Ordering
This information is intended for U.S. Pharmacists only.
COLAZAL
Salix's lead product, COLAZAL® (balsalazide disodium), was approved by the U.S. Food and Drug Administration (FDA) in July 2000 for the treatment of mildly to moderately active ulcerative colitis. COLAZAL Capsules 750 mg is an azo–bonded prodrug that delivers 99% of 5–ASA directly to the colon. It is sulfa-free and not pH dependent.
The dosing for COLAZAL is 3–750 mg capsules tid. (Each daily dose of COLAZAL,
6.75 g is equivalent to 2.4 g of mesalamine.)
To order COLAZAL, contact your wholesaler.
Wholesaler Account List and Order Entry Numbers
| Product |
NDC # |
| COLAZAL 280 ct |
65649-101-02 |
| COLAZAL 500 ct |
65649-101-50 |
| Wholesaler |
Product Number |
| COLAZAL |
| 280 ct | 500 ct |
| AmerisourceBergen | 4337911 | 875925 |
| Bellco Drug Co | 787895 | 144240 |
| Burlington Drug Co | 392779 | 378273 |
| Capital Wholesale Drug | 312056 | 312052 |
| Cardinal | 2999852 | 3690047 |
| D & K Wholesale | 823988 | 86835 |
| Dakota Drug | 106591 | 501874 |
| F. Dohmen Company | 164491 | 179054 |
| Dik Drug | 939108 | 230938 |
| H. D. Smith/Barnes | 117-9126 | 1837715 |
| F.W. Kerr | 9290 | n/a |
| King / Bellamy Drug | 139808 | n/a |
| Kinray | 612887 | 987942 |
| McQueary Bros. | 393258 | 498-521 |
| Miami Luken | 906180 | 38562 |
| Morris & Dickson | 377622 | 637843 |
| Mc Kesson | 1344787 | 1956937 |
| Mutual Wholesale Drug | 198804 | n/a |
| Peytons Kroger Stores | 3649035 | n/a |
| Peytons Non Kroger Stores | 231209 | n/a |
| Prescription Supply, Inc. | 285817 | n/a |
| Quality King Distributors | 71848 | 925 |
| Rochester Drug Cooperative | 10422509 | 10115491 |
| Smith Drug | 148999 | n/a |
| The Harvard Drug Group | 788001 | n/a |
| Valley Drug Company (OH) | 791699 | n/a |
| Valley Wholesaler | 83717 | 313718 |
| Value Drug Company | 87205 | 461475 |
To request a COLAZAL Formulary Dossier please call the Salix Medical Affairs Department at 1-800-508-0024.
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XIFAXAN
Salix's product, XIFAXAN® (rifaximin), was approved by the U.S. Food and Drug Administration in May 2004. XIFAXAN is a semi-synthetic, nonsystemic antibiotic. 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 is now approved in 19 countries and
has been used for over 19 years in Italy with over 500 million tablets prescribed.
XIFAXAN tablets are dosed one 200 mg tablet tid for 3 days.
To order XIFAXAN, contact your wholesaler.
