LAXATROL 50/8.6/MG FC TAB 100/FC TAB

Indications

Approved Uses

Short-term relief of constipation (including occasional constipation).

Off-Label Uses

Prevention of constipation/avoidance of straining in patients where straining is undesirable (e.g., post-op, post-MI, hemorrhoids/anal fissure, postpartum) and constipation management in palliative care; may be used as part of bowel regimens for opioid therapy.

Dosage & Administration

Dosing by Condition

Constipation (adults and ≥12 years): 2 tablets once daily at bedtime; may adjust to 2-4 tablets/day in single or divided doses; maximum 8 tablets/day (e.g., 4 tablets twice daily).

Initial Dose

Adults and children 12 years and older: 1 to 2 tablets at bedtime.

Maintenance Dose

1 to 4 tablets daily, adjusted to produce a comfortable, soft-formed stool.

Maximum Dose

4 tablets twice a day (8 tablets in 24 hours).

Children's Dosage

Children 6-12 years: 1 tablet once daily at bedtime (under medical supervision). Children 2-6 years: Not recommended without medical supervision. Not approved for children under 2 years.

Dose Adjustment Notes

Use the lowest effective dose for the shortest duration; do not use longer than 1 week unless directed by a clinician; adjust based on stool consistency/response.

How to Take

Oral use: swallow film‑coated tablet(s) whole with a full glass of water; may be taken with or without food; preferably take at bedtime to produce a bowel movement the next morning; maintain adequate fluid intake.

Side Effects

Common Side Effects

Abdominal cramps, diarrhea/loose stools, nausea; urine discoloration (yellow-brown, pink-red, or brown) may occur.

Side Effect Frequency

Common: abdominal cramping, diarrhea/loose stools, nausea. Less common/with prolonged or excessive use: electrolyte disturbances (e.g., hypokalemia), dehydration, laxative dependence, and melanosis coli; urine discoloration may occur with senna.

Safety & Warnings

Contraindications

Hypersensitivity to docusate or sennosides; intestinal obstruction/ileus or fecal impaction; acute surgical abdomen (e.g., appendicitis) or undiagnosed acute abdominal pain with nausea/vomiting; severe dehydration/electrolyte depletion; avoid concomitant mineral oil.

Warnings & Precautions

Short-term use only (generally ≤1 week) unless medically supervised; do not use with undiagnosed abdominal pain, nausea/vomiting, or suspected obstruction; stop and seek care if rectal bleeding occurs or no bowel movement after use; prolonged use may cause diarrhea, dehydration, electrolyte imbalance and dependence; ensure adequate fluids/fiber and use extra caution in elderly or those on hypokalemia-inducing drugs.

Age Restriction

Not recommended in children <2 years unless directed by a physician.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Mineral oil (avoid); drugs that increase hypokalemia risk with laxative overuse-diuretics, corticosteroids, amphotericin B, and licorice; cardiac glycosides (e.g., digoxin) and antiarrhythmics sensitive to hypokalemia (e.g., QT-prolonging agents); other laxatives (additive diarrhea/electrolyte loss).

Interaction Severity

MODERATE: Digoxin/cardiac glycosides and antiarrhythmics (risk increased with hypokalemia from diarrhea/overuse); diuretics and corticosteroids (additive hypokalemia). MINOR/AVOID: Mineral oil (docusate may increase mineral oil absorption).

Food Interaction

No clinically significant food restrictions; take with a full glass of water and maintain adequate hydration.

Alcohol Interaction

Safe

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Caution

Children

Children 6-12 years: 1 tablet once daily at bedtime (under medical supervision). Children 2-6 years: Not recommended without medical supervision. Not approved for children under 2 years.

Elderly

Start at the lowest effective dose (1 tablet once daily). Monitor closely for dehydration and electrolyte imbalances. Avoid prolonged use.

Kidney Impairment

No specific dose adjustment; use caution in severe renal impairment if prolonged/high-dose use due to higher consequence of dehydration/electrolyte imbalance.

Liver Impairment

No adjustment needed.

Storage & Patient Advice

Storage Conditions

Store below 30°C. Keep in original container, tightly closed. Keep out of reach of children.

Missed Dose

Take as soon as remembered; skip if near the time of the next scheduled dose. Do not double the dose.

Stopping the Medicine

Can be stopped at any time; not intended for long-term use-if used regularly for >1 week, reassess cause of constipation and tapering may be considered to minimize recurrence.

Overdose

Symptoms: abdominal cramping, severe diarrhea, dehydration, electrolyte disturbances (notably hypokalemia). Management: stop drug, oral/IV fluids and electrolyte replacement; medical evaluation/poison center advice-GI decontamination is rarely needed and only if very recent ingestion.

Patient Counseling

Oral use: take 1-2 tablets preferably at bedtime with a full glass of water; expect effect in ~6-12 hours. Maintain adequate fluid intake and dietary fiber. Use short-term only (generally ≤1 week) unless advised by a clinician. Stop and seek medical advice if severe abdominal pain/cramping, nausea/vomiting, rectal bleeding, or no bowel movement occurs after use, or if constipation persists. Urine may discolor (pink/red-brown) with senna; this is usually harmless.

Monitoring Requirements

No routine monitoring for short-term use; if prolonged/frequent use or high doses, monitor hydration and electrolytes (especially potassium) and assess for diarrhea/abdominal pain.

Pharmacology

Mechanism of Action

Docusate sodium is an anionic surfactant that lowers stool surface tension to allow water/lipids to penetrate and soften stool; sennosides are converted by colonic bacteria to active metabolites that stimulate colonic motility and increase fluid secretion/decrease absorption, promoting bowel evacuation.

Onset of Action

Typically 6-12 hours (may be longer in some patients).

Duration of Effect

Approximately 6-12 hours.

Half-Life

Not well characterized/clinically not meaningful due to minimal systemic absorption; use onset (6-12 hours) is the practical kinetic parameter rather than a reliable plasma half-life.

Bioavailability

Docusate sodium: minimal systemic absorption (primarily local GI action). Sennosides: poorly absorbed; act as prodrugs converted by colonic bacteria to active anthrone metabolites (e.g., rhein anthrone).

Metabolism

Sennosides: metabolized by colonic bacteria to active anthrone metabolites (e.g., rhein anthrone). Docusate sodium: minimal systemic metabolism; primarily local GI action with limited absorbed fraction undergoing hepatic metabolism if absorbed.

Excretion

Sennosides (and metabolites): mainly excreted in feces; a small fraction of metabolites (e.g., rhein) may be excreted in urine and can discolor urine. Docusate: largely eliminated in feces with minimal systemic excretion.

Product Information

Available Dosage Forms

Film-coated tablet.

Composition per Dose

Each film-coated tablet: 8.6mg sennosides and 50mg docusate sodium.

Generic Availability

Yes

OTC Alternatives

Polyethylene glycol (PEG 3350), psyllium (bulk-forming), lactulose (osmotic), bisacodyl (stimulant), glycerin suppositories; single-ingredient docusate or senna may also be options depending on patient needs.

Gi Condition

Constipation

Legal Disclaimer - Al Mujtama Pharmacy

The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment.

Al Mujtama Pharmacy assumes no legal or medical liability for:

• Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist
• Any discrepancy between the information provided and the product's package insert or SFDA guidelines
• Any misuse of medication resulting from personal interpretation of the content displayed

Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication.

By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation.

Your health is a trust - always consult your doctor first.