Sorbidiol 150mg

SORBIDIOL 150MG by FRANCO-INDIAN PHARMACEUTICALS PVT LTD

Name

• Brand Name: SORBIDIOL 150MG
• Common Name: Sorbidiol 150 Tablet

Composition

SORBIDIOL 150MG contains Ursodeoxycholic Acid (UDCA) as its active ingredient, with each tablet comprising 150 mg of the substance. Ursodeoxycholic Acid is a naturally occurring bile acid.

Uses

SORBIDIOL 150MG is prescribed for various liver and gallbladder conditions:

• Dissolution of Gallstones: It is primarily used to dissolve certain types of cholesterol-rich gallstones and can prevent their formation. It may also be used to prevent gallstones in overweight individuals undergoing rapid weight loss.
• Primary Biliary Cholangitis (PBC): It is effective in managing primary biliary cholangitis (previously known as primary biliary cirrhosis), a chronic liver disease, by supporting liver function, protecting bile ducts, and delaying disease progression.
• Liver Disease Associated with Cystic Fibrosis: It is used to manage liver conditions associated with cystic fibrosis in children aged 6 to less than 18 years.
• General Liver Support: It improves liver function in chronic liver disorders and protects liver cells from damage caused by toxic bile acids.

Dosage and Administration

• SORBIDIOL 150MG should be swallowed whole with a glass of water; it should not be crushed, broken, or chewed.
• It can be taken with or after meals. Taking the medicine after an evening meal might enhance gallstone dissolution.
• The exact dosage and duration of treatment are determined by the physician based on the patient's medical condition and body weight.
• It is crucial to continue taking the medicine for the prescribed duration, which may extend for several months or longer, even if symptoms improve or disappear.
• For gallstone dissolution, a typical dosage suggested is 8-10 mg/kg/day, divided into 2-3 doses.

Side Effects

While generally well-tolerated, some individuals may experience side effects.

• Common Side Effects: Abdominal pain or discomfort, diarrhea (which can manifest as soft, loose stools), nausea, hair thinning or loss, rash, itching, headache, fatigue, indigestion, dizziness, and weakness.
• Serious Side Effects (Rare): Severe abdominal pain, yellowing of the skin or eyes (jaundice), dark urine, or pale stools, which may indicate liver issues. Allergic reactions such as severe rash, itching, or swelling are also possible.
• To manage common side effects, taking the tablet with food might help with stomach upset, and consuming it after an evening meal could lessen diarrhea.

Precautions

• Contraindications: Do not use SORBIDIOL 150MG if you have an allergy to ursodeoxycholic acid, calcified gallstones (visible on X-rays), complete biliary obstruction, inflammation of the gallbladder or bile ducts, blockage of the common bile duct or cystic duct, frequent cramp-like pains in the upper abdomen, low bile flow in children, or improper gallbladder function.
• Drug Interactions:
  • Antacids (containing aluminum hydroxide): Can decrease absorption and effectiveness. Maintain a 2-4 hour gap between doses.
  • Bile acid sequestrants (e.g., cholestyramine, colestipol): Can reduce absorption. Maintain an appropriate time gap.
  • Oestrogens (e.g., ethinyl oestradiol) and hormonal birth control pills: Can increase the risk of gallstone formation, potentially limiting the effectiveness of SORBIDIOL 150MG. Discontinuation of hormonal birth control pills may be advised.
  • Lipid-regulating agents (e.g., clofibrate): Can also increase the risk of gallstone formation.
• Disease Interactions: Use with caution in patients with kidney problems, severe liver disease, or other specific liver conditions like ascites.
• Specific Warnings:
  • Pregnancy and Breastfeeding: Consult your doctor before use. Caution is advised.
  • Alcohol: Exercise caution as alcohol consumption may increase drowsiness and potentially lead to liver damage.
  • Children and Elderly: Use with caution, and consult a doctor.
  • Monitoring: Regular monitoring of liver function and bilirubin levels is advised, especially during long-term therapy. Ultrasound scans may also be necessary to monitor gallstone dissolution.
  • Diet: A healthy diet low in cholesterol and saturated fats can support the treatment process.
  • Gallstones may recur after dissolution.

Storage

Store SORBIDIOL 150MG in a cool and dry place, protected from direct sunlight and excessive moisture. The recommended storage temperature is below 30°C or between 15-30°C. Keep out of sight and reach of children.