Wholesaler Account List and Order Entry Numbers
| Product |
NDC # |
| XIFAXAN 30 ct |
65649-301-03 |
| XIFAXAN 100 ct |
65649-301-41 |
| XIFAXAN HUD* |
65649-301-05 |
*HUD - Hospital Unit Dose
| Wholesaler |
Product Number |
| XIFAXAN |
| 30 ct | 100 ct | HUD |
| AmerisourceBergen | 496683 | 875219 | 041044/4951273 |
| Bellco Drug Co | 963678 | 144231 | |
| Burlington Drug Co | 77016 | 378307 | |
| Capital Wholesale Drug | n/a | 312055 | |
| Cardinal | 3587524 | 3690369 | 3745239 |
| D & K Wholesale | 12971 | 86843 | |
| Dakota Drug | 473942 | n/a | |
| F. Dohmen Company | 801787 | 179031 | |
| Dik Drug | 996470 | 230946 | |
| H. D. Smith/Barnes | 158 5538 | 1837707 | |
| F.W. Kerr | 24893 | n/a | |
| King / Bellamy Drug | 148361 | 158428 | |
| Kinray | 817189 | 897843 | |
| McQueary Bros. | 375640 | 143-820 | |
| Miami Luken | 021-824 | 38630 | |
| Morris & Dickson | 547273 | 637850 | 676874 |
| Mc Kesson | 1272889 | 1957919 | 1399666 |
| Mutual Wholesale Drug | 433334 | n/a | |
| Peytons Kroger Stores | 3605649 | n/a | |
| Peytons Non Kroger Stores | 650192 | n/a | |
| Prescription Supply, Inc. | 372136 | n/a | |
| Quality King Distributors | 68709 | 926 | |
| Rochester Drug Cooperative | 10087047 | 10115483 | |
| Smith Drug | 236166 | n/a | |
| The Harvard Drug Group | 400029 | 788010 | |
| Valley Drug Company (OH) | 834523 | n/a | |
| Valley Wholesaler | 178004 | 313700 | |
| Value Drug Company | 369355 | 461467 | |
To request a XIFAXAN Formulary Dossier please call the Salix Medical Affairs Department at 1-800-508-0024.
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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), provides the efficacy of a 4–L PEG lavage in a tolerable lower volume. MoviPrep is the only PEG lavage with ascorbic acid and sodium ascorbate to increase stool volume and enhance taste.
MoviPrep is indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older. MoviPrep offers a tolerable dosing regimen that does not require the use of bisacodyl tablets, thereby avoiding bisacodyl-associated cramping in patients. Please click below to view MoviPrep's simple dosing and easy to follow patient instruction sheets.
Please click here (PDF 769KB) to view MoviPrep's simple dosing and easy to follow patient instruction sheets.
To order MoviPrep, contact your wholesaler.
Wholesaler Account List and Order Entry Numbers
| Product |
NDC # |
| MoviPrep |
65649-201-75 |
| Wholesaler |
Product Number |
| MoviPrep |
| AmerisourceBergen | 491220/4957288 |
| Bellco Drug Co | 193025 |
| Burlington Drug Co | n/a |
| Capital Wholesale Drug | n/a |
| Cardinal | 3780004 |
| CVS | 409757 |
| D & K Wholesale | 1859206 |
| Dakota Drug | 544825 |
| F. Dohmen Company | 3780004 |
| Dik Drug | 234187 |
| H. D. Smith/Barnes | 197 0847 |
| F.W. Kerr | 077016 |
| King / Bellamy Drug | 0165621 |
| Kinray | 024083 |
| McQueary Bros. | 936529 |
| Miami Luken | 047521 |
| Morris & Dickson | 699678 |
| Mc Kesson | 1859206 |
| Mutual Wholesale Drug | n/a |
| Peytons Non Kroger Stores | 764571 |
| Peytons Kroger Stores | 3617719 |
| Prescription Supply, Inc. | 406900 |
| Quality King Distributors | n/a |
| Rochester Drug Cooperative | 10138394 |
| Smith Drug | 37536 |
| The Harvard Drug Group | 788012 |
| Valley Drug Company (OH) | n/a |
| Valley Wholesaler | n/a |
| Value Drug Company | 546580 |
| Walgreens | 568183 |
| Wal-Mart | 3809778 |
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OSMOPREP
The newest addition to the Salix gastroenterology product line is OsmoPrep® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets.
OsmoPrep Tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older. This unique, virtually tasteless tablet formulation can be taken with any
clear liquid and has been demonstrated to improve patient compliance and satisfaction through improved patient tolerability.
To order OsmoPrep, contact your wholesaler.
