Waxsol

Approved Indications:

• Constipation: Treatment and prevention of occasional constipation by softening stools to ease passage.
• Facilitation of bowel movements: To prevent straining during defecation in conditions such as:
• Post-operative recovery
• Hemorrhoids
• Anal fissures
• Post-myocardial infarction or abdominal surgery where straining is contraindicated

Off-label Uses:

• Facilitation of fecal impaction disimpaction in combination with other agents
• Adjunctive therapy to ease stool passage in patients with opioid-induced constipation (often combined with stimulant laxatives)

Route: Oral (capsules, tablets, syrup), Rectal (enema, suppository)

Adults:

• Oral: 50–400 mg daily in divided doses (commonly 100 mg two or three times daily)
• Rectal (enema): One enema (typically 283 mg/60 mL) as a single dose

Pediatrics:

• 6 months to 12 years: 25–150 mg daily in divided doses depending on age and weight
• Under 6 months: Use only under medical supervision

Elderly:

• Same as adults; start at lower doses if sensitive

Renal/Hepatic Impairment:

• No dosage adjustment necessary; limited systemic absorption

Administration Notes:

• Oral formulations should be taken with a full glass of water.
• Do not use for more than one week unless directed by a physician.
• Enemas and suppositories should be used as per package instructions for rapid relief.

Docusate sodium is a surfactant stool softener that lowers surface tension of stool by facilitating the mixing of aqueous and fatty substances. This action increases water and fat penetration into the stool, softening it and making defecation easier and less painful without stimulating intestinal motility.

• Absorption: Minimal systemic absorption from the gastrointestinal tract.
• Distribution: Not applicable due to negligible systemic absorption.
• Metabolism: Metabolized by intestinal bacteria into active metabolites.
• Half-life: Not clinically relevant due to local action.
• Elimination: Excreted primarily in feces as inactive metabolites.

• Pregnancy: FDA Category C
• Animal studies have shown no evidence of harm, but well-controlled human studies are lacking.
• Use only if clearly needed and prescribed by a healthcare professional.
• Lactation: Considered compatible; minimal systemic absorption limits exposure to breastfed infants.

• Primary Class: Stool softener (Emollient laxative)
• Subclass: Anionic surfactant laxative

• Known hypersensitivity to docusate sodium or any component
• Intestinal obstruction or fecal impaction (without prior disimpaction)
• Acute abdominal conditions including nausea, vomiting, or abdominal pain of unknown cause
• Use with caution in cases of appendicitis, undiagnosed abdominal pain, or inflammatory bowel disease exacerbation

• Not intended for long-term use unless under medical supervision
• Overuse or prolonged use may cause electrolyte imbalance or dependency
• Use caution in patients with structural GI abnormalities
• Discontinue if severe abdominal cramping, diarrhea, or rectal bleeding occurs
• Avoid use in patients with ileus or intestinal perforation risk

Common:

• Mild abdominal cramping or discomfort
• Diarrhea
• Throat irritation (oral forms)

Less Common:

• Nausea
• Rash or allergic skin reactions

Rare / Serious:

• Electrolyte disturbances with prolonged use
• Severe hypersensitivity (rare)

Side effects are usually mild and transient; dose-dependent effects.

• May increase absorption of mineral oil if taken concurrently (can increase risk of systemic absorption of mineral oil).
• No significant interactions with major CYP450 enzymes.
• Avoid concurrent use with other laxatives without medical advice to prevent excessive diarrhea and dehydration.

• Current constipation management guidelines recommend docusate sodium mainly as a stool softener adjunct and not as a primary laxative for chronic constipation.
• Recent clinical evidence questions its efficacy as a sole agent for opioid-induced constipation, recommending combination with stimulant laxatives.
• Safety reaffirmed for short-term use, with emphasis on avoiding chronic use without medical supervision.

• Store at 20°C to 25°C (68°F to 77°F)
• Protect from moisture and excessive heat
• Keep container tightly closed
• Oral solutions should be shaken well before use
• Keep out of reach of children