Salix Products
Salix Gastrointestinal products for treating digestive diseases FULYZAQ RELISTOR XIFAXAN SOLESTA UCERIS APRISO GIAZO For full line of Salix products click here

Advancing Treatment in Gastroenterology

Salix Pharmaceuticals is a specialty pharmaceutical company that offers innovative gastroenterology treatments.

We are committed to licensing, developing, and marketing products to treat gastroenterology disorders. It is our mission to give healthcare professionals and patients the most effective solutions in gastroenterology.

From our corporate office in Raleigh, North Carolina, we license, develop, and market products such as XIFAXAN550, RUCONEST, RELISTOR, APRISO, GIAZO, MOVIPREP, OSMOPREP, SOLESTA, FULYZAQDEFLUX, UCERIS, GLUMETZA, CYCLOSET and ZEGERID to US healthcare professionals.


Indication for XIFAXAN 550 mg

XIFAXAN® (rifaximin) 550 mg tablets are indicated for reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients ≥ 18 years of age.

Important Safety Information about XIFAXAN 550 mg

XIFAXAN® (rifaximin) 550 mg tablets are not for everyone. Do not take XIFAXAN if you have a known hypersensitivity to rifaximin or any of the components in XIFAXAN.

XIFAXAN, like nearly all antibiotics, can alter the normal bacteria of the colon. This can lead to an overgrowth of Clostridium difficile (C. difficile) bacteria. If you take XIFAXAN, there is a chance you could experience diarrhea caused by C. difficile. C. difficile can cause symptoms ranging in severity from mild diarrhea to fatal colitis. If you suspect you have C. difficile–associated diarrhea, contact your healthcare provider immediately, as treatment may need to be discontinued.

XIFAXAN has not been studied in people with MELD scores over 25 and only 8.6% of people in the controlled study had MELD scores over 19. There is an increased chance that XIFAXAN will spread through your body if you have more severe hepatic dysfunction. Therefore, if you have severe hepatic impairment, which is a Child-Pugh score of C, you should talk to your healthcare provider before taking XIFAXAN.

Tell your doctor if you are taking drugs that are P-glycoprotein inhibitors (such as cyclosporine) as using these drugs with XIFAXAN may lead to increase in the amount of XIFAXAN absorbed by your body.

If you are pregnant, planning to become pregnant, or nursing, talk to your healthcare provider before taking XIFAXAN.

In the clinical study, the most common side effects associated with XIFAXAN 550 mg tablets—occurring in at least 10% of people receiving XIFAXAN—were peripheral edema (swelling, usually in the ankles or lower limbs), nausea (feeling sick to your stomach), dizziness, fatigue (feeling tired), and ascites (a buildup of fluid in the abdomen).

Xifaxan 550 mg is licensed by Alfa Wassermann S.p.A. to Salix Pharmaceuticals, Inc.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact:

Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: salix@medcomsol.com

Please see complete Prescribing Information for XIFAXAN.

Indication for RUCONEST

RUCONEST® is a C1 esterase inhibitor (recombinant) indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE). Because of the limited number of patients with laryngeal attacks, effectiveness was not established in HAE patients with laryngeal attacks.

Important Safety Information about RUCONEST

RUCONEST® (C1 esterase inhibitor [recombinant]) is not for everyone. Do not take RUCONEST if you have a known history of allergy to rabbits or products from rabbits. Do not take RUCONEST if you have a history of life-threatening immediate allergic reactions to C1 esterase inhibitor preparations, including anaphylaxis.

If you experience hives, pale red, raised, itchy bumps (urticaria), tightness of the chest, wheezing, low blood pressure (hypotension), and/or anaphylaxis during or after injection of RUCONEST, discontinue RUCONEST and immediately contact your doctor. These may be signs and symptoms of allergic reactions.

Products similar to RUCONEST have been associated with thromboembolic events. Before taking RUCONEST, please notify your doctor if you have an indwelling venous catheter/access device, history of blood clot (thrombosis), been told you have thickening of the walls of your arteries (atherosclerosis), use oral contraceptives (i.e. estrogen or progesterone), are extremely overweight and have significant difficulty moving around.

If you are pregnant, planning to become pregnant, or nursing, talk to your healthcare provider before taking RUCONEST.

The most common RUCONEST side effects in clinical studies include: headache, nausea, and diarrhea. Serious side effect anaphylaxis has been reported in RUCONEST clinical studies.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact:

Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: salix@medcomsol.com

Please see complete Prescribing Information for RUCONEST.

Indication for RELISTOR

RELISTOR® is indicated for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. Use of RELISTOR beyond four months has not been studied.

Important Safety Information about RELISTOR

Do not take RELISTOR® (methylnaltrexone bromide) Subcutaneous Injection if you have or may have a blockage in your intestines called a mechanical bowel obstruction. Symptoms of this blockage are vomiting, stomach pain, and swelling of your abdomen. Talk to your healthcare provider if you have any of these symptoms before taking RELISTOR.

