Salix Products

For full line of Salix products, click here.

Please see Important Safety Information including BOXED WARNING for OsmoPrep and Glumetza.

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 XIFAXAN® (rifaximin) 550 mg, RUCONEST® (C1 esterase inhibitor [recombinant]), RELISTOR® (methylnaltrexone bromide), APRISO® (mesalamine), GIAZO® (balsalazide disodium), MOVIPREP® (PEG-3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution), OSMOPREP® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP), SOLESTA®, FULYZAQ® (crofelemer), DEFLUX®, UCERIS® (budesonide) extended release tablets, UCERIS® (budesonide) rectal foam, GLUMETZA® (metformin), CYCLOSET® (bromocriptine mesylate) and ZEGERID® (omeprazole/sodium bicarbonate) to US healthcare professionals.


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 non-steroidal 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 non-steroidal 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 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

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.