Pronunciation:

tye-oh-PROE-nin

Brand Names:

• Thiola
• Thiola EC

Dosage Forms:

• Tablet, Delayed Release
• Tablet

Classifications:

Therapeutic—

Renal-Urologic Agent

Uses of This Medicine:

Tiopronin is used together with high fluid intake, alkali, and diet to prevent kidney stones in patients with severe homozygous cystinuria (too much cystine in the urine). This medicine works by removing the extra cystine from the body.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. 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.

Children—

Use in children weighing less than 20 kilograms (kg) or who cannot swallow tablets is not recommended. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tiopronin in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breast-feeding—

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.

Other medicines—

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

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:

• Toxicity to d-penicillamine, severe, history of—Use with caution. May increase the risk for unwanted effects.

• Kidney disease—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Take the tablet at least 1 hour before or 2 hours after meals. The delayed-release tablet may be taken with or without food.

If you cannot swallow the delayed-release tablet whole, you may crush it and mix on a tablespoonful of applesauce. You may swallow the mixture right away or keep it in the refrigerator for up to 2 hours. Throw away any mixture that has not been given within 2 hours.

Drink extra fluids so you will pass more urine while you are using this medicine. This may help prevent kidney problems.

Do not drink alcohol 2 hours before and 3 hours after using Thiola® EC.

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.

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 forms (delayed-release tablets, tablets):
  • To prevent kidney stones:
    • Adults—At first, 800 milligrams (mg) divided into 3 doses, given at the same times each day. Your doctor may change your dose as needed.
    • Children weighing 20 kilograms (kg) or more—Dose is based on body weight and must be determined by your doctor. At first, 15 milligrams (mg) per kilogram (kg) of body weight per day, divided into 3 doses. Your doctor may change your dose as needed. However, the dose is usually not more than 50 mg per kg per day.
    • Children weighing less than 20 kg—Use is not recommended.

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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Urine tests are needed to check for any unwanted effects.

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

This medicine may cause serious allergic reactions. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Bloating or swelling of the face, arms, hands, lower legs, or feet

cloudy urine

hives, itching, skin rash

pale skin

rapid weight gain

tingling of the hands or feet

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain or loss

Incidence not known

Bloody urine

blurred vision

chest pain or tightness

confusion

decreased frequency or amount of urine

dilated neck veins

dizziness

dry mouth

fainting

headache

increase in heart rate

increased thirst

irregular breathing

irregular heartbeat

lightheadedness

loss of appetite

lower back or side pain

nausea

nervousness

pounding in the ears

rapid breathing

slow or fast heartbeat

sunken eyes

vomiting

wrinkled skin

yellow skin or eyes

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:

More common

Bruising

cough

decreased interest in sexual intercourse

diarrhea

difficulty in moving

fever

inability to have or keep an erection

large, flat, blue or purplish patches in the skin

loss in sexual ability, desire, drive, or performance

mouth sores

muscle pain or stiffness

nausea

pain in the joints

skin wrinkling

stomach pain

Incidence not known

Arm, back, neck, or leg pain

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

change in or loss of taste

chapped lips

dry skin

excess air or gas in the stomach or bowels

feeling of constant movement of self or surroundings

full feeling

heartburn

increased sweating

increased weight

lack or loss of strength

passing gas

sensation of spinning

stomach discomfort

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.