Salts of docusate are stool softeners used to treat or prevent constipation or to prevent fecal impaction in adult and pediatric patients. Docusate originally was marketed as dioctyl (salt) sulfosuccinate, but later the generic name was shortened to the current version. The salt forms of docusate (e.g., docusate sodium, docusate calcium) are considered clinically interchangeable in terms of therapeutic effect; each provides minimal amounts of the associated cations. Interestingly, docusate sodium solution has been used off-label as a ceruminolytic to facilitate the removal of earwax following cerumen impaction; however, it offers no clear benefit over other widely used non-prescription therapies, including saline irrigation of the external ear canal, and thus it is not usually used in this manner. Docusate was initially FDA approved in 1957 and is available for non-prescription (OTC) use in the U.S.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific 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 to 8 ounces of milk, fruit juice, or infant formula to mask the bitter taste and prevent throat irritation.
Rectal Administration
Enema
-Instruct the patient to 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 a few drops of the medication. Applying lubricant to the anal area is recommended before inserting enema.
-With steady pressure, carefully and gently insert the tube shaft into the rectum. Insert up to the shoulder of the tube. Squeeze tube to empty contents and keep the tube squeezed until completely removed from the rectum. Discard empty tube; a small amount of liquid may remain in the unit after use.
Stool softeners such as docusate rarely cause adverse effects. Occasionally, mild GI cramping can occur. Throat irritation has been reported following oral administration of docusate liquid preparations, particularly if the preparations are not properly diluted with liquids prior to administration. Excessive oral doses can produce loose stools and rarely diarrhea. Rash (unspecified) has rarely been reported with all dosage forms. Rectal irritation may occur with rectal preparations; if irritation or rash around the anus appears, discontinue use.
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 2 weeks. Patients should not use this product for a period of 1 week or more without healthcare 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, encourage 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.
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 individual when such therapy is necessary.
For the prevention or treatment of constipation:
Oral dosage (oral liquid-filled capsules, soft-gels, or tablets containing docusate sodium):
Adults: 50 to 300 mg/day PO given in single or divided doses.
Children and Adolescents 12 to 17 years: 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 (oral docusate sodium solution or syrup):
Adults: 50 to 300 mg/day PO given in single or divided doses.
Children and Adolescents 12 to 17 years: 50 to 300 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: 50 to 150 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 (capsules containing docusate calcium):
Adults: 240 mg/day PO.
Children and Adolescents 12 to 17 years: 240 mg/day PO.
Rectal dosage (283 mg docusate sodium enema):
Adults: 1 to 3 rectal enemas 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.
Children and Adolescents 12 to 17 years: 1 to 3 rectal enemas 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 (100 mg docusate sodium enema):
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.
Maximum Dosage Limits:
NOTE: Do not exceed recommended dosage limits on the label for the specific product chosen.
-Adults
240 mg/day PO for docusate calcium; 300 mg/day PO for docusate sodium; 849 mg/day (three 283 mg enemas) PR docusate sodium.
-Geriatric
240 mg/day PO for docusate calcium; 300 mg/day PO for docusate sodium; 849 mg/day (three 283 mg enemas) PR docusate sodium.
-Adolescents
240 mg/day PO for docusate calcium; 300 mg/day PO for docusate sodium; 849 mg/day (three 283 mg enemas) PR docusate sodium.
-Children
12 to 17 years: 240 mg/day PO for docusate calcium; 300 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; 100 mg/day (one 100 mg enema) PR docusate sodium.
1 to 2 years: Safety and efficacy have not been established; however, up to 40 mg/day PO of docusate sodium has been used.
-Infants
6 to 11 months: Up to 40 mg/day PO of docusate sodium has been used clinically off-label under medical supervision.
1 to 6 months: Safety and efficacy have not been established.
-Neonates
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
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.
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.
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 to 3 days of therapy.
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 and drug transporters: None