Cases of holes or openings in your gastrointestinal (GI) tract have been reported in adult patients with opioid-induced constipation and advanced illness with certain conditions (i.e., cancer, peptic ulcer, Ogilvie's syndrome). These holes or openings have involved varying regions of the GI tract (e.g., stomach or intestines). Use RELISTOR with caution if you have a known or suspected wound or injury to the GI tract. If you get abdominal pain that is severe or will not go away, or nausea or vomiting that is new or worse, stop taking RELISTOR and call your healthcare provider.

If you get diarrhea that is severe or does not stop while taking RELISTOR, stop taking RELISTOR and call your healthcare provider.

Use of RELISTOR beyond four months has not been studied.

Safety and efficacy of RELISTOR have not been established in children.

The most common side effects of RELISTOR in clinical studies include: abdominal (stomach) pain, gas, nausea, dizziness, diarrhea, and sweating.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact:

Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: salix@medcomsol.com

Please see complete Prescribing Information for RELISTOR.

Indication for APRISO

APRISO® is a locally acting aminosalicylate indicated for the maintenance of remission of ulcerative colitis in patients 18 years and older.

The use of APRISO for treating ulcerative colitis beyond 6 months has not been evaluated in controlled clinical trials.

Important Safety Information about APRISO

You should not take APRISO® (mesalamine) extended-release capsules if you experience an allergic reaction to salicylates or aminosalicylates (sulfasalazine), or to any of the components of APRISO capsules.

It is recommended that you have an evaluation of kidney function prior to treatment with APRISO therapy and periodically while on therapy. Talk to your doctor if you have any kidney or renal problems before taking APRISO.

Mesalamine has been associated with an acute intolerance syndrome that may be difficult to distinguish from a flare of your ulcerative colitis. Symptoms include cramping, acute abdominal (stomach) pain and bloody diarrhea, sometimes fever, headache, and rash. Talk to your doctor if you experience a worsening of these problems after you start treatment.

If you have liver disease, talk to your doctor before taking APRISO. There have been reports of liver failure in patients with liver disease who have taken mesalamine.

You should not take APRISO while taking antacids because the dissolving of APRISO granules depends on pH. If you are 65 years old or older, talk to your doctor before taking APRISO. Blood cell count must be monitored closely if you are 65 or older and on mesalamine therapy. Additionally, if you have phenylketonuria (PKU), please be aware that APRISO contains 2.24 mg of phenylalanine per day.

In the clinical studies, the most common side effects occurring in at least 3% of adult patients taking APRISO were headache, diarrhea, upper abdominal (stomach) pain, nausea, nasopharyngitis (inflammation of the nasal passages), flu and flu-like illness, and inflammation of the sinuses.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact:

Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: salix@medcomsol.com

Please see complete Prescribing Information for APRISO.PDF

Indication for GIAZO

GIAZO® (balsalazide disodium) is indicated for the treatment of mildly to moderately active ulcerative colitis (UC) in male patients 18 years of age and older. Effectiveness in female patients was not demonstrated in clinical trials. Safety and effectiveness of GIAZO beyond 8 weeks have not been established.

Important Safety Information about GIAZO

Do not take GIAZOGIAZO® (balsalazide disodium) tablets if you experience an allergic reaction to salicylates, aminosalicylates, or to any of the components of GIAZO tablets.

Balsalazide is converted to mesalamine, which has been associated with an acute intolerance syndrome that may be difficult to distinguish from a flare of your ulcerative colitis. Symptoms include cramping, acute abdominal (stomach) pain and bloody diarrhea, sometimes fever, headache, and rash. Talk to your doctor if you experience a worsening of these problems after you start treatment.

Before GIAZO treatment and periodically throughout treatment, your kidney function should be evaluated by your doctor. If you have any history of kidney disease, talk to your doctor before taking GIAZO.

If you have liver disease, talk to your doctor before taking GIAZO. There have been reports of liver failure in patients with liver disease who have taken mesalamine.

The effectiveness of GIAZO in female patients was not demonstrated in clinical studies. The safety and effectiveness of GIAZO beyond 8 weeks have not been established.

Talk to your doctor if you need to control sodium intake. The recommended dose of GIAZO (6.6 g/day) provides about 756 mg of sodium per day.

The most common side effects occurring in at least 2% of male patients in the clinical study were anemia (iron deficiency), diarrhea, pharyngolaryngeal (mouth and throat) pain, urinary tract infection, arthralgia (joint pain), insomnia (sleeplessness), and muscle pain.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact:

Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: salix@medcomsol.com

Please see complete Prescribing Information for GIAZO.pdf


Indication for MOVIPREP

MOVIPREP® (PEG-3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution) is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older.

