EZILAX 10/G/15/ML SYRUP 300ML

Indications

Approved Uses

Constipation, Prevention and treatment of portal-systemic encephalopathy (hepatic encephalopathy).

Off-Label Uses

Minimal hepatic encephalopathy (some guidelines/clinical practice), constipation in special populations (e.g., opioid-associated constipation as an alternative when other agents unsuitable), and as an adjunct in bowel regimen protocols (institution-specific).

Dosage & Administration

Dosing by Condition

Constipation (Adults): 15-30 mL once daily (or divided), adjust as needed; usual range 15-45 mL/day; may increase up to 60 mL/day if required and tolerated.
Hepatic Encephalopathy (Adults): 30-45 mL orally 3-4 times daily, titrate to 2-3 soft stools/day.
Hepatic Encephalopathy (Rectal, when oral not feasible): 300 mL lactulose mixed with 700 mL water or normal saline as a retention enema for 30-60 minutes; may repeat every 4-6 hours as needed.

Initial Dose

15ml (10g) once daily for constipation in adults

Maintenance Dose

15-30ml (10-20g) once daily, adjusted to achieve 1-2 soft stools per day

Maximum Dose

60ml (40g) per day for constipation; up to 180ml/day in divided doses for hepatic encephalopathy under medical supervision

Children's Dosage

Infants (under 1 year): 2.5ml twice daily. Children 1-5 years: 5ml twice daily. Children 6-12 years: 10ml twice daily. Adolescents 12-18 years: 15ml once or twice daily. All doses adjusted to achieve 1-2 soft stools per day.

Dose Adjustment Notes

Titrate to clinical response and reduce if diarrhea/abdominal cramping occurs; constipation: aim for 1-2 soft stools/day; hepatic encephalopathy: aim for 2-3 soft stools/day; use the lowest effective dose and monitor for dehydration/electrolyte disturbances with higher or prolonged dosing.

How to Take

Oral use: measure the dose with a calibrated measuring cup/spoon or oral syringe; may be taken with or without food and may be taken undiluted or mixed with water, juice, or milk to improve taste; may be given once daily or in 2 divided doses; maintain adequate fluid intake; if multiple daily doses are used, space them evenly.

Side Effects

Common Side Effects

Flatulence, bloating, abdominal cramps, nausea, diarrhea (dose-dependent), belching

Side Effect Frequency

Very common (>10%): flatulence (and other GI discomfort such as bloating/abdominal distension). Common (1-10%): abdominal pain/cramps, nausea, diarrhea (dose-related). Uncommon/rare: vomiting; dehydration and electrolyte disturbances (e.g., hypokalemia/hypernatremia) mainly with excessive/prolonged diarrhea or high doses.

Safety & Warnings

Contraindications

Contraindicated in: galactosemia/need for a low-galactose diet; intestinal obstruction/ileus; hypersensitivity to lactulose or excipients.

Warnings & Precautions

Use with caution in diabetes and in patients requiring low-galactose/low-lactose intake (contains sugars); avoid use if intestinal obstruction is suspected; ensure adequate fluid intake; monitor electrolytes with prolonged/high-dose use or in elderly/debilitated patients; prolonged use without medical supervision is not recommended.

Age Restriction

No specific age restriction; can be used in adults and children, but use in infants/young children should be under medical supervision (and generally any pediatric use should follow clinician-directed dosing).

Driving Warning

Safe

Drug Interactions

Drug Interactions

Key interactions/considerations: other laxatives (additive diarrhea/electrolyte loss); non-absorbable antacids may reduce colonic acidification and lessen effect in hepatic encephalopathy; non-absorbable antibiotics (e.g., neomycin/rifaximin) may reduce effect by altering colonic flora; diarrhea/accelerated transit can reduce absorption of concomitant oral drugs (notably narrow therapeutic index agents).

Interaction Severity

MODERATE: Broad-spectrum or non-absorbable antibiotics (e.g., neomycin, rifaximin) may reduce lactulose metabolism/acidification and can reduce efficacy (especially for hepatic encephalopathy). MINOR: Antacids may blunt colonic acidification. MINOR: Other laxatives can increase diarrhea/dehydration risk and complicate titration.

Food Interaction

No clinically significant food restrictions; may be taken with or without food and may be mixed with water, juice, or milk to improve palatability.

