Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate

Description

11 DESCRIPTION Each Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution contains two 6 ounce bottles of solution. Each 6 ounce bottle contains: sodium sulfate 17.5 grams, potassium sulfate 3.13 grams, magnesium sulfate 1.6 grams. Inactive ingredients include: sodium benzoate, sucralose, malic acid, citric acid, lemon flavor, purified water. The solution is a clear to slightly hazy liquid. The solution is clear and colorless when diluted to a final volume of 16 ounces with water. Sodium Sulfate, USP The chemical name is Na 2 SO 4 . The average Molecular Weight is 142.04. The structural formula is: Potassium Sulfate, FCC, Granular The chemical name is K 2 SO 4 . The average Molecular Weight is 174.26. The structural formula is: Magnesium Sulfate, USP The chemical name is MgSO 4 . The average Molecular Weight: 120.37. The structural formula is: Each Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution package also contains a polypropylene mixing container. Structural Formula Figure 39b225fe-figure-03

What Is Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate Used For?

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

Dosage and Administration

2 DOSAGE & 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. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution should be taken as a split-dose oral regimen. The dose for colon cleansing requires administration of two bottles of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. Each bottle is administered as 16 ounces of diluted Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution with an additional 1 quart of water taken orally. The total volume of liquid required for colon cleansing (using two bottles) is 3 quarts (approximately 2.8 L) taken orally prior to the colonoscopy in the following way: Split-Dose (Two-Day) Regimen Day prior to colonoscopy: A light breakfast may be consumed, or have only clear liquids on the day before colonoscopy. Avoid red and purple liquids, milk, and alcoholic beverages. Early in the evening prior to colonoscopy: pour the contents of one bottle of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution into the mixing container provided. Fill the container with water to the 16 ounce fill line, and drink the entire amount. Drink two additional containers filled to the 16 ounce line with water over the next hour. Day of colonoscopy: Have only clear liquids until after the colonoscopy. Avoid red and purple liquids, milk, and alcoholic beverages. The morning of colonoscopy (10 to 12 hours after the evening dose): pour the contents of the second bottle of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution into the mixing container provided. Fill the container with water to the 16 ounce fill line, and drink the entire amount. Drink two additional containers filled to the 16 ounce line with water over the next hour. Complete all Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution and required water at least two hours prior to colonoscopy or as directed by physician.

Side Effects (Adverse Reactions)

6 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. 6.1 Clinical 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...

Drug Interactions

7 DRUG INTERACTIONS Some drugs increase risks due to fluid and electrolyte changes ( 7.1 ) Oral medication taken within 1 hour of start of each dose might not be absorbed properly ( 7.2 ) 7.1 Drugs That May Increase Risks Due to Fluid and Electrolyte Abnormalities 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 prolonged QT in the setting of fluid and electrolyte abnormalities. Consider additional patient evaluations as appropriate [see Warnings (5) ] in patients taking these concomitant medications. 7.2 Potential for Altered Drug Absorption Oral medication administered within one hour of the start of each Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution dose may be flushed from the gastrointestinal tract, and the medication may not be absorbed properly.

Contraindications

4 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) ]

Pregnancy and Breastfeeding

8.1 Pregnancy 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.

8.3 Nursing Mothers 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 Sulfate Oral Solution is administered to a nursing woman.

How Supplied

16 HOW SUPPLIED/STORAGE AND HANDLING Each Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution contains: