Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM CATION - UNII:LYR4M0NH37), POTASSIUM SULFATE (UNII: 1K573LC5TV) (POTASSIUM CATION - UNII:295O53K152), MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838)
Braintree Laboratories, Inc.
sodium sulfate
sodium sulfate 17.5 g in 1 mL
ORAL
PRESCRIPTION DRUG
SUPREP Bowel Prep Kit is indicated for cleansing of the colon as a preparation for colonoscopy in adult and pediatric patients 12 years of age and older. SUPREP Bowel Prep Kit is contraindicated in the following conditions: - Gastrointestinal obstruction or ileus [see Warnings and Precautions ( 5.6)] - Bowel perforation [see Warnings and Precaution ( 5.6)] - Toxic colitis or toxic megacolon - Gastric retention - Hypersensitivity to any of the ingredients in SUPREP Bowel Prep Kit Risk Summary There are no available data on SUPREP Bowel Prep Kit use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproductive studies have not been conducted with sodium sulfate, potassium sulfate, and magnesium sulfate (SUPREP Bowel Prep Kit). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies
Each SUPREP Bowel Prep Kit (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution (for adults) (NDC 52268-012-01) contains: Each SUPREP Bowel Prep Kit (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution (for pediatric patients 12 years of age and older) (NDC 52268-112-01) contains: Store at 20° to 25°C (68° to 77°F). Excursions permitted between 15° to 30°C (59° to 86°F). See USP controlled room temperature.
New Drug Application
Braintree Laboratories, Inc. ---------- MEDICATION GUIDE SUPREP ® (Soo-prep) Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) oral solution Read and understand this Medication Guide instructions at least 2 days before your colonoscopy and again before you start taking SUPREP Bowel Prep Kit. What is the most important information I should know about SUPREP Bowel Prep Kit? SUPREP Bowel Prep Kit and other bowel preparations can cause serious side effects, including: • Serious loss of body fluid (dehydration) and changes in blood salts (electrolytes) in your blood. These changes can cause: • abnormal heartbeats that can cause death seizures. This can happen even if you have never had a seizure. kidney problems Your chance of having fluid loss and changes in body salts with SUPREP Bowel Prep Kit is higher if you: • have heart problems • have kidney problems • take water pills or non-steroidal anti-inflammatory drugs (NSAIDS) Tell your healthcare provider right away if you have any of these symptoms of a loss of too much body fluid (dehydration) while taking SUPREP Bowel Prep Kit: o vomiting o urinating less often than normal o dizziness o headache See What are the possible side effects of SUPREP Bowel Prep Kit? for more information about side effects. What is SUPREP Bowel Prep Kit? SUPREP Bowel Prep Kit is a prescription medicine used by adults and children 12 years of age and older to clean the colon before a colonoscopy. SUPREP Bowel Prep Kit cleans your colon by causing you to have diarrhea. Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy. It is not known if SUPREP Bowel Prep Kit is safe and effective in children under 12 years of age. Do not take SUPREP Bowel Prep Kit if your healthcare provider has told you that you have: • a blockage in your intestine (bowel obstruction) • an opening in the wall of your stomach or intestine (bowel perforation) • a very dilated intestine (toxic megacolon) • problems wit Leggi il documento completo
SUPREP BOWEL PREP- SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE SOLUTION, CONCENTRATE BRAINTREE LABORATORIES, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SUPREP BOWEL PREP KIT SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SUPREP BOWEL PREP KIT SUPREP BOWEL PREP KIT (SODIUM SULFATE, POTASSIUM SULFATE, AND MAGNESIUM SULFATE) ORAL SOLUTION INITIAL U.S. APPROVAL: 08/2010 RECENT MAJOR CHANGES Indications and Usage ( 1) 8/2020 Dosage and Administration ( 2.1, 2.4) 8/2020 INDICATIONS AND USAGE SUPREP Bowel Prep Kit is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adult and pediatric patients 12 years of age and older. ( 1) DOSAGE AND ADMINISTRATION Preparation and Administration ( 2.2) Must dilute in water prior to ingestion. Administration of two bottles of SUPREP Bowel Prep Kit is required for a complete preparation for colonoscopy. One bottle is equivalent to one dose . Must consume additional water after each dose. Stop consumption of all fluids at least 2 hours before the colonoscopy. Recommended Dosage and Administration Split-Dose (two-day) regimen consists of two doses of SUPREP Bowel Prep Kit: first dose during the evening prior to colonoscopy and second dose the next day, during the morning of colonoscopy. ( 2.1, 2.3, 2.4) Recommended SUPREP Bowel Prep Kit dosage is: º ADULTS: Two 6-ounce doses. ( 2.3) º PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER: Two 4.5-ounce doses. ( 2.4) For complete information on preparation before colonoscopy and administration of the dosage regimen, see full prescribing Information. ( 2.1, 2.2, 2.3, 2.4) DOSAGE FORMS AND STRENGTHS SUPREP Bowel Prep Kit (FOR ADULTS): Two bottles each containing 6 ounces of an oral solution of 17.5 grams sodium sulfate, 3.13 grams potassium sulfate, and 1.6 grams magnesium sulfate. ( 3) SUPREP Bowel Prep Kit (FOR PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER): Two bottles each containing 4.5-ounces of an oral Leggi il documento completo