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Important Safety Information | Full Prescribing Information / Medication Guide
Important Safety Information | Full Prescribing Information / Medication Guide
SUFLAVE has a lemon-lime flavor.1

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BOWEL PREPARATION

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SUFLAVE
Patient Preference

Study Design1,2: This phase 3 trial was conducted in multiple sites. Of the 500 subjects who enrolled, 450 were evaluable for efficacy analyses. The primary endpoint was the percentage of subjects with successful cleansing, which was defined as a rating of excellent or good as assigned by the local endoscopist utilizing the US FDA Bowel Prep Scoring Scale. Independent central readers also reviewed all colonoscopy videos and provided a global cleansing grade, as well as segmental grades, on insertion and withdrawal using a 4-point scale of excellent, good, fair, and poor. The goal of the study was to establish non-inferiority of SUFLAVE to SUPREP Bowel Prep Kit, using a 10% non-inferiority margin. Most common adverse reactions (≥2%) are: nausea, abdominal distension, vomiting, abdominal pain and headache.

*Success was defined as an overall cleansing assessment of excellent or good by the blinded endoscopist; scores were assigned following completion of the colonoscopy;
P<0.001 in this non-inferiority clinical trial.
IMPORTANT SAFETY INFORMATION
SUFLAVE IMPORTANT SAFETY INFORMATION

SUFLAVE® (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution)

Indications and Usage

SUFLAVE is indicated for the cleansing of the colon as a preparation for colonoscopy in adults.

ADDITIONAL IMPORTANT SAFETY INFORMATION

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

SUFLAVE and other bowel preparations can cause serious side effects, including:
Serious loss of body fluid (dehydration) and changes in body 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.

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

  • a blockage in your bowel (obstruction) or a problem with food moving too slowly through your intestines (ileus).
  • an opening in the wall of your stomach or intestine (bowel perforation).
  • a very dilated intestine (toxic colitis or toxic megacolon).
  • problems with food and fluid emptying from your stomach (gastric retention).
  • allergies to any ingredient in SUFLAVE.

What are the possible side effects of SUFLAVE?

SUFLAVE can cause serious side effects, including:
  • Changes in certain blood tests. Your healthcare provider may do blood tests after you take SUFLAVE to check your blood for changes. Tell your healthcare provider if you have any symptoms of too much fluid loss, including:
  1. vomiting
  2. dizziness
  3. urinate less than usual
  1. nausea
  2. stomach (abdominal) cramping
  3. trouble drinking clear liquid
  1. bloating
  2. headache
  1. vomiting
  2. dizziness
  3. urinate less than usual
  4. nausea
  5. stomach (abdominal) cramping
  6. trouble drinking clear liquid
  7. bloating
  8. headache
  • Heart problems. SUFLAVE may cause abnormal heartbeats.
  • Seizures.
  • Ulcers of the bowel or bowel problems (ischemic colitis). Tell your healthcare provider right away if you have severe stomach-area (abdominal) pain or rectal bleeding.
  • Serious allergic reactions. Get medical help right away if you have any signs and symptoms of a serious allergic reaction while taking SUFLAVE, including:
  1. difficulty breathing
  2. swelling of the face, lips, tongue and throat
  3. raised red patches on your skin (hives)
  1. skin rash
  2. itching
  1. difficulty breathing
  2. swelling of the face, lips, tongue and throat
  3. raised red patches on your skin (hives)
  4. skin rash
  5. itching

Before taking SUFLAVE, tell your healthcare provider about all of your medical conditions, including if you:

  • have problems with serious loss of body fluid (dehydration) and changes in blood salts (electrolytes).
  • have heart problems.
  • have stomach or bowel problems including ulcerative colitis.
  • have problems with swallowing or gastric reflux, or if you inhale food or fluid into your lungs when eating or drinking (aspirate).
  • have a history of seizures.
  • are withdrawing from drinking alcohol or from taking benzodiazepines.
  • have a low blood salt (sodium) level.
  • have kidney problems.
  • are pregnant. It is not known if SUFLAVE will harm your unborn baby. Talk to your healthcare provider if you are pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if SUFLAVE passes into your breast milk. You and your healthcare provider should decide if you will take SUFLAVE while breastfeeding.

