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ANUSOL/PROCTOCORT

ANUSOL-HC® is available as either a 2.5% hydrocortisone cream or a 25 mg hydrocortisone acetate suppository. PROCTOCORT® is available as either a 1% hydrocortisone cream or a 30 mg hydrocortisone acetate suppository. Both ANUSOL-HC cream and PROCTOCORT cream are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. The suppository forms of ANUSOL-HC and PROCTOCORT are both indicated for use in inflamed hemorrhoids and post-irradiation (factitial) proctitis and as an adjunct in the treatment of chronic ulcerative colitis, cryptitis, other inflammatory conditions of the anorectum, and pruritis ani.

Important Safety Information about ANUSOL and PROCTOCORT.

Complete Prescribing Information for ANUSOL-HC Hydrocortisone Cream, 2.5%. pdf

Complete Prescribing Information for PROCTOCORT Hydrocortisone Cream, 1%. pdf

Complete Prescribing Information for ANUSOL-HC Hydrocortisone Acetate Suppository, 25 mg. pdf

Complete Prescribing Information for PROCTOCORT Hydrocortisone Acetate Suppository, 30 mg. pdf

To order ANUSOL-HC or PROCTOCORT, contact your wholesaler.

Wholesaler Account List and Order Entry Numbers
Product NDC #
ANUSOL-HC Cream 65649-401-30
ANUSOL-HC Suppository 12 ct. 65649-411-12
ANUSOL-HC Suppository 24 ct. 65649-411-24
PROCTOCORT Cream 65649-501-30
PROCTOCORT 12 ct. 65649-511-12

Wholesaler Product Number
ANUSOL-HC
Cream Supp 12 ct. Supp 24 ct.
AmerisourceBergen 31132 110569 110577
Bellco Drug Co 742668 793000 790998
Burlington Drug Co 669515 003558 003566
Capital Wholesale Drug 203215 203212 203213
Cardinal 3664653 3664661 3664679
Dakota Drug 392720 191791 n/a
Dik Drug 565606 21444 44321
F. W. Kerr 205393 205104 205237
H. D. Smith 504-0670 504-0688 504-0696
King Drug 877977 272377 n/a
Kinray 207-563 102-707 002-683
McKesson 1226521 1228980 1243948
Miami Luken 751198 70268 329983
Morris & Dickson 292433 512046 389122
Mutual Wholesale Drug 157222 158055 158063
Peytons Kroger Stores 610253 18895 n/a
Peytons Non Kroger Stores 3658366 3680071 n/a
Quality King Distributors 00739 00737 00738
Rochester Drug Cooperative 12403606 3366002 90012402
Smith Drug 13-8453 15-9004 71-3353
The Harvard Drug Group 327026 327037 n/a
Valley Wholesaler 386359 180711 180729
Value Drug Company 710632 140715 411298

Wholesaler Product Number
PROCTOCORT
Cream Supp 12 ct.
AmerisourceBergen 001786 373563
Bellco Drug Co 780932 684712
Burlington Drug Co 525113 266536
Capital Wholesale Drug 340426 340425
Cardinal 3659802 3664620
Dakota Drug 157891 n/a
Dik Drug 35147 866210
F. W. Kerr 204446 89334
H. D. Smith 504-0142 504-0266
King Drug n/a 970822
Kinray 78-105 472-043
McKesson 1381045 1250620
Miami Luken 246801 861807
Morris & Dickson 375295 201640
Mutual Wholesale Drug 133314 776054
Peytons Kroger Stores n/a 3681087
Peytons Non Kroger Stores n/a 14092
Prescription Supply, Inc 159509 260026
Quality King Distributors 70022 72603
Rochester Drug Cooperative 54174008 12403705
Smith Drug 32-5829 29-6558
The Harvard Drug Group 351044 653014
Valley Wholesaler 309682 34348
Value Drug Company 460964 958983

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APRISO

APRISO® (mesalamine) extended-release capsules are indicated for the maintenance of remission of ulcerative colitis (UC) in patients 18 years and older.

APRISO is available in 0.375 g capsules.

Important Safety Information about APRISO

Complete Prescribing Information for APRISO pdf

To order APRISO, contact your wholesaler.

