Isolac
Generic Name
Lactulose Oral Solution
Manufacturer
Acme Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
isolac 335 gm oral solution | ৳ 140.00 | N/A |
Description
Overview of the medicine
Isolac 335 gm Oral Solution is an osmotic laxative containing lactulose, a synthetic disaccharide. It is used to treat chronic constipation and to prevent or treat hepatic encephalopathy. Lactulose is minimally absorbed and works by drawing water into the colon, softening stools and promoting bowel movements. In hepatic encephalopathy, it reduces ammonia absorption by lowering colonic pH.
Uses & Indications
Dosage
Adults
Constipation: Initially 15-45 mL daily, adjusted according to patient response. Maintenance: 15-30 mL daily. Hepatic Encephalopathy: Initially 30-45 mL three to four times daily, adjusted to produce 2-3 soft stools per day with a pH of 5.0 to 5.5. Maintenance: 15-30 mL three to four times daily.
Elderly
No specific dosage adjustment required, but caution is advised in patients with pre-existing conditions (e.g., diabetes, electrolyte imbalance). Start with a lower dose and titrate slowly.
Renal_impairment
No specific dosage adjustment required as it is minimally absorbed and not renally metabolized.
How to Take
Can be taken undiluted or diluted with water, fruit juice, or milk. Take once daily for constipation, preferably in the morning. For hepatic encephalopathy, doses are typically divided throughout the day. Ensure adequate fluid intake.
Mechanism of Action
Lactulose is a synthetic disaccharide that is not absorbed or metabolized in the small intestine. It reaches the colon intact, where it is broken down by colonic bacteria into low molecular weight organic acids (lactic acid, acetic acid). These acids acidify the colonic contents, leading to several effects: 1) Increased osmotic pressure draws water into the colon, softening stools and increasing stool volume, thereby stimulating peristalsis and promoting defecation. 2) The lowered colonic pH inhibits the diffusion of ammonia from the colon into the blood and promotes the diffusion of ammonia from the blood into the colon, where it is converted to ammonium ions (NH4+). Ammonium ions are non-absorbable and are subsequently excreted in the feces, thus reducing blood ammonia levels in hepatic encephalopathy.
Pharmacokinetics
Onset
Laxative effect: 24-48 hours. Hepatic encephalopathy: May take 24-48 hours for initial effect, up to 72 hours for full therapeutic effect.
Excretion
Mainly excreted unchanged in the feces. The small amount absorbed is excreted unchanged in the urine.
Half life
Not applicable due to minimal systemic absorption.
Absorption
Minimally absorbed (less than 3%) from the gastrointestinal tract. What little is absorbed is excreted unchanged in urine.
Metabolism
Not metabolized by human intestinal enzymes. Metabolized by colonic bacteria into lactic acid, acetic acid, and other organic acids.
Side Effects
Contraindications
- Galactosemia (a hereditary disorder where the body cannot process galactose)
- Intestinal obstruction
- Hypersensitivity to lactulose or any component of the formulation
- Patients on a low-galactose diet
Drug Interactions
Antacids
May diminish the desired pH-lowering effect in the colon, reducing the efficacy of lactulose in hepatic encephalopathy.
Oral neomycin
May diminish the efficacy of lactulose by altering colonic flora.
Other laxatives
Concurrent use may lead to excessive fluid loss and electrolyte imbalance.
Non-absorbable antacids (e.g., magnesium hydroxide)
May interfere with the acidification of colonic contents by lactulose.
Storage
Store at room temperature (below 30°C). Do not freeze. Keep out of reach of children. Crystallization may occur at low temperatures, but this does not affect efficacy.
Overdose
Symptoms of overdose include abdominal pain, diarrhea, and electrolyte disturbances (e.g., hypokalemia, hyponatremia) due to excessive fluid loss. Management involves discontinuing the drug, correcting fluid and electrolyte imbalances, and providing symptomatic and supportive care.
Pregnancy & Lactation
Pregnancy: Lactulose is poorly absorbed, and adverse effects on the fetus are not expected. Can be used if clinically indicated. Lactation: Lactulose is minimally excreted in breast milk and is considered compatible with breastfeeding. Consult a physician before use.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years, refer to packaging for exact expiry date.
Availability
Pharmacies, Hospitals
Approval Status
Approved (Commonly available worldwide)
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Extensively studied in numerous clinical trials for its efficacy in chronic constipation and hepatic encephalopathy, demonstrating effectiveness and safety.
Lab Monitoring
- Serum electrolytes (especially potassium and sodium) if used for prolonged periods or in high doses for hepatic encephalopathy.
- Blood ammonia levels in hepatic encephalopathy.
- Stool pH in hepatic encephalopathy to ensure efficacy (target 5.0-5.5).
Doctor Notes
- Remind patients that the effect of lactulose is not immediate and may take up to 2 days.
- Counsel patients on adequate fluid intake to prevent dehydration, especially during initiation or dose titration.
- For hepatic encephalopathy, aim for 2-3 soft stools daily, adjusting dose as needed.
- Monitor for signs of electrolyte imbalance, particularly in elderly or debilitated patients on high doses.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Do not stop taking the medicine without consulting your doctor.
- Drink plenty of fluids while taking this medication to prevent dehydration.
- Report persistent diarrhea or severe abdominal pain to your doctor.
- The laxative effect may not occur immediately; it often takes 24-48 hours.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose.
Driving Precautions
Lactulose is not known to impair the ability to drive or operate machinery. However, if you experience dizziness or severe abdominal discomfort, avoid such activities.
Lifestyle Advice
- Maintain a high-fiber diet to support bowel regularity.
- Engage in regular physical activity.
- Ensure adequate daily fluid intake.
- Avoid straining during bowel movements.
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