Tell your healthcare provider about all the medicines you take, including

  • Prescription and over-the-counter medicines, vitamins, and herbal supplements.
  • SUFLAVE 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 SUFLAVE.
  • Especially tell your healthcare provider if you take: medicines to treat a blood salt (electrolyte) imbalance, medicines for blood pressure, heart problems, kidney problems, or seizures, water pills (diuretics), non-steroidal anti-inflammatory drugs (NSAIDs), medicines for depression or other mental health problems, and laxatives. Do not take other laxatives while taking SUFLAVE
  • starch-based thickeners. For patients who have trouble swallowing, do not mix SUFLAVE with starch-based thickeners.

The following medicines should be taken at least 2 hours before starting each dose of SUFLAVE and not less than 6 hours after taking each dose of SUFLAVE:

  1. tetracycline
  2. fluoroquinolone antibiotics
  1. iron
  2. digoxin
  1. chlorpromazine
  2. penicillamine
  1. tetracycline
  2. fluoroquinolone antibiotics
  3. iron
  4. digoxin
  5. chlorpromazine
  6. penicillamine

The most common side effects of SUFLAVE include:

  • nausea
  • stomach-area swelling (abdominal distension)
  • Vomiting
  • Upper stomach (abdominal) pain
  • nausea
  • stomach-area swelling (abdominal distension)
  • Vomiting
  • Upper stomach (abdominal) pain

These are not all the possible side effects of SUFLAVE.

The Important Safety Information does not include all the information needed to use SUFLAVE safely and effectively. Please see accompanying full Prescribing Information for SUFLAVE.

To Report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.

SUFLAVE® is a registered trademark of Azurity Pharmaceuticals, Inc.

PP-SUF-7061-US-EN-v1 03/26

View the Full Prescribing Information and Medication Guide.

References:
1. SUFLAVE [package insert]. Woburn, MA: Azurity Pharmaceuticals, Inc. 2. Bhandari R, Goldstein M, Mishkin DS, et al. Comparison of a novel, flavor-optimized, polyethylene glycol and sulfate bowel preparation with oral sulfate solution in adults undergoing colonoscopy. J Clin Gastroenterol. 2023;57(9):920-927. doi:10.1097/MCG.0000000000001894 3. Data on file. Woburn, MA: Azurity Pharmaceuticals, Inc.

SUTAB IMPORTANT SAFETY INFORMATION

SUTAB® (sodium sulfate, magnesium sulfate, and potassium chloride) tablets, for oral use

Indications and Usage

SUTAB is indicated for the cleansing of the colon as a preparation for colonoscopy in adults.

ADDITIONAL IMPORTANT SAFETY INFORMATION

What is the most important information I should know about SUTAB?
SUTAB and other bowel preparations can cause serious side effects, including:
Serious loss of body fluid (dehydration) and changes in body 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.

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

  • a blockage in your bowel (obstruction) or a problem with food moving too slowly through your intestines (ileus).
  • an opening in the wall of your stomach or intestine (bowel perforation).
  • a very dilated intestine (toxic colitis or toxic megacolon).
  • problems with food and fluid emptying from your stomach (gastric retention).
  • allergies to any ingredient in SUTAB.

What are the possible side effects of SUTAB?

