Ocaliva and Rybix ODT

• Generic Name: obeticholic acid
• Dosage Forms: tablet, film coated
• Other Brand Names: Ocaliva

Ocaliva (obeticholic acid) is a prescription medicine used to treat primary biliary cholangitis (PBC). This medicine is sometimes used together with another drug called ursodeoxycholic acid (UDCA).

Primary biliary cholangitis (PBC) is a chronic liver disease that gradually destroys bile ducts in the liver. These ducts deliver bile to the small intestines, to help your body digest fats and nutrients. When PBC destroys these ducts, the bile stays in your liver and damages its cells. This can lead to cirrhosis (scarring of the liver) and liver failure. PBC is a progressive disease that may have no symptoms for many years. Treating PBC can help keep the liver functioning normally.

Ocaliva was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, some people with PBC responded to this medicine, but further studies are needed.

It is not known if taking Ocaliva will improve your chance of survival or improve your symptoms of PBC.

• Generic Name: tramadol
• Dosage Forms: tablet, orally disintegrating
• Other Brand Names: ConZip, Ultram, Ultram ER, Rybix ODT, Ryzolt

Tramadol is used to relieve moderate to moderately severe pain, including pain after surgery. The extended-release capsules or tablets are used for chronic ongoing pain.

Tramadol belongs to the group of medicines called opioid analgesics. It acts in the central nervous system (CNS) to relieve pain.

When tramadol is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

This medicine is available only under a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.