Wholesaler Account List and Order Entry Numbers
Product NDC #
APRISO 65649-103-02

Wholesaler Product Number
APRISO
AmerisourceBergen 262-626
Bellco Drug Co 301760
Burlington Drug Co 797431
Cardinal 4141412
CVS 695008
Dakota Drug 680694
Dik Drug 371252
F. W. Kerr 055715
H. D. Smith 2219186
King Drug 177840
Kinray 329060
McKesson 3215423
Miami Luken 097-287
Morris & Dickson 948745
Mutual Wholesale Drug 706903
Peytons Kroger Stores 281279
Peytons Non Kroger Stores 3624996
Prescription Supply, Inc 551440
Quality King Distributors 78876
Rochester Drug Cooperative 10200475
Smith Drug 06-5953
The Harvard Drug Group 788013
Valley Wholesaler 397463
Value Drug Company 984583
Walgreens 499935
Rite Aid 602798

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AZASAN

Salix is the exclusive source for AZASAN® (azathioprine tablets) 75 mg and 100 mg. AZASAN is an immunosuppressive antimetabolite indicated as an adjunct therapy for the prevention of rejection in renal homotransplantations and for the management of active rheumatoid arthritis to reduce signs and symptoms.

AZASAN is available in 2 dose strengths - 75 mg and 100 mg scored tablets.

Important Safety Information about AZASAN, including BOXED WARNING

Complete Prescribing Information for AZASAN, including BOXED WARNING pdf

To order AZASAN, contact your wholesaler.

Wholesaler Account List and Order Entry Numbers
Product NDC #
AZASAN 75 mg 65649-231-41
AZASAN 100 mg 65649-241-41

Wholesaler Product Number
AZASAN
75 mg 100 mg
AmerisourceBergen 935686 935698
Bellco Drug Co 945360 945378
Burlington Drug Co 753020 753053
Capital Wholesale Drug 312040 312042
Cardinal 3542024 3542040
Dakota Drug 357632 357764
Dik Drug 995993 996009
F. W. Kerr 22616 22624
H. D. Smith 1481050 1481068
King Drug 144543 144550
Kinray 776-047 776-146
McKesson 1875772 1749142
Miami Luken 011-577 011585
Morris & Dickson 471474 471482
Mutual Wholesale Drug 401141 401133
Peytons Kroger Stores 3602687 3602695
Peytons Non Kroger Stores 948265 948315
Prescription Supply, Inc 366773 366781
Quality King Distributors 66658 66657
Rochester Drug Cooperative 10077717 10077725
Smith Drug 195305 198143
The Harvard Drug Group 788002 788003
Valley Wholesaler 160549 160556
Value Drug Company 308007 307991

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COLAZAL

COLAZAL® (balsalazide disodium) is a locally acting aminosalicylate indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older.

The dosing for COLAZAL is three 750 mg capsules t.i.d. (Each daily dose of COLAZAL,
6.75 g, is equivalent to 2.4 g of mesalamine.)

Important Safety Information about COLAZAL

Complete Prescribing Information for COLAZAL pdf

To order COLAZAL, contact your wholesaler.

Wholesaler Account List and Order Entry Numbers
Product NDC #
COLAZAL 65649-101-02

Wholesaler Product Number
COLAZAL
AmerisourceBergen 571844
Bellco Drug Co 787895
Burlington Drug Co 392779
Capital Wholesale Drug 312056
Cardinal 2999852
Dakota Drug 106591
Dik Drug 939108
F. W. Kerr 09290
H. D. Smith 117-9126
King Drug 139808
Kinray 612887
McKesson 1344787
Miami Luken 906180
Morris & Dickson 377622
Mutual Wholesale Drug 198804
Peytons Kroger Stores 3649035
Peytons Non Kroger Stores 231209
Prescription Supply, Inc 285817
Quality King Distributors 71848
Rochester Drug Cooperative 10422509
Smith Drug 148999
The Harvard Drug Group 788001
Valley Wholesaler 83717
Value Drug Company 87205

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DEFLUX

DEFLUX® (dextranomer/hyaluronic acid copolymer [DX/HA]) is a bulking agent indicated for treatment of children with vesicoureteral reflux (VUR) grades II-IV. Deflux is an injectable viscous gel consisting of dextranomer microspheres and non-animal stabilized hyaluronic acid.

DEFLUX is available in a 1-mL prefilled syringe.

Important Safety Information about DEFLUX

Complete Prescribing Information for DEFLUX pdf

To order DEFLUX, call 1-866-433-3589.

Product Item Number
DEFLUX 1-mL prefilled syringe 159034
DEFLUX needle (3.7 F x 23 G tip x 350 mm) 238953

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DIURIL

DIURIL® (chlorothiazide) for oral suspension is indicated for the management of hypertension and also as adjunctive therapy in edema associated with congestive heart failure, cirrhosis of the liver, corticosteroid and estrogen therapy, and renal dysfunction.

DIURIL is available in a 237 ml bottle.

