BULLETIN # 46. Manitoba Drug Benefits and Interchangeability Formulary Amendments. The following amendments will take effect on January 3, 2005.

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1 BULLETIN # 46 Manitoba Drug Benefits and Interchangeability Formulary Amendments The following amendments will take effect on January 3, The amended Manitoba Specified Drug Regulation and Drug Interchangeability Formulary Regulation will be available on the Manitoba Health website on the effective date of January 3, Bulletin 46 is currently available for download: Inside This Issue Part 1 Additions Pages 1-2 Part 2 Additions Page 2 Part 3 Additions Pages 2-4 New Interchangeable Categories Pages 4-6 New Interchangeable Products Pages 6-9 Product Deletions Pages 9-11 Category Deletions Page 11 Interchangeable Product Price Changes Pages Discontinued Products Pages Manufacturers Update Pages 14-15

2 Part 1 Additions DIN TRADE NAME GENERIC STRENGTH FORM MFR* Apo-Amiloride amiloride 5 mg APX / Apo-Atenidone atenolol/chlorthalidone mg/ APX mg Apo-Bisoprolol bisoprolol fumarate APX Apo-Clonidine clonidine HCl 0.0 APX mg Apo-Quinine quinine sulfate mg Capsules APX Co Atenolol atenolol mg COB Co Fluvoxamine fluvoxamine mg COB mg Co Lovastatin lovastatin mg COB mg Co Metformin metformin HCl COB Gen-Clindamycin clindamycin HCl mg Capsules GPM mg Controlled mg Gen-Diltiazem CD diltiazem HCl Delivery mg Capsules mg GPM Gen-Mirtazapine mirtazapine 30 mg GPM Novo-Dipam diazepam 2 mg 5 mg Novo-Mirtazapine mirtazapine 30 mg NOP Novo-Pramine imipramine HCl NOP Novo-Triptyn Octreotide Acetate Omega Plan B (Maximum 3 treatments [6 tablets] per benefit year.) pms-amitriptyline pms-diazepam pms-furosemide pms- Hydrochlorothiazide Rhoxal-acebutolol amitriptyline HCl octreotide acetate 50 mcg/ml 100 mcg/ml 200 mcg/ml 500 mcg/ml Injection NOP NOP OMA levonorgesterol 0.75 mg PAL amitriptyline HCl diazepam furosemide hydrochlorothiazide acebutolol HCl 2 mg 5 mg 20 mg 40 mg 100 mg 200 mg 400 mg Rhoxal-gliclazide gliclazide 80 mg RXP PMS PMS PMS PMS RXP 1 of 15

3 Part 1 (cont'd) Rhoxal-paroxetine Rhoxal-sotalol paroxetine HCl sotalol HCl 20 mg 30 mg 80 mg 160 mg 5 mg 7.5 mg Rhoxal-zopiclone zopiclone Sab-Trifluridine trifluridine 1% *Abbreviation of Manufacturers' Names RXP RXP RXP SIL Part 2 Additions Apo-Methylphenidate methylphenidate - For the treatment of attention deficit disorder and narcolepsy. 20 mg APX Co Etidronate etidronate disodium 200 mg COB (a) For the treatment of Paget's Disease; (b) For maintenance therapy in hypercalcemia of malignancy pms-ofloxacin ofloxacin 0.3% - For the treatment of ophthalmic infections caused by gram-negative organisms or those not responding to alternative agents. PMS Part 3 Additions The following products will be considered for Pharmacare reimbursement upon an individual prescriber/patient request basis Alphagan P brimonidine tartrate 0.15% - for intolerance to Alphagan ALL Apo-Leflunomide leflunomide 20 mg - For Rheumatoid Arthritis failing at least two (2) disease modifying antirheumatic drugs (DMARDs); e.g.: Gold, methotrexate (MTX), hydroxychloroquine, sulfasalazine, minocycline and doxycycline. APX 2 of 15

