Dexochol 300 Tablet 1 Strip

Dexochol 300 contains Ursodeoxycholic Acid, a bile acid used to dissolve certain cholesterol-rich gallstones, help prevent gallstone formation, and treat Primary Biliary Cirrhosis (PBC). It works by reducing cholesterol saturation in bile and promoting the gradual dissolution of cholesterol-based stones in the gallbladder.

Dexochol 300 should be taken with food, preferably after a meal, with a glass of water or milk. The required dose depends on the condition being treated and the patient's body weight. The capsule or tablet should be swallowed whole without chewing, crushing, or breaking it.

Treatment may need to continue for several months or longer, so it should be taken regularly as prescribed. Do not discontinue treatment simply because symptoms improve. Even after gallstones appear to have completely dissolved, treatment may need to continue for several weeks or months as advised by the physician.

Uses

Dexochol 300 is used for:

• Primary Biliary Cirrhosis (PBC)
• Dissolution of cholesterol-rich gallstones
• Prevention of gallstone formation in selected patients undergoing rapid weight loss
• Non-alcoholic fatty liver disease, where prescribed by a physician

How Dexochol 300 Works

Dexochol 300 contains Ursodeoxycholic Acid, which helps reduce the amount of cholesterol secreted into bile and decreases intestinal absorption of cholesterol. This reduces cholesterol saturation in bile and promotes the gradual dissolution of cholesterol-rich gallstones.

Ursodeoxycholic Acid also has hepatoprotective properties. It can help protect liver cells from injury caused by toxic bile acids, improve bile flow, and support improvement in liver function and liver enzyme abnormalities.

How to Use

Take Dexochol 300 exactly as prescribed by your doctor, including the recommended dose and duration.

• Take it with food.
• Swallow the medicine whole with water or milk.
• Do not chew, crush, or break it.
• Take it regularly to obtain the intended therapeutic benefit.

Dosage & Administration

Dissolution of Cholesterol-Rich Gallstones

Adults: 8–12 mg/kg once daily at bedtime or in 2 divided doses.

Treatment may continue for up to 2 years, depending on the response and stone size. Treatment is generally continued for several months after radiological disappearance of the gallstones.

Obese patients: The dose may be increased up to 15 mg/kg/day when clinically appropriate.

Primary Biliary Cirrhosis

Adults: 10–16 mg/kg/day in 2–4 divided doses. After the initial treatment period, once-daily evening administration may be considered according to the physician's advice.

Prevention of Gallstones During Rapid Weight Loss

Adults: 300 mg twice daily.

Non-Alcoholic Fatty Liver Disease

Adults: 13–15 mg/kg/day, when prescribed by a physician.

Missed Dose

If you forget to take a dose, take it when you remember unless it is nearly time for your next dose. In that case, skip the missed dose and continue according to your usual schedule. Do not take a double dose to make up for a missed one.

Side Effects

Commonly reported side effects may include:

• Abdominal pain or discomfort
• Diarrhea
• Dyspepsia or indigestion
• Nausea or vomiting
• Dizziness
• Back pain
• Itching (pruritus)
• Rash
• Hair loss (alopecia)
• Flatulence
• Headache
• Fatigue

Other reported adverse effects may include biliary pain, cholecystitis, peripheral edema, angioedema, peptic ulcer, urinary tract infection, hyperglycemia, leukopenia, and thrombocytopenia.

If diarrhea develops and persists, contact your doctor. The dose may need to be reduced or treatment discontinued depending on the severity.

Contraindications

Dexochol 300 should not be used in patients with:

• Hypersensitivity to Ursodeoxycholic Acid or any component of the formulation
• Acute inflammation of the gallbladder or biliary tract
• Biliary tract obstruction
• Frequent episodes of biliary colic
• Radiopaque or calcified gallstones
• Impaired gallbladder contractility
• A non-functioning gallbladder
• Inflammatory bowel disease
• Conditions affecting the enterohepatic circulation of bile acids
• Ileal resection or ileostomy
• Regional ileitis
• Active gastric or duodenal ulcer
• Acute, chronic, or severe liver disease
• Conditions associated with extrahepatic or intrahepatic cholestasis, where use is contraindicated by the treating physician

Precautions & Warnings

Use Dexochol 300 cautiously in patients with liver disease or other hepatobiliary disorders.

During treatment:

• Avoid excessive dietary intake of calories and cholesterol.
• Liver function tests and bilirubin levels should be monitored as advised by the physician.
• Liver function may be monitored monthly during the first 3 months and periodically thereafter.
• Ultrasound or other imaging examinations may be required to assess gallstones and treatment response.
• If persistent diarrhea occurs, consult your doctor as dose adjustment or discontinuation may be necessary.
• Do not stop treatment without consulting your doctor.
• Inform your doctor about all medicines and supplements you are taking.

Quick Tips

• Take Dexochol 300 with food, preferably after a meal.
• Swallow the medicine whole with a glass of water or milk.
• Maintain a healthy diet and exercise regularly.
• Avoid excessive intake of dietary calories and cholesterol.
• Avoid alcohol if advised by your physician.
• Drink sufficient fluids if diarrhea occurs and inform your doctor if it persists or if blood is present in the stool.
• Regular monitoring of liver function and bilirubin may be required during treatment.
• Continue treatment for the prescribed duration even if your symptoms improve.

Pregnancy & Lactation

Before using Dexochol 300 during pregnancy or breastfeeding, consult your doctor. The safety of Ursodeoxycholic Acid during pregnancy and lactation should be assessed based on the potential benefits and risks for the individual patient. It is not fully established whether Ursodeoxycholic Acid is excreted into human breast milk.

Drug Interactions

Ursodeoxycholic Acid may interact with several medicines:

• Cholestyramine, activated charcoal, and certain antacids: May reduce the absorption or effectiveness of Ursodeoxycholic Acid.
• Aluminium-containing antacids: May reduce its absorption.
• Estrogens and clofibrate: May increase cholesterol secretion into bile and potentially counteract the effect of Ursodeoxycholic Acid when used for gallstone dissolution.
• Ciclosporin: Ursodeoxycholic Acid may increase ciclosporin concentrations in the blood.
• Dapsone: Its therapeutic effectiveness may be reduced.
• Ciprofloxacin: Ursodeoxycholic Acid may reduce ciprofloxacin concentrations in some cases.
• Nitrendipine: May reduce its plasma concentration and potentially affect its therapeutic effect.

Always inform your doctor about all prescription medicines, over-the-counter medicines, and supplements you are taking.

Overdose

Diarrhea may occur after excessive intake. If an overdose is suspected, contact a healthcare professional. Management generally focuses on maintaining adequate fluid and electrolyte balance and monitoring the patient's condition.

Monitoring Parameters

Depending on the underlying condition, the physician may monitor:

• Liver function tests (LFTs)
• Bilirubin levels
• Gallbladder and gallstone status through imaging
• Clinical response and adverse effects

Therapeutic Class

Anti-gallstone Drugs: Bile Acids

Storage Conditions

Store in a cool, dry place and protect from light. Keep the medicine out of the reach of children.