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Sucraid

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Overview

What is Sucraid?

Sucraid (sacrosidase) Oral Solution is an enzyme replacement therapy for the treatment of genetically determined sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID).



What does Sucraid look like?



What are the available doses of Sucraid?

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What should I talk to my health care provider before I take Sucraid?

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How should I use Sucraid?

Sucraid (sacrosidase) Oral Solution is indicated as oral replacement therapy of the genetically determined sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID).

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).


What interacts with Sucraid?

Patients known to be hypersensitive to yeast, yeast products, glycerin (glycerol), or papain.



What are the warnings of Sucraid?

After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an oral antibacterial drug clinically effective against colitis.

Severe wheezing, 90 minutes after a second dose of sacrosidase, necessitated admission into the ICU for a 4-year-old boy. The wheezing was probably caused by sacrosidase. He had asthma and was being treated with steroids. A skin test for sacrosidase was positive.

Other serious events have not been linked to Sucraid.


What are the precautions of Sucraid?

Care should be taken to administer initial doses of Sucraid near (within a few minutes of travel) a facility where acute hypersensitivity reactions can be adequately treated. Alternatively, the patient may be tested for hypersensitivity to Sucraid through skin abrasion testing. Should symptoms of hypersensitivity appear, discontinue medication and initiate symptomatic and supportive therapy.

Skin testing as a rechallenge has been used to verify hypersensitivity in one asthmatic child who displayed wheezing after oral sacrosidase.

GENERAL

Although Sucraid provides replacement therapy for the deficient sucrase, it does not provide specific replacement therapy for the deficient isomaltase. Therefore, restricting starch in the diet may still be necessary to reduce symptoms as much as possible. The need for dietary starch restriction for patients using Sucraid should be evaluated in each patient.

It may sometimes be clinically inappropriate, difficult, or inconvenient to perform a small bowel biopsy or breath hydrogen test to make a definitive diagnosis of CSID. If the diagnosis is in doubt, it may be warranted to conduct a short therapeutic trial (e.g., one week) with Sucraid to assess response in a patient suspected of sucrase deficiency.

The effects of Sucraid have not been evaluated in patients with secondary (acquired) disaccharidase deficiencies.

INFORMATION FOR PATIENTS

See .  Patients should be instructed to discard bottles of Sucraid 4 weeks after opening due to the potential for bacterial growth. For the same reason, patients should be advised to rinse the measuring scoop with water after each use.

Sucraid is fully soluble with water, milk, and infant formula, but it is important to note that this product is sensitive to heat. Sucraid should not be reconstituted or consumed with fruit juice, since its acidity may reduce the enzyme activity.

USE IN DIABETICS

The use of Sucraid will enable the products of sucrose hydrolysis, glucose and fructose, to be absorbed. This fact must be carefully considered in planning the diet of diabetic CSID patients using Sucraid.

LABORATORY TESTS

The definitive test for diagnosis of CSID is the measurement of intestinal disaccharidases following small bowel biopsy.

Other tests used alone may be inaccurate: for example, the breath hydrogen test (high incidence of false negatives) or oral sucrose tolerance test (high incidence of false positives). Differential urinary disaccharide testing has been reported to show good agreement with small intestinal biopsy for diagnosis of CSID.

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.


What are the side effects of Sucraid?

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


What should I look out for while using Sucraid?

Patients known to be hypersensitive to yeast, yeast products, glycerin (glycerol), or papain.

Severe wheezing, 90 minutes after a second dose of sacrosidase, necessitated admission into the ICU for a 4-year-old boy. The wheezing was probably caused by sacrosidase. He had asthma and was being treated with steroids. A skin test for sacrosidase was positive.

Other serious events have not been linked to Sucraid.


What might happen if I take too much Sucraid?

Overdosage with Sucraid has not been reported.


How should I store and handle Sucraid?

