Cholic acid: Difference between revisions

Cholic acid
	Adult Indications & Dosage
	Pediatric Indications & Dosage
	Contraindications
	Warnings & Precautions
	Adverse Reactions
	Drug Interactions
	Use in Specific Populations
	Administration & Monitoring
	Overdosage
	Pharmacology
	Clinical Studies
	How Supplied
	Images
	Patient Counseling Information
	Precautions with Alcohol
	Brand Names
	Look-Alike Names

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Revision as of 17:28, 23 January 2017

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)

Indications

Bile Acid Synthesis Disorders due to Single Enzyme Defects

Cholic acid is indicated for the treatment of bile acid synthesis disorders due to single enzyme defects (SEDs).

Peroxisomal Disorders Including Zellweger Spectrum Disorders

Cholic acid 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.

Limitation of Use: The safety and effectiveness of cholic acid on extrahepatic manifestations of bile acid synthesis disorders due to SEDs or PDs including Zellweger spectrum disorders have not been established.

Dosage

Dosage Regimen for Bile Acid Synthesis Disorders due to Single Enzyme Defects and Peroxisomal Disorders including Zellweger Spectrum Disorders

The recommended dosage of cholic acid is 10 to 15 mg/kg administered orally once daily, or in two divided doses, in pediatric patients and in adults.

Tables 1 and 2 show the number of capsules that should be administered daily to approximate a 10 mg/kg/day and 15 mg/kg/day dosage, respectively, using the available 50 mg and 250 mg capsules alone or in combination.

Table 1: Number of cholic acid capsules Needed to Achieve a Recommended Dosage of 10 mg/kg/day

This image is provided by the National Library of Medicine.

Table 2: Number of cholic acid capsules Needed to Achieve a Recommended Dosage of 15 mg/kg/day

Patients with newly diagnosed, or a family history of, familial hypertriglyceridemia may have poor absorption of cholic acid from the intestine and require a 10% increase in the recommended dosage to account for losses due to malabsorption. The recommended dosage of cholic acid in patients with concomitant familial hypertriglyceridemia is 11 to 17 mg/kg orally once daily, or in two divided doses. Adequacy of the dosage regimen can be determined by monitoring of patients' clinical response including steatorrhea, and laboratory values including transaminases, bilirubin and PT/INR.

Off-Label Use and Dosage (Adult)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

The safety and effectiveness of CHOLBAM has been established in pediatric patients 3 weeks of age and older for the treatment of bile acid synthesis disorders due to SEDs, and for adjunctive treatment of patients with PDs including Zellweger spectrum disorders who exhibit manifestations of liver disease, steatorrhea or complications from decreased fat soluble vitamin absorption.

Dosage Regimen for Bile Acid Synthesis Disorders due to Single Enzyme Defects and Peroxisomal Disorders including Zellweger Spectrum Disorders

The recommended dosage of cholic acid is 10 to 15 mg/kg administered orally once daily, or in two divided doses, in pediatric patients and in adults.

Tables 1 and 2 show the number of capsules that should be administered daily to approximate a 10 mg/kg/day and 15 mg/kg/day dosage, respectively, using the available 50 mg and 250 mg capsules alone or in combination.

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

Take CHOLBAM with food. Take CHOLBAM at least 1 hour before or 4 to 6 hours (or at as great an interval as possible) after a bile acid binding resin or aluminum-based antacid. Do not crush or chew the capsules. For patients unable to swallow the capsules, the capsules can be opened and the contents mixed with either infant formula or expressed breast milk (for younger children), or soft food such as mashed potatoes or apple puree (for older children and adults) in order to mask any unpleasant taste: Hold the capsule over the prepared liquid/food, gently twist open, and allow the contents to fall into the liquid/food. Mix the entire capsule contents with one or two tablespoons (15 mL to 30 mL) of infant formula, expressed breast milk, or soft food such as mashed potatoes or apple puree. Stir for 30 seconds. The capsule contents will remain as fine granules in the milk or food, and will not dissolve. Administer the mixture immediately

Monitoring

Treatment with cholic acid should be initiated and monitored by an experienced hepatologist or pediatric gastroenterologist.

Monitor serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum gamma glutamyltransferase (GGT), alkaline phosphatase (ALP), bilirubin and INR every month for the first 3 months, every 3 months for the next 9 months, every 6 months during the subsequent three years and annually thereafter. Monitor more frequently during periods of rapid growth, concomitant disease, and pregnancy. Administer the lowest dose of cholic acid that effectively maintains liver function.

Discontinue treatment with cholic acid if liver function does not improve within 3 months of the start of treatment or complete biliary obstruction develops.

Discontinue treatment with cholic acid at any time if there are persistent clinical or laboratory indicators of worsening liver function or cholestasis. Concurrent elevations of serum gamma glutamyltransferase (GGT) and serum alanine aminotransferase (ALT) may indicate cholic acid overdose. Continue to monitor laboratory parameters of liver function and consider restarting at a lower dose when the parameters return to baseline.

Assessment of serum or urinary bile acid levels using mass spectrometry is used in the diagnosis of bile acid synthesis disorders due to SEDs and PDs including Zellweger spectrum disorders. The utility of bile acid measurements in monitoring the clinical course of patients and in decisions regarding dose adjustment has not been demonstrated.

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

{{#ask: Page Name::Cholic acid |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Cholic acid |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

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.

