Our products treat GI disorders

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.

Important Safety Information about COLAZAL

COLAZAL® (balsalazide disodium) Capsules 750 mg are indicated for the treatment of mildly to moderately active Ulcerative Colitis in patients 5 years of age and older. COLAZAL does not relieve symptoms in all patients; your patients' results may vary. In four well-controlled clinical trials, patients receiving a COLAZAL dose of 6.75g/day most frequently reported the following events (reporting frequency > 3%): headache (8%), abdominal pain (6%), diarrhea (5%), nausea (5%), vomiting (4%), respiratory infection (4%), and arthralgia (4%). Withdrawal from therapy due to adverse events was comparable to placebo. In the pediatric trial, patients most frequently reported the following adverse events: headache (15%), abdominal pain upper (13%), abdominal pain (12%), vomiting (10%), diarrhea (9%), colitis ulcerative (6%), nasopharyngitis (6%) and, pyrexia (6%). COLAZAL is contraindicated in patients with a hypersensitivity to salicylates or the components of COLAZAL capsules or balsalazide metabolites. The safety and effectiveness of COLAZAL beyond 8 weeks in children (ages 5-17 years) and 12 weeks in adults have not been established.

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 COLAZAL.

Indication for FULYZAQ

FULYZAQ™ is an anti-diarrheal indicated for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral 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 non-infectious 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% of 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).

Please see complete Prescribing Information for FULYZAQ.

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 GIAZO^® (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.

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

METOZOLV® ODT (metoclopramide HCl) orally disintegrating tablet therapy should not exceed 12 weeks in duration and is recommended for adults only (the safety and effectiveness in pediatric patients have not been established).

METOZOLV ODT is contraindicated in patients with intestinal obstruction, hemorrhage, or perforation; pheochromocytoma; known sensitivity or intolerance to metoclopramide; epilepsy; or are receiving concomitant medications with extrapyramidal reactions.

Extrapyramidal symptoms (EPS), manifested primarily as acute dystonic reactions, occur in approximately 1 in 500 patients treated with the usual adult dosages of 30 to 40 mg/day of metoclopramide. These usually are seen during the first 24 to 48 hours of treatment with metoclopramide, occur more frequently in pediatric patients and adult patients less than 30 years of age, and are even more frequent at higher doses.

Drug-induced Parkinsonism can occur during metoclopramide therapy, more commonly within the first 6 months after beginning treatment, but also after longer periods. Patients with a history of Parkinson’s disease should be given metoclopramide cautiously, if at all, since such patients can experience exacerbation of Parkinsonian symptoms when taking metoclopramide.

There have been rare reports of an uncommon but potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) associated with metoclopramide. Clinical manifestations of NMS include hyperthermia, muscle rigidity, altered consciousness, and evidence of autonomic instability. The management of NMS should include immediate discontinuation of metoclopramide and other drugs not essential to concurrent therapy.

Depression associated with metoclopramide use has occurred in patients with and without a history of depression. For those patients with a prior history of depression, metoclopramide should only be given if the expected benefits outweigh the potential risks.

In one study in hypertensive patients, intravenously administered metoclopramide was shown to release catecholamines; hence, caution should be exercised when metoclopramide is used in patients with hypertension. Any rapid rise in blood pressure associated with METOZOLV ODT use should result in immediate cessation of metoclopramide use in those patients.

Since metoclopramide produces a transient increase in plasma aldosterone, patients with cirrhosis or congestive heart failure may be at risk of developing fluid retention and volume overload. If these side effects occur at any time in any patients during metoclopramide therapy, the drug should be discontinued.

Patients may experience withdrawal symptoms after stopping METOZOLV ODT that could include dizziness, nervousness, and/or headaches.

METOZOLV ODT interacts with anticholinergics, narcotic analgesics, monoamine oxidase inhibitors, insulin, antidepressants, antipsychotics, and neuroleptics. METOZOLV ODT may alter drug absorption.

Elderly patients may be more sensitive to adverse reactions such as sedation and drug-induced movement disorders. In patients with impaired renal function, initial dosing may need to be reduced and titrated.

In clinical studies, the most frequently reported adverse events (≥2% occurrence) for METOZOLV ODT were headache, nausea, fatigue, somnolence, and vomiting.

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

Important Safety Information about PEPCID

PEPCID® (famotidine) for Oral Suspension is indicated for the short-term treatment of gastroesophageal reflux disease (GERD), active duodenal ulcer, active benign gastric ulcer, erosive esophagitis due to GERD, and peptic ulcer disease. Side effects reported in >1% of patients in clinical trials were headache 4.7%, diarrhea 1.7%, dizziness 1.3%, and constipation 1.2%. Care should be taken in dose selection for patients with moderate or severe renal impairment. Pepcid is contraindicated in patients who are hypersensitive to any component of the product or to any other H2-receptor antagonist.

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

Please see complete Prescribing Information for PEPCID.

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.

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

Rare cases of holes or openings in your gastrointestinal (GI) tract have been reported in advanced illness patients 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, 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.

Use of RELISTOR has not been studied in patients with catheters in their abdominal wall.

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 XIFAXAN 550 mg

XIFAXAN^® 550 mg is 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.

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 not available for sale outside the U.S.

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 550 mg.

