Sucraid (Page 2 of 4)

DRUG INTERACTIONS

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.

PREGNANCY

Teratogenic Effects

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

Dosage

  • 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.

Preparation Instructions
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.

Administration Instructions

  • 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.

HOW SUPPLIED

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).

Manufactured by:

QOL Medical, LLC Vero Beach, FL 32963
U.S. License No. 2195

www.sucraid.com
For questions call 1-866-469-3773

Rev <05/22> Part No. 0110

Instructions for Use

SUCRAID® (Su-kreid)

(sacrosidase)
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.

ifu-vials-1
(click image for full-size original)

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.

figure-1
(click image for full-size original)

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.

figure-2
(click image for full-size original)

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.

figure-3
(click image for full-size original)

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.

Manufactured by:
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.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.