Important Safety Information about MOVIPREP

Do not take MOVIPREP® (PEG-3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution) if you have a gastrointestinal (GI) obstruction (a blockage in your bowel), bowel perforation (an opening in the wall of your stomach or intestine), gastric retention (problems with food and fluid emptying from your stomach), ileus (bowel muscle unable to move stomach contents), toxic colitis (damage to the thickness of the intestinal wall) or toxic megacolon (an extremely dilated or distended colon with fever and/or abdominal pain at times), or if you have a known allergy to MOVIPREP or any of its components.

It is important to drink sufficient liquids before, during, and after the use of MOVIPREP. Liquid and blood salt changes can lead to serious side effects including abnormal heartbeats, seizures, and kidney problems. Talk to your doctor before taking MOVIPREP if you take any medications that increase the risk of blood salt abnormalities or if you have known or suspected low blood salt (sodium) level (hyponatremia).

If you have kidney problems or if you take medication that affects kidney function, talk to your doctor before taking MOVIPREP.

If you have suspected bowel blockage or a suspected opening in the wall of your stomach or intestine, talk to your doctor before taking MOVIPREP.

Talk to your doctor before taking MOVIPREP if you have problems swallowing, if you have gastric reflux, or if you are predisposed to aspiration.

If you have a condition that destroys red blood cells called glucose-6-phosphate dehydrogenase (G6PD) deficiency, talk to your doctor before taking MOVIPREP.

Please be advised that MOVIPREP contains 131 mg of phenylalanine per treatment.

If you are pregnant or planning to become pregnant, talk to your doctor before taking MOVIPREP.

In clinical studies with MOVIPREP, the most common side effects for split dosing were malaise (feeling uneasy), nausea, stomach (abdominal) pain, vomiting, and upper stomach pain. The most common side effects for evening only dosing were stomach swelling (abdominal distension), anal discomfort, thirst, nausea, stomach (abdominal) pain, sleep disorder, rigors (body shakes), hunger, malaise (feeling uneasy), vomiting, and dizziness.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact:

Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: salix@medcomsol.com

Please see complete Prescribing Information for MOVIPREP. pdf icon

Indication for OSMOPREP

OSMOPREP® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older.

Important Safety Information about OSMOPREP

WARNINGS

There have been rare, but serious reports of acute phosphate nephropathy in patients who received oral sodium phosphate products for colon cleansing prior to colonoscopy. Some cases have resulted in permanent impairment of renal function and some patients required long–term dialysis. While some cases have occurred in patients without identifiable risk factors, patients at increased risk of acute phosphate nephropathy may include those with increased age, hypovolemia, increased bowel transit time (such as bowel obstruction), active colitis, or baseline kidney disease, and those using medicines that affect renal perfusion or function (such as diuretics, angiotensin converting enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs], and possibly nonsteroidal anti–inflammatory drugs [NSAIDs]).

It is important to use the dose and dosing regimen as recommended (PM/AM split dose).

Do not take OSMOPREP® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) if you have had a kidney biopsy that shows you have kidney problems because of too much phosphate, a blockage of your intestines, had stomach surgery involving stapling or bypass, a hole or opening in your intestines, significant irritation of the bowels such as toxic megacolon or toxic colitis, or you are allergic to sodium phosphate salts or any of the ingredients in OSMOPREP.

Rare, but serious kidney problems can happen in people who take medicines made with sodium phosphate, including OSMOPREP, to clean the colon before colonoscopy. These kidney problems can sometimes lead to kidney failure or the need for dialysis. These problems occur within a few days, but may develop several months after taking OSMOPREP.

Conditions that can make you more at risk for having serious kidney problems with OSMOPREP include: the loss of too much body fluid (dehydration), slow moving bowels, bowels blocked with stool (constipation), severe stomach pain or bloating, any disease that causes bowel inflammation (colitis), kidney disease or kidney problems, heart failure, and the use of water pills or non‐steroidal anti‐inflammatory drugs (NSAIDS). Your age may also affect your risk for having kidney problems with OSMOPREP. Talk to your doctor before you start to take OSMOPREP.

If you have a history of seizures or are at risk for seizures due to certain medications (such as tricyclic antidepressants), are undergoing withdrawal from alcohol or benzodiazepines, or if you have hyponatremia, you should talk to your doctor before you take OSMOPREP.

If you have been told you are at high risk for developing an arrhythmias or irregular heartbeat, you should tell your doctor.

It is important to drink sufficient liquids before, during, and after use of OSMOPREP.

If you have had an inflammatory bowel disease diagnosis or a blockage/opening of your intestines, tell your doctor before taking OSMOPREP.

If you are pregnant, planning to become pregnant, or nursing, talk to your healthcare provider before taking OSMOPREP.