4 mg Co Meloxicam meloxicam 15 mg - For the long-term treatment of osteoarthritis or rheumatoid arthritis in patients who have one or more of the following risk factors: (a) Previous peptic ulcer, gastrointestinal bleeding, gastric outlet obstruction (endoscopy or radiographic evidence); (b) Elderly (more than 65 years of age); (c) Concurrent warfarin therapy; (d) Bleeding disorders; and (e) Concurrent prednisone therapy at doses greater than 5 mg/day for more than 2 weeks. OR Where at least 3 NSAID's have been tried and failed or were not tolerated. NOTE: For treatment of osteoarthritis, patients must have completed an adequate trial of acetaminophen. If a patient is receiving a proton pump inhibitor (PPI) for reflux disease, COX-2 inhibitors are not warranted for additional protection. COB mg Gen-Meloxicam meloxicam 15 mg - For the long-term treatment of osteoarthritis or rheumatoid arthritis in patients who have one or more of the following risk factors: (a) Previous peptic ulcer, gastrointestinal bleeding, gastric outlet obstruction (endoscopy or radiographic evidence); (b) Elderly (more than 65 years of age); (c) Concurrent warfarin therapy; (d) Bleeding disorders; and (e) Concurrent prednisone therapy at doses greater than 5 mg/day for more than 2 weeks. OR Where at least 3 NSAID's have been tried and failed or were not tolerated. NOTE: For treatment of osteoarthritis, patients must have completed an adequate trial of acetaminophen. If a patient is receiving a proton pump inhibitor (PPI) for reflux disease, COX-2 inhibitors are not warranted for additional protection. GPM mg Novo-Meloxicam meloxicam 15 mg - For the long-term treatment of osteoarthritis or rheumatoid arthritis in patients who have one or more of the following risk factors: (a) Previous peptic ulcer, gastrointestinal bleeding, gastric outlet obstruction (endoscopy or radiographic evidence); (b) Elderly (more than 65 years of age); (c) Concurrent warfarin therapy; (d) Bleeding disorders; and (e) Concurrent prednisone therapy at doses greater than 5 mg/day for more than 2 weeks. OR Where at least 3 NSAID's have been tried and failed or were not tolerated. NOTE: For treatment of osteoarthritis, patients must have completed an adequate trial of acetaminophen. If a patient is receiving a proton pump inhibitor (PPI) for reflux disease, COX-2 inhibitors are not warranted for additional protection. NOP 3 of 15

5 Part 3 (cont'd) Rhoxal-anagrelide anagrelide HCl 0.5 mg Capsule RXP - For the treatment of: (a) Polycythemia (an excess of red blood cells); (b) Thrombocythemia (increased platelet count) for patients failing or with contraindications to hydroxyurea Rhoxal-loperamide loperamide HCl 2 mg RXP For the treatment of: (a) an ileostomy or a colostomy; (b) bowel resection, including short bowel syndrome; (c) Inflammatory Bowel Diseases, i.e. Crohn's Disease, Ulcerative Colitis (this may include nonspecific colitis, microscopic colitis), and "diabetic gut" (neuropathy of the gut); (d) Cancer, including chemotherapy or radiation therapy; (e) HIV/AIDS; (f) fecal incontinence Serc betahistine dihydrochloride 24 mg SPH - For the treatment of Meniere's Disease. New Interchangeable Categories The following new interchangeable categories and products were added: Generic Name - Strength - Form DIN Trade Name Manufacturer Price in Dollars Amiloride HCl - 5 mg - Tablet $ Midamor MFX Apo-Amiloride APX Amitriptyline HCl - - $ pms-amitriptyline PMS Novo-Triptyn NOP Apo-Amitriptyline APX Amitriptyline HCl - - $ pms-amitriptyline PMS Novo-Triptyn NOP Apo-Amitriptyline APX Amitriptyline HCl - - $ pms-amitriptyline PMS Novo-Triptyn NOP Apo-Amitriptyline APX of 15

