Suclear

Do not use this medication if you have a perforated bowel, a bowel obstruction or severe constipation, or colitis or toxic megacolon. Polyethylene glycol electrolyte solution can cause dangerous or life-threatening side effects in people with these conditions.

Polyethylene glycol electrolyte solution is a powder medicine that must be mixed with water before using it. Follow all directions on your medicine label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Do not add any flavorings to this medicine, such as sugar, honey, artificial sweetener, fruit juices, or other beverages.

Do not take polyethylene glycol electrolyte solution if it has been less than 1 hour since you last ate solid food. For best results, take the medicine 2 to 4 hours after you last ate.

Store unmixed medicine at room temperature away from moisture and heat.

Store the mixed medicine in a refrigerator in an upright position.

Drink plenty of clear liquids (such as water, broth, black coffee, tea, clear soda) before, during, and after your treatment. Avoid foods and beverages that contain pulp or are red or purple in color. You may also eat popsicles (not fruit bars or fudge bars) or gelatin without fruit pieces or toppings.

This medicine comes with instructions about when and what to eat or drink on your first day of treatment. Each brand may have different instructions.

Shake the liquid well just before you measure a dose. Drink this medicine in the exact portions at the exact time intervals prescribed by your doctor.

The usual dose of the medication is 8 ounces every 10 to 15 minutes. Drink each portion as quickly as possible, rather than sipping it slowly. The first watery stool should appear within 1 hour after you start drinking polyethylene glycol electrolyte solution.

Polyethylene glycol electrolyte solution will produce watery diarrhea. Keep taking the medicine until your stool is watery and clear. In most cases, at least 3 liters of polyethylene glycol electrolyte solution is needed for the full effect.

Throw away any polyethylene glycol electrolyte solution you have not used within 24 to 48 hours after it was mixed (follow directions for your specific brand of this medicine).

Do not eat or drink anything within 2 hours before your medical test.

Other drugs may interact with polyethylene glycol electrolyte solution, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

• If you have an allergy to sodium, potassium, magnesium, polyethylene glycol, sulfates, or any other part of Suclear (sodium sulf/potassium sulf/mag sulf/polyethylene glycol-electrolyte soln).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Bowel block, enlarged colon, hole in the GI (gastrointestinal) tract, or slow-moving GI (gastrointestinal) tract.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Suclear with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• If you are not able to drink the solution.
• A fast heartbeat.
• Very bad belly pain.
• Very bad headache.
• Very bad bleeding from rectum or rectal pain.

Suclear is contraindicated in patients with the following:

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

Drugs That May Increase Risks Due to Fluid and Electrolyte Abnormalities

Certain medical conditions and concomitant medications may increase the risk for developing fluid and electrolyte disturbances or may increase the risk of seizure, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities when taking Suclear. This includes patients receiving drugs which may be associated with hypokalemia (such as diuretics or corticosteroids, or drugs where hypokalemia is a particular risk, such as cardiac glycosides) or hyponatremia. Use caution when Suclear is used in patients on nonsteroidal anti-inflammatory drugs (NSAIDS) or drugs known to induce Antidiuretic Hormone Secretion (SIADH), such as tricyclic antidepressants, selective serotonin re-uptake inhibitors, antipsychotic drugs and carbamazepine, as these drugs may increase the risk of water retention and/or electrolyte imbalance. Consider additional patient evaluations as appropriate [see Warnings and Precautions (5)].

Potential for Altered Drug Absorption

Oral medication administered within one hour of the start of each Suclear dose may be flushed from the gastrointestinal tract, and the medication may not be absorbed properly.

Stimulant Laxatives

Concurrent use of stimulant laxatives and Suclear may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking Suclear.

Mechanism of Action

The primary mode of action of Suclear is the osmotic effect of the unabsorbed polyethylene glycol (PEG) and sulfate salts. 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.

PEG is also a largely unabsorbed osmotic agent which causes water to be retained within the gastrointestinal tract.

Pharmacodynamics

The osmotic effect of the unabsorbed PEG or sulfate ions, when ingested, produces a copious watery diarrhea.

Pharmacokinetics

Oral sulfates: Following oral administration of oral sulfate solution, approximately 20% of dose undergoes systemic absorption, with the remainder of the dose excreted in feces. Renal elimination appears to be the predominant route of clearance for absorbed sulfate. After administration of Suclear (only the 6-oz bottle of sulfate salts) to six healthy volunteers, the time at which serum sulfate reached its highest point (Tmax) was approximately 5.5 hours after the first dose of sulfates. Serum sulfate levels declined with a half-life of 8.5 hours.