SUTAB can cause serious side effects, including:
  • Changes in certain blood tests. Your healthcare provider may do blood tests after you take SUTAB to check your blood for changes. Tell your healthcare provider if you have any symptoms of too much fluid loss, including:
  1. vomiting
  2. dizziness
  3. urinate less than usual
  1. nausea
  2. stomach (abdominal) cramping
  3. trouble drinking clear liquid
  1. bloating
  2. headache
  1. vomiting
  2. dizziness
  3. urinate less than usual
  4. nausea
  5. stomach (abdominal) cramping
  6. trouble drinking clear liquid
  7. bloating
  8. headache
  • Heart problems. SUTAB may cause abnormal heartbeats.
  • Seizures.
  • Ulcers of the bowel or bowel problems (ischemic colitis). Tell your healthcare provider right away if you have severe stomach-area (abdominal) pain or rectal bleeding.
  • Serious allergic reactions. Get medical help right away if you have any signs and symptoms of a serious allergic reaction while taking SUTAB, including:
  1. swelling of your hands, face lips, mouth or tongue
  2. breathing problems
  3. raised red patches on your skin
  1. rash
  2. severe itching
  1. swelling of your hands, face lips, mouth or tongue
  2. breathing problems
  3. raised red patches on your skin
  4. rash
  5. severe itching
  • Take SUTAB exactly as your healthcare provider tells you. Each SUTAB bottle contains a drying agent (desiccant) to keep the tablets dry. Do not swallow the desiccant. Remove and throw away the desiccant from both bottles the evening before your colonoscopy. Swallowing the desiccant by mistake has been reported and may cause choking or stomach and bowel problems.

Before taking SUTAB, tell your healthcare provider about all of your medical conditions, including if you:

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

Tell your healthcare provider about all the medicines you take, including

  • Prescription and over-the-counter medicines, vitamins, and herbal supplements.
  • SUTAB 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 SUTAB.
  • Especially tell your healthcare provider if you take: medicines for blood pressure or heart problems, kidney problems, or seizures, water pills (diuretics), non-steroidal anti-inflammatory drugs (NSAIDs), medicines for depression or other mental health problems, and laxatives. Do not take other laxatives while taking SUTAB.
  • The following medicines should be taken at least 2 hours before starting each dose of SUTAB and not less than 6 hours after taking each dose of SUTAB:
  1. tetracycline
  2. fluoroquinolone antibiotics
  1. iron
  2. digoxin
  1. chlorpromazine
  2. penicillamine
  1. tetracycline
  2. fluoroquinolone antibiotics
  3. iron
  4. digoxin
  5. chlorpromazine
  6. penicillamine

The most common side effects of SUTAB include:

  • nausea
  • stomach-area swelling (abdominal distension)
  • Vomiting
  • Upper stomach (abdominal) pain
  • nausea
  • stomach-area swelling (abdominal distension)
  • Vomiting
  • Upper stomach (abdominal) pain

These are not all the possible side effects of SUTAB.

The Important Safety Information does not include all the information needed to use SUTAB safely and effectively. Please see accompanying full Prescribing Information for SUTAB.

To Report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.

SUTAB® is a registered trademark of Azurity Pharmaceuticals, Inc.

PP-STB-7062-US-EN-v1 03/26

View the Full Prescribing Information and Medication Guide.

INFORMACIÓN DE SEGURIDAD IMPORTANTE

SUFLAVE® (polietilenglicol 3350, sulfato de sodio, cloruro de potasio, sulfato de magnesio y cloruro de sodio para solución oral)

Indicaciones y uso

SUFLAVE está indicado para la limpieza del colon en preparación para la colonoscopia en adultos.

INFORMACIÓN DE SEGURIDAD IMPORTANTE ADICIONAL

¿Cuál es la información más importante que debo conocer acerca de SUFLAVE?

SUFLAVE y otras preparaciones del intestino pueden causar efectos secundarios graves, que incluyen los siguientes:
Pérdida grave de líquido corporal (deshidratación) y cambios en las sales (electrolitos) de la sangre.
Estos cambios pueden ocasionar lo siguiente:

  • latidos cardíacos irregulares que pueden causar la muerte;
  • convulsiones; esto puede ocurrir incluso si nunca tuvo convulsiones; y
  • problemas renales.