6 New IC Categories (Cont'd) Anagrelide HCl mg - Capsules $ Agrylin SHI Rhoxal-anagrelide RXP Atenolol/Chlorthalidone - / - $ Tenoretic AZC Apo-Atenidone APX Atenolol/Chlorthalidone mg/ - $ Tenoretic AZC Apo-Atenidone APX Clonidine HCl Tablet $ Dixarit BOE Apo-Clonidine APX Diazepam - 2 mg - $ Novo-Dipam NOP pms-diazepam PMS Apo-Diazepam APX Imipramine HCl - - $ Novo-Pramine NOP Apo-Imipramine APX Leflunomide - - $ Arava AVT Apo-Leflunomide APX Leflunomide - 20 mg - $ Arava AVT Apo-Leflunomide APX Octreotide Acetate - 50 mcg/ml - Injection Per ml $ Sandostatin NVT Octreotide Acetate Omega OMA Octreotide Acetate mcg/ml - Injection Per ml $ Sandostatin NVT Octreotide Acetate Omega OMA Octreotide Acetate mcg/ml - Injection Per ml $ Sandostatin NVT Octreotide Acetate Omega OMA of 15

7 New IC Categories (Cont'd) Octreotide Acetate mcg/ml - Injection Per ml $ Sandostatin NVT Octreotide Acetate Omega OMA Trifluridine - 1% - Per ml $ Viroptic BWE Sab-Trifluridine SIL New Interchangeable Products The following products have been added to existing interchangeable drug categories: Acebutolol HCl mg - $ Rhoxal-acebutolol RXP Acebutolol HCl mg - $ Rhoxal-acebutolol RXP Acebutolol HCl mg - $ Rhoxal-acebutolol RXP Atenolol - - $ Co Atenolol COB Atenolol mg - $ Co Atenolol COB Bisoprolol Fumarate - 5 mg - $ Apo-Bisoprolol APX ** Bisoprolol Fumarate - - $ Apo-Bisoprolol APX ** Clindamycin HCl Capsules $ Gen-Clindamycin GPM ** Clindamycin HCl mg - Capsules $ Gen-Clindamycin GPM ** Diazepam - 5 mg - $ pms-diazepam PMS Novo-Dipam NOP ** of 15

8 New IC Products (Cont'd) Diazepam - - $ pms-diazepam PMS Novo-Dipam NOP ** Diltiazem HCl mg - Controlled Delivery Capsules $ Gen-Diltiazem CD GPM Diltiazem HCl mg - Controlled Delivery Capsules $ Gen-Diltiazem CD GPM Diltiazem HCl mg - Controlled Delivery Capsules $ Gen-Diltiazem CD GPM Diltiazem HCl mg - Controlled Delivery Capsules $ Gen-Diltiazem CD GPM Etidronate Disodium mg - $ Co Etidronate COB ** Fluvoxamine Maleate - - $ Co Fluvoxamine COB Fluvoxamine Maleate mg - $ Co Fluvoxamine COB Furosemide - 20 mg - $ pms-furosemide PMS Furosemide - 40 mg - $ pms-furosemide PMS Gliclazide - 80 mg - $ Rhoxal-gliclazide RXP Hydrochlorothiazide - - $ pms-hydrochlorothiazide PMS Hydrochlorothiazide - - $ pms-hydrochlorothiazide PMS Imipramine HCl - - $ Novo-Pramine NOP of 15

9 New IC Products (Cont'd) Imipramine HCl - - $ Novo-Pramine NOP Loperamide - 2 mg - $ Rhoxal-loperamide RXP Lovastatin - 20 mg - $ Co Lovastatin COB Lovastatin - 40 mg - $ Co Lovastatin COB Meloxicam mg - $ Co Meloxicam COB Gen-Meloxicam GPM Novo-Meloxicam NOP Meloxicam - 15 mg - $ Co Meloxicam COB Gen-Meloxicam GPM Novo-Meloxicam NOP Metformin HCl mg - $ Co-Metformin COB Metformin HCl $ Co-Metformin COB Methylphenidate - - $ Apo-Methylphenidate APX ** Methylphenidate - 20 mg - $ Apo-Methylphenidate APX ** Mirtazapine - 30 mg - $ Gen-Mirtazapine GPM Novo-Mirtazapine NOP ** Ofloxacin - 0.3% - Per ml $ pms-ofloxacin PMS ** Paroxetine HCl - - $ Rhoxal-paroxetine RXP ** of 15