@@ Line 7: / Line 7: @@
 |indication=patients with bile acid [[synthesis]] disorders due to single [[enzyme]] defects (SEDs) and as an adjunctive treatment of [[peroxisomal disorder]]s (PDs) including [[Zellweger]] spectrum disorders in patients who exhibit manifestations of [[liver disease]], [[steatorrhea]] or complications from decreased [[fat soluble vitamin]] [[absorption]]
 |adverseReactions=[[diarrhea]], [[reflux esophagitis]], [[malaise]], [[jaundice]], [[skin lesion]], [[nausea]], [[abdominal pain]], [[intestinal polyp]] , [[urinary tract infection]], and [[peripheral neuropathy]]  (≥1%)
-|fdaLIADAdult=
+|fdaLIADAdult=======Indications======
-======Indications======
+:*'''[[Bile Acid]] [[Synthesis]] Disorders due to Single [[Enzyme]] Defects'''
-:*[[Bile Acid]] [[Synthesis]] Disorders due to Single [[Enzyme]] Defects
 Cholic acid  is indicated for the treatment of [[bile acid]] [[synthesis]] disorders due to single [[enzyme]] defects (SEDs).
-:*[[Peroxisomal Disorder]]s Including [[Zellweger]] Spectrum Disorders
+:*'''[[Peroxisomal Disorder]]s Including [[Zellweger]] Spectrum Disorders'''
 Cholic acid 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]].
-'''Limitation of Use'''
+'''Limitation of Use''':
 The safety and effectiveness of cholic acid on extrahepatic manifestations of bile acid synthesis disorders due to SEDs or PDs including Zellweger spectrum disorders have not been established.
@@ Line 33: / Line 32: @@
 Patients with newly diagnosed, or a family history of, [[familial hypertriglyceridemia]] may have poor absorption of cholic acid from the intestine and require a 10% increase in the recommended dosage to account for losses due to [[malabsorption]]. The recommended dosage of cholic acid in patients with concomitant [[familial hypertriglyceridemia]] is 11 to 17 mg/kg orally once daily, or in two divided doses. Adequacy of the dosage regimen can be determined by monitoring of patients' clinical response including [[steatorrhea]], and laboratory values including [[transaminases]], [[bilirubin]] and [[PT]]/[[INR]].
+|fdaLIADPed=The safety and effectiveness of CHOLBAM has been established in pediatric patients 3 weeks of age and older for the treatment of bile acid synthesis disorders due to SEDs, and for adjunctive treatment of patients with PDs including Zellweger spectrum disorders who exhibit manifestations of liver disease, steatorrhea or complications from decreased fat soluble vitamin absorption.
+:*Dosage Regimen for Bile Acid Synthesis Disorders due to Single Enzyme Defects and Peroxisomal Disorders including Zellweger Spectrum Disorders
+The recommended dosage of cholic acid is 10 to 15 mg/kg administered orally once daily, or in two divided doses, in pediatric patients and in adults.
+Tables 1 and 2 show the number of capsules that should be administered daily to approximate a 10 mg/kg/day and 15 mg/kg/day dosage, respectively, using the available 50 mg and 250 mg capsules alone or in combination.
+|administration=Take CHOLBAM with food.
+Take CHOLBAM at least 1 hour before or 4 to 6 hours (or at as great an interval as possible) after a bile acid binding resin or aluminum-based antacid.
+Do not crush or chew the capsules.
+For patients unable to swallow the capsules, the capsules can be opened and the contents mixed with either infant formula or expressed breast milk (for younger children), or soft food such as mashed potatoes or apple puree (for older children and adults) in order to mask any unpleasant taste:
+Hold the capsule over the prepared liquid/food, gently twist open, and allow the contents to fall into the liquid/food.
+Mix the entire capsule contents with one or two tablespoons (15 mL to 30 mL) of infant formula, expressed breast milk, or soft food such as mashed potatoes or apple puree.
+Stir for 30 seconds.
+The capsule contents will remain as fine granules in the milk or food, and will not dissolve.
+Administer the mixture immediately
+|monitoring=Treatment with cholic acid should be initiated and monitored by an experienced hepatologist or pediatric gastroenterologist.
+Monitor serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum gamma glutamyltransferase (GGT), alkaline phosphatase (ALP), bilirubin and INR every month for the first 3 months, every 3 months for the next 9 months, every 6 months during the subsequent three years and annually thereafter. Monitor more frequently during periods of rapid growth, concomitant disease, and pregnancy. Administer the lowest dose of cholic acid that effectively maintains liver function.
+Discontinue treatment with cholic acid if liver function does not improve within 3 months of the start of treatment or complete biliary obstruction develops.
+Discontinue treatment with cholic acid at any time if there are persistent clinical or laboratory indicators of worsening liver function or cholestasis. Concurrent elevations of serum gamma glutamyltransferase (GGT) and serum alanine aminotransferase (ALT) may indicate cholic acid overdose. Continue to monitor laboratory parameters of liver function and consider restarting at a lower dose when the parameters return to baseline.
+Assessment of serum or urinary bile acid levels using mass spectrometry is used in the diagnosis of bile acid synthesis disorders due to SEDs and PDs including Zellweger spectrum disorders. The utility of bile acid measurements in monitoring the clinical course of patients and in decisions regarding dose adjustment has not been demonstrated.
 }}