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Dosage/Direction for Use
Oral Chronic constipation Adult: Prevention and treatment: As cap or 50 mg/5 mL oral solution: Up to Max of 500 mg daily in divided doses. Treatment must be started with large doses (e.g. 100 mg tid) according to response, then decreased as the patient condition improves. Dosage recommendations may vary among individual products or between countries (refer to detailed product guideline). Child: As 12.5 mg/5 mL oral solution: Infants >6 months 12.5 mg tid; Children 12.5-25 mg tid. Dilute dose in a glass of flavoured drink or milk then take within 30 minutes of preparation. As cap: ≥12 years Same as adult dose. Dosage recommendations may vary among individual products or between countries (refer to detailed product guideline). Oral Adjunct in abdominal radiological procedures Adult: As 50 mg/5 mL oral solution: 400 mg to be given with barium meal. Child: As 12.5 mg/5 mL oral solution: 75 mg to be given with barium meal. Otic/Aural Softening of ear wax Adult: As 0.5% or 5% ear drops: Apply a sufficient amount to fill the affected ear(s) once at night for up to 2 consecutive nights, before syringing with warm water if needed. Child: As 0.5% or 5% ear drops: Same as adult dose. Rectal Constipation Adult: As enema: 120 mg as a single dose; another dose may be used on the same or the next day if necessary. Alternatively, 283 mg (1 enema) 1-3 times daily may be used. Dosage recommendations may vary among individual products or between countries (refer to detailed product guideline). Child: ≥12 years As enema: Same as adult dose. |
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Contraindications
Presence of abdominal pain which is not constipation-related, nausea and vomiting, intestinal obstruction (oral, rectal); rectocolitis, ileus, inflammatory bowel disease, anal bleeding, haemorrhoids or anal fissures (rectal). Otic: Eardrum perforation, ear inflammation or pain. Oral: Concomitant use with mineral oil laxatives (e.g. liquid paraffin).
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Special Precautions
Avoid prolonged use. Children. Pregnancy and lactation. Monitoring Parameters Rectal: Perform rectal exams periodically in patients with impaired rectal function, particularly loss of sensation.
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Adverse Reactions
Significant: Atonic non-functioning colon and hypokalaemia (prolonged use); ear pain or inflammation (otic).
Gastrointestinal disorders: Burning sensation in the mouth and throat (oral solution); anorectal pain or bleeding (rectal). Rarely, diarrhoea, nausea, abdominal cramps.
General disorders and administration site conditions: Rarely, application site reactions including transient stinging or irritation (otic).
Skin and subcutaneous tissue disorders: Rash, pruritus; contact dermatitis, allergic skin reactions (otic).
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Overdosage
Oral: Symptoms: Excessive loss of fluid and electrolytes. Management: Fluid and electrolyte replacement.
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Drug Interactions
Increased absorption of anthraquinone derivative laxatives.
Potentially Fatal: May enhance the gastrointestinal uptake of liquid paraffin. |
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Action
Docusate sodium, an anionic surfactant, is a stool softener that also possesses a stimulant activity. It lowers the surface tension and allows penetration of accumulated hard dry faeces by water and salts. It also softens ear wax through rapid penetration into the dry matrix of the ceruminous mass resulting in semi-solid debris.
Onset: Bowel movement: Within 12-72 hours (oral); within 2-20 minutes (rectal). Absorption: Absorbed from the gastrointestinal tract. Distribution: Enters breast milk. Excretion: Via bile. |
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Storage
Oral: Store between 15-30°C. Do not freeze. Protect from light and heat humidity. Otic/Aural: Store between 15-30°C. Do not freeze. Protect from light and heat humidity. Rectal: Store between 15-30°C. Do not freeze. Protect from light and heat humidity.
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CIMS Class
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ATC Classification
A06AA02 - docusate sodium ; Belongs to the class of softeners, emollients laxatives.
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