10 New IC Products (Cont'd) Paroxetine HCl - 20 mg - $ Rhoxal-paroxetine RXP Paroxetine HCl - 30 mg - $ Rhoxal-paroxetine RXP Quinine Sulfate mg - Capsules $ Apo-Quinine APX Quinine Sulfate mg - Capsules $ Apo-Quinine APX ** Sotalol HCl - 80 mg - $ Rhoxal-sotalol RXP Sotalol HCl mg - $ Rhoxal-sotalol RXP Zopiclone - 5 mg - $ Rhoxal-zopiclone RXP Zopiclone mg - $ Rhoxal-zopiclone RXP ** The price change has resulted in a change to the lowest price in the category. Product Deletions The following products have been deleted (notification was provided in Bulletins 44 and 45) Atropine Sulfate atropine sulfate 1% Cortate hydrocortisone 1% Topical Cream ($0.214) Demerol meperidine /ml Injection Demerol meperidine /ml Injection Demerol meperidine 75 mg/ml Injection Demerol meperidine 100 mg/ml Injection Demerol meperidine 100 mg/ml Injection Dexamethasone Sodium Phosphate dexamethasone sodium phosphate 0.1% /Otic 9 of 15

11 Product Deletions (Cont'd) Erythromycin erythromycin 0.5% Ointment Gemfibrozil gemfibrozil 300 mg Capsules Gemfibrozil gemfibrozil 600 mg Gen-Combo Sterinebs ipratropium/salbutamol 0.2 mg/1 mg/ml Unit Dose Vial Gentamicin Sulfate gentamicin sulfate 0.3% Hydrocortisone hydrocortisone 1% Topical Cream Inflamase Forte prednisolone sodium phosphate 1% Lasix furosemide 80 mg Levobunolol levobunolol HCl 0.25% Hydrochloride Levobunolol levobunolol HCl 0.5% Hydrochloride Meperidine HCl meperidine /ml Injection Meperidine HCl meperidine /ml Injection Meperidine HCl meperidine /ml Injection Meperidine HCl meperidine 75 mg/ml Injection Meperidine HCl meperidine 100 mg/ml Injection Morphine EPD morphine 0.5 mg/ml Injection Morphine EPD morphine 1 mg/ml Injection Morphine Sulphate morphine 2 mg/ml Injection Morphine Sulphate morphine /ml Injection Morphine Sulphate morphine 15 mg/ml Injection Morphine Sulphate morphine /ml Injection Morphine Sulphate morphine /ml Injection Narcan Pilocarpine Hydrochloride Pilocarpine Hydrochloride Pilocarpine Hydrochloride Prednisolone Sodium Phosphate Forte naloxone HCl 0.4 mg/ml 1 mg/ml pilocarpine HCl 1% pilocarpine HCl 2% pilocarpine HCl 4% prednisolone sodium phosphate Quibron-T/SR theophylline 300 mg Rebetron interferon alfa-2b + ribavirin 1% 18 MIU/Pen mg Injection Sustained Release Multi-Dose Pen + Capsules Staticin erythromycin/alcohol 1.5% Lotion Surmontil trimipramine 75 mg Capsules Taro-Carbamazepine carbamazepine 200 mg Tobramycin tobramycin 0.3% Tropicamide tropicamide 1% 10 of 15