In clinical trials, the most common side effects occurring in at least 3% of adult patients taking OSMOPREP were bloating, abdominal (stomach) pain, nausea, and vomiting.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact:

Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: salix@medcomsol.com

Please see complete Prescribing Information for OSMOPREP, including BOXED WARNING.

Indication for OSMOPREP

OSMOPREP® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older.

Important Safety Information about OSMOPREP

WARNINGS

There have been rare, but serious reports of acute phosphate nephropathy in patients who received oral sodium phosphate products for colon cleansing prior to colonoscopy. Some cases have resulted in permanent impairment of renal function and some patients required long–term dialysis. While some cases have occurred in patients without identifiable risk factors, patients at increased risk of acute phosphate nephropathy may include those with increased age, hypovolemia, increased bowel transit time (such as bowel obstruction), active colitis, or baseline kidney disease, and those using medicines that affect renal perfusion or function (such as diuretics, angiotensin converting enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs], and possibly nonsteroidal anti–inflammatory drugs [NSAIDs]).

It is important to use the dose and dosing regimen as recommended (PM/AM split dose).

OSMOPREP® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets are contraindicated in patients with a biopsy-proven acute phosphate nephropathy, gastrointestinal (GI) obstruction, gastric bypass or stapling surgery, bowel perforation, toxic colitis, toxic megacolon, and known allergy or hypersensitivity to sodium phosphate salts or any component of OSMOPREP.

Renal impairment may occur with OSMOPREP. Assess renal function before treatment and during therapy. Use OSMOPREP with caution in patients with impaired renal function (creatinine clearance less than 30mL/minute), patients with a history of acute phosphate nephropathy, known or suspected electrolyte disturbances (such as dehydration), or people taking concomitant medications that may affect electrolyte levels (such as diuretics). Patients with electrolyte abnormalities (such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia) should have their electrolytes corrected before treatment with OSMOPREP Tablets.

Seizures due to electrolyte abnormalities can occur. OSMOPREP should be used with caution in patients with a history of seizures or at higher risk of seizure [e.g. patients using concomitant medications that lower the seizure threshold (such as tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia].

Use caution in patients with higher risk of arrhythmias (e.g., patients with a history of cardiomyopathy, prolonged QT, uncontrolled arrhythmias, or recent myocardial infarction).

Advise patients to hydrate adequately before, during, and after the use of OSMOPREP.

Use OSMOPREP with caution in patients with history of Inflammatory Bowel Disease. In patients with suspected GI obstruction or perforation, rule out the diagnosis before administration of OSMOPREP.

Animal reproduction studies have not been performed. OSMOPREP should only be given to a pregnant woman if clearly needed.

In clinical trials, the most commonly reported adverse reactions (reporting frequency >3%) were abdominal bloating, abdominal pain, nausea, and vomiting.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact:

Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: salix@medcomsol.com

Please see complete Prescribing Information for OSMOPREP, including BOXED WARNING.

Indication for SOLESTA

SOLESTA® is indicated for the treatment of fecal incontinence in patients 18 years and older who have failed conservative therapy (eg. diet, fiber therapy, anti-motility medications).

Important Safety Information about SOLESTA

It is important for you to know that SOLESTA® (hyaluronic acid/dextranomer) does not work for everyone and you may not benefit from SOLESTA treatment. It is also important for you to know that you may not experience immediate improvement after your first treatment with SOLESTA and the full effects of SOLESTA may not be apparent until 3 to 6 months after treatment.

People who have an infection or who are currently experiencing bleeding in the rectum or anus should not receive SOLESTA. People who have problems in the rectum or anus, such as tumor, abnormal anatomy, large dilated blood vessels (hemorrhoids), or cracks in the tissue (anal fissures) should not receive SOLESTA. People who have active inflammation of their bowels (Crohn’s disease or ulcerative colitis) should not receive SOLESTA. People who have trouble fighting off infection (immunodeficiency disorder such as HIV/AIDS) or who take medication to suppress the immune system, such as those used in cancer or organ transplant patients, should not receive SOLESTA. If you already have a device or material placed in your rectum or anus, or if you have had radiation treatments in your pelvic area before, you should not receive SOLESTA.

The most common risks of treatment with SOLESTA in the clinical study were mild or moderate pain or discomfort in the rectum or anus, and minor to moderate bleeding or spotting from the rectum following treatment. Some patients experience fever, abdominal pain, diarrhea, or constipation after treatment.

More serious risks including infection and inflammation of the tissues in the anus may occur but are not common.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact:

Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: salix@medcomsol.com

Please see complete Prescribing Information for SOLESTA.

Indication

FULYZAQ® is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy.

Important Safety Information about Fulyzaq

FULYZAQ® (crofelemer) delayed-release tablets should not be used for the treatment of infectious diarrhea. It is important that your healthcare provider considers infectious causes of diarrhea before you start taking FULYZAQ. If infectious causes are not considered, and you begin taking FULYZAQ based on a probable diagnosis of noninfectious diarrhea, there is a risk that you will not receive the appropriate treatments, and your disease may worsen.