Here are some frequently asked questions about SORBIDIOL 150MG by FRANCO-INDIAN PHARMACEUTICALS PVT LTD, along with concise answers:

What is SORBIDIOL 150MG used for?

SORBIDIOL 150MG, which contains Ursodeoxycholic Acid (UDCA), is primarily used to dissolve certain types of gallstones that are rich in cholesterol and to prevent their formation. It is also prescribed for the management of primary biliary cholangitis (PBC), a chronic liver disease, and other liver disorders, including those associated with cystic fibrosis and excess cholesterol in bile.

How does SORBIDIOL 150MG work?

SORBIDIOL 150MG works by decreasing the production and absorption of cholesterol in the blood and intestines, thereby reducing the cholesterol content in bile. This action helps to dissolve existing cholesterol gallstones and prevent new ones from forming. Additionally, it has a protective effect on liver cells from injury caused by toxic bile acids and helps improve overall liver function by increasing bile flow.

What is the usual dosage of SORBIDIOL 150MG?

The dosage of SORBIDIOL 150MG is determined by a doctor based on the condition being treated and the individual's body weight. For dissolving cholesterol-rich gallstones, a common adult dosage is 8-12 mg/kg daily, often taken once daily at bedtime or in two divided doses. For primary biliary cholangitis, the dosage typically ranges from 12-16 mg/kg daily, divided into 2-4 doses for the first few months, and may then be given once daily in the evening. It is important to swallow the tablet whole after a meal, with a glass of milk or water, and to take it regularly as prescribed, even if symptoms improve.

What are the possible side effects of SORBIDIOL 150MG?

While generally well-tolerated, some individuals may experience side effects. Common side effects include abdominal pain or discomfort, diarrhea, nausea, rash, hair loss, headache, dizziness, indigestion, and weakness. Most side effects are temporary and resolve as the body adjusts to the medication. However, if any side effects persist or cause concern, it is advisable to consult a doctor promptly.

Is SORBIDIOL 150MG safe during pregnancy or breastfeeding?

For pregnancy, SORBIDIOL 150MG is generally advised to be used with caution, and only if prescribed by your doctor, as there is limited information on its safety in humans, though animal studies have shown harmful effects on developing babies. Women of childbearing age should use non-hormonal contraceptive measures or low estrogen oral contraceptive pills. During breastfeeding, SORBIDIOL 150MG is considered safe with minimal risk to the baby, but caution is still advised, and consultation with a doctor is recommended.

Can SORBIDIOL 150MG be taken with other medications?

SORBIDIOL 150MG can interact with certain medications. Antacids containing aluminum, bile acid sequestrants (like cholestyramine and colestipol), and cholesterol-lowering agents (like clofibrate) can decrease the absorption or effectiveness of SORBIDIOL 150MG. Hormonal birth control pills and estrogens can increase the risk of gallstone formation, potentially limiting the effectiveness of SORBIDIOL 150MG, so alternative contraceptive methods should be considered. It may also affect the absorption of certain antibiotics (e.g., ciprofloxacin, dapsone), antihypertensives (e.g., nitrendipine), and can increase the effect of immunosuppressants (e.g., ciclosporin). Always inform your doctor about all other medications you are taking.

What precautions should be taken while using SORBIDIOL 150MG?

Before taking SORBIDIOL 150MG, it is crucial to inform your doctor about any pre-existing medical conditions, especially inflammation of the gallbladder or bile ducts, frequent cramp-like abdominal pains, coughing up blood, or rapid weight gain. Regular monitoring of liver function through blood tests and ultrasound scans may be necessary during treatment. It's recommended to avoid consuming alcohol as it could lead to increased drowsiness and liver damage. Taking the tablet whole after a meal with a glass of milk or water is advised. Also, avoid a high-cholesterol diet, as it may affect the medication's effectiveness.

What happens if a dose of SORBIDIOL 150MG is missed?

If you forget to take a dose of SORBIDIOL 150MG, simply skip that missed dose and continue with your regular dosing schedule. It is important not to take a double dose to make up for the missed one. Just take the next scheduled dose as usual.

How should SORBIDIOL 150MG be stored?

SORBIDIOL 150MG should be stored in a cool and dry place, away from sunlight. It should be kept out of sight and reach of children, and typically stored at temperatures between 10ºC to 25ºC or below 30ºC.