PEG3350: The pharmacokinetics of PEG3350 following administration of Suclear were not assessed. Available pharmacokinetic information for oral PEG3350 suggests that it is poorly absorbed, primarily excreted in feces, and, to the extent it is absorbed it is eliminated in urine.

Pharmacokinetic Studies in Patients with Hepatic Impairment or Renal Impairment

The disposition of sulfate after ingestion of one 6-oz bottle of the Suclear sulfate solution was studied in patients (N=6) with mild-moderate hepatic impairment [Child-Pugh grades A (n = 5) and B (n = 1)] and in patients (N=6) with moderate renal impairment (creatinine clearance of 30 to 49 mL/min). Following administration of one 6-oz dose of sulfates, the renal impairment group had the highest serum sulfate levels, followed by the hepatic impairment group, and then by healthy subjects. Renal impairment resulted in 43% higher mean Cmax than healthy subjects. Urinary excretion of sulfate over 30 hours in subjects who received two 6-oz doses of sulfates was similar between hepatic patients and normal volunteers, but was approximately 16% lower in moderate renal impairment patients than in healthy volunteers. The mean sulfate levels of all three groups returned to their respective baseline levels by Day 6 after dose initiation.

PK for PEG3350 at the recommended dose was not assessed in patients with organ impairment.

The colon cleansing efficacy of Suclear was evaluated in two randomized, single-blind (colonoscopist only), active-controlled, multicenter studies (Studies 1 and 2) in patients scheduled to undergo an elective colonoscopy. A total of 737 adult patients were included in the efficacy analysis: 366 from Study 1 and 371 from Study 2. Patients ranged in age from 21 to 86 years (mean age 57 years), and 54% were female. Self-identified race distribution was as follows: 82% White, 10% Black, and 8% other.

Patients randomized to Suclear in the two studies were treated with one of two dosing regimens:

• In Study 1, Suclear was given by “Day-Before” (evening before) dosing, where both doses were taken sequentially on the day before the colonoscopy, with the first dose taken at approximately 6:00 PM, followed by one 16-oz container (provided with the kit) of water, and the second dose taken 2 hours after starting the first dose. Patients were recommended to drink at least one additional 16-oz container of water on the evening prior to colonoscopy.
  
  The comparator for Study 1 was a preparation containing two liters of PEG plus electrolytes (sodium chloride, sodium bicarbonate, and potassium chloride) for oral solution and two 5-mg bisacodyl tablets, administered the day before the procedure. All patients in both the Suclear and comparator group were limited to a clear liquid diet on the day before the procedure until after completion of the colonoscopy.
  
• In Study 2, Suclear was given by “Split-Dose” (evening before and day of) dosing, where the first dose was taken the evening before the colonoscopy (at approximately 6:00 PM), followed by one 16-oz container of water (with a recommendation to drink at least one additional 16-oz container of water on the evening prior to colonoscopy), and the second dose was taken the morning of the colonoscopy (at approximately 6:00 AM). The second dose had to be completed at least 2 hours prior to colonoscopy. Patients in the Suclear group were limited to a clear liquid diet on the day before the procedure until after completion of the colonoscopy.
  
  The comparator for Study 2 was a preparation containing two liters of PEG plus electrolytes (sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid) for oral solution, administered as split doses. Patients receiving Suclear were limited to a clear liquid diet on the day before the procedure until completion of the colonoscopy. Patients receiving the comparator were allowed to have a normal breakfast, a light lunch, clear soup and/or plain yogurt for dinner the day prior to colonoscopy. They were limited to a clear liquid diet from the time the preparation was started until after completion of the colonoscopy.

The primary efficacy endpoint in both studies was the proportion of patients with successful colon cleansing as assessed by the colonoscopists, who were not informed about the type of preparation received. Successful colon cleansing was defined as bowel preparations that were graded excellent (no more than small bits of adherent feces/fluid) or good (small amounts of feces or fluid not interfering with the exam) by the colonoscopist. Failed colon cleansing was defined as bowel preparations that were graded fair (enough feces or fluid to prevent a completely reliable exam) or poor (large amounts of fecal residue, additional cleansing required). The proportion of patients with successful colon cleansing was numerically similar between treatment groups for both studies. See Tables 3 and 4.

See FDA-Approved Patient Labeling (Medication Guide).

• Ask patients if they have trouble swallowing or are prone to regurgitation or aspiration. Patients with impaired gag reflex and patients prone to regurgitation or aspiration should be observed during administration of Suclear solution.
• Instruct patients that each bottle needs to be diluted in water before ingestion and that they need to drink additional water according to the instructions. Direct ingestion of the undiluted solution may increase the risk of nausea, vomiting, and dehydration.
• Inform patients that oral medications may not be absorbed properly if they are taken within one hour of starting each dose of Suclear.
• Tell patients not to take other laxatives while they are taking Suclear.