FULYZAQ tablets should be swallowed whole. FULYZAQ tablets should not be crushed or chewed. You may take FULYZAQ with or without food. You should follow the instructions of your healthcare provider.

If you are pregnant, or planning to become pregnant, talk to your healthcare provider before taking FULYZAQ. The safety and effectiveness of FULYZAQ have not been established in people younger than 18 years of age.

In clinical studies, the most common adverse reactions associated with FULYZAQ—occurring in at least 3% patients taking FULYZAQ—were upper respiratory tract infection, bronchitis (inflammation of the lining of the tubes which carry air to and from your lungs), cough, flatulence (intestinal gas passed through your rectum), and increased bilirubin (a waste product of the breakdown of red blood cells).

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact:

Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: salix@medcomsol.com

Please see complete Prescribing Information for FULYZAQ. PDF

Salix obtained rights to crofelemer under license from Napo Pharmaceuticals, Inc.

Indication for METOZOLV ODT

METOZOLV® ODT is indicated for short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux disease that fails to respond to conventional therapy (refractory GERD) and for the relief of symptoms associated with acute and recurrent diabetic gastroparesis (gastric stasis) in adults.

Important Safety Information about METOZOLV ODT

WARNING: TARDIVE DYSKINESIA

See full prescribing information for complete boxed warning.

Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with the duration of treatment and the total cumulative dose.

Metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia. In some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped.

Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia.

Do not take METOZOLV ODT (metoclopramide hydrochloride) if you have stomach or intestine problems that could get worse with METOZOLV ODT, such as bleeding, blockage or a tear in your stomach or bowel wall; have an adrenal tumor called pheochromocytoma; are allergic to metoclopramide or any of the ingredients in METOZOLV ODT; take medicines that can cause uncontrolled movements, such as medicines for mental illness; or have seizures. 

METOZOLV ODT can cause serious side effects, including:
Tardive dyskinesia (abnormal muscle movements): these movements happen mostly in the face muscles. You cannot control these movements. They may not go away even after stopping METOZOLV ODT. There is no treatment for tardive dyskinesia, but symptoms may lessen or go away over time after you stop taking METOZOLV ODT.

Uncontrolled spasms of your face and neck muscles, or muscles of your body, arms, and legs (dystonia): these muscle spasms can cause abnormal movements and body positions. These spasms usually start within the first 2 days of treatment. These spasms happen more often in children and adults younger than 30.

Parkinsonism: symptoms include slight shaking, body stiffness, trouble moving or keeping your balance. If you have Parkinson’s Disease, your symptoms may become worse while you are taking METOZOLV ODT.

Neuroleptic Malignant Syndrome (NMS): NMS is a rare but very serious condition that can happen with METOZOLV ODT. NMS can cause death and must be treated in a hospital. Symptoms of NMS include: high fever, stiff muscles, problems thinking, very fast or uneven heartbeat, and increased sweating.

Depression, thoughts about suicide, and suicide: some people who take METOZOLV ODT may become depressed. You may have thoughts about hurting or killing yourself. Some people who have taken metoclopramide products have ended their own lives (suicide).

High blood pressure: METOZOLV ODT can cause your blood pressure to increase.

Too much body water: people who have certain liver problems or heart failure and take METOZOLV ODT may hold too much water in their body (fluid retention). Tell your doctor right away if you have sudden weight gain, or swelling of your hands, legs, or feet.

Symptoms from stopping (withdrawal) METOZOLV ODT: you may still have side effects after you stop METOZOLV ODT such as headaches, and feeling dizzy or nervous.

METOZOLV ODT comes as a tablet that melts in your mouth.  Take METOZOLV ODT exactly as prescribed by your doctor. Do not change your dose unless your doctor tells you to.  You should not take METOZOLV ODT for more than 12 weeks. Take METOZOLV ODT at least 30 minutes before eating and at bedtime. 

It is not known if METOZOLV ODT is safe or works in children.

The elderly may be at greater risk for sleepiness and movement disorders with METOZOLV ODT.

If you have kidney problems, speak with your healthcare provider before taking METOZOLV ODT.

The most common side effects of METOZOLV ODT are:  headache, nausea, vomiting, tiredness, and sleepiness. You may have more side effects the longer you take METOZOLV ODT and the more you take. Tell your doctor about any side effects that bother you or do not go away. These are not all the possible side effects of METOZOLV ODT.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact:

Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: salix@medcomsol.com

Please see complete Prescribing Information for METOZOLV ODT, including BOXED WARNING.pdf

Indication for DEFLUX

Deflux® is indicated for treatment of children with vesicoureteral reflux (VUR) grades II-IV.

