SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE

SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE- sodium sulfate, potassium sulfate and magnesium sulfate anhydrous solution
Novel Laboratories, Inc.

1 INDICATIONS & USAGE

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

2 DOSAGE & ADMINISTRATION

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.

3 DOSAGE FORMS & STRENGTHS

• Two 6 ounce bottles of oral solution.

Each 6 ounce bottle contains: sodium sulfate 17.5 grams, potassium sulfate 3.13 grams, magnesium sulfate 1.6 grams.

4 CONTRAINDICATIONS

  • Gastrointestinal obstruction
  • Bowel perforation
  • Gastric retention
  • Ileus
  • Toxic colitis or toxic megacolon
  • Known allergies to components of the kit [see Description (11)]

5 WARNINGS AND PRECAUTIONS

5.1 Serious 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)]. Uric acid fluctuations in patients with gout may precipitate an acute flare. The potential for uric acid elevation should be considered before administering Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution to patients with gout or other disorders of uric acid metabolism.

5.2 Cardiac Arrhythmias

There have been rare reports of serious arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation. Use caution when prescribing Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution for patients at increased risk of arrhythmias (e.g., patients with a history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy). Pre-dose and post-colonoscopy ECGs should be considered in patients at increased risk of serious cardiac arrhythmias.

5.3 Seizures

There have been reports of generalized tonic-clonic seizures and/or loss of consciousness associated with use of bowel preparation products in patients with no prior history of seizures. The seizure cases were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia) and low serum osmolality. The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities.

Use caution when prescribing Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution for patients with a history of seizures and in patients at increased risk of seizure, such as patients taking medications that lower the seizure threshold (e.g., tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia.

5.4 Renal Impairment

Use caution when prescribing Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution for patients with impaired renal function or patients taking concomitant medications that may affect renal function (such as diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal anti-inflammatory drugs). Advise these patients of the importance of adequate hydration, and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients.

5.5 Colonic Mucosal Ulcerations and Ischemic Colitis

Administration of osmotic laxative products may produce colonic mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Concurrent use of stimulant laxatives and Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution may increase these risks. The potential for mucosal ulcerations resulting from the bowel preparation should be considered when interpreting colonoscopy findings in patients with known or suspect inflammatory bowel disease (IBD).

5.6 Use in Patients with Significant Gastrointestinal Disease

If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution.

Use with caution in patients with severe active ulcerative colitis.

5.7 Aspiration

Use with caution in patients with impaired gag reflex and patients prone to regurgitation or aspiration. Such patients should be observed during administration of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution.

5.8 Not for Direct Ingestion

Each bottle must be diluted with water to a final volume of 16 ounces and ingestion of additional water as recommended is important to patient tolerance. Direct ingestion of the undiluted solution may increase the risk of nausea, vomiting, dehydration, and electrolyte disturbances.

6 ADVERSE REACTIONS

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 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.

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