Distributed by Braintree Laboratories, Inc. Braintree, MA 02185

Medication Guide

SuclearTM (Soo-kleer)

(sodium sulfate, potassium sulfate and magnesium sulfate oral solution; and PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution)

Read this Medication Guide before you start taking Suclear. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about Suclear?

Suclear can cause serious side effects, including:

Serious loss of body fluid (dehydration) and changes in blood salts (electrolytes) in your blood. These changes can cause:

• abnormal heartbeats that can cause death
• seizures. This can happen even if you have never had a seizure.
• kidney problems

Your risk of having fluid loss and changes in blood salts with Suclear is higher if you:

• have heart problems
• have kidney problems
• take water pills (diuretics) or non-steroidal anti-inflammatory drugs (NSAIDS)

Tell your healthcare provider right away if you have any of these symptoms of a loss of too much body fluid (dehydration) while taking Suclear:

• vomiting that prevents you from keeping down the additional prescribed amount of water listed in the Instructions for Use in the “Patient Instructions for Use” booklet
• dizziness
• urinating less often than normal
• headache

See “What are the possible side effects of Suclear?” for more information about side effects.

What is Suclear?

Suclear is a prescription medicine used by adults to clean the colon before a colonoscopy. Suclear cleans your colon by causing you to have diarrhea. Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy.

It is not known if Suclear is safe and effective in children.

Who should not take Suclear?

Do not take Suclear if your healthcare provider has told you that you have:

• a blockage in your intestine (bowel obstruction)
• an opening in the wall of your stomach or intestine (bowel perforation)
• problems with food and fluid emptying from your stomach (gastric retention)
• a very dilated intestine (toxic megacolon)
• an allergy to any of the ingredients in Suclear. See the end of this leaflet for a complete list of ingredients in Suclear.

What should I tell my healthcare provider before taking Suclear?

Before you take Suclear, tell your healthcare provider if you:

• have heart problems
• have a history of seizures
• have kidney problems
• have ulcerative colitis
• have stomach or bowel problems
• have problems with swallowing or gastric reflux
• have gout
• are withdrawing from drinking alcohol
• have a low blood salt (sodium) level
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if Suclear will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Suclear passes into your breast milk. You and your healthcare provider should decide if you will take Suclear while breastfeeding.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Suclear may affect how other medicines work. Medicines taken by mouth may not be absorbed properly when taken within 1 hour before the start of each dose of Suclear.

Especially tell your healthcare provider if you take:

• medicines for blood pressure or heart problems
• medicines for kidney problems
• medicines for seizures
• water pills (diuretics)
• non-steroidal anti-inflammatory medicines (NSAID) pain medicine s
• laxatives
• medicines for depression or mental health problems

Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure if you are taking any of the medicines listed above.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take Suclear?

See the Instructions for Use in the “Patient Instructions for Use” booklet for dosing instructions. You must read, understand, and follow these instructions to take Suclear the right way.

• Take Suclear exactly as your healthcare provider tells you to take it. Your healthcare provider will prescribe the Split-Dosing option or the Day-Before Dosing option, depending on the scheduling of your colonoscopy.
• Suclear comes in a kit. The contents of each bottle in the Suclear Kit must be mixed with water (diluted) before drinking. Do not take Suclear oral solution or powder that has not been mixed with water, it may increase your risk of nausea, vomiting, and fluid loss (dehydration). It is important for you to drink the additional prescribed amount of water listed in the Instructions for Use to help prevent fluid loss (dehydration).
• Do not take other laxatives while taking Suclear.
• Do not eat solid foods or drink milk or alcohol on the day before your colonoscopy and until after your colonoscopy. Drink only clear liquids:
  • the day before your colonoscopy
  • while taking Suclear
  • after taking Suclear until 2 hours before your colonoscopy.

  Do not eat or drink anything 2 hours before your colonoscopy.

• Drink clear liquids before, during, and after you take Suclear to avoid fluid loss (dehydrated). Examples of clear liquids are:
  • water
  • clear fruit juices without pulp including apple, white grape, or white cranberry
  • strained limeade or lemonade
  • coffee or tea (Do not use any dairy or non-dairy creamer)
  • clear broth
  • clear soda
  • gelatin (without added fruit or topping)
  • popsicles without pieces of fruit or fruit pulp

Do not eat or drink anything colored red or purple.

What are the possible side effects of Suclear?