Wholesaler Account List and Order Entry Numbers
| Product |
NDC # |
| OsmoPrep |
65649-701-41 |
| Wholesaler |
Product Number |
OsmoPrep 100 ct |
| AmerisourceBergen | 4938601 754-270 |
| Bellco Drug Co | 175046 |
| Burlington Drug Co | 454447 |
| Capital Wholesale Drug | n/a |
| Cardinal | 3729951 |
| D & K Wholesale | 1677715 |
| Dakota Drug | 524363 |
| F. Dohmen Company | 213436 |
| Dik Drug | 232629 |
| H. D. Smith/Barnes | 1921451 |
| F.W. Kerr | 060632 |
| King / Bellamy Drug | 162552 |
| Kinray | 991737 |
| McQueary Bros. | 534935 |
| Miami Luken | 046722 |
| Morris & Dickson | 672642 |
| Mc Kesson | 1677715 |
| Mutual Wholesale Drug | 551-200 |
| Peytons Non Kroger Stores | 681478 |
| Peytons Kroger Stores | 3607082 |
| Prescription Supply, Inc. | 400556 |
| Quality King Distributors | n/a |
| Rochester Drug Cooperative | 10130680 |
| Smith Drug | 10811 |
| The Harvard Drug Group | 006119 |
| Valley Drug Company (OH) | n/a |
| Valley Wholesaler | 324269 |
| Value Drug Company | 525279 |
| Walgreens | 583434 |
| CVS | 396063 |
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AZASAN
Salix is now the exclusive source for AZASAN® (azathioprine tablets) 75 mg and 100 mg. AZASAN is a potent immunosuppressive antimetabolite indicated as an adjunct therapy for the
prevention of rejection in renal homotransplantations and for the management of severe active rheumatoid arthritis. Immunosuppressants such as azathioprine are effective in helping to control the
inflammatory process and thus reducing the need for chronic steroid treatment and its related adverse events.
AZASAN® is available in two dose strengths - 75 mg and 100 mg scored tablets - so therapy can be tailored to optimal therapeutic effect. Previously azathioprine was only available in a
50 mg dose- AZASAN is the only azathioprine available in the 75 mg and 100 mg strengths.
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 |
| D & K Wholesale | 996068 | 996025 |
| Dakota Drug | 357632 | 357764 |
| F. Dohmen Company | 615542 | 615559 |
| Dik Drug | 995993 | 996009 |
| H. D. Smith/Barnes | 1481050 | 1481068 |
| F.W. Kerr | 22616 | 22624 |
| King / Bellamy Drug | 144543 | 144550 |
| Kinray | 776-047 | 776-146 |
| McQueary Bros. | 350-486 | 240-958 |
| Miami Luken | 011-577 | 011585 |
| Morris & Dickson | 471474 | 471482 |
| Mc Kesson | 1875772 | 1749142 |
| 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 Drug Company (OH) | 308007 | 307991 |
| Valley Wholesaler | 160549 | 160556 |
| Value Drug Company | 308007 | 307991 |
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ANUSOL/PROCTOCORT
ANUSOL-HC® is available as either a 2.5% hydrocortisone cream or a 25 mg hydrocortisone acetate suppository to provide soothing relief from anorectal itching, burning, and inflammation.
Applied as a thin film to the affected area using a convenient, easily inserted dispensing cap, the concentrated cream forms a protective coating over tissues with no greasy build-up. Providing symptom
relief as the product is absorbed, the suppository offers easy, consistent administration for inflammatory processes in the anorectum that require a mild suppository.
PROCTOCORT® is available either as a 1% hydrocortisone cream or a 30 mg hydrocortisone acetate suppository to provide soothing relief from anorectal itching, burning, and inflammation.
The cream is a nonstaining, water miscible preparation with a mild unique acid mantle base. The suppository provides convenient, accurate, and consistent dose administration for problems requiring a
higher potency agent.
To order ANUSOL-HC or PROCTOCORT, contact your wholesaler.
