Docusate and senna are used together in an oral preparation to treat or prevent constipation. Docusate is a surfactant that facilitates the admixture of fat and water to soften the stool. Docusate originally was marketed as dioctyl (salt) sulfosuccinate (DSS), but later the generic name was shortened to the current version. The salt forms of docusate, docusate sodium, docusate potassium, or docusate calcium are considered clinically interchangeable in terms of therapeutic effect; each provides minimal amounts of the associated cations. Senna is an anthraquinone laxative similar to cascara. It is a plant derivative. Senna is used for relief of constipation in adult and pediatric patients. Senna is useful for constipation due to opiate analgesics; in adults, the American Gastroenterology Association (AGA) recommends the daily use of an osmotic laxative in combination with a stimulant laxative at least 2 to 3 times per week as first-line therapy in patients with opioid-induced constipation (OIC); docusate can be added to promote soft stools. Senna-containing products have been marketed since the late 1930s. Concerns over a risk for carcinogenicity due to stimulant laxatives prompted the FDA to review the status of senna. Data were submitted to the FDA regarding senna's safety and efficacy as a non-prescription (OTC) laxative, and experts note that there is little evidence that routine use of stimulant laxatives such as senna is harmful to the colon. Many products formerly containing stimulant laxative ingredients like cascara or casanthranol, which were removed from the market due to concerns over tumorigenicity, were reformulated to contain senna instead.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Oral Administration
-Docusate; senna products are administered orally.
Oral Solid Formulations
-Administer by mouth with a full glass of water.
-Doses may be taken as a single daily dose, preferably in the evening/bedtime, or in divided doses. Follow the directions of the specific product chosen.
-Generally produces a bowel movement within 6 to 12 hours.
This monograph discusses the adverse reactions of docusate sodium and senna combination products. Clinicians may wish to consult the individual monographs for more information about each agent.
Stool softeners such as docusate rarely cause adverse effects. Senna is relatively free from adverse effects if used occasionally and for short periods, or used appropriately as directed for longer periods. Stimulant laxatives like senna, by the nature of their effect, may cause mild abdominal pain, discomfort, or cramping, at rates higher than placebo. Bloating, flatulence and fecal urgency have also been reported with the use of senna.
Docusate; senna is relatively free from adverse effects if used occasionally and for short periods, or used appropriately as directed for longer periods. Abuse of stimulant laxatives can cause abdominal pain, diarrhea, nausea, vomiting, or hypokalemia; however, when used as directed, prospective studies have not found an increase in these events with the appropriate use of senna for up to 1 year. There is no addictive potential of senna, though misuse occurs primarily in psychiatric patients or those who abuse the drug to produce diarrhea with the misguided belief that this aids weight loss (use or abuse insignificantly affects dry weight). A long-term effect noted with the use of some anthraquinone laxatives is the development of 'melanosis coli,' pigmentation of the colon mucosa; the cause of the pigmentation is not clear, but the pigment is not considered to be of functional significance. Senna-containing products have been marketed since the late 1930s. Concerns over risk for carcinogenicity due to certain stimulant laxatives prompted the FDA to review the status of senna. Data were submitted to the FDA regarding senna's safety and efficacy as a non-prescription (OTC) laxative, and experts note that there is little evidence that routine use of stimulant laxatives such as senna is harmful to the colon. Laxative tolerance does not appear to occur in most users of senna. Prolonged use of stimulant laxatives has been thought to result in physiological dependence on the laxative ('cathartic colon'), leading to reduced normal bowel function and constipation after therapy is discontinued; however, tolerance and physiologic dependence is rare except in patients with slow colonic motility disorders who benefit from the stimulant laxative action to have regular, normal bowel movement frequency.
Urine discoloration can occur during senna administration, and varies from red-pink in alkaline urine to yellow-brown in acidic urine.
Respiratory and hypersensitivity-type reactions may occur with docusate sodium; senna. Throat irritation has been reported following oral administration of docusate sodium preparations. Wheezing or asthma, anaphylactoid reactions, rash (unspecified), and rhinoconjunctivitis have been reported with the use of senna.
