Neither drug-drug nor drug-food interactions are expected or have been reported with the use of Sucraid. Do not mix or consume Sucraid with fruit juice, since 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.
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.
The Sucraid enzyme is broken down in the stomach and intestines, and the component amino acids and peptides are then absorbed as nutrients.
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 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 with Sucraid has not been reported.
- Patients weighing 15 kg and less: The recommended dosage is 1 mL (8,500 International Units) administered orally with each meal or snack.
- Patients weighing more than 15 kg: The recommended dosage is 2 mL (17,000 International Units) administered orally with each meal or snack.
1 mL (8,500 International Units) dose for patients weighing 15 kg or less:
- Multiple-Dose Bottle: Measure 1 scoop (provided) or 28 drops using the multiple-dose bottle in 60 mL of water, milk, or infant formula and mix well. Rinse the measuring scoop with water after each use.
2 mL (17,000 International Units) dose for patients weighing more than 15 kg:
- Multiple-Dose Bottle: Measure 2 scoops (provided) or 56 drops using the multiple-dose bottle in 120 mL of water, milk, or infant formula and mix well. Rinse the measuring scoop with water after each use.
- Single-Use Container: Empty the entire contents of the 2 mL single-use container in 120 mL of water, milk, or infant formula and mix well.
- Administer half of the mixed solution at the beginning of the meal or snack and the other half during the meal or snack.
- Serve the beverage or infant formula cold or at room temperature. Do not warm or heat the beverage or infant formula before or after addition of Sucraid.
- Administration of Sucraid with liquids other than water, milk, or infant formula has not been studied and is not recommended. Do not mix or consume Sucraid with fruit juice.
118 mL Multiple-Dose Bottle
Sucraid (sacrosidase) Oral Solution is available in 118 mL (4 fluid ounces) multiple-dose translucent plastic bottles, packaged two bottles per carton. Each mL of solution contains 8,500 International Units of sacrosidase. A 1 mL measuring scoop is provided with each bottle. A full measuring scoop is 1 mL.
NDC# 67871-111-04 (2 x 118 mL multiple-dose bottles)
Store under refrigeration at 2°C to 8°C (36°F to 46°F). Discard four weeks after first opening due to the potential for bacterial growth. Protect from heat and light.
2 mL Single-Use Container
Sucraid (sacrosidase) Oral Solution is available in 2 mL, single-use containers that are packaged into a foil pouch. Each 2 mL single-use container contains 17,000 International Units of sacrosidase.
Each foil pouch holds a card of 5 containers. Five pouches are then packaged in a box (25 containers). Six boxes are further packaged in a carton (150 containers).
NDC# 67871-111-07 (150 x 2 mL single-use containers)
Store under refrigeration, 2°C to 8°C (36°F to 46°F). Protect from light. Single-use container can be removed from refrigeration and stored at 15°C to 25°C (59°F to 77°F) for up to 3 days (72 hours).
QOL Medical, LLC Vero Beach, FL 32963
U.S. License No. 2195
For questions call 1-866-469-3773
Rev <05/22> Part No. 0110
oral solution2 mL Single-Use Container
Read this Instructions for Use before you start taking or giving SUCRAID to a child, and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your or your child’s medical condition or treatment.
Important information you need to know before taking or giving SUCRAID:
- The 2 mL single-use container is for a child and adult more than 33 pounds (15 kg).
- SUCRAID is supplied in 2 mL single-use containers in a foil pouch. Each foil pouch holds 5 single-use containers.
Each container is one 2 mL SUCRAID dose.
- Your healthcare provider will decide the right dose of SUCRAID for you or your child. Do not change the dose of SUCRAID without talking to your healthcare provider.
- SUCRAID can only be dissolved with cold or room temperature water, milk, or infant formula. Do not put SUCRAID in warm or hot liquids. Do not dissolve SUCRAID with fruit juice. Do not give or take SUCRAID with fruit juice.
- Do not warm or heat the mixed solution before taking or giving SUCRAID.
- SUCRAID should be taken or given with each meal or snack. Half of the SUCRAID dose should be taken at the beginning of each meal or snack. Take or give the remaining SUCRAID dose during the meal or snack.
- Do not use the SUCRAID single-use container if the seal has been damaged. Contact your pharmacist or healthcare provider if you cannot use the SUCRAID single-use container.
Supplies needed to take or give SUCRAID:
- 1 SUCRAID 2 mL container
- 4 ounces of cold or room temperature water, milk, or infant formula (not included)
- Meal or snack (not included)
- Spoon to mix (not included)
How to take or give SUCRAID:
Step 1: Check the expiration date on the SUCRAID foil pouch. Do not use SUCRAID if it is past the expiration date.Remove 1 SUCRAID 2 mL container from a foil pouch.
Step 2: Twist the cap to the left to remove it from the container. See Figure 1.
Step 3: Squeeze all the SUCRAID solution in the container into 4 ounces of cold or room temperature water, milk, or infant formula. See Figure 2.
Step 4: Mix your or your child’s prescribed dose in 4 ounces of cold or room temperature water, milk, or infant formula.See Figure 3.
Step 5: Take or give half of the mixed solution at the beginning of each meal or snack. Take or give the remaining mixed solution during the meal or snack.
Throwing away (disposal of) SUCRAID:
- Throw away expired or empty SUCRAID containers in your household trash.
How should I store SUCRAID?
- Store the SUCRAID single-use container in the refrigerator between 36°F to 46°F (2°C to 8°C).
- The SUCRAID single-use container may be stored between 59°F to 77°F (15° to 25°C) for up to 3 days.
- Protect SUCRAID from heat and light.
Keep SUCRAID and all medicines out of the reach of children.
QOL Medical, LLC Vero Beach, FL 32963
U.S. License No. 2195
For more information, go to www.sucraid.com or call 1-866-469-3773.
This Instructions for Use has been approved by the U.S. Food and Drug Administration. Issued: May 2022
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.