Colace - Drug Monograph

Introduction

Colace (docusate sodium) is a widely used stool softener that belongs to the surfactant class of laxatives. It is an over-the-counter medication primarily indicated for the prevention and treatment of occasional constipation. Unlike stimulant laxatives, Colace works by softening stool rather than directly promoting bowel motility, making it a gentler option for many patients.

Mechanism of Action

Colace functions as a surfactant or stool softener. Its mechanism of action involves reducing the surface tension of the oil-water interface of stool, allowing water and lipids to penetrate and soften the fecal mass. Docusate sodium promotes the incorporation of water into stool by facilitating the mixing of aqueous and fatty substances, which results in softer stool consistency and easier passage without directly stimulating peristalsis.

Indications

• Prevention of constipation in patients who should avoid straining (post-operative, cardiovascular conditions, rectal surgery)
• Treatment of occasional constipation
• Adjunct therapy in patients with hemorrhoids or anal fissures
• Constipation management in pregnant patients (under medical supervision)

Dosage and Administration

• 50-500 mg daily, typically 100 mg once or twice daily
• Maximum daily dose: 500 mg

• 40-120 mg daily in divided doses

• 20-60 mg daily in divided doses

• Geriatric patients: Use lowest effective dose
• Renal impairment: No dosage adjustment typically needed
• Hepatic impairment: No specific recommendations; use with caution

• Oral administration with full glass of water
• May be taken with or without food
• Typically produces bowel movement within 24-72 hours

Pharmacokinetics

Contraindications

• Known hypersensitivity to docusate sodium or any component of the formulation
• Acute abdominal pain, nausea, or vomiting of unknown origin
• Intestinal obstruction or ileus
• Fecal impaction

Warnings and Precautions

• Not for long-term use without medical supervision (beyond 1 week)
• Use with caution in patients with pre-existing electrolyte imbalances
• Discontinue use if severe diarrhea, cramping, or rectal bleeding occurs
• Not recommended for use in patients with appendicitis symptoms
• Prolonged use may lead to laxative dependence or electrolyte abnormalities

Drug Interactions

• Mineral oil: Increased systemic absorption of mineral oil (avoid concomitant use)
• Other laxatives: Potential additive effects
• Oral medications: May theoretically affect absorption of other drugs due to altered GI transit time (clinical significance uncertain)

Adverse Effects

• Abdominal cramping
• Mild diarrhea
• Throat irritation (liquid formulation)
• Nausea

• Severe allergic reactions (rash, itching, swelling)
• Electrolyte imbalances with prolonged use
• Severe abdominal pain
• Rectal bleeding

Monitoring Parameters

• Bowel movement frequency and consistency
• Signs of dehydration or electrolyte imbalance with prolonged use
• Abdominal symptoms (pain, distension)
• Therapeutic effectiveness (softened stools, reduced straining)
• Adverse effects (diarrhea, cramping)

Patient Education

• Take with a full glass of water to enhance effectiveness
• Do not use for more than 1 week unless directed by healthcare provider
• Report severe abdominal pain, rectal bleeding, or no bowel movement after use
• Maintain adequate fluid intake and fiber-rich diet while using this medication
• Not for immediate relief of constipation (works in 1-3 days)
• Store at room temperature away from moisture
• Keep out of reach of children

References

1. American Society of Health-System Pharmacists. AHFS Drug Information. Bethesda, MD: ASHP; 2023. 2. Lexicomp Online. Docusate Sodium: Drug Information. Wolters Kluwer Clinical Drug Information; 2023. 3. Brenner GM, Stevens CW. Pharmacology. 6th ed. Philadelphia, PA: Elsevier; 2022. 4. National Institutes of Health. DailyMed: Colace - docusate sodium capsule. Updated 2023. 5. Wald A. Constipation: Advances in Diagnosis and Treatment. JAMA. 2016;315(2):185-191. 6. Ford AC, Moayyedi P, Lacy BE, et al. American College of Gastroenterology monograph on the management of irritable bowel syndrome and chronic idiopathic constipation. Am J Gastroenterol. 2014;109 Suppl 1:S2-S26.