This monograph discusses the contraindications/precautions of docusate sodium and senna combination products. Clinicians may wish to consult the individual monographs for more information about each agent.
Do not use docusate sodium; senna in patients with a known hypersensitivity to the drugs or any of the product components.
Advise patients to consult their healthcare professional before taking docusate; senna products if they have nausea, vomiting, abdominal pain, or if they have notice a sudden change in their bowel habits that lasts for more than 2 weeks. Patients with serious GI disease, such as inflammatory bowel disease, should consult their health care provider prior to nonprescription use. Docusate; senna products should not be used in patients with undiagnosed abdominal pain. Use of stimulant laxatives like senna is generally contraindicated in patients with bowel or other GI obstruction. Patients should discontinue self-medication and consult their health care provider if they experience diarrhea, rectal GI bleeding or if they fail to have a bowel movement after docusate; senna administration; these may be signs of a more serious condition.
Systemic absorption of docusate and the sennosides is minimal and there have been no reports of teratogenicity or an increased risk of congenital anomalies due to senna use in humans. The intermittent use of senna with docusate should be limited to use under the advice of a qualified health care professional and after safer agents alone have failed to produce intended results. The safest first-line treatments to use for constipation during pregnancy are those that are not absorbed systemically (e.g., fiber, bulk-forming laxatives, stool softeners such as docusate alone) in order to minimize drug exposure to the fetus. Polyethylene glycol 3350 also has minimal systemic absorption and is considered a first-line option for chronic constipation during pregnancy.
Docusate sodium; senna is generally considered compatible for use in breast-feeding. Docusate is not systemically absorbed. Senna is not excreted into human milk, but it is a prodrug which is metabolized in vivo to the sennosides. Sennosides are glucosides of rhein, and the sennosides are essentially undetectable in human milk. Rhein appears to be excreted only in minimal amounts. There is a lack of reported adverse events in nursing infants whose mothers ingested sennosides during lactation. Agents that are non-absorbed or poorly absorbed (e.g., bulk-forming laxatives or stool softeners such as docusate alone) are often the preferred drugs for first-line use in the lactating female when such therapy is necessary. Other agents that may be considered based on lack of systemic effect or lack of reported adverse effects in nursing infants include magnesium hydroxide, polyethylene glycol 3350, and bisacodyl.
Nonprescription use of docusate; senna is not recommended in infants. Most nonprescription products may be used in children 2 years and older. While the literature describes off-label use of senna for occasional constipation or for bowel preparation in infants as young as 1 month of age, under a prescriber's advice and observation, commercially available formulations of docusate; senna are not ammenable to use in infants, and some products contain ingredients that may not be safe for neonates.
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 laxatives may cause flatulence, bloating, and abdominal pain in debilitated or elderly patients.
For the treatment of constipation:
Oral dosage (oral tablets or capsules containing 50 mg docusate sodium; 8.6 mg sennosides):
Adults: 2 to 4 tablets or capsules PO daily until bowel movements are normal. Doses may be taken as single or divided doses; bedtime dosing is suggested.
Children and Adolescents 12 to 17 years: 2 to 4 tablets or capsules PO daily. Doses may be taken as single or divided doses; bedtime dosing is suggested.
Children 6 to 11 years: 1 to 2 tablets or capsules PO daily. Doses may be taken as single or divided doses; bedtime dosing is suggested.
Children 2 to 5 years: 1 tablet or capsule PO daily until bowel movements are normal. Bedtime dosing is suggested. Dosage forms may not be appropriate for young children.
Maximum Dosage Limits:
-Adults
200 mg/day PO for docusate sodium; 34.4 mg sennosides; or 4 units (tablets or capsules)/day PO.
-Geriatric
200 mg/day PO for docusate sodium; 34.4 mg sennosides; or 4 units (tablets or capsules)/day PO.
-Adolescents
200 mg/day PO for docusate sodium; 34.4 mg sennosides; or 4 units (tablets or capsules)/day PO.
