Sucraid (Page 2 of 3)

DRUG INTERACTIONS

Neither drug-drug nor drug-food interactions are expected or have been reported with the use of Sucraid. However, Sucraid should not be reconstituted or consumed with fruit juice, since its acidity may reduce the enzyme activity.

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

Long-term studies in animals with Sucraid have not been performed to evaluate the carcinogenic potential. Studies to evaluate the effect of Sucraid on fertility or its mutagenic potential have not been performed.

PREGNANCY

Teratogenic effects. Pregnancy Category C. Animal reproduction studies have not been conducted with Sucraid. Sucraid is not expected to cause fetal harm when administered to a pregnant woman or to affect reproductive capacity. Sucraid should be given to a pregnant woman only if clearly needed.

NURSING MOTHERS

The Sucraid enzyme is broken down in the stomach and intestines, and the component amino acids and peptides are then absorbed as nutrients.

PEDIATRIC USE

Sucraid has been used in patients as young as 5 months of age. Evidence in one controlled trial in primarily pediatric patients shows that Sucraid is safe and effective for the treatment of the genetically acquired sucrase deficiency, which is part of CSID.

ADVERSE REACTIONS

Adverse experiences with Sucraid in clinical trials were generally minor and were frequently associated with the underlying disease.

In clinical studies of up to 54 months duration, physicians treated a total of 52 patients with Sucraid. The adverse experiences and respective number of patients reporting each event (in parenthesis) were as follows: abdominal pain (4), vomiting (3), nausea (2), diarrhea (2), constipation (2), insomnia (1), headache (1), nervousness (1), and dehydration (1).

Note: diarrhea and abdominal pain can be a part of the clinical presentation of the genetically determined sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID).

One asthmatic child experienced a serious hypersensitivity reaction (wheezing) probably related to sacrosidase (see Warnings). The event resulted in withdrawal of the patient from the trial but resolved with no sequelae.

OVERDOSAGE

Overdosage with Sucraid has not been reported.

DOSAGE AND ADMINISTRATION

The recommended dosage is 1 or 2 mL (8,500 to 17,000 I.U.) or 1 or 2 full measuring scoops (each full measuring scoop equals 1 mL; 28 drops from the Sucraid container tip equals 1 mL) taken orally with each meal or snack diluted with 2 to 4 ounces (60 to 120 mL) of water, milk, or infant formula. The beverage or infant formula should be served cold or at room temperature. The beverage or infant formula should not be warmed or heated before or after addition of Sucraid because heating is likely to decrease potency. Sucraid should not be reconstituted or consumed with fruit juice since its acidity may reduce the enzyme activity.

It is recommended that approximately half of the dosage be taken at the beginning of the meal or snack and the remainder be taken during the meal or snack.

The recommended dosage is as follows:

1 mL (8,500 I.U.) (one full measuring scoop or 28 drops) per meal or snack for patients up to 15 kg in body weight.

2 mL (17,000 I.U.) (two full measuring scoops or 56 drops) per meal or snack for patients over 15 kg in body weight.

Dosage may be measured with the 1 mL measuring scoop (provided) or by drop count method (1 mL equals 28 drops from the Sucraid container tip).

HOW SUPPLIED

Sucraid® (sacrosidase) Oral Solution is available in 118 mL (4 fluid ounces) translucent plastic bottles, packaged two bottles per box. Each mL of solution contains 8,500 International Units (I.U.) of sacrosidase. A 1 mL measuring scoop is provided with each bottle. A full measuring scoop is 1 mL.

Store in a refrigerator at 2°- 8°C (36°- 46°F). Discard four weeks after first opening due to the potential for bacterial growth. Protect from heat and light.

Rx only.

