Sacrosidase is a yeast-based enzyme that replaces an enzyme called sucrase which is normally produced in the body. Sucrase helps the body breakdown and process certain sugars during digestion. In people who lack the sucrase enzyme, sugar can pass into the intestines where it can interact with bacteria. This can cause bloating, gas, stomach pain, and watery diarrhea.

Sacrosidase is used to treat sucrase deficiency that occurs in people with congenital sucrase-isomaltase deficiency (CSID). CSID is a genetic enzyme deficiency and sacrosidase will not cure this condition.

Do not use sacrosidase to treat any medical condition that has not been checked by your doctor. sacrosidase is not for use in treating general indigestion or stomach disorders caused by other conditions.

Sacrosidase may also be used for purposes not listed in this medication guide.

sacrosidase sometimes causes a severe allergic reaction. Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Follow all directions on your prescription label. Do not take sacrosidase in larger or smaller amounts or for longer than recommended.

Sacrosidase sometimes causes a severe allergic reaction. Before you start the medicine, your doctor may recommend a skin test to make sure you are not allergic to sacrosidase.

Your doctor may want to give your first dose of this medicine in a hospital or clinic setting to quickly treat any serious side effects that occur. A severe allergic reaction could occur which may require immediate care.

Sacrosidase is usually taken with each meal or snack. It is best to take one half of the dose when you start eating and take the other half during your meal or snack.

This medicine comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Measure your dose using the scoop provided with sacrosidase. Rinse and dry the scoop after each use.

Sacrosidase liquid should be mixed with 2 to 4 ounces of water, milk, or baby formula that is no hotter than room temperature. Do not mix with warm or hot liquids or the medicine will not be as effective.

Do not mix sacrosidase with fruit juice or drink fruit juice when taking the medicine.

Sacrosidase may be only part of a complete program of treatment that also includes a special diet. Follow the diet plan created for you by your doctor or nutrition counselor. Get familiar with the list of foods you must avoid to help control your condition.

Store this medicine in the refrigerator. Do not freeze. Protect from light. Keep the bottle tightly closed when not in use.

When you first open a bottle of sacrosidase, write the date on the label. Throw away any unused sacrosidase 4 weeks after first opening the bottle.

Usual Adult Dose for Sucrase-Isomaltase Deficiency:

Up to 15 kg: 1 mL (8500 international units) OR 1 full measuring scoop OR 28 drops orally per meal or snack
Over 15 kg: 2 mL (17,000 international units) OR 2 full measuring scoops OR 56 drops orally per meal or snack

Comment: Half the dose should be administered at beginning of meal or snack and the remainder during the meal or snack.

Use: Oral replacement therapy of genetically determined sucrase deficiency in patients with congenital sucrase-isomaltase deficiency (CSID)

Usual Pediatric Dose for Sucrase-Isomaltase Deficiency:

5 months and older:
-Up to 15 kg: 1 mL (8500 international units) OR 1 full measuring scoop OR 28 drops orally per meal or snack
-Over 15 kg: 2 mL (17,000 international units) OR 2 full measuring scoops OR 56 drops orally per meal or snack

Comment: Half the dose should be administered at beginning of meal or snack and the remainder during the meal or snack.

Use: Oral replacement therapy of genetically determined sucrase deficiency in patients with CSID

You should not use this medicine if you are allergic to yeast, yeast products, glycerin (glycerol), or papain (Accuzyme, Ethezyme, Gladase, Kovia, and others).

To make sure sacrosidase is safe for you, tell your doctor if you have diabetes. Sacrosidase changes the way your body absorbs sugar and your glucose levels may change. Your doctor will tell you if any of your medication doses need to be changed.

FDA pregnancy category C. It is not known whether sacrosidase will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

Tell your doctor if you are breast-feeding a baby while taking sacrosidase.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

An overdose of sacrosidase is not likely to produce any symptoms.

You may need to avoid eating a lot of starch (found mainly in rice, potatoes, corn, pasta, and bread). Follow your doctor's instructions about any special diet while you are taking sacrosidase.

Follow your doctor's instructions about any other restrictions on food or beverages while you are using sacrosidase.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Sacrosidase may cause serious side effects. Call your doctor at once if you have:

• worsening stomach pain, nausea, vomiting, or diarrhea; or

• feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin.

Some of these side effects may be symptoms of your CSID condition and not actual side effects of sacrosidase.

Common side effects of sacrosidase may include:

• stomach pain, mild nausea;

• mild diarrhea, constipation;

• sleep problems (insomnia);

• headache; or

• nervous feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.