Wholesaler Account List and Order Entry Numbers
| Product |
NDC # |
| Anusol CREAM |
65649-401-30 |
| Anusol SUPP 12s |
65649-411-12 |
| Anusol SUPP 24s |
65649-411-24 |
| PROCTOCORT CREAM |
65649-501-30 |
| PROCTOCORT SUPP 12s |
65649-511-12 |
| PROCTOCORT SUPP 24s |
65649-511-24 |
| Wholesaler |
Product Number |
| ANUSOL-HC |
| Cream |
Supp-12s |
Supp-24s |
| AmerisourceBergen | 031132 | 110569 | 110577 |
| -- Bergen | 4870192 | 4871497 | 4871513 |
| Bellco Drug Co | 742668 | 793000 | 790998 |
| Burlington Drug Co | 669515 | 003558 | 003566 |
| Capital Wholesale Drug | 203215 | 203212 | 203213 |
| Cardinal | 3664653 | 3664661 | 3664679 |
| D & K Wholesale | 440116 | 710164 | 462039 |
| Dakota Drug | 392720 | 191791 | n/a |
| F. Dohmen Company | 43273 | 107987 | 107953 |
| Dohman Distribution SouthEast | 810887 | 961250 | 962845 |
| Dik Drug | 565606 | 21444 | 44321 |
| Diversified Health Care | 440116 | 710164 | 462039 |
| H. D. Smith/Barnes | 504-0670 | 504-0688 | 504-0696 |
| F.W. Kerr | 205393 | 205104 | 205237 |
| King / Bellamy Drug | 877977 | 272377 | n/a |
| Kinray | 207-563 | 102-707 | 002-683 |
| McQueary Bros. | 517852 | 772461 | 628859 |
| Miami Luken | 751198 | 70268 | 329983 |
| Morris & Dickson | 292433 | 512046 | 389122 |
| Mc Kesson | 1226521 | 1228980 | 1243948 |
| North Carolina Mutual | 157222 | 158055 | 158063 |
| Peytons Non Kroger Stores | 610253 | 18895 | n/a |
| Peytons Kroger Stores | 3658366 | 3680071 | n/a |
| Prescription Supply, Inc. | n/a | n/a | n/a |
| Quality King Distributors | 0 0739 | 0 0737 | 0 0738 |
| Rochester Drug Cooperative | 12403606 | 3366002 | 90012402 |
| Smith Drug | 13-8453 | 15-9004 | 71-3353 |
| The Harvard Drug Group | 327026 | 327037 | n/a |
| Valley Drug Company (OH) | 89458 | 445593 | 51383 |
| Valley Wholesaler | 386359 | 180711 | 180729 |
| Value Drug Company | 710632 | 140715 | 411298 |
| Wholesaler |
Product Number |
| PROCTOCORT |
| Cream |
Supp-12s |
Supp-24s |
| AmerisourceBergen | 001786 | 373563 | 456863 |
| -- Bergen | 4864286 | 4871521 | 4871539 |
| Bellco Drug Co | 780932 | 684712 | 749291 |
| Burlington Drug Co | 525113 | 266536 | n/a |
| Capital Wholesale Drug | 340426 | 340425 | n/a |
| Cardinal | 3659802 | 3664620 | 3664646 |
| D & K Wholesale | 192252 | 330582 | 908142 |
| Dakota Drug | 157891 | n/a | n/a |
| F. Dohmen Company | 112219 | 85712 | n/a |
| Dohman Distribution SouthEast | 938928 | 321729 | 722918 |
| Dik Drug | 35147 | 866210 | n/a |
| Diversified Health Care | 192252 | 330582 | 908124 |
| H. D. Smith/Barnes | 504-0142 | 504-0266 | 103-1079 |
| F.W. Kerr | 204446 | 89334 | n/a |
| King / Bellamy Drug | n/a | 970822 | n/a |
| Kinray | 78-105 | 472-043 | 553-586 |
| McQueary Bros. | 487058 | 985147 | 853720 |
| Miami Luken | 246801 | 861807 | 881953 |
| Morris & Dickson | 375295 | 201640 | 318949 |
| Mc Kesson | 1381045 | 1250620 | 1265644 |
| North Carolina Mutual | 133314 | 776054 | 022681 |
| Peytons Non Kroger Stores | n/a | 14092 | n/a |
| Peytons Kroger Stores | n/a | 3681087 | n/a |
| Prescription Supply, Inc. | 159509 | 260026 | n/a |
| Quality King Distributors | 70022 | 72603 | 78502 |
| Rochester Drug Cooperative | 54174008 | 12403705 | n/a |
| Smith Drug | 32-5829 | 29-6558 | 39-3504 |
| The Harvard Drug Group | 351044 | 653014 | n/a |
| Valley Drug Company (OH) | 46789 | 747998 | n/a |
| Valley Wholesaler | 309682 | 34348 | n/a |
| Value Drug Company | 460964 | 958983 | 19661 |
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VISICOL
VISICOL® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets. VISICOL is available in 40 and 100 count bottles.