Important Safety Information about DIURIL

Complete Prescribing Information for DIURIL pdf

To order DIURIL, contact your wholesaler.

Wholesaler Account List and Order Entry Numbers
Product NDC #
DIURIL 65649-311-12

Wholesaler Product Number
DIURIL
AmerisourceBergen 091181
Bellco Drug Co 259101
Burlington Drug Co 090324
Cardinal 4044772
Dakota Drug 493429
Dik Drug 155713
F. W. Kerr 045898
H. D. Smith 2140499
Kinray 061549
McKesson 1491950
Miami Luken 284281
Morris & Dickson 826685
Mutual Wholesale Drug 665364
Rochester Drug Cooperative 24849002
Smith Drug 169326
Value Drug Company 116319

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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.

The most common adverse reactions occurring in at least 2% of male patients and at a rate greater than placebo in the clinical study were anemia, diarrhea, pharyngolaryngeal pain, urinary tract infection, arthralgia, insomnia, and musculoskeletal pain.

Important Safety Information about GIAZO

Please see complete Prescribing Information for GIAZO.pdf

To order GIAZO, contact your wholesaler.

Wholesaler Account List and Order Entry Numbers
Product NDC #
GIAZO 65649-102-02

Wholesaler Product Number
GIAZO
AmerisourceBergen 201-558/10111151
Bellco Drug Co 483760
Burlington Drug Co 874800
Cardinal 4800652
Dakota Drug 009993
H. D. Smith 357-7392
F.W. Kerr 121822
Kinray 880-229
Morris & Dickson 205872
Mc Kesson 2011401
Mutual Wholesale Drug O57075
Peytons Kroger Stores  401802
Prescription Supply, Inc. 680546
Rochester Drug Cooperative 10402345
Smith Drug 617951
Value Drug Company 107818

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METOZOLV ODT

FDA-approved in September 2009, METOZOLV® ODT (metoclopramide HCl) is an orally disintegrating metoclopramide tablet.

METOZOLV ODT is indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux disease (GERD) who fail to respond to conventional therapy and for the relief of symptoms associated with acute and recurrent diabetic gastroparesis (gastric stasis) in adults. Therapy with METOZOLV ODT should not exceed 12 weeks in duration and is recommended only for adults. The safety and effectiveness in pediatric patients have not been established.

METOZOLV ODT is available in 5-mg tablets.

Important Safety Information about METOZOLV ODT, including BOXED WARNING

Complete Prescribing Information for METOZOLV ODT, including BOXED WARNING pdf

To order METOZOLV ODT, contact your wholesaler.

Wholesaler Account List and Order Entry Numbers
Product NDC #
METOZOLV ODT 5 mg 65649-431-02

Wholesaler Product Number
METOZOLV ODT
5 mg
AmerisourceBergen 041-954
Bellco Drug Co 348550
Burlington Drug Co 903740
Cardinal 4254082
Dik Drug 155168
F. W. Kerr 087346
HEB 157171
H. D. Smith 2289502
King Drug 180653
Kinray 421-073
McKesson 1457969
Miami Luken 104-810
Morris & Dickson 020834
Mutual Wholesale Drug 765909
Peytons Kroger Stores 3629763
Peytons Non Kroger Stores 390062
Prescription Supply, Inc 564385
Quality King Distributors 60473
Rochester Drug Cooperative 10217164
Smith Drug 24-4012
The Harvard Drug Group 788014
Value Drug Company 066787

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MOVIPREP

FDA approved in August 2006, MOVIPREP® (PEG 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution) is indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older.

Important Safety Information about MOVIPREP

Complete Prescribing Information for MOVIPREP pdf

To order MOVIPREP, contact your wholesaler.

Wholesaler Account List and Order Entry Numbers
Product NDC #
MOVIPREP 65649-201-75

Wholesaler Product Number
MOVIPREP
AmerisourceBergen 491220
Bellco Drug Co 193025
Cardinal 3780004
CVS 409757
Dakota Drug 544825
Dik Drug 234187
F. W. Kerr 077016
H. D. Smith 197 0847
King Drug 0165621
Kinray 024083
McKesson 1859206
Miami Luken 047521
Morris & Dickson 699678
Peytons Kroger Stores 3617719
Peytons Non Kroger Stores 764571
Prescription Supply, Inc 406900
Quality King Distributors 71164
Rochester Drug Cooperative 10138394
Smith Drug 37536
The Harvard Drug Group 788012
Value Drug Company 546580
Walgreens 568183
Wal-Mart 3809778

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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, including BOXED WARNING

Complete Prescribing Information for OSMOPREP, including BOXED WARNING pdf

To order OSMOPREP, contact your wholesaler.

