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Colace
Classes
Enemas for Constipation
Softeners, Emollients
Administration
Give tablets or soft-gel capsules with full glass of water.
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.
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.
Adverse Reactions
throat irritation / Early / 0-1.0
diarrhea / Early / 0-1.0
rash / Early / 0-1.0
Common Brand Names
BeneHealth Stool Softner, Colace, Colace Clear, Correctol, D.O.S., DC, Diocto, Doc-Q-Lace, Docu Liquid, DocuLace, Docusoft S, DocuSol, DocuSol Kids, DocuSol Kids Mini, DOK, DOK Extra Strength, Dulcolax, Dulcolax Pink, Enemeez, ENEMEEZ Kids, Fleet, Fleet Pedia-Lax, Genasoft, Kao-Tin, Kaopectate Liqui-Gels, Phillips Stool Softener, Plus PHARMA, Silace, Stool Softener, Stool Softener DC, Stool Softener Extra Strength, Sur-Q-Lax, Surfak, Uni-Ease, VACUANT
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
Dosage And Indications
50 to 300 mg/day PO given in single or divided doses.
50 to 300 mg/day PO given in single or divided doses.
50 to 150 mg/day PO given in single or divided doses.
50 to 300 mg/day PO given in single or divided doses.
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.
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.
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.
240 mg/day PO.
240 mg/day PO.
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.
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.
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.
Dosing Considerations
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
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.
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.
How Supplied
BeneHealth Stool Softner/Colace/Colace Clear/Correctol/D.O.S./DC/Doc-Q-Lace/DocuLace/Docusate/Docusate Calcium/Docusate Sodium/Docusoft S/DOK/DOK Extra Strength/Dulcolax/Dulcolax Pink/Genasoft/Kaopectate Liqui-Gels/Kao-Tin/Phillips Stool Softener/Stool Softener/Stool Softener DC/Stool Softener Extra Strength/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
Diocto/Docu Liquid/Docusate/Docusate Sodium/Fleet Oral Liq: 5mL, 50mg
Diocto/Docu Liquid/Docusate/Docusate Sodium/Fleet/Fleet Pedia-Lax Oral Sol: 5mL, 10mL, 15mL, 50mg, 100mg
Docusate/Docusate Sodium Oral Susp: 5mL, 50mg
Docusate/Docusate Sodium/DocuSol/DocuSol Kids/Enemeez/ENEMEEZ Kids/VACUANT Rectal Enema: 100mg, 283mg
Docusate/Docusate Sodium/DOK/Plus PHARMA/Stool Softener Oral Tab: 100mg
Maximum Dosage
NOTE: Do not exceed recommended dosage limits on the label for the specific product chosen.
240 mg/day PO for docusate calcium; 300 mg/day PO for docusate sodium; 849 mg/day (three 283 mg enemas) PR docusate sodium.
240 mg/day PO for docusate calcium; 300 mg/day PO for docusate sodium; 849 mg/day (three 283 mg enemas) PR docusate sodium.
240 mg/day PO for docusate calcium; 300 mg/day PO for docusate sodium; 849 mg/day (three 283 mg enemas) PR docusate sodium.
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.
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.
Safety and efficacy have not been established.
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
Pregnancy And Lactation
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.