Distributed by:
QOL Medical, LLC
Vero Beach, FL 32963

To order, or for any questions, call 1-866-469-3773

www.sucraid.net

NDC# 67871-111-04

PATIENT PACKAGE INSERT: INFORMATION FOR PATIENTS

Figure 1Figure 2

Sucraid® (sacrosidase) Oral Solution

Please read this leaflet carefully before you take Sucraid® (sacrosidase) Oral Solution or give Sucraid to a child. Please do not throw away this leaflet. You may need to read it again at a later date. This leaflet does not contain all the information on Sucraid. For further information or advice, ask your doctor or pharmacist.

BEFORE TAKING SUCRAID

WARNING: Sucraid may cause a serious allergic reaction. If you notice any swelling or have difficulty breathing, get emergency help right away. Before taking your first and second doses, be sure that there are health professionals nearby (within a few minutes of travel) just in case there is an allergic reaction.

INFORMATION ABOUT YOUR MEDICINE

The name of your medicine is Sucraid (sacrosidase) Oral Solution. It can be obtained only with a prescription from your doctor.

The purpose of your medicine:

Sucraid is an enzyme replacement therapy for the treatment of the genetically determined sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID). CSID is a condition where your body lacks the enzymes needed to break down and absorb sucrose (table sugar) and other sugars from starch.

The symptoms of CSID often include frequent watery diarrhea, abdominal pain, bloating, and gas. In many cases, the symptoms of CSID are similar to other medical problems. Only your doctor can make a definite diagnosis of CSID.

Sucraid can help improve the breakdown and absorption of sucrose (table sugar) from the intestine and can help relieve the gastrointestinal symptoms of CSID.

Sucraid does not break down some sugars resulting from the digestion of starch. Therefore, you may need to restrict the amount of starch in your diet. Your doctor will tell you if you should restrict the amount of starch in your diet.

Discuss the following important information with your doctor before you begin to take Sucraid:

Tell your doctor if you are allergic to, have ever had a reaction to, or have ever had difficulty taking yeast, yeast products, papain, or glycerin (glycerol).

Tell your doctor if you have diabetes. With Sucraid, sucrose (table sugar) can be absorbed from your diet and your blood glucose levels may change. Your doctor will tell you if your diet or diabetes medicines need to be changed.

Side effects to watch for:

Some patients may have worse abdominal pain, vomiting, nausea, or diarrhea. Constipation, difficulty sleeping, headache, nervousness, and dehydration have also occurred. Other side effects may also occur. If you notice these or any other side effects during treatment with Sucraid, check with your doctor.

Stop taking Sucraid and get emergency help immediately if any of the following side effects occur: difficulty breathing, wheezing, or swelling of the face.

How to take your medicine:

Each bottle of Sucraid is supplied with a plastic screw cap which covers a dropper dispensing tip. Remove the outer cap and measure out the required dose. Reseal the bottle after each use by replacing and twisting the cap until tight.

Write down the date the sealed bottle is first opened in the space provided on the bottle label. Always throw away the bottle four weeks after first opening it because Sucraid contains no preservatives. For the same reason, you should rinse the measuring scoop with water after each time you finish using it.

To get the full benefits of this medicine, it is very important to take Sucraid as your doctor has prescribed. The usual dosage is 1 to 2 milliliters (mL) with each meal or snack: 1mL = 1 full measuring scoop (28 drops from the bottle tip) and 2 mL = 2 full measuring scoops (56 drops from the bottle tip).

Measure your dose with the measuring scoop provided (see Figure 1). Do not use a kitchen teaspoon or other measuring device since it will not measure an accurate dose.

Figure 1. Measure dose with measuring scoop.

Figure 1

Mix your dose in 2 to 4 ounces of water, milk, or infant formula (see Figure 2). Sucraid should not be dissolved in or taken with fruit juice.

NEVER HEAT SUCRAID OR PUT IT IN WARM OR HOT BEVERAGES OR INFANT FORMULA. Heating Sucraid causes it to lose its effectiveness. The beverage or infant formula should be taken cold or at room temperature.

Figure 2. Mix dose in beverage or infant formula.

Figure 2

It is recommended that approximately half of your dosage be taken at the beginning of each meal or snack and the remainder of your dosage be taken during the meal or snack.

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