pharmacopeia
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/api/v1/drug/sacrosidase

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Enzymatic Activity.

Indications

Sourced from openFDA
  • Sucraid ® (sacrosidase) Oral Solution is indicated for the treatment of sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID), in adult and pediatric patients 5 months of age and older.

Contraindications

Sourced from openFDA
  • Sucraid is contraindicated in patients known to be hypersensitive to yeast, yeast products, glycerin (glycerol), or papain (see WARNINGS).contraindicated

Dosage & administration

Sourced from openFDA

Important Administration Information Administer Sucraid with each meal or snack. Mix Sucraid with cold or room temperature water, milk or infant formula prior to administration. Administration of Sucraid in 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. Do not warm or heat the water, milk, or infant formula before or after addition of Sucraid. Administer half of the dose at the beginning of the meal or snack and the other half of the dose during the meal or snack. Recommended Dosage The recommended dosage is: Patients weighing 15 kg and less: 8,500 International Units (1 mL) administered orally with each meal or snack. Patients weighing more than 15 kg: 17,000 International Units (2 mL) administered orally with each meal or snack. Preparation and Administration Instructions for Patients Weighing 15 kg or Less Multiple-Dose Bottle: Using the measuring scoop provided, add 1 scoop of Sucraid (1 mL) to 60 mL of cold or room temperature water, milk, or infant formula. Stir to mix well. Administer half of the mixed Sucraid solution (30 mL) at the beginning of the meal or snack and the other half of the mixed solution (30 mL) during the meal or snack. Do not save any of the mixed Sucraid solution for later use. Rinse the measuring scoop with water. Single-Use Container: Empty the entire contents of the single-use container (2 mL) in 120 mL of cold or room temperature water, milk, or infant formula. Stir to mix well. Divide the mixed Sucraid solution into two separate 60 mL portions.

Warnings & precautions

Sourced from openFDA

Severe Hypersensitivity Reactions Severe hypersensitivity reactions, including wheezing, rash, and pruritis, have been reported with administration of Sucraid. Sucraid contains papain, which is associated with hypersensitivity reactions (see DESCRIPTION). A pediatric patient in the clinical trials experienced a hypersensitivity reaction of severe wheezing that required hospitalization. Postmarketing cases of cutaneous hypersensitivity reactions have also been reported. Instruct patients or caregivers to stop Sucraid and seek medical attention if symptoms suggestive of a hypersensitivity reaction occur. Sucraid is contraindicated in patients who have had a known hypersensitivity reaction (see CONTRAINDICATIONS).

Adverse reactions

Sourced from openFDA

The following adverse reactions associated with the use of sacrosidase were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. In clinical studies of up to 54 months duration, a total of 52 patients were treated with Sucraid. The reported adverse reactions (number of patients) were as follows: abdominal pain (4), vomiting (3), nausea (2), diarrhea (2), constipation (2), insomnia (1), headache (1), nervousness (1), and dehydration (1). Hypersensitivity reactions (wheezing, rash, and pruritis) have been reported (see WARNINGS).

Use in specific populations

Sourced from openFDA

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.

Approval history

Sourced from openFDA
  • Apr 9, 1998BLABLA020772Qol Medcl

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
165 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Diarrhoea3119%
  2. 2Abdominal Pain3018%
  3. 3Nausea1811%
  4. 4Abdominal Distension148.5%
  5. 5Drug Ineffective148.5%
  6. 6Flatulence148.5%
  7. 7Headache127.3%
  8. 8Product Quality Issue127.3%
  9. 9Vomiting116.7%
  10. 10Dizziness95.5%
  11. 11Insomnia95.5%
  12. 12Fatigue84.8%
  13. 13Product Taste Abnormal84.8%
  14. 14Decreased Appetite74.2%
  15. 15Pruritus74.2%

Literature

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Recent PubMed references pinned to Sacrosidase as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 4 most recently updated of 4 ClinicalTrials.gov registrations naming Sacrosidase as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Sacrosidase work?
Mechanism-of-action class: Enzymatic Activity.
What is Sacrosidase used for?
According to FDA labeling, Sacrosidase carries indications including: Sucraid ® (sacrosidase) Oral Solution is indicated for the treatment of sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID), in adult and pediatric patients 5 months of age and older.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Sacrosidase?
Sacrosidase is classified as Enzymes, Sucrose-specific Enzyme, Enzymatic Activity, Increased Glucose Transport into Cells.
What are the brand names for Sacrosidase?
Sacrosidase is marketed under brand names including Sucraid.
What are the contraindications for Sacrosidase?
Sacrosidase labeling lists contraindications including: Sucraid is contraindicated in patients known to be hypersensitive to yeast, yeast products, glycerin (glycerol), or papain (see WARNINGS).. Always consult the full prescribing information and a clinician.
Note. Data for sacrosidase is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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