Important Safety Information about XIFAXAN 200 mg

XIFAXAN® (rifaximin) 200 mg Tablets are indicated for the treatment of patients (≥12 years of age) with travelers’ diarrhea caused by noninvasive strains of Escherichia coli. XIFAXAN should not be used in patients with diarrhea complicated by fever or blood in the stool or diarrhea due to pathogens other than E coli. XIFAXAN should be discontinued if diarrhea symptoms get worse or persist more than 24 to 48 hours and alternative antibiotic therapy should be considered. E coli has been shown to develop resistance to rifaximin in vitro. However, the clinical significance of such an effect has not been studied.

In clinical trials, XIFAXAN was generally well tolerated. The most common side effects (vs placebo) were flatulence 11.3% (vs 19.7%), headache 9.7% (vs 9.2%), abdominal pain 7.2% (vs 10.1%), rectal tenesmus 7.2% (vs 8.8%), defecation urgency 5.9% (vs 9.2%), and nausea 5.3% (vs 8.3%).

Please see complete Prescribing Information for XIFAXAN 200 mg.

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.

Please see complete Prescribing Information for MOVIPREP.

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

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.

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

Important Safety Information about ANUSOL-HC and PROCTOCORT

ANUSOL-HC® (hydrocortisone cream, 2.5%) and PROCTOCORT® (hydrocortisone cream, 1%) are both indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

ANUSOL-HC® (hydrocortisone acetate suppository, 25 mg) and PROCTOCORT® (hydrocortisone acetate suppository, 30 mg) are both indicated for use in inflamed hemorrhoids, post-irradiation (factitial) proctitis, as an adjunct in the treatment of chronic Ulcerative Colitis, cryptitis, and other inflammatory conditions of the anorectum, and pruritis ani.

ANUSOL-HC and PROCTOCORT are contraindicated in patients with a history of hypersensitivity to any of the components. Adverse effects include various types of skin and hair follicle irritation such as burning and itching, which may necessitate discontinuing product. Any infection should be treated; if response is not prompt, the corticosteroid should be discontinued until the infection clears. These products are in Pregnancy Category C; therefore, topical corticosteroids should be used during the pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time. Caution is advised for use in nursing mothers.

Creams: If hypothalamic-pituitary-adrenal (HPA) axis suppression occurs, withdraw the drug, and use supplemental systemic corticosteroid (if necessary), reduce frequency of application, or substitute less potent steroid. Treated skin should not be bandaged or otherwise covered unless directed by a physician. If infection develops when using occlusive dressings, discontinue dressings and institute antimicrobial therapy. For pediatric patients use in smallest area possible and avoid chronic use, as pediatric patients may be more susceptible to systemic toxicity.

Suppositories: Products should not be used unless an adequate proctologic examination has been made.

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

Please see complete Prescribing Information about ANUSOL-HC and PROCTOCORT:

ANUSOL-HC® Hydrocortisone Cream, 2.5%

PROCTOCORT® Hydrocortisone Cream, 1%

For ANUSOL-HC® Hydrocortisone Acetate Suppository, 25 mg

For PROCTOCORT® Hydrocortisone Acetate Suppository, 30 mg

Important Safety Information about AZASAN

AZASAN® (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.

Important Safety Information about DIURIL

DIURIL® (chlorothiazide) for Oral Suspension is indicated for the treatment of high blood pressure and also as adjunctive therapy in edema associated with congestive heart failure, cirrhosis of the liver, corticosteroid and estrogen therapy, and kidney disease. When used for high blood pressure, it can be used alone or with other high blood pressure medications. Use with caution in patients with severe renal disease; thiazides may precipitate azotemia. Thiazides may add to or potentiate the action of other hypertensive drugs. Use with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma. Sensitivity reactions may occur in patients with or without a history of allergy or bronchial asthma. The possibility of exacerbation or activation of systemic lupus erythematosus has been reported. Lithium generally should not be given with diuretics. DIURIL is contraindicated in patients with anuria or who are hypersensitive to this product or to any other sulfonamide-derived drugs.

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 DIURIL.

Indication for DEFLUX

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

Important Safety Information about DEFLUX

DEFLUX^® (hyaluronic acid/dextranomer) is contraindicated in patients with any of the following conditions: non-functional kidney(s), hutch diverticulum, ureterocele, active voiding dysfunction, and ongoing urinary tract infection.

DEFLUX must not be injected intravascularly as injection into blood vessels may cause vascular occlusion.

DEFLUX should only be administered by qualified surgeons experienced in the use of a cystoscope and trained in subureteral injection procedures.

Safety and efficacy of treatment of duplex systems, use of more than 6 mL of DEFLUX (3 mL at each ureteral orifice) at the same treatment session, and treatment of children under 1 year of age have not been established.

Ureters with grossly dilated orifices may render the patient unsuitable for treatment.

There is a risk of infection and bleeding that is associated with the cystoscopic procedure used to inject DEFLUX. The usual precautions associated with cystoscopy (e.g., sterile technique, proper dilation, etc.) should be followed.

The safety of DEFLUX in the treatment of VUR is based on a randomized study in which 39 children were treated with DEFLUX for VUR, and two nonrandomized studies in which 170 children were treated with DEFLUX for VUR. Treatment-related adverse events from the randomized and the nonrandomized studies were: urinary tract infection (UTI), ureteral dilation, and nausea/vomiting/abdominal pain.

Although vascular occlusion, ureteral obstruction, dysuria, hematuria/bleeding, urgency, and urinary frequency have not been observed in any of the clinical studies, they are potential adverse events associated with subureteral injection procedures. Following approval, rare cases of postoperative dilatation of the upper urinary tract with or without hydronephrosis leading to temporary placement of a ureteric stent have been reported.

Please see complete Prescribing Information for DEFLUX.

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.