMACOKINETICS

    Docusate calcium is administered orally; docusate sodium is administered orally and rectally. Because docusate salts are minimally absorbed and exert their effects locally, standard pharmacokinetic parameters do not apply. Some systemic absorption occurs in the jejunum and duodenum, but the extent of this is unknown and unlikely to be significant; any systemically absorbed drug is subsequently excreted in the bile. Fecal softening begins 1 to 3 days following initiation of oral docusate administration.
     
    Affected cytochrome P450 isoenzymes: none