Cholbam

Bile acid synthesis disorders, peroxisomal disorders who have symptoms of liver disease, steatorrhea, or have difficulty in absorbing fat soluble vitamins are treated with bile acids such as cholic acid.

This drug requires a prescription.

Before taking this drug, the risks and benefits for your body should be discussed with your healthcare provider. Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals.

Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications.

No pediatric-specific problems that would limit the usefulness of cholic acid in children 3 weeks of age and older have been recorded. The relationship of age to the effects of cholic acid has not been performed in the geriatric population, and there are no geriatric-specific problems have been documented to date.

Infant risk has not been determined when using this drug during breastfeeding. Consult your healthcare provider about the benefits and risks of this drug while breastfeeding.

Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects.

Inform your healthcare professional if you are taking any other drugs such as:

• Aluminum Carbonate
• Basic Aluminum Hydroxide
• Aluminum Phosphate
• Dihydroxyaluminum
• Aminoacetate Dihydroxyaluminum Sodium Carbonate
• Cyclosporine, and Magaldrate

Intake of specific food or using alcohol or tobacco with cholic acid is associated with an increased risk of certain side effects. Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco.

Inform your healthcare provider for any other medical problems especially familial hypertriglyceridemia and liver disease which may increase the risk of serious side effects.

This drug must be taken exactly as prescribed by your doctor. Additional or prolonged doses could increase the chance of side effects.

Take this medicine with food and swallow it wholly. You may open it and mix the contents of the capsule with 1 to 2 tablespoons of infant formula or expressed breast milk, or soft foods, if you cannot swallow the capsules. Take cholic acid at least 1 hour before or 4 to 6 hours after, If you are also taking cholestyramine, colesevelam, colestipol, or aluminum-containing antacids.

The dose of this drug will be variable for different patients. The directions on the label or the prescription by your healthcare professional should be followed.

The dosage of this drug you take depends on the medical problem for which you are using this drug.

• Adults and children 3 weeks of age and older with bile acid synthesis disorders and peroxisomal disorders are prescribed an oral dosage form (capsules based on body weight with the dosage usually being 10 to 15 milligrams per kilogram of body weight once a day, or divided in two doses.
• Use and dose for children younger than 3 weeks of age must be determined by your healthcare professional.

A missed dose should be taken as soon as possible. However, skip the missed dose and go back to your regular dosing schedule if it is almost time for your next dose.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Dispose any outdated or expired drugs and ask your healthcare professional for the proper disposal of the drugs

Regular visits and laboratory tests should be made to your healthcare provider to track your progress and to monitor the effectiveness of the drug as well as check for unwanted effects.

Consult with your healthcare professional if your condition worsens or does not improve within 3 months, or if you have symptoms of a serious liver problem such as:

• Pain or tenderness in the upper stomach
• Pale stools
• Dark urine
• Loss of appetite
• Nausea
• Vomiting
• Yellow eyes or skin

Side effects may vary for each individual and prompt medical attention should be given if they occur.

More common side effects are:

• Abdominal or stomach pain
• Chills clay-colored stools
• Dark urine
• Diarrhea
• Dizziness
• Fever
• General feeling of tiredness or weakness
• Headache
• Itching or rash
• Light-colored stools
• Loss of appetite, nausea
• Stomach pain
• Continuing unpleasant breath odor
• Unusual tiredness or weakness
• Vomiting of blood
• Yellow eyes or skin

Less common side effects include:

• Bladder pain bloody or cloudy urine
• Clay-colored stools
• Dark urine, difficult
• Burning
• Painful urination
• Frequent urge to urinate
• Lower back or side pain
• Unpleasant breath odor

Some side effects may occur that usually do not need medical attention.

As your body adjusts to the medicine, the side effects will slowly disappear.

Ask your healthcare professional about ways to prevent or reduce some of these side effects.

If any of the following side effects persists, or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional.

Some reported side effects are:

• Burning
• Numbness
• Tingling
• Painful sensations chest pain
• Difficulty with swallowing
• General feeling of discomfort
• Illness heartburn pain or
• Burning in the throat skin lesions sores,
• Ulcers
• White spots on the lips or tongue or inside the mouth
• Unsteadiness or awkwardness weakness in the arms, hands, legs and feet

If you notice any other effects, check with your healthcare professional.

Report any side effects to the FDA hotline at 1-800-FDA-1088.