Pronunciation:

sak-ROE-si-dase

Brand Names:

• Sucraid

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Gastrointestinal Agent

Uses of This Medicine:

Sacrosidase is used an as oral replacement therapy in patients with sucrase deficiency (cannot digest certain sugars), which is part of congenital sucrase-isomaltase deficiency (CSID).

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—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of sacrosidase in children 5 months of age and older. Safety and efficacy have been established.

Older adults—

No information is available on the relationship of age to the effects of sacrosidase in geriatric patients.

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.

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:

• Asthma or
• Diabetes—Use with caution. May make these conditions worse.

• Glycerin (glycerol) allergy or
• Papain allergy or
• Positive skin test for sacrosidase or
• Yeast allergy—Should not use in patients with these conditions.

Proper Use of This Medicine:

Take this medicine exactly 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.

This medicine comes with a patient information leaflet and patient instructions. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

This medicine comes in 2 forms: a 118 mL multiple-dose bottle and a 2 mL single-use container.

Mix this medicine with cold or room temperature water, milk, or infant formula. Do not mix it with warm or hot liquids. Do not mix it with fruit juice. Do not give or take this medicine with fruit juice.

Do not warm or heat the mixture before taking or giving it.

To use 2 mL single-use container:

• Do not use it if the seal has been damaged.
• Remove the container from a foil pouch. Twist the cap to the left to remove it from the container. Squeeze all the solution in the container into 4 ounces of cold or room temperature water, milk, or infant formula and mix it.
• For patients weighing 15 kilograms (kg) or more: Take or give half of the mixture (2 ounces) at the start of the meal or snack and take or give the remaining half of the mixture during meal or snack.
• For patients weighing less than 15 kg:
  • Divide the 4-ounce mixture into two separate 2-ounce portions.
  • Take or give 1 ounce at the start of the meal or snack and take or give the other half of the first portion during meal or snack.
  • Store the second portion in the refrigerator for the next meal or snack and repeat the steps.
  • Throw away the second portion if not used within 24 hours.

To use the 118 mL multiple-dose bottle:

• Do not use the multiple-dose bottle if the seal has been damaged.
• Remove the plastic screw by twisting the cap to the left. Use the measuring scoop to measure the prescribed dose.
• Mix the prescribed dose in 2 or 4 ounces of cold or room temperature water, milk, or infant formula.
• Take or give half of the mixture at the start of each meal or snack. Take or give the remaining mixture during meal or snack. Rinse the scoop after using.

Your doctor may tell you or your child to limit the amount of starch (eg, wheat, rice, or potatoes) that you eat. Carefully follow any special diet that your doctor gives you.

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 (solution):
  • To help digest sugar:
    • Adults and children weighing 15 kilograms (kg) or more—2 milliliters (mL) or 56 drops with food or snack during the day.
    • Children weighing less than to 15 kg—1 mL or 28 drops with food or snack during the day.

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 in the refrigerator. Do not freeze.

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.

You may store the 2 mL single-use container at room temperature for up to 3 days.

Throw away any unused 118 mL multiple-dose bottle 4 weeks after opening the bottle.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits, to see if this medicine is working properly and to decide if you should continue to take it.

Sacrosidase may cause serious allergic reactions, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you or your child have difficulty breathing or swallowing, fast heartbeat, skin itching, rash or redness, swelling of the face, throat, or tongue, or trouble breathing.

Your doctor may order a skin test before you or your child start using this medicine. The skin test is used to see if you have an allergy to sacrosidase. Tell your doctor if you or anyone in your home has ever had a positive skin test reaction to sacrosidase.

This medicine will help your body absorb sugar. This might change the level of sugar in your blood and urine. If you or your child have diabetes, you might need to measure your blood or urine sugar more often. Check with your doctor before changing your diet or the dose of your diabetes medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

Incidence not known

Chest pain

increase in heart rate

itching

nervousness

rapid breathing

rash

swelling of the face, tongue, and throat

trouble breathing

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:

Less common

Confusion

constipation

decreased urination

diarrhea

dizziness

dry mouth

fainting

headache

increased thirst

lightheadedness

nausea and vomiting

sleeplessness

stomach pain

sunken eyes

thirst

trouble with sleeping

unable to sleep

unusual tiredness or weakness

wrinkled skin

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.