12 Product Deletions (Cont'd) T-Stat erythromycin/alcohol 2% Lotion Vitamin B 6 pyridoxine 100 mg/ml Injection Vitamin B 12 cyanocobalamin 100 mcg/ml Injection Vitamin B 12 cyanocobalamin 1000 mcg/ml Injection Vitamin K 1 phytonadione 1 mg/0.5 ml Injection Vitamin K 1 phytonadione /ml Injection ( ) Denotes the price of the lowest generic product in the product category. The following products have been deleted from the Formulary: Garamycin gentamicin 40 mg/ml Injection mg Vioxx rofecoxib Gentamicin Sulfate - 40 mg/ml - Injection - Hydrocortisone - 1% - Topical Cream Category Deletions Interchangeable Product Price Changes The following changes in prices have occurred: ($) Airomir salbutamol sulfate 100 mcg Metered Dose Inhaler Androcur cyproterone acetate ** Apo-Salvent CFC Free salbutamol sulfate 100 mcg Metered Dose Inhaler ** Baciguent bacitracin 500 IU/g Topical Ointment Betaderm betamethasone- 17-valerate 0.05% Cream ** Betaderm betamethasone- 17-valerate 0.1% Cream Betaderm betamethasone- 17-valerate 0.05% Ointment ** Betaderm betamethasone- 17-valerate 0.1% Ointment ** Celestoderm V betamethasone- 17-valerate 0.1% Cream Didronel etidronate disodium 200 mg Fosamax alendronate 5 mg Fosamax alendronate Imodium loperamide HCl 2 mg Caplets of 15

13 IC Product Price Changes (Cont'd) $ Hydrea hydroxyurea 500 mg Capsules Micatin miconazole nitrate 2% Topical Cream ** Monistat Derm miconazole nitrate 2% Topical Cream ** (0.3146) ratio-prednisolone prednisolone acetate 1% Suspension ratio-salbutamol HFA salbutamol sulfate 100 mcg Metered Dose Inhaler ratio-paroxetine paroxetine HCl 20 mg ratio-paroxetine paroxetine HCl 30 mg Tylenol No. 1 acetaminophen compound with codeine 8 mg ** The price change has resulted in a change to the lowest price in the category. ( ) Denotes the price of the lowest generic product in the product category. The following products will be deleted with the next Formulary amendments Allernix diphenhydramine HCl Allernix Extra Strength diphenhydramine HCl Allernix diphenhydramine HCl 12.5 mg/5 ml Elixir Alti-Acyclovir acyclovir 800 mg Alti-Bromazepam bromazepam 6 mg Alti-Cyclobenzaprine cyclobenzaprine mg Alti-Diltiazem diltiazem HCl mg Alti-Doxepin doxepin HCl Capsules mg Alti-Prazosin Discontinued Products prazosin HCl 2 mg 5 mg Motrin ibuprofen 300 mg Motrin ibuprofen 400 mg Nizoral ketoconazole 2% Cream Novo-Paroxetine paroxetine 20 mg ** Novo-Paroxetine paroxetine 30 mg ** ratio-ectosone betamethasone- 17-valerate 0.05% Cream ** ratio-ectosone betamethasone- 17-valerate 0.1% Cream ratio-oxycocet oxycodone HCl/ acetaminophen 5 mg/ ratio-oxycodan oxycodone HCl/ASA 5 mg/ Asmavent salbutamol sulfate 5 mg/ml Respirator Atrovent (CFC) ipratropium bromide 20 mcg Metered Dose Inhaler Betaderm betamethasone-17- valerate 0.05% Cream Betaderm betamethasone-17- valerate 0.05% Ointment Betaderm betamethasone-17- valerate 0.1% Ointment Chlorpromanyl chlorpromazine 22.2 mg/ml Syrup 12 of 15

14 Discontinued Products (Cont'd) Cortoderm hydrocortisone 0.5% Topical Ointment Cortoderm hydrocortisone 0.1% Topical Ointment Deproic valproic acid 2/5 ml Syrup Diclotec diclofenac sodium mg Suppositories mg Diovan valsartan mg Capsules Docusate Sodium docusate sodium 4 mg/ml Syrup Docusate Sodium docusate sodium /ml Oral Drops mg Effexor venlafaxine HCl mg Fluoderm fluocinolone acetonide 0.025% Cream Fluoderm fluocinolone acetonide 0.025% Ointment Fluoderm fluocinolone acetonide 0.01% Cream Gemfibrozil gemfibrozil 300 mg Capsules Gemfibrozil gemfibrozil 600 mg Macrodantin nitrofurantoin Capsules Motilidone domperidone maleate Nadostine nystatin 100,000 IU/mL Oral Suspension Neotopic polymyxin b sulfate/ neomycin sulfate/ zinc bacitracin 5,000 U/ 3.5 mg/ 400 U per g Ointment Novo-Chlorpromazine chlorpromazine HCl Novo-Clopamine clomipramine HCl Novo-Desipramine desipramine HCl 75 mg Novo-Diltiazem SR Novo-Dipiradol diltiazem HCl dipyridamole 60 mg 90 mg 120 mg 75 mg Sustained Release Capsules Novo-Maprotiline maprotiline HCl Novo-Meprazine methotrimeprazine 5 mg mg Novo-Salmol salbutamol mg Novo-Tenoxicam tenoxicam 20 mg Novo-Tripramine trimipramine 100 mg Novo-Veramil verapamil HCl 120 mg Nyaderm nystatin 100,000 U/g Topical Cream Nyaderm nystatin 100,000 U/g Topical Ointment Nyaderm nystatin 100,000 U/mL Oral Liquid Orafen ketoprofen 100 mg Suppositories mg mg Peptol cimetidine mg mg Pilocarpine Hydrochloride pilocarpine hydrochloride 1% 2% 4% ratio-desipramine desipramine HCl 75 mg 13 of 15