Unopened vials of gemcitabine for injection, USP are stable until the expiration date indicated on the package when stored at controlled room temperature 20° to 25°C (68° to 77°F) and that allows for excursions between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature] [].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). Product is sterile until opened. Discard four weeks after first opening due to the potential for bacterial growth. Protect from heat and light.Rx only.Distributed by:QOL Medical, LLCVero Beach, FL 32963To order, or for any questions, call 1-866-469-3773www.sucraid.netNDC# 67871-111-04Sucraid® (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). Product is sterile until opened. Discard four weeks after first opening due to the potential for bacterial growth. Protect from heat and light.Rx only.Distributed by:QOL Medical, LLCVero Beach, FL 32963To order, or for any questions, call 1-866-469-3773www.sucraid.netNDC# 67871-111-04Sucraid® (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). Product is sterile until opened. Discard four weeks after first opening due to the potential for bacterial growth. Protect from heat and light.Rx only.Distributed by:QOL Medical, LLCVero Beach, FL 32963To order, or for any questions, call 1-866-469-3773www.sucraid.netNDC# 67871-111-04Sucraid® (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). Product is sterile until opened. Discard four weeks after first opening due to the potential for bacterial growth. Protect from heat and light.Rx only.Distributed by:QOL Medical, LLCVero Beach, FL 32963To order, or for any questions, call 1-866-469-3773www.sucraid.netNDC# 67871-111-04Sucraid® (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). Product is sterile until opened. Discard four weeks after first opening due to the potential for bacterial growth. Protect from heat and light.Rx only.Distributed by:QOL Medical, LLCVero Beach, FL 32963To order, or for any questions, call 1-866-469-3773www.sucraid.netNDC# 67871-111-04Sucraid® (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). Product is sterile until opened. Discard four weeks after first opening due to the potential for bacterial growth. Protect from heat and light.Rx only.Distributed by:QOL Medical, LLCVero Beach, FL 32963To order, or for any questions, call 1-866-469-3773www.sucraid.netNDC# 67871-111-04Sucraid® (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). Product is sterile until opened. Discard four weeks after first opening due to the potential for bacterial growth. Protect from heat and light.Rx only.Distributed by:QOL Medical, LLCVero Beach, FL 32963To order, or for any questions, call 1-866-469-3773www.sucraid.netNDC# 67871-111-04


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Congenital sucrase-isomaltase deficiency (CSID) is a chronic, autosomal recessive, inherited, phenotypically heterogeneous disease with very variable enzyme activity. CSID is usually characterized by a complete or almost complete lack of endogenous sucrase activity, a very marked reduction in isomaltase activity, a moderate decrease in maltase activity, and normal lactase levels.

Sucrase is naturally produced in the brush border of the small intestine, primarily the distal duodenum and jejunum. Sucrase hydrolyzes the disaccharide sucrose into its component monosaccharides, glucose and fructose. Isomaltase breaks down disaccharides from starch into simple sugars. Sucraid does not contain isomaltase.

In the absence of endogenous human sucrase, as in CSID, sucrose is not metabolized. Unhydrolyzed sucrose and starch are not absorbed from the intestine and their presence in the intestinal lumen may lead to osmotic retention of water. This may result in loose stools.

Unabsorbed sucrose in the colon is fermented by bacterial flora to produce increased amounts of hydrogen, methane, and water. As a consequence, excessive gas, bloating, abdominal cramps, nausea, and vomiting may occur.

Chronic malabsorption of disaccharides may result in malnutrition. Undiagnosed/untreated CSID patients often fail to thrive and fall behind in their expected growth and development curves. Previously, the treatment of CSID has required the continual use of a strict sucrose-free diet.

CSID is often difficult to diagnose. Approximately 4% to 10% of pediatric patients with chronic diarrhea of unknown origin have CSID. Measurement of expired breath hydrogen under controlled conditions following a sucrose challenge (a measurement of excess hydrogen excreted in exhalation) in CSID patients has shown levels as great as 6 times that in normal subjects.

A generally accepted clinical definition of CSID is a condition characterized by the following: stool pH <6, an increase in breath hydrogen of > 10 ppm when challenged with sucrose after fasting and a negative lactose breath test. However, because of the difficulties in diagnosing CSID, it may be warranted to conduct a short therapeutic trial (e.g., one week) to assess response in patients suspected of having CSID.

Non-Clinical Toxicology
Patients known to be hypersensitive to yeast, yeast products, glycerin (glycerol), or papain.

Severe wheezing, 90 minutes after a second dose of sacrosidase, necessitated admission into the ICU for a 4-year-old boy. The wheezing was probably caused by sacrosidase. He had asthma and was being treated with steroids. A skin test for sacrosidase was positive.

Other serious events have not been linked to Sucraid.

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.

Care should be taken to administer initial doses of Sucraid near (within a few minutes of travel) a facility where acute hypersensitivity reactions can be adequately treated. Alternatively, the patient may be tested for hypersensitivity to Sucraid through skin abrasion testing. Should symptoms of hypersensitivity appear, discontinue medication and initiate symptomatic and supportive therapy.

Skin testing as a rechallenge has been used to verify hypersensitivity in one asthmatic child who displayed wheezing after oral sacrosidase.

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

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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