Important Safety Information about DEFLUX

Patients should not receive DEFLUX® (hyaluronic acid/dextranomer) if they have any of the following conditions: kidneys that don't work (non-functional kidney[s]), bulging or herniation in the skin of the bladder (hutch diverticulum), swelling at the bottom of the ureter (ureterocele), a disorder in eliminating urine (active voiding dysfunction), and ongoing urinary tract infection.

Safety and efficacy of treatment in children under 1 year of age have not been established.

Safety and efficacy of treatment of duplex kidney systems have not been established.

There is a risk of infection and bleeding that is associated with the cystoscopic procedure used to inject DEFLUX.

Talk to your doctor if your child has ureters with grossly dilated orifices before receiving DEFLUX treatment.

DEFLUX should only be administered by qualified surgeons experienced performing urological procedures.

In clinical studies the most common side effects associated with DEFLUX were: urinary tract infection (UTI), ureteral dilation, and nausea/vomiting/abdominal pain.

The following adverse events have been reported with Deflux : blockage of the ureters (some cases require temporary placement of a ureteric stent), painful urination, blood in the urine, urgency of urination, frequency of urination, swelling of the kidneys, inflammation of the kidneys, urinary tract infection, foreign body reaction, calcification, and fever.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact:

Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: salix@medcomsol.com

Please see complete Prescribing Information for DEFLUX.Deflux Vesicoureteral Reflux Prescribing Information (PI)

Indication for UCERIS

UCERIS® extended release tablets are a prescription corticosteroid medicine used to help get mild to moderate ulcerative colitis (UC) under control (induce remission).

Important Safety Information about UCERIS

UCERIS® (budesonide) extended release tablets are not for everyone. Do not take UCERIS extended release tablets if you are allergic to budesonide or any of the ingredients in UCERIS.

UCERIS is a steroid. When UCERIS extended release tablets are taken for a long period of time, the adrenal glands do not make enough steroid hormones. Tell your healthcare provider if you are under stress or have any of the following symptoms: tiredness, vomiting, weakness, low blood pressure, and nausea.

UCERIS may weaken your immune system. Taking medicines that weaken your immune system makes you more likely to get infections. Avoid contact with people who have contagious diseases such as chicken pox or measles while taking UCERIS extended release tablets.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter vitamins, and herbal supplements. UCERIS extended release tablets and other medicines may affect each other and cause side effects. If you take certain other steroid medicines to treat allergies, switching to UCERIS extended release tablets may cause your allergies to come back. These allergies may include eczema (a skin disease) or rhinitis (inflammation inside your nose). Tell your healthcare provider if any of your allergies become worse while taking UCERIS extended release tablets.

Before you take UCERIS extended release tablets tell your healthcare provider if you have liver problems, are planning to have surgery, have an infection, have or had a family history of diabetes, cataracts or glaucoma, have or had tuberculosis, have high blood pressure (hypertension), have decreased bone mineral density (osteoporosis), stomach ulcers, or any other medical condition. Do not eat grapefruit or drink grapefruit juice while taking UCERIS. Eating grapefruit or drinking grapefruit juice can increase the level of this medicine in your blood.

In clinical studies, the most common side effects (occurring in ≥ 2% of people) were headache, nausea, decreased blood cortisol (a hormone made by the adrenal glands), stomach-area pain, tiredness, stomach or intestinal gas, bloating, acne, urinary tract infection, joint pain, and constipation.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact:

Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: salix@medcomsol.com

Please see complete Prescribing Information for UCERIS extended release tablets.pdf

Indication for GLUMETZA

GLUMETZA® (metformin hydrochloride extended-release tablets) is a prescription medicine that contains metformin hydrochloride used with diet and exercise to help control high blood sugar in adults with type 2 diabetes. GLUMETZA is not for people with type 1 diabetes. GLUMETZA is not for people with diabetic ketoacidosis (increased ketones in your blood or urine).

Important Safety Information about GLUMETZA

WARNING: LACTIC ACIDOSIS

  • Lactic acidosis is a rare, but serious, complication that can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic impairment, renal impairment, and acute congestive heart failure.
  • The onset of lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress.
  • Laboratory abnormalities include low pH, increased anion gap, and elevated blood lactate.
  • If acidosis is suspected, GLUMETZA (metformin hydrochloride extended-release tablets), should be discontinued and the patient hospitalized immediately.

Do not take GLUMETZA® (metformin hydrochloride extended-release tablets) if you:

  • have kidney problems
  • are allergic to the metformin hydrochloride in GLUMETZA or any of the ingredients in GLUMETZA.
  • are going to get an injection of dye or contrast agents for an x-ray procedure, GLUMETZA will need to be stopped for a short time. Talk to your doctor about when you should stop GLUMETZA and when you should start GLUMETZA again.
  • have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in your blood or urine).

Tell your healthcare provider if you drink alcohol very often, or drink a lot of alcohol in short-term.

