Hepa
Generic Name
Ursodeoxycholic Acid
Manufacturer
Hypothetical Pharma Co. Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| hepa 500 mg tablet | ৳ 1.20 | N/A |
Description
Overview of the medicine
Hepa 500 mg Tablet contains Ursodeoxycholic Acid, a naturally occurring bile acid. It is used to dissolve cholesterol gallstones, and in the treatment of primary biliary cholangitis (PBC) and other cholestatic liver diseases. It works by reducing the cholesterol content of bile and increasing bile flow.
Uses & Indications
Dosage
Adults
Cholesterol gallstones: 8-10 mg/kg/day, usually given in 2-3 divided doses. Primary Biliary Cholangitis (PBC): 13-15 mg/kg/day, usually given in 2-4 divided doses.
Elderly
No specific dosage adjustment needed, but monitor for comorbidities.
Renal_impairment
No dosage adjustment needed as it is primarily excreted via feces.
How to Take
Take orally with food. For gallstone dissolution, administration before bedtime may be beneficial. Tablets should be swallowed whole with water, do not chew.
Mechanism of Action
Ursodeoxycholic Acid reduces the cholesterol saturation of bile by suppressing hepatic cholesterol synthesis and secretion, and by altering the ratio of bile acids. It also protects liver cells from toxic bile acids and has immunomodulatory effects.
Pharmacokinetics
Onset
Gallstone dissolution: Months; PBC symptom improvement: Weeks to months.
Excretion
Excreted primarily in feces, small amount in urine.
Half life
Approximately 3-6 days (for the absorbed fraction in enterohepatic circulation).
Absorption
Well absorbed orally, undergoes extensive enterohepatic recirculation.
Metabolism
Undergoes hepatic conjugation with glycine and taurine, and bacterial degradation in the intestine.
Side Effects
Contraindications
- Acute cholecystitis
- Cholangitis
- Biliary obstruction
- Calcified cholesterol gallstones
- Non-functioning gallbladder
- Pancreatitis
- Pregnancy (first trimester)
Drug Interactions
Cyclosporine
UDCA may increase cyclosporine absorption; monitor cyclosporine levels.
Estrogens, Oral Contraceptives, Clofibrate
Can increase hepatic cholesterol secretion and gallstone formation, counteracting UDCA's effects.
Cholestyramine, Colestipol, Antacids (aluminum hydroxide)
Can reduce UDCA absorption; administer UDCA at least 2 hours before or after these agents.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Diarrhea is the primary symptom of overdose. Treatment is symptomatic and supportive. Electrolyte and fluid balance should be monitored.
Pregnancy & Lactation
Pregnancy Category B. Use only if clearly needed. Lactation: Limited data, use with caution. Consult doctor.
Side Effects
Contraindications
- Acute cholecystitis
- Cholangitis
- Biliary obstruction
- Calcified cholesterol gallstones
- Non-functioning gallbladder
- Pancreatitis
- Pregnancy (first trimester)
Drug Interactions
Cyclosporine
UDCA may increase cyclosporine absorption; monitor cyclosporine levels.
Estrogens, Oral Contraceptives, Clofibrate
Can increase hepatic cholesterol secretion and gallstone formation, counteracting UDCA's effects.
Cholestyramine, Colestipol, Antacids (aluminum hydroxide)
Can reduce UDCA absorption; administer UDCA at least 2 hours before or after these agents.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Diarrhea is the primary symptom of overdose. Treatment is symptomatic and supportive. Electrolyte and fluid balance should be monitored.
Pregnancy & Lactation
Pregnancy Category B. Use only if clearly needed. Lactation: Limited data, use with caution. Consult doctor.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
3 years from manufacturing date
Availability
Available in pharmacies and hospitals
Approval Status
Approved by major regulatory bodies (e.g., FDA, EMA, DGDA)
Patent Status
Off-patent (generic available)
Clinical Trials
Numerous clinical trials have established the efficacy and safety of Ursodeoxycholic Acid for gallstone dissolution and treatment of cholestatic liver diseases.
Lab Monitoring
- Liver function tests (ALT, AST, ALP, GGT, Bilirubin) at baseline and periodically (every 3-6 months) during treatment
- Gallbladder ultrasound (initially and every 6-12 months for gallstone dissolution)
Doctor Notes
- Emphasize adherence to treatment duration, especially for gallstone dissolution.
- Advise regular follow-up for liver function tests and ultrasound.
- Counsel patients on potential drug interactions.
Patient Guidelines
- Take as directed by your doctor.
- Do not stop taking without consulting your doctor.
- Report any unusual symptoms.
- Avoid antacids containing aluminum within 2 hours of taking this medicine.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Generally no known adverse effects on driving or operating machinery. If dizziness or fatigue occurs, avoid these activities.
Lifestyle Advice
- Maintain a balanced diet.
- Regular exercise.
- Avoid rapid weight loss (which can increase gallstone risk).
- Limit alcohol intake.
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Global Brand Names
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