Hartsol
Generic Name
Ursodeoxycholic Acid
Manufacturer
General Pharmaceuticals Ltd.
Country
Bangladesh
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Description
Overview of the medicine
Ursodeoxycholic acid (UDCA) is a bile acid used to dissolve small to medium-sized cholesterol gallstones in patients who cannot undergo surgery, and to treat primary biliary cholangitis (PBC). It improves bile flow and protects liver cells.
Uses & Indications
Dosage
Adults
Gallstones: 8-10 mg/kg/day, usually divided into 2-3 doses. PBC: 13-15 mg/kg/day, divided into 2-4 doses.
Elderly
No specific dose adjustment required, but caution with comorbidities.
Renal_impairment
No dose adjustment required for renal impairment as it's primarily eliminated via bile.
How to Take
Should be taken orally with food, usually in the evening or at bedtime.
Mechanism of Action
UDCA reduces the cholesterol content of bile by suppressing hepatic cholesterol synthesis and secretion and by increasing the solubility of cholesterol in bile. It also has immunomodulatory and cytoprotective effects, particularly beneficial in cholestatic liver diseases.
Pharmacokinetics
Onset
Gallstone dissolution can take several months; PBC symptom improvement can be slower.
Excretion
Primarily excreted in feces via bile.
Half life
3.5 to 5.8 days.
Absorption
Readily absorbed from the gastrointestinal tract (about 90%).
Metabolism
Undergoes enterohepatic recirculation; conjugated with glycine or taurine in the liver.
Side Effects
Contraindications
- Hypersensitivity to bile acids
- Acute cholecystitis
- Cholangitis
- Biliary obstruction
- Calcified cholesterol stones
- Non-functioning gall bladder
Drug Interactions
Oral contraceptives, Estrogens, Clofibrate
May increase cholesterol secretion, counteracting UDCA's effect.
Cholestyramine, Colestipol, Antacids (aluminum-containing)
May reduce absorption of UDCA. Administer UDCA at least 1 hour before or 4 hours 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. Treatment is symptomatic and supportive. No specific antidote.
Pregnancy & Lactation
Pregnancy Category B. Use only if clearly needed. UDCA is excreted in breast milk; caution advised.
Side Effects
Contraindications
- Hypersensitivity to bile acids
- Acute cholecystitis
- Cholangitis
- Biliary obstruction
- Calcified cholesterol stones
- Non-functioning gall bladder
Drug Interactions
Oral contraceptives, Estrogens, Clofibrate
May increase cholesterol secretion, counteracting UDCA's effect.
Cholestyramine, Colestipol, Antacids (aluminum-containing)
May reduce absorption of UDCA. Administer UDCA at least 1 hour before or 4 hours 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. Treatment is symptomatic and supportive. No specific antidote.
Pregnancy & Lactation
Pregnancy Category B. Use only if clearly needed. UDCA is excreted in breast milk; caution advised.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months from manufacturing date.
Availability
Available in pharmacies nationwide
Approval Status
Approved by regulatory authorities (e.g., FDA, DGDA)
Patent Status
Patent expired; generic versions available
Clinical Trials
Numerous clinical trials have established the efficacy and safety of Ursodeoxycholic Acid for gallstone dissolution and PBC.
Lab Monitoring
- Liver function tests (ALT, AST, ALP, bilirubin) at baseline and periodically (every 3-6 months).
- Gallbladder ultrasound (every 6 months for gallstone dissolution).
Doctor Notes
- Advise patients on the importance of adherence, especially for long-term treatment.
- Monitor liver function and gallstone size regularly.
- Educate on potential drug interactions.
Patient Guidelines
- Take exactly as prescribed.
- Do not stop treatment without consulting your doctor, especially for gallstone dissolution.
- Report any severe diarrhea or new symptoms.
- Maintain a balanced diet and healthy lifestyle.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it's almost time for the next dose, skip the missed dose and continue with your regular schedule. Do not double the dose.
Driving Precautions
No known adverse effects on driving or operating machinery.
Lifestyle Advice
- Maintain a healthy weight.
- Avoid rapid weight loss.
- Consume a low-cholesterol diet.
- Regular exercise.
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