To order VISICOL®, contact your wholesaler.
Wholesaler Account List and Order Entry Numbers
| Product |
NDC # |
| VISICOL 40 ct |
66934-100-40 |
| VISICOL 100 ct |
66934-100-01 |
| Wholesaler |
Product Number |
| VISICOL |
| 40 ct | 100 ct |
| AmerisourceBergen | 476503 | 476717 |
| Bellco Drug Co | 854125 | 144178 |
| Burlington Drug Co | 390872 | 109538 |
| Capital Wholesale Drug | 502100 | n/a |
| Cardinal | 3715620 | 3715612 |
| D & K Wholesale | 800244 | 021903 |
| Dakota Drug | 75259 | n/a |
| F. Dohmen Company | 172262 | 814160 |
| Dik Drug | 939793 | 996686 |
| H. D. Smith/Barnes | 1321439 | 1625300 |
| F.W. Kerr | 013722 | n/a |
| King / Bellamy Drug | 140178 | n/a |
| Kinray | 612606 | 828517 |
| McQueary Bros. | 548170 | 808547 |
| Miami Luken | 906917 | 029017 |
| Morris & Dickson | 109199 | 562124 |
| Mc Kesson | 3675576 | 1117373 |
| Mutual Wholesale Drug | n/a | 455253 |
| Peytons Kroger Stores | 3634029 | n/a |
| Peytons Non Kroger Stores | 015388 | n/a |
| Prescription Supply, Inc. | 285650 | 381715 |
| Quality King Distributors | 66254 | 128 |
| Rochester Drug Cooperative | 10423408 | 10094670 |
| Smith Drug | 15-8691 | n/a |
| The Harvard Drug Group | 787001 | 002700 |
| Valley Drug Company (OH) | 795146 | 843243 |
| Valley Wholesaler | 084764 | n/a |
| Value Drug Company | 087361 | 389825 |
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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.
For complete Prescribing Information please click product name below:
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
APRISO™ is a locally-acting aminosalicylate indicated for the maintenance of remission of ulcerative colitis in patients 18 years and older.
APRISO is contraindicated in patients with hypersensitivity to salicylates, aminosalicylates, or to any of the components of APRISO capsules.
The recommended dose of APRISO is four 0.375 g capsules once daily in the morning (1.5 g/day) with or without food. Because dissolution of the coating of APRISO
granules depends on pH, APRISO should not be coadministered with antacids. Patients with phenylketonuria should be aware that APRISO contains aspartame,
equivalent to 0.56 mg of phenylalanine. In two well-controlled clinical trials, the most common treatment-related adverse events occurring in at least 3%
of adult patients taking 1.5 g/day of APRISO were headache (11% vs. 8% for placebo), diarrhea (8% vs. 7% for placebo), upper abdominal pain (5% vs 3% for placebo),
nausea (4% vs 3% for placebo), nasopharyngitis (4% vs 3% for placebo), influenza and influenza-like illness (4% vs 4% for placebo) and sinusitis (3% vs 3% for placebo).
For complete Prescribing Information, please click here.
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.
WARNING: Chronic immunosuppression with this purine antimetabolite increases risk of neoplasia in humans. 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. See WARNINGS section in complete Prescribing Information.
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. 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.
For complete Prescribing Information, please click here.
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.
For complete Prescribing Information, please click here.
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.
For complete Prescribing Information, please click here.
Important Safety Information about METOZOLV ODT
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.
