Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate Oral
Generic Name: sodium sulfate, potassium sulfate and magnesium sulfate oral
Brand Names:
Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate Oral
11 DESCRIPTION Sodium sulfate, potassium sulfate and magnesium sulfate oral solution (for adults) is an osmotic laxative and is provided as two bottles each containing 6 ounces of solution. Each bottle contains: 17.5 grams sodium sulfate, 3.13 grams potassium sulfate, and 1.6 grams magnesium sulfate. Inactive ingredients include: citric acid monohydrate USP, mixberry flavor, malic acid USP-NF, purified water, sodium benzoate USP-NF, sucralose USP-NF.
Overview
11 DESCRIPTION Sodium sulfate, potassium sulfate and magnesium sulfate oral solution (for adults) is an osmotic laxative and is provided as two bottles each containing 6 ounces of solution. Each bottle contains: 17.5 grams sodium sulfate, 3.13 grams potassium sulfate, and 1.6 grams magnesium sulfate. Inactive ingredients include: citric acid monohydrate USP, mixberry flavor, malic acid USP-NF, purified water, sodium benzoate USP-NF, sucralose USP-NF.
Uses
1 INDICATIONS AND USAGE Sodium sulfate, potassium sulfate and magnesium sulfate oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adult and pediatric patients 12 years of age and older. Sodium sulfate, potassium sulfate and magnesium sulfate oral solution 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
2 DOSAGE AND ADMINISTRATION Preparation and Administration (2.2) Must dilute in water prior to ingestion Administration of two bottles of sodium sulfate, potassium sulfate and magnesium sulfate oral solution 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 sodium sulfate, potassium sulfate and magnesium sulfate oral solution: first dose during the evening prior to colonoscopy and second dose the next day, during the morning of colonoscopy.
Side Effects
6 ADVERSE REACTIONS Most common adverse reactions are: Adults (>2%): overall discomfort, abdominal distention, abdominal pain, nausea, and vomiting. (6.1) Pediatric Patients (>10%): nausea, abdominal pain, abdominal bloating and vomiting. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Strides Pharma Inc. at 1-877-244-9825 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Interactions
7 DRUG INTERACTIONS Drugs that increase risk of fluid and electrolyte imbalance. (7.1) 7.1 Drugs That May Increase Risks of Fluid and Electrolyte Abnormalities Use caution when prescribing sodium sulfate, potassium sulfate and magnesium sulfate oral solution to patients taking medications that increase the risk of fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities [see Warnings and Precautions (5.1, 5.2, 5.3, 5.4)]. 7.2 Potential for Reduced Drug Absorption Sodium sulfate, potassium sulfate and magnesium sulfate oral solution can reduce the absorption of other co-administered drugs [see Dosage and Administration (2.1)] .
Warnings
5 WARNINGS AND PRECAUTIONS Risk of fluid and electrolyte abnormalities : Encourage adequate hydration, assess concurrent medications, and consider laboratory assessments prior to and after each use. (5.1, 7.1) Cardiac arrhythmias : Consider pre-dose and post-colonoscopy ECGs in patients at increased risk. (5.2) Seizures : Use caution in patients with a history of seizures and patients at increased risk of seizures, including medications that lower the seizure threshold. (5.3, 7.1) Patients with renal impairment or taking concomitant medications that affect renal function : Use caution, ensure adequate hydration and consider laboratory testing. (5.4, 7.1) Suspected GI obstruction or perforation: Rule out the diagnosis before administration. 4 CONTRAINDICATIONS Sodium sulfate, potassium sulfate and magnesium sulfate oral solution 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 sodium sulfate, potassium sulfate an...
Pregnancy
8.1 Pregnancy Risk Summary There are no available data on sodium sulfate, potassium sulfate and magnesium sulfate oral solution 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 (sodium sulfate, potassium sulfate and magnesium sulfate oral solution). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Each sodium sulfate, potassium sulfate and magnesium sulfate oral solution (for adults) (NDC 64380-116-01) contains: Two bottles (NDC 64380-116-02) 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 as a clear to slightly hazy liquid.
Frequently Asked Questions
What is Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate Oral used for?▼
1 INDICATIONS AND USAGE Sodium sulfate, potassium sulfate and magnesium sulfate oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adult and pediatric patients 12 years of age and older. Sodium sulfate, potassium sulfate and magnesium sulfate oral solution 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).
What are the side effects of Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate Oral?▼
6 ADVERSE REACTIONS Most common adverse reactions are: Adults (>2%): overall discomfort, abdominal distention, abdominal pain, nausea, and vomiting. (6.1) Pediatric Patients (>10%): nausea, abdominal pain, abdominal bloating and vomiting. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Strides Pharma Inc. at 1-877-244-9825 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Can I take Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate Oral during pregnancy?▼
8.1 Pregnancy Risk Summary There are no available data on sodium sulfate, potassium sulfate and magnesium sulfate oral solution 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 (sodium sulfate, potassium sulfate and magnesium sulfate oral solution). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
What are the important warnings for Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate Oral?▼
5 WARNINGS AND PRECAUTIONS Risk of fluid and electrolyte abnormalities : Encourage adequate hydration, assess concurrent medications, and consider laboratory assessments prior to and after each use. (5.1, 7.1) Cardiac arrhythmias : Consider pre-dose and post-colonoscopy ECGs in patients at increased risk. (5.2) Seizures : Use caution in patients with a history of seizures and patients at increased risk of seizures, including medications that lower the seizure threshold. (5.3, 7.1) Patients with renal impairment or taking concomitant medications that affect renal function : Use caution, ensure adequate hydration and consider laboratory testing. (5.4, 7.1) Suspected GI obstruction or perforation: Rule out the diagnosis before administration. 4 CONTRAINDICATIONS Sodium sulfate, potassium sulfate and magnesium sulfate oral solution 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 sodium sulfate, potassium sulfate an...
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.