COLACE

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.
-Avoid chewing or crushing oral solid formulations if possible; the taste is unacceptable to most patients.

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
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 after 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 been rarely 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 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.

Description: Salts of docusate are stool softeners used to treat or prevent constipation or to prevent fecal impaction. 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 potassium, or docusate calcium) are considered clinically interchangeable in terms of therapeutic effect; each provides minimal amounts of the associated cations. A stool softer is recommended to aid in the passage of stool in pediatric patients with idiopathic constipation. Docusate sodium solution has been effectively used in this population; the solution's bitter taste, however, limits its acceptance. Tasteless alternatives, such as polyethylene glycol (e.g., Miralax) may be preferred. Interestingly, docusate sodium solution has been administered off-label as a ceruminolytic to facilitate the removal of earwax following cerumen impaction; however, the drug may offer no clear benefit over other widely used therapies, including saline irrigation of the external ear canal, and thus it is not usually used in this manner. Docusate is available for non-prescription (OTC) use in the US, and is used clinically in pediatric patients as young as infants for constipation.

For the prevention and treatment of constipation:
Oral dosage (oral docusate sodium solution or syrup):
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.
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.
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.
Oral dosage (oral liquid-filled capsules, soft-gels, or tablets containing docusate sodium):
Children 2 to 11 years: 50 to 150 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.
Oral dosage (capsules containing docusate calcium):
Children and Adolescents 12 to 17 years: 240 mg/day PO.
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.
Rectal dosage (283 mg docusate sodium enema):
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.

Maximum Dosage Limits:
-Neonates
Safety and efficacy have not been established.
-Infants
1 to 6 months: Safety and efficacy have not been established.
6 to 11 months: Up to 40 mg/day PO of docusate sodium has been used clinically off-label under medical supervision.
-Children
1 to 2 years: Up to 40 mg/day PO of docusate sodium has been used clinically off-label under medical supervision.
2 to 11 years: 150 mg/day PO for docusate sodium; 100 mg/day (one 100 mg enema) PR for docusate sodium.
12 years: 240 mg/day PO for docusate calcium; 300 mg/day PO for docusate sodium but up to 500 mg/day has been used off-label; 849 mg/day (three 283 mg enemas) PR for docusate sodium.
-Adolescents
240 mg/day PO for docusate calcium; 300 mg/day PO for docusate sodium but up to 500 mg/day has been used off-label; 849 mg/day (three 283 mg enemas) PR for docusate sodium.

Patients with Hepatic Impairment Dosing
No dosage adjustments are needed.

Patients with Renal Impairment Dosing
No dosage adjustments are needed.

*non-FDA-approved indication

Monograph content under development

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 1-3 days following initiation of oral docusate administration.

Affected cytochrome P450 isoenzymes: none