Wholesaler Account List and Order Entry Numbers
Product NDC #
OSMOPREP 65649-701-41

Wholesaler Product Number
OSMOPREP
AmerisourceBergen 754-270
Bellco Drug Co 175046
Burlington Drug Co 454447
Cardinal 3729951
CVS 396063
Dakota Drug 524363
Dik Drug 232629
F. W. Kerr 060632
H. D. Smith 1921451
King Drug 162552
Kinray 991737
McKesson 1677715
Miami Luken 046722
Morris & Dickson 672642
Mutual Wholesale Drug 551-200
Peytons Kroger Stores 3607082
Peytons Non Kroger Stores 681478
Prescription Supply, Inc 400556
Quality King Distributors 62432
Rochester Drug Cooperative 10130680
Smith Drug 10811
The Harvard Drug Group 006119
Valley Wholesaler 324269
Value Drug Company 525279
Walgreens 583434

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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, and erosive esophagitis due to GERD. PEPCID is also indicated for maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer and pathological hypersecretory conditions.

Important Safety Information about PEPCID

Complete Prescribing Information for PEPCID pdf

To order PEPCID, contact your wholesaler.

Wholesaler Account List and Order Entry Numbers
Product NDC #
PEPCID 65649-211-24

Wholesaler Product Number
PEPCID
AmerisourceBergen 102848
Bellco Drug Co 259098
Burlington Drug Co 455923
Cardinal 4044731
Dakota Drug 092593
Dik Drug 392696
F. W. Kerr 000380
H. D. Smith 2147569
Kinray 109173
McKesson 1495225
Miami Luken 607903
Morris & Dickson 826693
Mutual Wholesale Drug 837427
Quality King Distributors 62195
Rochester Drug Cooperative 10104909
Smith Drug 190488
The Harvard Drug Group 788000
Valley Wholesaler 393561
Value Drug Company 603290

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RELISTOR

Salix is now the exclusive source for RELISTOR® (methylnaltrexone bromide) subcutaneous injection. 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.

RELISTOR is administered as a subcutaneous injection.

Important Safety Information about RELISTOR

Complete Prescribing Information for RELISTORpdf

To order RELISTOR, contact your wholesaler.

Wholesaler Account List and Order Entry Numbers
Product NDC #
RELISTOR 12 mg Vial 65649-551-02
RELISTOR PFS 8 mg 1x7 Tray 65649-552-04
RELISTOR PFS 12 mg 1x7 Tray 65649-551-03

Wholesaler Product Number
RELISTOR RELISTOR PFS
12 mg Vial 8 mg 1x7 Tray 12 mg 1x7 Tray
AmerisourceBergen 138-204 154-898/
10102529
154-904/
10102540
Bellco Drug Co 448500 459233 459225
Burlington Drug Co 714998 992370 992362
Cardinal 4521324 4559605 4559613
Dakota Drug 653600 987198 987271
Dik Drug 357475 510370 510388
F. W. Kerr n/a n/a n/a
H. D. Smith 252-8552 256-9150 256-9168
Kinray 718700 4559605/
762-252
4559613/
762-260
McKesson 1404219 2493047 2492817
Morris & Dickson 964882 269076 269084
Mutual Wholesale Drug n/a n/a n/a
Prescription Supply, Inc n/a n/a n/a
Rochester Drug Cooperative n/a 10272243 10272250
Smith Drug 562975 575910 575902
The Harvard Drug Group n/a n/a n/a
Value Drug Company 756007 993444 993451

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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).

SOLESTA is available in a 1-mL prefilled syringe.

Important Safety Information about SOLESTA

Complete Prescribing Information for SOLESTA pdf

To order SOLESTA, call 1-866-435-7981.

Product PMA
SOLESTA 89114-850-03

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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

Complete Prescribing Information for XIFAXAN 550 mg pdf

To order XIFAXAN 550 mg , contact your wholesaler.

