FDA

Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate

Approved 23 Feb 2017OralSolution

The FDA lists this product in 7 strengths and forms.

Indications

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 ) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is indicated for cleansing of the colon as a preparation for colonoscopy in adults.

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 ) Gastrointestinal obstruction Bowel perforation Gastric retention Ileus Toxic colitis or toxic megacolon Known allergies to components of the kit [see Description (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 perforation – rule out the diagnosis before administration ( 4 , 5.6 ) Patients at risk for aspiration – observe during administration ( 5.7 ) Not for direct ingestion – dilute and take with additional water ( 5.8 )

5.1Serious Fluid and Serum Chemistry Abnormalities

Advise all patients to hydrate adequately before, during, and after the use of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. If a patient develops significant vomiting or signs of dehydration after taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN). Fluid and electrolyte disturbances can lead to serious adverse events including cardiac arrhythmias, seizures and renal impairment.

Patients with electrolyte abnormalities should have them corrected before treatment with Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. In addition, use caution when prescribing Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution for patients with conditions, or who are using medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and renal impairment. [See Drug Interactions (7.1)] Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution can cause temporary elevations in uric acid. [See Adverse Reactions (6.1) ].

Indications

Contraindications

Warnings and precautions

5.1Serious Fluid and Serum Chemistry Abnormalities

Adverse reactions

Most common adverse reactions (≥3%) are: overall discomfort, abdominal fullness, nausea, abdominal cramping, and vomiting ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Novel Laboratories, Inc. at 866-403-7592 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in clinical studies of another drug and may not reflect the rates observed in practice. In a multicenter, controlled clinical trial comparing Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution with a bowel prep containing polyethylene glycol and electrolytes (PEG + E) that were administered in a split-dose (2-day) regimen, the most common adverse reactions after administration of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution were overall discomfort, abdominal distention, abdominal pain, nausea, vomiting, and headache; see Table 1, below.

Less common Adverse Reactions occurring were AV Block (1 case) and CK increase. In this study, patients receiving Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution were limited to a light breakfast followed by clear liquids; patients receiving the PEG + E bowel prep were allowed to have a normal breakfast and a light lunch, followed by clear liquids. Table 1: Treatment-Emergent Adverse Reactions Observed in at Least 2% of Patients on the Split-Dose (2-Day) Regimen Symptom Split-Dose (2-Day) Regimen Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution N=190 PEG + E Product N=189 Overall Discomfort 54% 67% Abdominal Distension 40% 52% Abdominal Pain 36% 43% Nausea 36% 33% Vomiting 8% 4% Headache 1.1% 0.5% Table 2 shows the percentages of patients who developed new abnormalities of important electrolytes and uric acid after completing the bowel preparation with either Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution or PEG+E administered as a split-dose (2-day) regimen.

Table 2: Patients with Normal Baseline Serum Chemistry with A Shift to an Abnormal Value While on the Split-Dose (2-Day) Regimen Day of Colonoscopy n (%)* Day 30n (%)* Anion gap (high) † Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 14 (8.9) 3 (1.9) PEG + Electrolytes 12 (7.6) 2 (1.4) Bicarbonate (low) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 20 (12.7) 7 (4.4) PEG + Electrolytes 24 (15.2) 4 (2.7) Bilirubin, total (high) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 14 (8.5) 0 (0) PEG + Electrolytes 20 (11.7) 3 (1.9) BUN (high) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 2 (1.6) 14 (11.2) PEG + Electrolytes 4 (2.9) 19 (14.5) Calcium (high) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 16 (10.4) 8 (5.2) PEG + Electrolytes 6 (3.7) 6 (3.9) Chloride (high) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 4 (2.4) 6 (3.7) PEG + Electrolytes 20 (12.2) 6 (3.8) Creatinine (high) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 3 (1.9) 5 (3.2) PEG + Electrolytes 2 (1.2) 8 (5.2) Osmolality (high) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 8 (5.8) NA PEG + Electrolytes 19 (12.9) NA Osmolality (low) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 3 (2.2) NA PEG + Electrolytes 2 (1.4) NA Potassium (high) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 3 (1.8) 6 (3.7) PEG + Electrolytes 5 (2.9) 8 (4.9) Sodium (low) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 5 (3.1) 1 (0.6) PEG + Electrolytes 4 (2.3) 2 (1.2) Uric acid (high) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 27 (23.5) 13 (11.5) PEG + Electrolytes 12 (9.5) 20 (16.7) There were also 408 patients who participated in a study in which either Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution or PEG+E were administered in an evening-only (1-day) regimen.

Higher rates of overall discomfort, abdominal distention, and nausea were observed with the evening-only (1-day) regimen compared to the split-dose (2-day) regimen for both preparations. Patients treated with Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution had increased rates of vomiting with the evening-only (1-day) regimen. An evening-only (1-day) dosing regimen was associated with higher rates of abnormal values for some electrolytes when compared to the split-dose (2-day) regimen for both preparations.

For Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution, the evening-only (1-day) regimen was associated with higher rates of total bilirubin (high), BUN (high), creatinine (high), osmolality (high), potassium (high) and uric acid (high) than the Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution split dose (2-day) regimen. Administration of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution in an evening-only (1-day) dosing regimen is not recommended.

Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate

Indications

Contraindications

Warnings and precautions

5.1Serious Fluid and Serum Chemistry Abnormalities

Two medicines in one question?

Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate

Indications

Contraindications

Warnings and precautions

5.1Serious Fluid and Serum Chemistry Abnormalities

Two medicines in one question?

5.2Cardiac Arrhythmias

5.3Seizures

5.4Renal Impairment

5.5Colonic Mucosal Ulcerations and Ischemic Colitis Administration

5.6Use in Patients with Significant Gastrointestinal Disease

5.7Aspiration Use

5.8Not for Direct Ingestion

Interactions

7.1Drugs That May Increase Risks Due to Fluid and Electrolyte Abnormalities

7.2Potential for Altered Drug Absorption

Pregnancy and breastfeeding

8.1Pregnancy

Adverse reactions

6.1Clinical Studies Experience

Composition

Strengths and forms

Official product information

At a glance