Tell your healthcare provider if you are scheduled to have any tests that use radiocontrast or an injected dye or if you are having any surgical procedure that requires you to restrict your intake of food or liquids.

Your doctor should do blood tests to check how well your kidneys and liver are working before and during your treatment with GLUMETZA.

Tell your healthcare provider if you have problems with your liver. GLUMETZA may decrease your levels of Vitamin B12. Your doctor should monitor your blood levels on a yearly basis.

Tell your healthcare provider if you are taking insulin, or any of the following drugs as GLUMETZA may not be the right choice for you: amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, or vancomycin.

Safety and effectiveness in children younger than 18 years of age have not been established.

There have been no clinical studies that have been able to conclude a beneficial effect of GLUMETZA or any other oral anti-diabetic drug on reducing cardiovascular outcomes.

The most common adverse reactions (>5% of GLUMETZA-treated patients and at a rate greater than placebo) were low blood sugar (hypoglycemia). Symptoms of low blood sugar include: shaking, sweating, rapid heartbeat, change in vision, hunger, headache and change in mood. Other common adverse reactions include diarrhea, nausea, and upset stomach or stomach pain.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact:

Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: salix@medcomsol.com

Please see complete Prescribing Information for GLUMETZA.pdf

Indication for CYCLOSET

CYCLOSET® (bromocriptine mesylate) Tablets are a prescription medicine used with diet and exercise to lower blood sugar in adults with type 2 diabetes. CYCLOSET may be taken alone or with other medicines that also help to control blood sugar. CYCLOSET should not be used to treat type 1 diabetes or diabetic ketoacidosis. There is limited data in combination with other diabetes medications such as thiazolidinediones (TZD) and insulin.

Important Safety Information about CYCLOSET

CYCLOSET® (bromocriptine mesylate) Tablets are not for everybody. Do not use CYCLOSET if you are allergic to bromocriptine or any other ingredient of CYCLOSET or if you are taking ergot medicines. You should not use CYCLOSET if you have fainting (syncopal) migraine headaches. If you are breastfeeding, you should not use CYCLOSET as it may inhibit lactation.

CYCLOSET can cause severe dizziness or fainting especially when starting or increasing the dose. This can happen when your blood pressure lowers rapidly after you stand up from a lying down position. You should change your posture slowly to avoid these problems. If you are taking a medication for high blood pressure, tell your healthcare provider.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take medicines for mental health conditions (particularly anti-psychotic medicines), for migraines or other types of headache, and any medications used to treat Parkinson’s disease, hyperproloactinemia, restless leg syndrome, or acromegaly. Tell your healthcare provider if you are using any medications that are dopamine antagonists such as neuroleptics (e.g., phenothiazines, butyrophenones, thioxanthenes) or metoclopramide.

CYCLOSET may cause somnolence (fatigue) especially at the beginning of your treatment, and when your doctor increases the dose you are taking. If you have somnolence from CYCLOSET you should not drive or use other heavy machines until the somnolence is better.

There have been no clinical studies that have been able to conclude a beneficial effect of CYCLOSET or any other oral anti-diabetic drug on reducing cardiovascular outcomes. CYCLOSET does not increase the risk of cardiovascular events.

The safety and effectiveness of CYCLOSET in pediatric patients have not been established.

In clinical studies, the most common adverse reactions reported in ≥ 5% of patients treated with CYCLOSET and reported more commonly than in patients treated with placebo (sugar-pill), included nausea, fatigue, dizziness, vomiting, and headache. Postmarketing reports with higher doses of bromocriptine used for other indications include psychotic disorders, hallucinations, and fibrotic complications.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact:
1-877-757-0666 or veroscience@tmacmail.com.

Please see complete Prescribing Information for CYCLOSET.pdf

Indication for ZEGERID

ZEGERID® (omeprazole/sodium bicarbonate) is a prescription medicine called a proton pump inhibitor (PPI). ZEGERID reduces the amount of acid in your stomach. ZEGERID is used in adults for:

  • short-term to heal ulcers in the first part of the small bowel (duodenal ulcers).
  • short-term healing of stomach ulcers.
  • treatment of heartburn and other symptoms that happen with gastroesophageal reflux disease (GERD).
  • healing of acid-related damage to the lining of the esophagus (called erosive esophagitis or EE).
  • maintenance of healing of the esophagus. It is not known if ZEGERID is safe and effective if used longer than 12 months (1 year).
  • reduction of the risk of stomach bleeding in critically ill people.

Important Safety Information about ZEGERID

Do not take ZEGERID® (omeprazole/sodium bicarbonate) if you are allergic to any of the ingredients in ZEGERID or are allergic to any other proton pump inhibitor (PPI) medicine.