Wholesaler Account List and Order Entry Numbers
Product NDC #
XIFAXAN 550 mg
Bottles of 60 tablets
65649-303-02
XIFAXAN 550 mg
Hospital Unit Dose
60 tablets in 6 cards of 10 tablets
65649-303-03

Wholesaler Product Number
XIFAXAN 550 mg
60 count HUD
AmerisourceBergen 080-093 081-529
Bellco Drug Co 366248  
Burlington Drug Co 922732  
Capital Wholesale Drug TBD  
Cardinal 4300315 4301313
Dakota Drug 793752  
Dik Drug 421107  
F. W. Kerr 093807  
HEB 028505  
H.D. Smith 232-4325  
King / Bellamy Drug 181933  
Kinray 479-816  
McKesson 1968460 1972736
Miami Luken 109-116  
Morris & Dickson 067942 067959
Mutual Wholesale Drug 787-036  
Peytons Kroger Stores 046755  
Prescription Supply, Inc 571497  
Quality King Distributors 60721  
Rite Aid 600897  
Rochester Drug Cooperative 10228831  
Smith Drug 713388  
The Harvard Drug Group 788015  
Value Drug Company 677138  
Walgreens 461558  

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XIFAXAN 200 mg

XIFAXAN® (rifaximin) 200 mg was approved by the FDA in May 2004. XIFAXAN 200 mg tablets are indicated for the treatment of patients (12 years of age and older) with travelers' diarrhea caused by noninvasive strains of Escherichia coli.

XIFAXAN tablets are dosed one 200 mg tablet t.i.d. for 3 days.

Important Safety Information about XIFAXAN 200 mg

Complete Prescribing Information for XIFAXAN 200 mg pdf

To order XIFAXAN 200 mg , contact your wholesaler.

Wholesaler Account List and Order Entry Numbers
Product NDC #
XIFAXAN 200 mg 30 ct 65649-301-03
XIFAXAN 200 mg 100 ct 65649-301-41

Wholesaler Product Number
XIFAXAN 200 mg
30 ct 100 ct
AmerisourceBergen 496683 875219
Bellco Drug Co 963678 144231
Burlington Drug Co 77016 378307
Capital Wholesale Drug n/a 312055
Cardinal 3587524 3690369
Dakota Drug 473942 n/a
Dik Drug 996470 230946
F. W. Kerr 24893 n/a
H. D. Smith 158 5538 1837707
King Drug 148361 158428
Kinray 817189 897843
McKesson 1272889 1957919
Miami Luken 021-824 38630
Morris & Dickson 547273 637850
Mutual Wholesale Drug 433334 n/a
Peytons Kroger Stores 650192 n/a
Peytons Non Kroger Stores 3605649 n/a
Prescription Supply, Inc 372136 n/a
Quality King Distributors 68709 926
Rochester Drug Cooperative 10087047 10115483
Smith Drug 236166 355560
The Harvard Drug Group 400029 788010
Valley Wholesaler 178004 313700
Value Drug Company 369355 461467

To request a XIFAXAN 200 mg Formulary Dossier please call the Salix Medical Affairs Department at 1-800-508-0024.

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Important Safety Information about ANUSOL-HC and PROCTOCORT

ANUSOL-HCANUSOL-HC® (hydrocortisone cream, 2.5%) and PROCTOCORTPROCTOCORT® (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%pdf

PROCTOCORT® Hydrocortisone Cream, 1%pdf

For ANUSOL-HC® Hydrocortisone Acetate Suppository, 25 mgpdf

For PROCTOCORT® Hydrocortisone Acetate Suppository, 30 mgpdf

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

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

Important Safety Information about COLAZAL

COLAZALCOLAZAL® (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.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)

Important Safety Information about DIURIL

DIURILDIURIL® (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.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 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 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.

Important Safety Information about PEPCID

PEPCIDPEPCID® (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.pdf

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 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 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: customerservice@salix.com

Please see complete Prescribing Information for XIFAXAN.

Indication for XIFAXAN 200 mg

The treatment of patients (≥ 12 years of age) with travelers' diarrhea (TD) caused by noninvasive strains of Escherichia coli.

Important Safety Information about XIFAXAN 200 mg

XIFAXAN® (rifaximin) 200 mgXIFAXAN® (rifaximin) 200 mg tablets are not for everyone. Do not take XIFAXAN if you have a known hypersensitivity to rifaximin or any of the ingredients in XIFAXAN.

If you have a fever and/or blood in your stool, XIFAXAN is not the right option for you. If your healthcare provider has told you that the cause of your diarrhea is something other than E. coli, XIFAXAN is not the right option for you. If your symptoms of diarrhea get worse or last more than 24-48 hours, you should call your healthcare provider.

XIFAXAN, like nearly all antibiotics, can alter the normal bacteria of the gut. 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.

There is an increased chance that XIFAXAN will spread through your body if your liver is not working well. 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—occurring in at least 5% of patients—were gas, headache, stomach pain, feeling of constantly needing to pass stools, feeling the need to pass stools urgently, and nausea.

Xifaxan 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 200 mg.pdf

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

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

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