Peri-Colace

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Peri-Colace

Classes

Contact/Stimulant Laxatives

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.

Adverse Reactions
Severe

anaphylactoid reactions / Rapid / Incidence not known

Moderate

hypokalemia / Delayed / Incidence not known
tolerance / Delayed / Incidence not known
melanosis coli / Delayed / Incidence not known
wheezing / Rapid / Incidence not known

Mild

fecal urgency / Early / Incidence not known
abdominal pain / Early / Incidence not known
flatulence / Early / Incidence not known
nausea / Early / Incidence not known
diarrhea / Early / Incidence not known
vomiting / Early / Incidence not known
urine discoloration / Early / Incidence not known
throat irritation / Early / Incidence not known
rash / Early / Incidence not known

Common Brand Names

Colace, Dok Plus, Laxacin, Peri-Colace, Senexon-S, Senna Plus, Senna-S, Senna-Time-S, SennaLax-S, Senohot-S, Senokot-S, SenoSol-SS, Stool Softener with Laxative

Dea Class

OTC

Description

Oral combination of a stool softener (docusate) and a plant-derived anthraquinone stimulant laxative (senna); long history of safe and effective use
Useful for constipation in adult and pediatric patients
Senna is effective in the management of opioid-induced constipation (OIC)

Dosage And Indications
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.

Dosing Considerations
Hepatic Impairment

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Renal Impairment

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Drug Interactions

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.

How Supplied

Colace/Docusate Sodium, Sennosides/Docusate, Sennosides/Dok Plus/Laxacin/Peri-Colace/Senexon-S/Senna Plus/SennaLax-S/Senna-S/Senna-Time-S/Senohot-S/Senokot-S/SenoSol-SS/Stool Softener with Laxative Oral Tab: 50-8.6mg

Maximum Dosage
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.

Mechanism Of Action

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.

Pharmacokinetics

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

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.

Pregnancy And Lactation
Pregnancy

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.[27500] [42282] [46842] [46846] [46847] [61291]