LAXOCODYL 5/MG SUPP FOR CHIDREN 10/SUPP

Indications

Approved Uses

Short-term relief of constipation; bowel evacuation/preparation before diagnostic procedures (e.g., radiological examinations/colonoscopy) or surgery when bowel emptying is required.

Dosage & Administration

Dosing by Condition

Constipation (rectal): children 2-10 years: 5 mg (1 suppository) once daily as needed; adults and children >10 years: 10 mg once daily as needed; bowel preparation: per physician-directed regimen.

Initial Dose

5mg rectally once daily (children 2-10 years)

Maintenance Dose

5mg rectally as needed, not to exceed once daily

Maximum Dose

Rectal use (suppository): Children 2-10 years: insert 1 suppository (5 mg) into the rectum once daily as needed; maximum 1 suppository per 24 hours. Adults and children ≥10 years: insert 1 suppository (5 mg) into the rectum once daily as needed; maximum 1 suppository per 24 hours.

Children's Dosage

Children 6-12 years: one-half suppository (approximately 2.5 mg) rectally once daily; children over 12 years: one full suppository (5 mg) rectally once daily. For children under 6 years, consult a healthcare provider.

Dose Adjustment Notes

No specific renal or hepatic dose adjustment is generally required; use the lowest effective dose for the shortest duration and avoid use for more than 5-7 days unless directed by a clinician.

How to Take

For rectal use: remove the suppository from the blister/foil, insert one suppository into the rectum (preferably pointed end first) and try to retain it for about 15-20 minutes if possible; wash hands before and after use.

Side Effects

Common Side Effects

Abdominal cramps/abdominal pain, diarrhea, nausea; rectal irritation/burning or discomfort can occur with suppositories.

Side Effect Frequency

Common: abdominal cramps/abdominal pain, diarrhea, nausea; Uncommon: vomiting, dizziness, rectal irritation/burning; Rare/with prolonged or excessive use: dehydration and electrolyte disturbances (e.g., hypokalemia), rectal mucosal injury, and blood in stool/rectal bleeding (requires evaluation).

Safety & Warnings

Contraindications

Contraindicated in: intestinal obstruction/ileus; acute surgical abdomen (e.g., appendicitis) or undiagnosed acute abdominal pain with nausea/vomiting; severe dehydration; hypersensitivity to bisacodyl; and (for rectal products) proctitis/rectal inflammation and painful anorectal conditions (e.g., anal fissure) where suppository insertion may worsen injury/bleeding.

Warnings & Precautions

Use for short-term relief only; if no bowel movement or symptoms persist, seek medical advice. Do not use when there is severe/undiagnosed abdominal pain, nausea/vomiting, or suspected obstruction. Avoid prolonged or frequent use due to risk of dependence and electrolyte imbalance/dehydration. Use with caution in children (especially <2 years), the elderly, and those at risk of fluid/electrolyte disturbances; rectal irritation may occur.

Age Restriction

Children 6-12 years: one-half suppository rectally; children over 12 years: one full suppository rectally. For children under 6 years, oral administration is not recommended. Pediatric use under 6 years requires medical advice.

Drug Interactions

Drug Interactions

Clinically relevant: diuretics and systemic corticosteroids (↑ risk of hypokalemia/dehydration); digoxin (hypokalemia may increase toxicity/arrhythmia risk). Not relevant to this rectal suppository: interactions involving premature dissolution of enteric coating with antacids/H2 blockers/milk apply to oral enteric-coated tablets, not suppositories.

Interaction Severity

MODERATE: diuretics and systemic corticosteroids (additive hypokalemia/electrolyte imbalance risk with excessive/prolonged laxative use); MODERATE: digoxin (hypokalemia may increase digoxin toxicity risk); Oral-form-only: antacids/H2 blockers/PPIs and milk may affect enteric-coated tablets (not relevant to suppository).

Food Interaction

Not applicable for this product (rectal suppository); food interactions are relevant only to oral bisacodyl tablets.

Special Populations

Pregnancy

Caution

Breastfeeding

Unknown; it is unknown if bisacodyl rectal is excreted into breast milk. Pregnant or breastfeeding patients should seek the advice of a health professional before using over-the-counter drugs.

Children

Children 6-12 years: one-half suppository (approximately 2.5 mg) rectally once daily; children over 12 years: one full suppository (5 mg) rectally once daily. For children under 6 years, consult a healthcare provider.

Elderly

Standard dosing; use with caution due to increased risk of electrolyte imbalance and dehydration; ensure adequate fluid intake

Storage & Patient Advice

Missed Dose

Usually used as needed; if on a scheduled regimen and a dose is missed, use it when remembered unless it is close to the next dose-do not use more than one suppository in 24 hours unless directed by a clinician.

Stopping the Medicine

May be stopped at any time; do not use continuously beyond 5-7 days without medical review (not intended for long-term daily use).

Overdose

Symptoms: profuse diarrhea, abdominal cramping, dehydration, and electrolyte disturbances (notably hypokalemia); management: stop drug, oral/IV fluid and electrolyte replacement, and medical assessment (urgent if severe symptoms, children, or comorbidities).

Patient Counseling

Rectal use only; insert one suppository into the rectum (pointed end first) and try to retain it until it works; onset is usually 15-60 minutes. Use the lowest effective dose and do not use more than once daily; use short-term only and seek medical advice if constipation persists beyond ~5-7 days or if recurrent. Stop and seek urgent advice if severe abdominal pain, vomiting, rectal bleeding, or no bowel movement after use. Store below 30°C (per SFDA).

Monitoring Requirements

No routine monitoring for short-term use; with prolonged/frequent use or in high-risk patients, monitor hydration status and electrolytes (especially potassium) and assess for laxative dependence.

Pharmacology

Mechanism of Action

Stimulant laxative: locally stimulates colonic enteric nerves/mucosa to increase peristalsis and promotes accumulation of water and electrolytes in the colon (reduced absorption and/or increased secretion), softening stool.

Onset of Action

15-60 minutes after rectal administration.

Duration of Effect

Typically produces a bowel movement within 15-60 minutes after rectal administration (often around 30 minutes).

Bioavailability

Minimal systemic absorption after rectal administration; clinically low bioavailability (generally only small amounts of active metabolite appear systemically).

Metabolism

Converted (hydrolyzed) in the intestine/colon by enzymes (including bacterial/intestinal esterases) to the active metabolite bis-(p-hydroxyphenyl)-pyridyl-2-methane (BHPM); minimal hepatic metabolism.

Excretion

Primarily excreted in feces; any absorbed active metabolite is mainly excreted in urine as glucuronide conjugates (with some biliary/fecal elimination).

Product Information

Available Dosage Forms

Suppository; gastro-resistant (enteric-coated) tablet.

Composition per Dose

Each suppository: 5mg bisacodyl

Generic Availability

Yes

OTC Alternatives

Glycerin suppositories (OTC); oral osmotic laxatives such as lactulose or polyethylene glycol/macrogol (OTC availability varies by country-use per local labeling/with pharmacist or clinician advice, especially in children).

Gi Condition

Constipation

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