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

BeneHealth Stool Softner, Colace, Colace Clear, Correctol, D.O.S., DC, Diocto, Doc-Q-Lace, Docu Liquid, DocuLace, Docusoft S, DocuSol, DocuSol Kids Mini, DOK, DOK Extra Strength, Dulcolax, Dulcolax Pink, Enemeez, 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

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 Extra Strength/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
Diocto/Docu Liquid/Docusate/Docusate Sodium/Fleet Oral Liq: 5mL, 50mg
Diocto/Docu Liquid/Docusate/Docusate Sodium/Fleet/Fleet Pedia-Lax Oral Sol: 5mL, 15mL, 50mg
Docusate/Docusate Sodium Oral Susp: 5mL, 50mg
Docusate/Docusate Sodium/DocuSol/DocuSol Kids Mini/Enemeez/VACUANT Rectal Enema: 100mg, 283mg
Docusate/Docusate Sodium/DOK/Plus PHARMA/Stool Softener Oral Tab: 100mg

DOSAGE & INDICATIONS

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.

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.

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:
- Protect from freezing
- Protect from light
- Store at controlled room temperature (between 68 and 77 degrees F)
BeneHealth Stool Softner:
- Store at 77 degrees F; excursions permitted to 59-86 degrees F
Colace:
- Store at 77 degrees F; excursions permitted to 59-86 degrees F
Colace Clear:
- Store at 77 degrees F; excursions permitted to 59-86 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:
- Avoid excessive heat (above 104 degrees F)
- 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:
- Avoid excessive heat (above 104 degrees F)
- 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)
DocuSol Kids Mini:
- 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
Dulcolax Pink:
- Store at 77 degrees F; excursions permitted to 59-86 degrees F
Enemeez:
- Store at room temperature (between 59 to 86 degrees F)
Fleet:
- Avoid excessive heat (above 104 degrees F)
- Store at room temperature (between 59 to 86 degrees F)
Fleet Pedia-Lax:
- Storage information not provided in labeling
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
Plus PHARMA:
- Store at room temperature
- Store in a dry place
Silace:
- Avoid excessive heat (above 104 degrees F)
- 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 Softener DC:
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Stool Softener Extra Strength:
- 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:
- Store at room temperature (between 59 to 86 degrees F)

CONTRAINDICATIONS / PRECAUTIONS

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.

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.

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.

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

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.
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

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