Suclear can cause serious side effects, including:

• See “What is the most important information I should know about Suclear?”
• changes in certain blood tests. Your healthcare provider may do blood tests after you take Suclear to check your blood for changes. Tell your healthcare provider if you have any symptoms of too much fluid loss, including:
  • vomiting
  • nausea
  • bloating
  • dizziness
  • stomach (abdominal) cramping
  • headache
  • urinate less than usual
  • trouble drinking clear liquid
• ulcers of the bowel or bowel problems (ischemic colitis). Tell your healthcare provider right away if you have severe stomach-area (abdomen) pain or rectal bleeding.

The most common side effects of Suclear include:

• discomfort
• stomach-area (abdomen) bloating, pain, and tenderness
• nausea
• vomiting
• headache

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Suclear. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Suclear?

• Store Suclear at room temperature, between 68ºF to 77°F (20ºC to 25°C).

Keep Suclear and all medicines out of the reach of children.

General information about the safe and effective use of Suclear.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Suclear for a condition for which it was not prescribed. Do not give Suclear to other people, even if they are going to have the same procedure you are. It may harm them.

This Medication Guide summarizes the most important information about Suclear. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Suclear that is written for health professionals.

For more information, go to www.braintreelabs.com or call 1-800-874-6756.

What are the ingredients in Suclear?

Active ingredients:

Oral solution: sodium sulfate, potassium sulfate, and magnesium sulfate.

Powder for solution: polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride.

Inactive ingredients:

Oral solution: sodium benzoate, sucralose, malic acid, citric acid, flavoring ingredients, purified water.

Powder for solution: Cherry, Lemon-Lime, Orange and Pineapple flavor packs.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Braintree Laboratories, Inc.

Braintree, MA 02185, USA

Issued: 01/2013

Principal Display Panel – Dose 1 6oz Bottle Label

NDC #52268-902-01 For use with Suclear™ kit only

DOSE 1
(sodium sulfate, potassium sulfate,
magnesium sulfate) Oral Solution
(17.5g/3.13g/1.6g)

Dispense the enclosed Medication Guide to each patient.
This bottle contains 6 ounces (177 mL) of liquid bowel prep.
See complete instructions in the enclosed booklet or on the box
before using.

DIRECTIONS:

Dilute the solution concentration prior to use.
See enclosed booklet for complete dosage
and administration instructions.

Keep this and other drugs out of
reach of children. Store at 25°C
(77°F); excursions permitted to
15-30°C (59-86°F).

Distributed by Braintree Laboratories, Braintree, MA Rx only Rev January, 2013

Principal Display Panel – Dose 2 2L Bottle Label

NDC #52268-903-01

For use with Suclear™ kit only

DOSE 2
(PEG-3350, sodium chloride, sodium bicarbonate
and potassium chloride) for Oral Solution
Dispense the enclosed Medication Guide to each patient.
See complete instructions in the enclosed booklet or on the box
before using.

DIRECTIONS: add 1 flavor pack. Add drinking water to the top
of the fill line on the bottle. Shake. Drink one (16-oz) glass of solution
every 20 minutes. Drink all the solution.

Distributed by Braintree Laboratories, Braintree, MA Rx only Rev January, 2013

Principal Display Panel – Flavor Packs Labels

Pineapple

FLAVOR
PACK

For use with Suclear only.

Net Wt. 1.0 g Rev. 1/13

Lemon-
Lime

FLAVOR
PACK

For use with Suclear only.

Net Wt. 1.0 g Rev. 1/13

Orange

FLAVOR
PACK

For use with Suclear only.

Net Wt. 1.0 g Rev. 1/13

Cherry

FLAVOR
PACK

For use with Suclear only.

Net Wt. 1.0 g Rev. 1/13

Principal Display Panel - Carton Label

NDC #52268-901-01

Dispense the enclosed Medication Guide to each patient.

SuclearTM

(sodium sulfate, potassium sulfate, and magnesium sulfate oral solution; and PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution)

THIS CARTON CONTAINS:

Full Prescribing Information and one Patient Instruction Booklet with the Medication Guide

DOSE 1

One 6-ounce (177 mL) bottle of sodium sulfate 17.5 g, potassium sulfate 3.13 g, and magnesium sulfate 1.6 g Oral Solution

One 16-ounce mixing cup

DOSE 2
One 2-liter bottle of PEG-3350 210 g, sodium bicarbonate 2.86 g, sodium chloride 5.6 g, and potassium chloride 0.74 g for Oral Solution

DILUTE AS DIRECTED PRIOR TO USE
NOTE: both doses are required for a complete prep.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).

Rev January, 2013

Rx only

Braintree LABORATORIES INC