-Children
>= 12 years: 200 mg docusate sodium with 34.4 mg sennosides PO per day; or 4 units (tablets or capsules)/day PO.
6-11 years: 100 mg docusate sodium with 17.2 mg sennosides PO per day; or 2 units (tablets or capsules)/day PO.
2-5 years: 50 mg docusate sodium with 8.6 mg sennosides PO per day.
< 2 years: Not recommended; consult medical professional.
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
Atropine; Difenoxin: (Moderate) Diphenoxylate can decrease GI motility. Drugs used to treat constipation, such as laxatives, would counteract the effect of antidiarrheals. In general, it would be illogical to concurrently administer these drugs at the same time. If an antidiarrheal medication is needed, it would be wise to temporarily discontinue use of agents with laxative effects.
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.
Diphenoxylate; Atropine: (Moderate) Diphenoxylate can decrease GI motility. Drugs used to treat constipation, such as laxatives, would counteract the effect of antidiarrheals. In general, it would be illogical to concurrently administer these drugs at the same time. If an antidiarrheal medication is needed, it would be wise to temporarily discontinue use of agents with laxative effects.
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.
Polyethylene Glycol: (Moderate) When polyethylene glycol is used as pre-procedure bowel preparation, avoid concomitant use of stimulant laxatives. Colonic mucosal aphthous ulcerations and ischemic colitis have been observed following use of osmotic laxatives for bowel preparation and concomitant use of stimulant laxatives may increase this risk.
Polyethylene Glycol; Electrolytes: (Moderate) When polyethylene glycol is used as pre-procedure bowel preparation, avoid concomitant use of stimulant laxatives. Colonic mucosal aphthous ulcerations and ischemic colitis have been observed following use of osmotic laxatives for bowel preparation and concomitant use of stimulant laxatives may increase this risk.
Polyethylene Glycol; Electrolytes; Ascorbic Acid: (Moderate) When polyethylene glycol is used as pre-procedure bowel preparation, avoid concomitant use of stimulant laxatives. Colonic mucosal aphthous ulcerations and ischemic colitis have been observed following use of osmotic laxatives for bowel preparation and concomitant use of stimulant laxatives may increase this risk.
Polyethylene Glycol; Electrolytes; Bisacodyl: (Moderate) When polyethylene glycol is used as pre-procedure bowel preparation, avoid concomitant use of stimulant laxatives. Colonic mucosal aphthous ulcerations and ischemic colitis have been observed following use of osmotic laxatives for bowel preparation and concomitant use of stimulant laxatives may increase this risk.
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.
This stimulant laxative-stool softener combination works synergistically to relieve constipation.
-Docusate: 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 is not considered a laxative. Docusate has a delayed onset of action, with softening of the stool becoming apparent after 1 to 3 days of therapy.
-Senna: Anthraquinone derivatives such as senna are stimulant laxatives. Stimulant laxatives work by irritating luminal sensory nerve endings, thereby stimulating colonic motility and reducing colonic water absorption. Senna can alter permeability of cell walls in the colon because it increases cyclic 3',5'-adenosine monophosphate, which also regulates active ion secretion. The result is increased fluid accumulation in the colon and a laxative action. Tolerance to stimulant laxatives is uncommon.
Docusate sodium; senna is administered orally.
-Docusate sodium: 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.
-Senna: Free anthraquinones are released in the colon as a result of enzymatic hydrolysis of the glycosides. There is little documentation on distribution of senna. Absorbed anthraquinones are believed to be metabolized by the liver and may be excreted via the bile in feces, and, possibly, in urine. There is insufficient evidence of distribution into breast milk.
Affected cytochrome P450 isoenzymes: none
-Route-Specific Pharmacokinetics
Oral Route
-Docusate sodium: Docusate sodium is minimally absorbed and exert its effects locally. Fecal softening begins 1-3 days following initiation of oral docusate administration.
-Senna: There is minimal GI absorption of senna following oral administration. Laxative effect is produced in 6-12 hours but can take as long as 24 hours.