Description
Product Features
| Product Name | : | Obetix |
| Generic Name | : | Obeticholic Acid |
| Formulation | : | Tablet |
| Available Pack Size | : | 30’s Pot |
| Available Strength | : | 5 mg |
| Registrations | : | Export Only |
Indication
Obetix (Obeticholic Acid), a Farnesoid X Receptor (FXR) agonist, indicate for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.
FXR a nuclear receptor expressed in the liver and intestine. This is a key regulator of bile acid, inflammatory, fibrotic, and metabolic pathways. After activation decreases the intracellular hepatocyte concentrations of bile acids by suppressing de novo synthesis from cholesterol and by increasing transport of bile acids out of the hepatocytes, these mechanisms limit the overall size of the circulating bile acid pool while promoting chlorosis, thus reducing hepatic exposure to bile acids.
Pharmacodynamics
The activation of the FXR by obeticholic acid reduces the synthesis of bile acids, inflammation, and the resulting hepatic fibrosis. This may increase the survival of patients with PBC, but an association between Obetix and survival in PBC has not been established.
Mechanism of action
Primary biliary cirrhosis is an autoimmune process by which the bile ducts and liver are damaged progressively, leading to fibrosis and cirrhosis. Bile acids increase the risk of damage and fibrosis to the damaged bile ducts.
Obeticholic acid is a potent agonist of the farnesoid X receptor, which regulates the hepatic metabolism of bile and cholesterol. This drug acts by binding to the farnesoid X receptor (FXR), found in the nucleus of liver and intestinal cells. This in turn increases liver bile flow, suppressing its production and decreasing hepatocyte exposure to excess levels of bile with cholestasis. Cholestasis is a process that normally causes inflammation and cirrhosis of the liver.
Prescribing Medicine Information
Obeticholic acid use alone or in combination with ursodiol (Actigall, Urso) to treat primary biliary cholangitis (PBC; a type of liver disease that destroys bile ducts, which allows bile to stay in the liver and causes damage) in people who cannot take ursodiol or in people who were not treated successfully with ursodiol alone. Obetix is in a class of medications called farnesoid X receptor agonists. It works by decreasing bile production in the liver and increasing the removal of bile from the liver.
Process of using this medicine
Obeticholic acid comes as a tablet to take by mouth. It is usually taken once a day with or without food. Take Obetix at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Obetix exactly as directed. Do not take more or less of it or more often than your doctor prescribes it.
Your doctor may need to temporarily or permanently stop your treatment or decrease your dose of Obeticholic acid during your treatment. Likewise, This will depend on how well the medication works for you or if you experience certain side effects. Continue to take obeticholic acid even if you feel well. Do not stop taking Obetix without talking to your doctor. Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.
precautions Before taking Obeticholic acid
- Tell your doctor and pharmacist if you are allergic to obeticholic acid, other medications, or any ingredients in obeticholic acid tablets. Ask your pharmacist for a list of the ingredients.
- Similarly, tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Moreover, make sure to mention any of the following: caffeine (found in certain medications to treat drowsiness and headaches), theophylline (Elixophyllin, Theo-24, Theochron, others), tizanidine (Zanaflex), or warfarin (Coumadin, Jantoven). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with obeticholic acid. Be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
- On the other hand, if you are taking cholestyramine (Prevalite), colestipol (Colestid), or colesevelam (Welchol), take them at least 4 hours before or 4 hours after obeticholic acid.
- For instance, if you have bile duct obstruction (blockage in the tubes that carry bile from the liver to the gallbladder and small intestine). Your doctor may tell you not to take obeticholic acid.
- Most importantly, if you have or have ever had high cholesterol or thyroid disease.
- Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking obeticholic acid, call your doctor.
If you forget a dose
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Side effects of this medication
Obeticholic acid may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- Mouth or throat pain.
- Fast, irregular, or pounding heartbeat.
- Dizziness.
- Fainting.
- Swelling of the hands, feet, ankles, or lower legs.
- Tiredness or weakness.
- Joint or muscle pain.
- Constipation.
In short, Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:
- Severe itching.
- Fever, chills, or other signs of infection.
- Dryness, irritation, redness, crusting, or drainage of the skin.
In conclusion, Obeticholic acid may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
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