Cholic acid
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Martin Nino [2]
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Overview
Cholic acid is a bile acid that is FDA approved for the treatment of patients with bile acid synthesis disorders due to single enzyme defects (SEDs) and as an adjunctive treatment of peroxisomal disorders (PDs) including Zellweger spectrum disorders in patients who exhibit manifestations of liver disease, steatorrhea or complications from decreased fat soluble vitamin absorption.. Common adverse reactions include diarrhea, reflux esophagitis, malaise, jaundice, skin lesion, nausea, abdominal pain, intestinal polyp , urinary tract infection, and peripheral neuropathy (≥1%)..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
1.1 Bile Acid Synthesis Disorders due to Single Enzyme Defects CHOLBAM is indicated for the treatment of bile acid synthesis disorders due to single enzyme defects (SEDs) [see CLINICAL TRIALS (14.1)].
1.2 Peroxisomal Disorders Including Zellweger Spectrum Disorders CHOLBAM is indicated for adjunctive treatment of peroxisomal disorders (PDs) including Zellweger spectrum disorders in patients who exhibit manifestations of liver disease, steatorrhea or complications from decreased fat soluble vitamin absorption [see CLINICAL TRIALS (14.2)].
1.3 Limitation of Use The safety and effectiveness of CHOLBAM on extrahepatic manifestations of bile acid synthesis disorders due to SEDs or PDs including Zellweger spectrum disorders have not been established.
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Cholic acid FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
There is limited information regarding Cholic acid Contraindications in the drug label.
Warnings
There is limited information regarding Cholic acid Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Cholic acid Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Cholic acid Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Cholic acid Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Cholic acid in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Cholic acid in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Cholic acid during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Cholic acid in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Cholic acid in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Cholic acid in geriatric settings.
Gender
There is no FDA guidance on the use of Cholic acid with respect to specific gender populations.
Race
There is no FDA guidance on the use of Cholic acid with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Cholic acid in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Cholic acid in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Cholic acid in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Cholic acid in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Cholic acid Administration in the drug label.
Monitoring
There is limited information regarding Cholic acid Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Cholic acid and IV administrations.
Overdosage
There is limited information regarding Cholic acid overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Cholic acid Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Cholic acid Mechanism of Action in the drug label.
Structure
There is limited information regarding Cholic acid Structure in the drug label.
Pharmacodynamics
There is limited information regarding Cholic acid Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Cholic acid Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Cholic acid Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Cholic acid Clinical Studies in the drug label.
How Supplied
There is limited information regarding Cholic acid How Supplied in the drug label.
Storage
There is limited information regarding Cholic acid Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Cholic acid Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Cholic acid interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Cholic acid Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Cholic acid Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.