Description
MG Medicals, Quality Assurance
CompositionObeticholic Acid 5mg
SimilarityObeticholic Acid 5mg
StorageRoom Temperature
MG Medicals, Briefing of Ocaliva 5mg 30 Tablet
Uses of Ocaliva 5mg 30 TabletOcaliva is reserved for the treatment of initial biliary cholangitis in combination with ursodeoxycholic acid in grown-ups with a deficient response to ursodeoxycholic acid, or as a solitary treatment in grown-ups not able to endure ursodeoxycholic acid.
Ocaliva 5mg 30 Tablet side reactionsPain in the middle part of the throat (oropharyngeal), Severe itching of the skin (pruritus), Abdominal pain and discomfort, Generalized weakness, Joint pain (arthralgia), Fatigue, Dizziness, Constipation, Headache, Mild fever
How to take Ocaliva 5mg 30 TabletThe tablet should be taken orally with or without food.
How Ocaliva 5mg 30 Tablet worksObeticholic acid is a selective and potent agonist for the farnesoid X receptor (FXR), a nuclear receptor expressed at high levels in the liver and intestine. FXR is thought to be a key regulator of bile acid, inflammatory, fibrotic, and metabolic pathways. FXR activation decreases the intracellular hepatocyte concentrations of bile acids by suppressing de novo synthesis from cholesterol, as well as, by increasing transport of bile acids out of the hepatocytes. These mechanisms limit the overall size of the circulating bile acid pool while promoting choleresis, thus reducing hepatic exposure to bile acids.
MG Medicals, More Suggestion
Suggestion for Ocaliva 5mg 30 Tablet
- International normalised ratio (INR) is decreased following co-administration of warfarin and obeticholic acid. INR should be monitored and the dose of warfarin adjusted, if needed, to maintain the target INR range when co-administering obeticholic acid and warfarin.
- Obeticholic acid may increase the exposure to concomitant medicinal products that are CYP1A2 substrates. Therapeutic monitoring of CYP1A2 substrates with narrow therapeutic index (e.g. theophylline and tizanidine) is recommended.
- Bile acid binding resins such as cholestyramine, colestipol, or colesevelam adsorb and reduce bile acid absorption and may reduce efficacy of obeticholic acid. When concomitant bile acid binding resins are administered, obeticholic acid should be taken at least 4-6 hours before or 4-6 hours after taking a bile acid binding resin, or at as great an interval as possible.
MG Medicals, Tips & Warnings
Alcohol
There are no sufficient data. Please consult your doctor.
Pregnancy
caution
There are no data on the use of obeticholic acid in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity . As a precautionary measure, it is preferable to avoid the use of obeticholic acid during pregnancy.
Lactation
WEIGH RISKS VS BENEFITS
It is unknown whether obeticholic acid is excreted in human milk. Based on animal studies and intended pharmacology, obeticholic acid is not expected to interfere with breast-feeding or the growth or development of a breast-fed child. A decision should be made whether to discontinue breast-feeding or to discontinue/abstain from obeticholic acid therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Driving
safe
Obeticholic acid has no or negligible influence on the ability to drive and use machines.
Kidney
caution
Limited data exists in patients with mild and moderate renal impairment and no data exists in severe renal impairment. No dose adjustment is required for patients with renal impairment.
Liver
safe
Limited data exists in elderly patients. No dose adjustment is required for elderly patients.
MG Medicals, If miss a dose
If you miss a dose, please take the next dose as soon as you remember.
Disclaimer
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