OBETICHOLIC ACID - ORAL

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OBETICHOLIC ACID - ORAL

PHONETIC PRONUNCIATION: (oh-BET-i-KOE-lik AS-id)

COMMON BRAND NAME(S): Ocaliva

GENERIC NAME(S): obeticholic acid

Uses

USES: This medication is used alone or in combination treatment for a certain liver disease (primary biliary cholangitis-PBC). This disease slowly destroys the bile ducts in the liver. When bile ducts are damaged, harmful substances can build up in bile and scar the liver. Obeticholic acid works by causing your liver to make less bile, and by helping bile flow out of the liver. Obeticholic acid may help slow worsening of primary biliary cholangitis and decrease symptoms such as tiredness, itchy skin, abdominal pain, and dry eyes and mouth.


How to use OBETICHOLIC ACID - ORAL

HOW TO USE: See also Warning section. Read the Medication Guide provided by your pharmacist before you start taking obeticholic acid and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor. The dosage is based on your medical condition, lab tests, and response to treatment. If you have side effects, your doctor may direct you to temporarily stop taking this medication, or to take it less often. Ask your doctor or pharmacist if you are not sure about your dosage instructions. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day you have a scheduled dose. If your doctor has prescribed a once- or twice-weekly schedule, it may help to mark your calendar. If you also take certain other drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take obeticholic acid at least 4 hours before or at least 4 hours after taking these medications. These products can keep you from absorbing obeticholic acid fully. Tell your doctor if your condition does not get better or if it gets worse.

Side Effects

SIDE EFFECTS: Tiredness, mouth/throat pain, or fast/pounding heartbeat may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Although this medication is used to treat primary biliary cholangitis (PBC), it may also cause worsening of some liver symptoms. Tell your doctor right away if you have symptoms such as new or worsening skin itching, nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine, muscle/joint pain, swelling legs/feet/abdomen, or mental/mood changes. Your doctor may prescribe other medications such as bile acid-binding resins or antihistamines, or temporarily stop/adjust your dose of medication to help manage some side effects. Talk with your doctor about the risks and benefits of taking this medication. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: Before taking obeticholic acid, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: bile duct blockage. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: See also How to Use section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Images

OCALIVA 5 MG TABLET
OCALIVA 5 MG TABLET
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off-white
shape
round
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INT, 5
OCALIVA 10 MG TABLET
OCALIVA 10 MG TABLET
color
off-white
shape
3 sided
imprint
INT, 10

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Faq for OBETICHOLIC ACID - ORAL

Obeticholic acid is an oral medication used to treat primary biliary cholangitis (PBC), a chronic liver disease.

Obeticholic acid works by targeting specific receptors in the liver to reduce inflammation and block the accumulation of toxic bile acids, which can damage the liver in PBC.

Obeticholic acid is usually taken once daily with or without food. It is important to follow the instructions provided by your doctor or pharmacist for the correct dosage and administration.

Common side effects of obeticholic acid include itching, nausea, diarrhea, abdominal pain, and fatigue. However, not everyone will experience these side effects, and they may vary in severity.

No, obeticholic acid should not be used during pregnancy or while breastfeeding. It may cause harm to the unborn baby or be passed through breast milk.

Some medications may interact with obeticholic acid, so it is important to inform your doctor about all the medications you are currently taking. This includes prescription drugs, over-the-counter medications, and herbal supplements.

The effects of obeticholic acid may take several months to be noticeable. It is important to continue taking the medication as prescribed by your doctor, even if you do not see immediate improvements.

Obeticholic acid is not a cure for primary biliary cholangitis. However, it can help slow down the progression of the disease and improve liver function in many patients.

If you miss a dose, take it as soon as you remember. However, if it is close to the 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 dose.

Answer: Obeticholic Acid is a medication used to treat primary biliary cholangitis (PBC), a chronic liver disease that damages the bile ducts in the liver.

Answer: Obeticholic Acid works by reducing the amount of bile acids produced by the liver and by increasing the elimination of bile acids from the body. This helps to slow down the progression of liver damage in patients with PBC.

Answer: The common side effects of Obeticholic Acid include itching, fatigue, stomach pain, nausea, and joint pain. However, these side effects are usually mild and go away on their own.

Answer: Obeticholic Acid may start working within a few months of starting treatment. However, it may take up to 6 months to see the full benefits. It is important to take the medication as prescribed by your doctor and follow up regularly.

Answer: Obeticholic Acid is specifically approved for adults with primary biliary cholangitis who have an inadequate response to or are unable to tolerate ursodeoxycholic acid, another medication used to treat PBC. It is important to consult with your doctor to determine if Obeticholic Acid is suitable for you.

Answer: It is generally recommended to avoid alcohol while taking Obeticholic Acid. Alcohol can worsen liver damage and may interfere with the effectiveness of the medication.

Answer: Obeticholic Acid is taken orally in the form of tablets. It is usually taken once daily with or without food. Follow the instructions provided by your doctor or pharmacist for the correct dosage and timing.

Answer: Yes, Obeticholic Acid may interact with certain medications, including bile acid sequestrants. It is important to inform your doctor about all the medications, supplements, and herbal products you are taking before starting Obeticholic Acid.

Answer: The duration of Obeticholic Acid treatment may vary depending on the individual and the severity of the condition. Your doctor will determine the appropriate duration for you. It is important to continue taking the medication as prescribed, even if you start feeling better.

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Warning

WARNING: Although this medication is used to treat a certain liver disease, it has caused serious (even fatal) worsening of liver function, especially when taken at a higher dose than recommended. Your doctor should prescribe your dose based on your medical condition and response to treatment. For some patients whose liver disease is more serious, the starting dose is decreased to once weekly. To lower your chance of side effects, follow your doctor's dosage instructions carefully.


Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.