Please see accompanying Prescribing Information for METOZOLV ODT, including
BOXED WARNINGS.
METOZOLV™ ODT
(metoclopramide HCl) is indicated as short-term 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 (diabetic gastric
stasis) in adults. Therapy should not exceed 12 weeks in duration. 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. METOZOLV ODT should be used with caution in patients showing acute dystonic reactions, drug-induced Parkinsonism, or other extrapyramidal symptoms;
neuroleptic malignant syndrome; with a prior history of depression; hypertension; congestive heart failure and ventricular arrhythmia. Patients may experience
withdrawal symptoms after stopping the use of METOZOLV ODT.
In clinical studies, the most frequently reported adverse events (>2% occurrence) were headache, nausea, fatigue, somnolence, and vomiting.
For complete Prescribing Information, please click here.
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. MoviPrep is contraindicated in patients who have had a severe hypersensitivity reaction
to any of its components. MoviPrep should be used with caution in patients using concomitant medications that increase the risk of electrolyte abnormalities, in patients with known or suspected hyponatremia,
severe ulcerative colitis, ileus, gastrointestinal obstruction or perforation, gastric retention, toxic colitis, toxic megacolon, or glucose-6-phosphate dehydrogenase deficiency. In clinical trials, abdominal
distention, anal discomfort, thirst, nausea, and abdominal pain were the most common adverse reactions to MoviPrep administration. MoviPrep contains a maximum of 2.33 mg of phenylalanine per treatment.
Consult with your physician to see if this product is right for you.
For complete Prescribing Information, please click here.
Important Safety Information about OsmoPrep
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).
Please see accompanying brief summary of Prescribing Information for OsmoPrep, including
BOXED WARNINGS.
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. Considerable caution should be advised before OsmoPrep is used in
patients with severe renal insufficiency, congestive heart failure, ascites, unstable angina, gastric retention, ileus, severe chronic constipation,
bowel perforation, toxic megacolon, gastric bypass or stapling surgery, or hypomotility syndrome. Use with caution in patients with impaired renal
function, patients with a history of seizures or at higher risk of seizure, patients with higher risk of cardiac arrhythmias, known or suspected electrolyte
disturbances (such as dehydration), or people taking drugs that affect electrolyte levels. Patients with electrolyte abnormalities such as
hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia should have their electrolytes corrected before treatment with OsmoPrep.
OsmoPrep is contraindicated in patients with a known allergy or hypersensitivity to sodium phosphate salts or any of its ingredients, and in patients with
biopsy–proven acute phosphate nephropathy. In clinical trials, the most commonly reported adverse reactions (reporting frequency >3%) were
abdominal bloating, nausea, abdominal pain, and vomiting. It is recommended that patients receiving OsmoPrep be advised to adequately hydrate before,
during, and after the use of OsmoPrep.
For complete Prescribing Information, please click here.
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.
For complete Prescribing Information, please click here.
VISICOL® (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. VISICOL is not to be used in patients with congestive heart failure, ascites, unstable angina pectoris, gastric retention, ileus or acute obstruction or
pseudo-obstruction, severe chronic constipation, bowel perforation, acute colitis, toxic megacolon, or hypomotility syndrome. Use with caution in patients with impaired renal function, pre-existing electrolyte
disturbances, or people taking drugs that affect electrolyte levels. VISICOL is contraindicated in patients with a known allergy or hypersensitivity to sodium phosphate salts or any of its ingredients. In clinical
trials, the most commonly observed (>1%) adverse reactions occurring with use of VISICOL were generally transient and self-limited and included nausea, vomiting, abdominal bloating, abdominal pain, dizziness and
headache.
Consult with your physician to see if this product is right for you.
For complete Prescribing Information, please click here.
SAFETY CONSIDERATIONS
Xifaxan® (rifaximin) 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 Escherichia coli. Xifaxan should be
discontinued if diarrhea symptoms get worse or persist more than 24-48 hours and alternative antibiotic therapy should be considered. Escherichia 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%).
For complete Prescribing Information, please click here.
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
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