Cholbam

Generic name: cholic acid
Drug class: Digestive enzymes

Medically reviewed by  A Ras MD.

What is Cholbam?

Cholbam is a prescription medicine that is used to treat certain bile acid problems caused by single enzyme defects (SEDs). It is used to treat peroxisomal disorders like Zellweger spectrum disorders.

Description

Cholic acid is a bile acid produced by the liver where it is synthesized from cholesterol. The chemical formula is C 24H 40O 5, the molecular weight is 408.57 and the chemical structure is:

Cholic acid is a white to off-white powder. It is practically insoluble in water and in 0.1 M HCl at 20°C and is sparingly soluble in 0.1 M NaOH at 20°C. It is soluble in glacial acetic acid, alcohols, and acetone. A saturated solution in water at 20°C has a pH of 4.4.

CHOLBAM capsules contain 50 mg or 250 mg of cholic acid as the active ingredient in size 2 Swedish orange or size 0 white opaque gelatin capsules, respectively. Inactive ingredients in CHOLBAM include silicified microcrystalline cellulose, magnesium stearate, and hard gelatin capsules. The size 2 shells contain gelatin, red iron oxide and titanium dioxide, and the size 0 shells contain gelatin and titanium dioxide. CHOLBAM is administered orally.

 Mechanism of Action

Cholic acid is a primary bile acid synthesized from cholesterol in the liver. In bile acid synthesis disorders due to SEDs in the biosynthetic pathway, and in PDs including Zellweger spectrum disorders, deficiency of primary bile acids leads to unregulated accumulation of intermediate bile acids and cholestasis. Bile acids facilitate fat digestion and absorption by forming mixed micelles and facilitate absorption of fat-soluble vitamins in the intestine.

Endogenous bile acids including cholic acid enhance bile flow and provide the physiologic feedback inhibition of bile acid synthesis. The mechanism of action of cholic acid has not been fully established; however, it is known that cholic acid and its conjugates are endogenous ligands of the nuclear receptor, farnesoid X receptor (FXR). FXR regulates enzymes and transporters that are involved in bile acid synthesis and in the enterohepatic circulation to maintain bile acid homeostasis under normal physiologic conditions.

Before taking Cholbam, tell your doctor:

• If you are allergic to Cholbam; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are taking cyclosporine.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Cholbam with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Cholbam?

For all patients taking Cholbam:

• Tell all of your health care providers that you take Cholbam. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Cholbam while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Children:

• If giving Cholbam to your child and your child’s weight changes, talk with the doctor. The dose of Cholbam may need to be changed.

How is Cholbam best taken?

Use Cholbam as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take Cholbam with food.
• Swallow whole. Do not chew or crush.
• If you cannot swallow the capsule whole, you may open the capsule and mix the contents with certain foods. For younger children, the contents may be mixed with infant formula or breast milk. For older children and adults, the contents may be mixed with soft food like mashed potatoes or apple sauce. Stir for 30 seconds and swallow right away. Do not store for future use.
• If you also take cholestyramine, colesevelam, colestipol, or an antacid that has aluminum, do not take it within 4 to 6 hours before or 1 hour after Cholbam.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of Cholbam that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of new or worse liver problems like dark urine, not hungry, upset stomach or stomach pain, light-colored stools, any bruising or bleeding, feeling very tired, throwing up, or yellow skin or eyes.

What are some other side effects of Cholbam?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Diarrhea.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Cholbam?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL – 50 MG CAPSULE BOTTLE LABEL

• NDC 45043- 001-02
  90 capsules
• Cholbam™
  (cholic acid) capsules
• 50 mg
• Rx Only
• Manufactured for:
  Manchester Pharmaceuticals, Inc.,
  San Diego, CA 92130
• Manufactured by:
  Patheon France SA
  38300 Bourgoin-Jallieu, France
• For product information please call 844-246-5226.

PRINCIPAL DISPLAY PANEL – 250 MG CAPSULE BOTTLE LABEL

• NDC 45043- 002-02
  90 capsules
• Cholbam™
  (cholic acid) capsules
• 250 mg
• Rx Only
• Manufactured for:
  Manchester Pharmaceuticals, Inc.,
  San Diego, CA 92130
• Manufactured by:
  Patheon France SA
  38300 Bourgoin-Jallieu, France
• For product information please call 844-246-5226.

SRC: NLM .