No tome SUFLAVE si su proveedor de atención médica le ha indicado que tiene:

  • una obstrucción intestinal o un problema que hace que los alimentos se desplacen muy lentamente a través de sus intestinos (íleo);
  • un orificio en la pared de su estómago o intestino (perforación intestinal);
  • los intestinos muy dilatados (colitis tóxica o megacolon tóxico);
  • problemas para evacuar alimentos y líquidos del estómago (retención gástrica);
  • alergia a alguno de los ingredientes de SUFLAVE.

¿Cuáles son los posibles efectos secundarios de SUFLAVE?

SUFLAVE puede causar efectos secundarios graves, que incluyen:
  • Cambios en ciertos análisis de sangre. Su proveedor de atención médica puede realizar análisis de sangre después de que usted tome SUFLAVE para controlar los cambios en la sangre. Dígale a su proveedor de atención médica si tiene síntomas de una pérdida excesiva de líquidos, que incluyen:
  1. vómitos
  2. mareos
  3. orinar menos de lo habitual
  1. náuseas
  2. cólicos estomacales (abdominales)
  3. problemas para beber líquidos claros
  1. hinchazón
  2. dolor de cabeza
  1. vómitos
  2. mareos
  3. orinar menos de lo habitual
  4. náuseas
  5. cólicos estomacales (abdominales)
  6. hinchazón
  7. dolor de cabeza
  8. problemas para beber líquidos claros
  • Problemas cardíacos. SUFLAVE puede causar latidos cardíacos irregulares.
  • Convulsiones.
  • Úlceras intestinales o problemas intestinales (colitis isquémica). Indique a su proveedor de atención médica de inmediato si tiene dolor agudo en la zona del estómago (abdominal) o sangrado rectal.
  • Reacciones alérgicas graves. Obtenga ayuda médica de inmediato si presenta signos y síntomas de una reacción alérgica grave mientras toma SUFLAVE, entre ellos:
  1. dificultad para respirar
  2. hinchazón de la cara, los labios, la lengua y la garganta
  3. manchas rojas levantadas en la piel (urticaria)
  1. sarpullido
  2. comezón
  1. dificultad para respirar
  2. hinchazón de la cara, los labios, la lengua y la garganta
  3. sarpullido
  4. comezón
  5. manchas rojas levantadas en la piel (urticaria)

Antes de tomar SUFLAVE, informe a su proveedor de atención médica acerca de todos sus problemas de salud, especialmente si usted:

  • tiene problemas de pérdida grave de líquido corporal (deshidratación) y cambios en las sales (electrolitos) de su sangre;
  • tiene problemas cardíacos;
  • tiene problemas estomacales o intestinales, incluida la colitis ulcerativa;
  • tiene problemas para deglutir o tiene reflujo gástrico, o si inhala alimentos o líquidos a los pulmones (aspira) cuando come o bebe;
  • tiene antecedentes de convulsiones;
  • está dejando de beber alcohol o de tomar benzodiazepinas;
  • presenta bajo nivel de sales (sodio) en la sangre;
  • tiene problemas renales;
  • está embarazada. Se desconoce si SUFLAVE puede dañar al bebé por nacer. Hable con su proveedor de atención médica si está embarazada;
  • está amamantando o planea amamantar. Se desconoce si SUFLAVE puede transferirse por la leche materna. Usted y su proveedor de atención médica deben decidir si usted tomará SUFLAVE mientras amamanta.

Informe a su proveedor de atención médica sobre todos los medicamentos que toma, incluidos:

  • Medicamentos recetados y de venta libre, vitaminas y suplementos herbarios.
  • SUFLAVE puede afectar la eficacia de otros medicamentos. Los medicamentos que se toman por vía oral una hora antes del inicio de cada dosis de SUFLAVE pueden no absorberse adecuadamente.
  • Informe especialmente a su proveedor de atención médica si toma: medicamentos para tratar desequilibrios de sales en la sangre (electrolitos), medicamentos para la presión arterial, problemas cardíacos, problemas renales o convulsiones, pastillas para eliminar líquidos (diuréticos), medicamentos antiinflamatorios no esteroideos (AINE), medicamentos para la depresión u otros problemas de salud mental, y laxantes. No use otros laxantes mientras toma SUFLAVE.
  • Espesantes a base de almidón. En los pacientes que tienen problemas de deglución, no mezclar SUFLAVE con espesantes a base de almidón.

