Suprep Bowel Prep

Suprep Bowel Prep Kit should be taken as a split-dose oral regimen.

The dose for colon cleansing requires administration of two bottles of Suprep Bowel Prep Kit. Each bottle is administered as 16 ounces of diluted SUPREP 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 Suprep Bowel Prep Kit 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 Suprep Bowel Prep Kit 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 Suprep Bowel Prep Kit and required water at least two hours prior to colonoscopy or as directed by physician.

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.

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 Suprep Bowel Prep Kit 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 Suprep Bowel Prep Kit 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 Suprep Bowel Prep Kit 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 2 shows the percentages of patients who developed new abnormalities of important electrolytes and uric acid after completing the bowel preparation with either Suprep Bowel Prep Kit or PEG+E administered as a split-dose (2-day) regimen.

There were also 408 patients who participated in a study in which either Suprep Bowel Prep Kit 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 Suprep Bowel Prep Kit 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 Suprep Bowel Prep Kit, 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 Suprep Bowel Prep Kit split-dose (2-day) regimen. Administration of Suprep Bowel Prep Kit in an evening-only (1-day) dosing regimen is not recommended.

Mechanism of Action

Sulfate salts provide sulfate anions, which are poorly absorbed. The osmotic effect of unabsorbed sulfate anions and the associated cations causes water to be retained within the gastrointestinal tract.

Pharmacodynamics

The osmotic effect of the unabsorbed ions, when ingested with a large volume of water, produces a copious watery diarrhea.

Pharmacokinetics

Fecal excretion was the primary route of sulfate elimination. After administration of Suprep Bowel Prep Kit in six healthy volunteers, the time at which serum sulfate reached its highest point (Tmax) was approximately 17 hours after the first half dose or approximately 5 hours after the second dose, and then declined with a half-life of 8.5 hours.

The disposition of sulfate after Suprep Bowel Prep Kit was also studied in patients (N=6) with mild-moderate hepatic impairment (Child-Pugh grades A and B) and in patients (N=6) with moderate renal impairment (creatinine clearance of 30 to 49 mL/min). The renal impairment group had the highest serum sulfate AUC and Cmax, followed by the hepatic impairment group, and then by healthy subjects. Systemic exposure of serum sulfate (AUC and Cmax) was similar between healthy subjects and hepatic impairment patients. Renal impairment resulted in 54% higher mean AUC and 44% higher mean Cmax than healthy subjects. The mean sulfate levels of all three groups returned to their respective baseline levels by Day 6 after dose initiation. Urinary excretion of sulfate over 30 hours, starting after the first half dose, was similar between hepatic patients and normal volunteers, but was approximately 16% lower in moderate renal impairment patients than in healthy volunteers.

The colon cleansing efficacy of Suprep Bowel Prep Kit was evaluated in a randomized, single-blind, active-controlled, multicenter study. In this study, 363 adult patients were included in the efficacy analysis. Patients ranged in age from 20 to 84 years (mean age 55 years) and 54% were female. Race distribution was 86% Caucasian, 9% African-American, and 5% other.

Patients were randomized to one of the following two colon preparation regimens: Suprep Bowel Prep Kit or a marketed polyethylene glycol (PEG) bowel prep. In the Study Suprep Bowel Prep Kit was administered according to a split-dose preparation regimen [see Dosage and Administration (2.1)]. The PEG bowel prep was also given as a split-dose preparation according to its labeled instructions. Patients receiving Suprep Bowel Prep Kit were limited to a light breakfast followed by clear liquids on the day prior to the day of colonoscopy; patients receiving the PEG bowel prep were allowed to have a normal breakfast and a light lunch, followed by clear liquids.

The primary efficacy endpoint was the proportion of patients with successful colon cleansing as assessed by the colonoscopists, who were not informed about the type of preparation received. In the study, no clinically or statistically significant differences were seen between the group treated with Suprep Bowel Prep Kit and the group treated with the PEG bowel prep. See Table 3 below.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Get emergency medical help if you have signs of an allergic reaction to Suprep: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• headache, dizziness, vomiting, little or no urinating;

• bloating, stomach cramps, trouble swallowing liquids;

• fast, slow, or uneven heart rate;

• fever, sudden or severe stomach pain, rectal bleeding or bright red bowel movements;

• seizure (blackout or convulsions); or

• no bowel movement after use.

Common Suprep side effects may include:

• nausea;

• vomiting; or

• bloating or mild stomach discomfort.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• heart or blood pressure medication;

• seizure medicine;

• medicine to treat kidney problems;

• a diuretic or "water pill";

• other laxatives; or

• NSAIDs (nonsteroidal anti-inflammatory drugs) - aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may interact with magnesium, potassium, and sodium sulfates, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.