Thiola

Thiola is used to prevent kidney stones, which may develop due to too much cystine in the urine (cystinuria). This medicine works by removing the extra cystine from the body.

In addition to the helpful effects of this medicine, it has side effects that can be very serious. Before you take tiopronin, be sure that you have discussed its use with your doctor.

Tiopronin is available only with your doctor's prescription. This product is available in the following dosage forms:

• Tablet

Before using Thiola, you must know all about the risks and complications associated with it. This is a decision you and your doctor will make.

For this medicine, the following should be considered:

Allergies: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric Population: Although there is no specific information comparing the use of tiopronin in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric Population: Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. 

Although there is no specific information comparing the use of tiopronin in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy: All Trimesters: Category C: Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding: There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions: Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions: Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems: The presence of other medical problems may affect the use of this medicine.

Make sure you tell your doctor if you have any other medical problems, especially:

• Blood problems (or a history of) 
• Kidney disease (or a history of) 
• Liver disease—Tiopronin may make these conditions worse

To use Thiola properly, you must follow all instructions given by your doctor. Take this medicine on an empty stomach (at least 30 minutes before meals or 2 hours after meals).

You should drink 2 full glasses (8 ounces each) of water with each meal and at bedtime. You should also drink another 2 full glasses during the night.

It is important that you follow any special instructions from your doctor, such as following a low-methionine diet. Methionine is found in animal proteins such as milk, eggs, cheese, and fish. 

Also, make certain your health care professional knows if you are on any special diet, such as a low-sodium or low-sugar diet. If you have any questions about this, check with your doctor.

Take this medicine regularly as directed. Do not stop taking it without first checking with your doctor, since stopping the medicine and then restarting it may increase the chance of side effects.

Dosing: The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):

• To prevent kidney stones:
  • Adults—To start, 800 milligrams (mg) a day, divided into three doses. Your doctor may change your dose if needed.
  • Children up to 9 years of age—Dose must be determined by your doctor.
  • Children 9 years and older—Dose is based on body weight and must be determined by your doctor. The usual dose to start is 15 mg per kilogram (kg) (6.8 mg per pound) of body weight a day, divided into three doses. Your doctor may change your dose if needed.

Missed Dose: If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage: 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. Do not keep outdated medicine or medicine no longer needed.

Before using Thiola, there are some precautions you must take. Your doctor should check your progress at regular visits to make sure that this medicine is working properly and does not cause unwanted effects.

As with many medications, there are several potential side effects associated with Thiola. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. 

Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.