Otegal
Generic Name
Ursodeoxycholic Acid
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| otegal 150 mg capsule | ৳ 170.00 | ৳ 1,700.00 |
Description
Overview of the medicine
Otegal 150 mg capsule contains Ursodeoxycholic Acid, a naturally occurring bile acid used to dissolve cholesterol gallstones and treat certain liver conditions like Primary Biliary Cholangitis (PBC). It works by reducing the amount of cholesterol produced by the liver and absorbed by the intestines, which helps to dissolve cholesterol-rich gallstones.
Uses & Indications
Dosage
Adults
For gallstone dissolution: 8-10 mg/kg/day, usually given in 2-3 divided doses. For PBC: 13-15 mg/kg/day, usually given in 2-4 divided doses with food.
Elderly
No specific dosage adjustment is generally required, but caution should be exercised in elderly patients with significant comorbidities.
Renal_impairment
No dosage adjustment is necessary as ursodeoxycholic acid is primarily excreted via feces, and renal elimination is negligible.
How to Take
Otegal capsules should be taken orally with food, usually in divided doses. Swallow the capsule whole with water. For gallstone dissolution, a significant portion of the daily dose is often taken at bedtime.
Mechanism of Action
Ursodeoxycholic acid (UDCA) works by altering the composition of bile, reducing cholesterol synthesis and secretion into bile, and increasing the solubility of cholesterol. This leads to the gradual dissolution of cholesterol gallstones. Additionally, UDCA has cytoprotective, anti-inflammatory, and immunomodulatory effects, which are beneficial in cholestatic liver diseases like PBC.
Pharmacokinetics
Onset
Gallstone dissolution may take 6 months to 2 years. For symptomatic relief in PBC, effects may be noticed within weeks, but full benefit takes longer.
Excretion
Primarily excreted in feces, with a small amount excreted in urine.
Half life
Approximately 3.5-5.8 days (due to extensive enterohepatic recirculation).
Absorption
Well absorbed from the gastrointestinal tract (about 90%). Peak plasma concentration occurs within 1-3 hours.
Metabolism
Undergoes extensive enterohepatic recirculation, conjugated with glycine and taurine in the liver. A small portion is metabolized by gut bacteria.
Side Effects
Contraindications
- Hypersensitivity to ursodeoxycholic acid or any components of the formulation.
- Acute inflammation of the gallbladder or biliary tract.
- Calcified gallstones (radiopaque gallstones).
- Non-functioning gallbladder.
- Frequent episodes of biliary colic.
- Biliary tract obstruction.
Drug Interactions
Dapsone, Ciprofloxacin, Nitrendipine
UDCA may reduce the absorption of these drugs.
Oral Contraceptives, Estrogens, Clofibrate
May increase cholesterol saturation of bile, counteracting the effect of UDCA.
Cholestyramine, Colestipol, Antacids (containing aluminum hydroxide)
These agents bind bile acids and reduce the absorption of UDCA. Administer UDCA at least 2 hours before or after these drugs.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
In case of an overdose, diarrhea is the primary symptom. Treatment should be symptomatic and supportive, focusing on fluid and electrolyte replacement.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have shown no evidence of impaired fertility or harm to the fetus. However, there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed. UDCA is excreted in breast milk in very small amounts, generally considered compatible with breastfeeding, but use with caution.
Side Effects
Contraindications
- Hypersensitivity to ursodeoxycholic acid or any components of the formulation.
- Acute inflammation of the gallbladder or biliary tract.
- Calcified gallstones (radiopaque gallstones).
- Non-functioning gallbladder.
- Frequent episodes of biliary colic.
- Biliary tract obstruction.
Drug Interactions
Dapsone, Ciprofloxacin, Nitrendipine
UDCA may reduce the absorption of these drugs.
Oral Contraceptives, Estrogens, Clofibrate
May increase cholesterol saturation of bile, counteracting the effect of UDCA.
Cholestyramine, Colestipol, Antacids (containing aluminum hydroxide)
These agents bind bile acids and reduce the absorption of UDCA. Administer UDCA at least 2 hours before or after these drugs.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
In case of an overdose, diarrhea is the primary symptom. Treatment should be symptomatic and supportive, focusing on fluid and electrolyte replacement.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have shown no evidence of impaired fertility or harm to the fetus. However, there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed. UDCA is excreted in breast milk in very small amounts, generally considered compatible with breastfeeding, but use with caution.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from the date of manufacture.
Availability
Pharmacies, Hospitals
Approval Status
Approved by relevant health authorities
Patent Status
Off-patent (Generic available)
Clinical Trials
Ursodeoxycholic acid has been extensively studied in numerous clinical trials for gallstone dissolution and PBC, demonstrating its efficacy and safety. Ongoing research explores its potential in other cholestatic and liver diseases.
Lab Monitoring
- Liver function tests (ALT, AST, ALP, GGT, Bilirubin) at baseline and every 3-6 months during therapy, especially during the first year.
- For gallstone dissolution, ultrasound examination of the gallbladder should be performed every 6 months.
Doctor Notes
- Emphasize the importance of patient adherence for long-term efficacy in both gallstone dissolution and PBC.
- Regular monitoring of liver function tests and imaging for gallstones is crucial.
- Counsel patients on lifestyle modifications, especially dietary adjustments, to support treatment outcomes.
Patient Guidelines
- Take Otegal regularly as prescribed by your doctor.
- Do not stop treatment abruptly, even if you feel better.
- Report any severe or persistent diarrhea to your doctor.
- For gallstone dissolution, treatment can be long-term (up to 2 years).
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 continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Otegal is generally not expected to impair the ability to drive or operate machinery. However, if you experience dizziness or fatigue, avoid such activities.
Lifestyle Advice
- Maintain a healthy, balanced diet with reduced cholesterol intake.
- Regular physical activity is beneficial for overall liver health.
- Avoid excessive alcohol consumption, as it can worsen liver conditions.
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