Alcohol Interaction

Safe

Special Populations

Pregnancy

Safe

Breastfeeding

Safe

Children

Infants (under 1 year): 2.5ml twice daily. Children 1-5 years: 5ml twice daily. Children 6-12 years: 10ml twice daily. Adolescents 12-18 years: 15ml once or twice daily. All doses adjusted to achieve 1-2 soft stools per day.

Elderly

Start at lower end of dose range (10-15ml once daily); monitor for dehydration and electrolyte imbalance; ensure adequate fluid intake

Kidney Impairment

No renal dose adjustment needed.

Liver Impairment

No hepatic dose adjustment required; in hepatic encephalopathy the dose is titrated to clinical response (target 2-3 soft stools/day).

Storage & Patient Advice

Storage Conditions

Store below 30°C. Do not refrigerate or freeze.

Missed Dose

Take the missed dose as soon as remembered; if it is close to the next scheduled dose, skip the missed dose and resume the regular schedule; do not double doses.

Stopping the Medicine

Can be stopped without tapering; for hepatic encephalopathy, discontinuation or major dose changes should be clinician-directed because dosing is titrated to 2-3 soft stools/day.

Overdose

Overdose/toxicity: profuse diarrhea, abdominal cramping, dehydration and electrolyte disturbances (e.g., hypokalemia, hypernatremia/hyponatremia); management is to stop/reduce lactulose and provide fluid/electrolyte replacement and supportive care, with medical evaluation if severe.

Patient Counseling

Take by mouth as directed (often once daily; may be divided). It may take 24-48 hours to work. Drink adequate fluids. You may mix the syrup with water or fruit juice to improve taste. Gas/bloating/cramps can occur at the start; reduce dose if troublesome. Do not exceed the recommended dose-stop/seek advice if severe or persistent diarrhea occurs (risk of dehydration/electrolyte imbalance). If you have diabetes, note it contains sugars. Seek medical advice before use if you have severe abdominal pain, nausea/vomiting, or suspected bowel obstruction. Storage: store below 30°C; do not refrigerate or freeze (per SFDA).

Monitoring Requirements

Monitor stool frequency/consistency and symptoms of dehydration; with prolonged use, high doses, elderly, renal impairment, or hepatic encephalopathy therapy, monitor serum electrolytes (especially potassium, sodium, bicarbonate) periodically; in hepatic encephalopathy also monitor mental status/clinical response (ammonia levels may be followed but are not required for routine titration).

Pharmacology

Mechanism of Action

Non-absorbable synthetic disaccharide that reaches the colon where bacteria metabolize it to organic acids, increasing osmotic water retention and stimulating peristalsis; the lowered colonic pH traps ammonia as ammonium and reduces ammonia absorption (benefit in hepatic encephalopathy).

Onset of Action

Constipation: typically 24-48 hours (may take up to 72 hours in some patients). Hepatic encephalopathy: clinical improvement may begin within hours to 1-2 days depending on severity and achieving target stools.

Duration of Effect

With continued dosing, effect is maintained; after stopping, bowel pattern typically returns toward baseline within ~1-2 days (variable).

Half-Life

Not clinically applicable/meaningful because systemic absorption is minimal and the effect is local in the colon.

Bioavailability

Oral systemic absorption is negligible; typically <3%.

Metabolism

Not metabolized by human enzymes; metabolized by colonic bacteria into short-chain organic acids (lactic acid, acetic acid, formic acid, CO2)

Excretion

Mostly excreted in feces after colonic bacterial metabolism; the small absorbed fraction is excreted unchanged in urine (generally within ~24 hours).

Protein Binding

Not applicable/unknown clinically due to negligible systemic absorption.

Product Information

Available Dosage Forms

For this product (EZILAX): Oral syrup (oral solution). In general lactulose is also available as oral solution/syrup and as rectal solution/enema for hepatic encephalopathy; some markets have oral packets, but that is product-specific and not implied for EZILAX.

Composition per Dose

Each 15ml: 10g lactulose (as lactulose solution 0.67g/ml)

Generic Availability

Yes

OTC Alternatives

Polyethylene glycol (macrogol/PEG), bisacodyl, senna, glycerin suppositories, and bulk-forming fiber (psyllium/ispaghula); docusate has limited efficacy but is sometimes used.

Gi Condition

Constipation

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