Before you take ZEGERID, tell your doctor if you have been told that you have low magnesium, calcium, or potassium levels in your blood, have liver problems, heart failure, or have Bartter’s syndrome (a rare kidney disorder).

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. ZEGERID may affect how other medicines work, and other medicines may affect how ZEGERID works. This can cause serious side effects. Be sure to tell your doctor if you are taking:

  • diazepam (Valium®)
  • warfarin (Coumadin® Jantoven)
  • phenytoin (Dilantin®)
  • cyclosporine (Gengraf, Neoral, Sandimmune)
  • disulfiram (Antabuse®)
  • a benzodiazepine medicine
  • ketoconazole (Nizoral®)
  • an antibiotic that contains ampicillin
  • products that contain irondigoxin (Lanoxin®)
  • voriconazole (Vfend®)
  • atazanavir (Reyataz®)
  • nelfinavir (Viracept®)
  • tacrolimus (Prograf®)
  • saquinavir (Fortovase®)
  • clarithromycin (Biaxin®, Biaxin XL)
  • clopidogrel (Plavix®)
  • St. John's Wort (Hypericum perforatum)
  • rifampin (Rifater, Rifamate, Rimactane, Rifadin)
  • methotrexate

Do not substitute two 20 mg capsules for one 40 mg capsule of ZEGERID because you will receive twice the amount of sodium bicarbonate. Do not substitute two 20 mg packets for one 40 mg packet of ZEGERID Powder for Oral Suspension because you will receive twice the amount of sodium bicarbonate.

Your doctor may stop ZEGERID if you have low magnesium levels in your body. This problem can be serious. Low magnesium can happen in some people who take a proton pump inhibitor medicine for at least 3 months. If low magnesium levels occur, it is usually after a year of treatment. You may or may not have symptoms of low magnesium.

People who are taking multiple daily doses of proton pump inhibitor medicines for a long period of time may have an increased risk of fractures of the hip, wrist, or spine.

If you are on a low-sodium diet or at risk of developing congestive heart failure (CHF), you and your doctor should decide if you will take ZEGERID.

It is not known if ZEGERID is safe and effective in children and adolescents less than 18 years of age.

If you are pregnant, planning to become pregnant, or nursing, talk to your healthcare provider before taking ZEGERID. It is unknown if ZEGERID can harm your unborn baby.

The most common side effects with ZEGERID include headache, abdominal pain, nausea, diarrhea, vomiting, and gas. However, tell your doctor right away if you develop the following symptoms: seizures, dizziness, abnormal or fast heartbeat, jitteriness, jerking movements or shaking (tremors), muscle weakness, spasms of the hands and feet, cramps or muscle aches, or spasm of the voice box.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact:

Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: salix@medcomsol.com

Please see complete Medication Guide and Prescribing Information for ZEGERID.pdf

Important Safety Information about AZASAN

WARNING: Chronic immunosuppression with this purine antimetabolite increases risk of malignancy in humans. Reports of malignancy include post-transplant lymphoma and hepatosplenic T-cell lymphoma (HSTCL) in patients with inflammatory bowel disease. Physicians using this drug should be very familiar with this risk as well as with the mutagenic potential to both men and women and with possible hematologic toxicities. Physicians should inform patients of the risk of malignancy with AZASAN. See WARNINGS.

AZASANAZASAN® (azathioprine tablets) 75/100 mg is indicated as an adjunct for the prevention of rejection in renal homotransplantations, and also for the management of active rheumatoid arthritis to reduce signs and symptoms. Patients are at increased risk of developing lymphoma and other malignancies, particularly of the skin. Exposure to sunlight and ultraviolet light should be limited by wearing protective clothing and a high SPF sunscreen. Patients should have complete blood count (CBC), including platelet counts periodically during treatment. TPMT testing should be conducted to identify with absent or reduced TPMT activity. The most commonly reported side effects associated with AZASAN therapy are leukopenia and/or thrombocytopenia, secondary infections, neoplasia, nausea, vomiting, diarrhea, fever, myalgias, skin rashes, and hepatotoxicity. AZASAN therapy should be given cautiously when used concomitantly with allopurinol, ACE inhibitors, and other agents affecting myelopoiesis. Patients with rheumatoid arthritis previously treated with alkylating agents (cyclophosphamide, chlorambucil, melphalan, or others) may have a prohibitive risk of malignancy if treated with AZASAN. AZASAN is contraindicated in pregnant and lactating women and in patients who have shown hypersensitivity to this product.

Consult with your physician to see if this product is right for you.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact:

Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: salix@medcomsol.com

Please see complete Prescribing Information for AZASAN, including BOXED WARNING.pdf

For product information, adverse event reports, and product complaint reports please call:
Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: salix@medcomsol.com

Santarus, Inc. is a wholly owned subsidiary of Salix Pharmaceuticals, Inc.


The information contained on this page is intended for US residents, healthcare providers, and pharmacists only.

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