sacrosidase

sacrosidase

sacrosidase

What is sacrosidase?

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

Do not use sacrosidase to treat any condition that has not been evaluated by your doctor. Sacrosidase is not suitable for treating general indigestion or stomach problems caused by other medical conditions.

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

Sacrosidase side effects

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

Sacrosidase can cause serious side effects. Call your doctor immediately if you have:

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

• Feeling intensely thirsty or hot, unable to urinate, sweating profusely, or having 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 can report side effects to FDA at 1-800-FDA-1088.

Warnings

Sacrosidase sometimes causes a serious allergic reaction.Get medical help right away if you notice any of these signs of an allergic reaction: hives; difficult breathing; Swelling of your face, lips, tongue, or throat.

Before you take this medicine

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 the dosage of your medication needs 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 medication.

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

How should I take sacrosidase?

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

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

Your doctor may want to give you the first dose of this medicine in a hospital or clinic to quickly treat any serious side effects that occur. A serious allergic reaction may occur that requires immediate treatment.

Sacrosidase is usually taken with every meal or snack. It is best to take half the dose at the beginning of food and the other half during a meal or snack.

This medicine comes with patient instructions for safe and effective use. Follow these instructions carefully. If you have any questions, contact your doctor or pharmacist.

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

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

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

Sacrosidase can only be part of a complete treatment program, which also includes a special diet. Follow the diet plan created for you by your doctor or nutritionist. Familiarize yourself with the list of foods to avoid to 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. Discard unused sacrosidase 4 weeks after first opening the bottle.

Sacrosidase dosage information

Usual adult dosage for sucrase-isomaltase deficiency:

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

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

Use: Oral replacement therapy for genetic 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 scoop OR 28 drops orally per meal or snack
-Over 15 kg: 2 ml (17,000 international units) OR 2 full scoops OR 56 drops orally per meal or snack

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

Use: Oral replacement therapy for genetic sucrase deficiency in patients with CSID

What happens if I miss a dose?

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

What happens if I overdose?

An overdose of sacrosidase is unlikely to cause symptoms.

What should I avoid while taking sacrosidase?

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

Follow your doctor's instructions regarding any other food and drink restrictions while using sacrosidase.

What other drugs will affect sacrosidase?

Other medications can interact with sacrosidase, including prescription and over-the-counter medications, vitamins, and herbal products. Tell each of your healthcare providers about all medications you are taking now and any medications you are starting or stopping taking.

More information

Remember to keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medicine only for the prescribed indication.