Los siguientes medicamentos deben tomarse al menos 2 horas antes de iniciar cada dosis de SUFLAVE y como mínimo 6 horas después de haber tomado cada dosis de SUFLAVE:

  1. tetraciclina
  2. antibióticos de las familias de la fluoroquinolona
  1. hierro
  2. digoxina
  1. clorpromazina
  2. penicilamina
  1. tetraciclina
  2. antibióticos de las familias de la fluoroquinolona
  3. hierro
  4. digoxina
  5. clorpromazina
  6. penicilamina

Los efectos secundarios más comunes de SUFLAVE incluyen:

  • náuseas
  • inflamación del área estomacal (distensión abdominal)
  • vómitos
  • dolor en la parte superior del estómago (abdominal)
  • náuseas
  • inflamación del área estomacal (distensión abdominal)
  • vómitos
  • dolor en la parte superior del estómago (abdominal)

Estos no son todos los posibles efectos secundarios de SUFLAVE.

La Información importante de seguridad no incluye toda la información necesaria para usar SUFLAVE de manera segura y eficaz. Consulte la información de prescripción completa adjunta para SUFLAVE.

Para informar SOSPECHAS DE REACCIONES ADVERSAS, comuníquese con Azurity Pharmaceuticals, Inc. al 1-800-461-7449, o con la FDA al 1-800-FDA-1088 o www.fda.gov/MedWatch.

SUFLAVE® es una marca comercial registrada de Azurity Pharmaceuticals, Inc.

PP-SUF-7061-US-EN-v1 03/26

View the Full Prescribing Information and Medication Guide.

References:
1. SUFLAVE [package insert]. Woburn, MA: Azurity Pharmaceuticals, Inc. 2. Bhandari R, Goldstein M, Mishkin DS, et al. Comparison of a novel, flavor-optimized, polyethylene glycol and sulfate bowel preparation with oral sulfate solution in adults undergoing colonoscopy. J Clin Gastroenterol. 2023;57(9):920-927. doi:10.1097/MCG.0000000000001894 3. Data on file. Woburn, MA: Azurity Pharmaceuticals, Inc.

References: 1. Rex DK, Anderson JC, Butterfly LF, et al. Quality indicators for colonoscopy. Gastrointest Endosc. 2024;100(3):352-381. doi:10.1016/j.gie.2024.04.2905 2. SUFLAVE [package insert]. Woburn, MA: Azurity Pharmaceuticals, Inc. 3. Bhandari R, Goldstein M, Mishkin DS, et al. Comparison of a novel, flavor-optimized, polyethylene glycol and sulfate bowel preparation with oral sulfate solution in adults undergoing colonoscopy. J Clin Gastroenterol. 2023;57(9):920-927. doi:10.1097/MCG.0000000000001894 4. SUTAB [package insert]. Woburn, MA: Azurity Pharmaceuticals, Inc. 5. Di Palma JA, Bhandari R, Cleveland M, et al. A safety and efficacy comparison of a new sulfate-based tablet bowel preparation versus a PEG and ascorbate comparator in adult subjects undergoing colonoscopy. Am J Gastroenterol. 2021;116(2):319-328. doi:10.14309/ajg.0000000000001020
Azurity
© 2026 Azurity Pharmaceuticals, Inc. All rights reserved. PP-SUF-6462-US-EN-v2 July 2026
Please see Important Safety Information and Full Prescribing Information and Medication Guide
Please see Important Safety Information,
Full Prescribing Information and Medication Guide for SUFLAVE, and
Full Prescribing Information and Medication Guide for SUTAB