Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750), POTASSIUM SULFATE (UNII: 1K573LC5TV) (SULFATE ION - UNII:7IS9N8KPMG), MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I) (MAGNESIUM CATION - UNII:T6V3LHY838)
Novel Laboratories, Inc.
ORAL
PRESCRIPTION DRUG
Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is indicated for cleansing of the colon as a preparation for colonoscopy in adults. - Gastrointestinal obstruction - Bowel perforation - Gastric retention - Ileus - Toxic colitis or toxic megacolon - Known allergies to components of the kit [see Description (11)] Teratogenic effects: Pregnancy Category C. Animal reproduction studies have not been conducted with Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. It is also not known whether Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution should be given to a pregnant woman only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Sodium Sulfate, Potassium Sulfate and Magnesium
Each Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution contains: • Two (2) 6 ounce bottles of oral solution. • One (1) 19 ounce mixing container with a 16 ounce fill line. Storage: Store at 20º to 25°C (68º to 77°F). Excursions permitted between 15º to 30°C (59º to 86°F). See USP controlled room temperature. Keep out of reach of children. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution Package NDC 40032-700-83
Abbreviated New Drug Application
MAGNESIUM SULFATE SOLUTION Novel Laboratories, Inc. ---------- MEDICATION GUIDE Sodium Sulfate (soe' dee um sul' fate), Potassium Sulfate (poe tas' ee um sul' fate) and Magnesium Sulfate ( mag nee' zee um sul' fate) Oral Solution Read this Medication Guide before you start taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate oral solution. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. What is the most important information I should know about Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution? Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution and other osmotic 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 Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 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 Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution: • vomiting that prevents you from keeping down the additional prescribed amount of water listed in the Instructions for Use in the Patient Instructions for Use Booklet • dizziness • urinating less often than normal • headache See Section "What are the possible side effects of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution?" for more information about side effects. What is Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution? Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is a Leggi il documento completo
SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE- SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE SOLUTION NOVEL LABORATORIES, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE. SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE (SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE) SOLUTION FOR ORAL USE. INITIAL U.S. APPROVAL: 08/2010 RECENT MAJOR CHANGES Dosage and Administration 11/2012 INDICATIONS AND USAGE Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults (1) DOSAGE AND ADMINISTRATION Dilute the solution prior to use. See FULL PRESCRIBING INFORMATION for complete dosing and administration instructions (2) Split Dose (2-Day) Regimen Evening before colonoscopy: dilute one bottle with water to a total volume of 16 ounces (up to the fill line) and drink the entire amount. Drink 32 ounces of water over the next hour. Next morning: repeat both steps using the second bottle. Complete preparation at least 2 hours before colonoscopy or as directed by physician. DOSAGE FORMS AND STRENGTHS Two 6 ounce bottles of oral solution, each containing sodium sulfate 17.5 grams, potassium sulfate 3.13 grams, and magnesium sulfate 1.6 grams. (3) CONTRAINDICATIONS Gastrointestinal obstruction (4,5.6) Bowel perforation (4, 5.6) Gastric retention (4) Ileus (4) Toxic colitis or toxic megacolon (4) Known allergies to components of the kit (4, 11) WARNINGS AND PRECAUTIONS Risk of fluid and electrolyte abnormalities, arrhythmias, seizures and renal impairment– assess concurrent medications and consider testing in some patients (5.1,5.2,5.3) Patients with renal insufficiency– use caution, ensure adequate hydration and consider testing (5.4) Suspected GI obstruction or per Leggi il documento completo