Docusate sodium


Generic Medicine Info
Indications and Dosage
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.
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).
Special Precautions
Avoid prolonged use. Children. Pregnancy and lactation.
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).
Monitoring Parameters
Rectal: Perform rectal exams periodically in patients with impaired rectal function, particularly loss of sensation.
Overdosage
Oral: Symptoms: Excessive loss of fluid and electrolytes. Management: Fluid and electrolyte replacement.
Drug Interactions
Increased absorption of anthraquinone derivative laxatives.
Potentially Fatal: May enhance the gastrointestinal uptake of liquid paraffin.
Action
Description: 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).
Pharmacokinetics:
Absorption: Absorbed from the gastrointestinal tract.
Distribution: Enters breast milk.
Excretion: Via bile.
Chemical Structure

Chemical Structure Image
Docusate sodium

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 23673837, Docusate sodium. https://pubchem.ncbi.nlm.nih.gov/compound/Docusate-sodium. Accessed Apr. 27, 2021.

Storage
Store between 15-30°C. Do not freeze. Protect from light, heat and humidity.
ATC Classification
A06AA02 - docusate sodium ; Belongs to the class of softeners, emollients laxatives.
References
Anon. Docusate. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 10/01/2021.

Buckingham R (ed). Docusates. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/01/2021.

Docusate Mini Enema (Major Pharmaceuticals). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 09/03/2021.

Docusate Sodium Capsule, Liquid Filled (Akron Pharma Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 10/01/2021.

Docusate Sodium Capsule, Liquid Filled (Precision Dose, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 10/01/2021.

Docusol Adult Oral Solution (Typharm Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 10/01/2021.

Docusol Paediatric Oral Solution (Typharm Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 10/01/2021.

Dulcoease 100 mg Capsules (Aventis Pharma Limited, trading as Sanofi). MHRA. https://products.mhra.gov.uk. Accessed 10/01/2021.

Joint Formulary Committee. Docusate Sodium. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/01/2021.

Molcer Ear Drops (Wallace Manufacturing Chemists Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 10/01/2021.

Norgalax Rectal Gel (Essential Pharma). MHRA. https://products.mhra.gov.uk. Accessed 10/01/2021.

Soluwax Ear Drops (HOE Pharmaceuticals Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 10/01/2021.

Soluwax Ear Drops (Zuellig Pharma Pte Ltd). MIMS Singapore. http://www.mims.com/singapore. Accessed 10/01/2021.

Waxsol Ear Drops, 0.5% w/v (Mylan Products Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 10/01/2021.

Disclaimer: This information is independently developed by MIMS based on Docusate sodium from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 MIMS. All rights reserved. Powered by MIMS.com
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