For Healthcare Providers
For Patients

Taking Reltone®

How to take Reltone® for gallstone dissolution

Determine Your Dosage
  • Your doctor will calculate the amount of Reltone® you should take based on your weight.
  • For example, if you weigh 70 kg, you would take between 560 mg and 700 mg of Reltone® each day (70 kg x 8 mg = 560 mg, 70 kg x 10 mg = 700 mg).
Determine Your Dosage
  • While you may take the total prescribed dose of Reltone® once a day, dividing it to 2 or 3 doses per day would help reduce potential side effects.
Monitoring Progress with Ultrasound
01
Initial and Ongoing Monitoring: You would need a diagnostic evaluation for detection of gallstone. The most common test is an abdominal ultrasound which evaluates the gallbladder. The test is non-invasive, painless and doesn’t involve any radiation. The ultrasound may be done in your doctor’s office if equipped with an ultrasound machine. Otherwise, it may be done at a radiology center.

Your doctor may begin monitoring with an ultrasound of the gallbladder to establish a baseline before starting Reltone. It is recommended to monitor progress with additional ultrasounds every 6 months during the first year of treatment in order to assess the response to Reltone® and check for reduction in size of the gallstones.
02
Evaluating Dissolution: If gallstones appear to be dissolving, 
it is important to confirm with a repeat ultrasound within 1 to 3 months. Once the dissolution of the gallstones has been verified with the ultrasound, then a decision may be made whether continued treatment with Reltone® is necessary.
03
Assessment After 12 Months: If there is no sign of stone dissolution by the 12-month evaluation, the likelihood of successful treatment with Reltone® is significantly reduced. 
At this point, consider consulting with a healthcare provider to discuss alternative treatments or adjustments to the therapy plan.

How to Take Reltone® for Gallstone Prevention

While Undergoing Rapid Weight Loss.
Step-by-Step Instructions for Reltone® Dosage

Confirm Dosage with Healthcare Provider

It is essential to take Reltone® exactly as prescribed by your doctor. The general recommendation for gallstone prevention in patients experiencing rapid weight loss is 600 mg per day¹. In most cases following bariatric surgery, ursodiol is continued for six month since it is expected that patients lose weight most rapidly during that period and are most susceptible to forming gallstones.
You may be instructed to divide the daily dosage into two or three smaller doses to help minimize potential side effects.

Monitoring and Adjustment

Regular follow-ups with your healthcare provider are crucial. Monitoring through ultrasound images of the gallbladder every six months can help assess the effectiveness of Reltone® in preventing gallstones. Based on the findings, your doctor may adjust the dosage accordingly.

Tips for taking daily medicine

Taking your medicine regularly is important to allow it to work effectively.
Consult Your Pharmacist: Always verify the exact dose and timing 
of Reltone® with your pharmacist before starting the treatment to ensure accuracy.
Adherence to Schedule: It is crucial to follow the prescribed medication schedule strictly. Take Reltone® at the same times each day.
Storage: Store Reltone® in a secure, childproof place at room temperature, away from moisture and heat to preserve its efficacy.
Medication Disposal: Safely dispose of expired or unused Reltone. Follow the disposal instructions provided on the medicine label or mix the medication with substances like coffee grounds or cat litter to prevent misuse.
Pill Organizers and Reminders: Use daily or weekly pill organizers to help manage doses accurately. Setting alarms on your phone or using reminder apps can also aid in maintaining a consistent medication intake schedule.
Medication Tracking: Keep a medication journal or use a calendar to record each dose taken. This helps in monitoring adherence and can be useful during follow-ups with your healthcare provider.

Indications

Reltone (ursodiol capsules) is indicated for patients with radiolucent, noncalcified gallbladder stones <20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, or idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of Reltone beyond 24 months is not established.

Reltone is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.

Important Safety Information

Therapy with Reltone is for patients with specific situations and gallstone types, and other therapies should be considered when selecting treatment. Dissolving a gallstone with Reltone takes months of therapy. In some patients, gallstones do not completely dissolve. Up to half (50%) of patients whose stones dissolve on bile acid therapy have stones return within 5 years. It has not been established if Reltone is safe to use for longer than 24 months.

Your healthcare provider should check the levels of certain liver enzymes when you first start taking Reltone and at times as you continue taking it. Tell your healthcare provider if you have liver disease.

Reltone will not dissolve gallstones that are:

  • Made up of hardened (calcified) cholesterol • Visible with x-ray (radiopaque)
  • Made up of bile pigments and invisible with X-ray (radiolucent)

Reltone should not be used by people who have a strong medical reason to have surgery to remove the gallbladder. These reasons may include sudden, persistent swelling of the gallbladder (unremitting acute cholecystitis); infected bile ducts (cholangitis); blocked bile ducts (biliary obstruction); inflamed pancreas caused by gallstones (gallstone pancreatitis); or an abnormal connection between organs (biliary-gastrointestinal fistula).

Do not use Reltone if you have an allergy to bile acids.

When Reltone is used for dissolving gallstones, the most common side effects (more frequent than placebo by ≥3%) include diarrhea, indigestion, inflamed throat (pharyngitis), and arthritis. When Reltone is used for preventing gallstones, the most common side effects (more frequent than placebo by ≥3%) include back pain, diarrhea, constipation, nausea, and dizziness.

Using Reltone when pregnant is not recommended. Using the correct dose of Reltone is important, especially for elderly people. It is unknown if Reltone is safe or effective in children.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please see full Prescribing Information enclosed.

Please click here for Prescribing Information of Reltone®

 

REFERENCES:

1. Reltone. Prescribing information. Intra-Sana
Laboratories LLC; 2021.

© 2024 Reltone. All Rights Reserved.

Important Safety Information

Therapy with Reltone is for patients with specific situations and gallstone types, and other therapies should be considered when selecting treatment. Dissolving a gallstone with Reltone takes months of therapy. In some patients, gallstones do not completely dissolve. Up to half (50%) of patients whose stones dissolve on bile acid therapy have stones return within 5 years. It has not been established if Reltone is safe to use for longer than 24 months.

Your healthcare provider should check the levels of certain liver enzymes when you first start taking Reltone and at times as you continue taking it. Tell your healthcare provider if you have liver disease.

Reltone will not dissolve gallstones that are:

  • Made up of hardened (calcified) cholesterol • Visible with x-ray (radiopaque)
  • Made up of bile pigments and invisible with X-ray (radiolucent)

Reltone should not be used by people who have a strong medical reason to have surgery to remove the gallbladder. These reasons may include sudden, persistent swelling of the

gallbladder (unremitting acute cholecystitis); infected bile ducts (cholangitis); blocked bile ducts (biliary obstruction); inflamed pancreas caused by gallstones (gallstone pancreatitis); or an abnormal connection between organs (biliary-gastrointestinal fistula).

Do not use Reltone if you have an allergy to bile acids.

When Reltone is used for dissolving gallstones, the most common side effects (more frequent than placebo by ≥3%) include diarrhea, indigestion, inflamed throat (pharyngitis), and arthritis. When Reltone is used for preventing gallstones, the most common side effects (more frequent than placebo by ≥3%) include back pain, diarrhea, constipation, nausea, and dizziness.

Using Reltone when pregnant is not recommended. Using the correct dose of Reltone is important, especially for elderly people. It is unknown if Reltone is safe or effective in children.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please see full Prescribing Information enclosed.