15 Discontinued Products (Cont'd) Renagel sevelamer HCl 400 mg Rubion cyanocobalamin 1 mg/ml Injection Salofalk 5-acetylsalicylic acid 2 Suppositories Serc betahistine dihydrochloride 8 mg mg Sotamol sotalol HCl mg Stieva-A tretinoin 0.05% Surmontil trimipramine 12.5 mg Synflex naproxen sodium 275 mg Synflex DS naproxen sodium Taro-Sone betamethasone dipropionate 0.05% Topical Cream Taro-Sone betamethasone dipropionate 0.05% Topical Lotion Thiotepa thiotepa 15 mg Injection Thio Tepa thiotepa 15 mg Injection Triaderm triamcinolone acetonide 0.025% Cream Triaderm triamcinolone acetonide 0.1% Cream Triaderm triamcinolone acetonide 0.1% Ointment Ultradol etodolac 300 mg Capsules Viaderm KC neomycin/gramicidin/ nystatin/triamcinolone 2.5 mg/0./ 100,000 U/1 mg Topical Ointment per g Manufacturer Updates The following products have been transferred to Axcan Pharma Inc. (AXC): Bentylol dicyclomine HCl 20 mg Bentylol dicyclomine HCl /5 ml Syrup Proctosedyl Proctosedyl framycetin sulfate/esculin/ hydrocortisone/ dibucaine HCl framycetin sulfate/esculin/ hydrocortisone/ dibucaine HCl // 5 mg/5 mg // 5 mg/5 mg Ointment Suppositories Sulcrate sucralfate 1 g Sulcrate sucralfate 1 g/5 ml Liquid The following products have been transferred to Paladin Labs Inc. (PAL): Sabril vigabatrin 500 mg 500 mg Sachets 14 of 15

16 Mfr Updates (Cont'd) Notice of product name change for Pfizer (PFI): Detrol LA (Previously: Unidet) tolterodine l-tartrate 2 mg 4 mg Extended Release Capsules The following product will be distributed by Prestwick Canada (PRC): Nitoman tetrabenazine Notice of Product Name Change for ratiopharm (RPH): ratio-salbutamol (Previously: Alti-Salbutamol) salbutamol 1./2.5 ml Unit Dose Nebules The following product has been transferred to SteriMax Inc. (SMI): Migranal dihydroergotamine mesylate 4 mg/ml Nasal Spray The following products have been transferred to Triton Pharma Inc. (TRI): Trinipatch nitroglycerin 0.2 mg 0.4 mg 0.6 mg Transdermal Patch The following products have been transferred to Valeo Pharma Inc. (VPI): Acetoxyl benzoyl peroxide 2.5% 5% 10% Aristocort C triamcinolone acetonide 0.5% Topical Cream Aristocort R triamcinolone acetonide 0.1% Topical Cream Aristocort R triamcinolone acetonide 0.1% Topical Ointment Aristospan triamcinolone hexacetonide 20 mg/ml Injection % Capsaicin capsaicin % Topical Cream Gel Notice of Company Name Change: ICN Canada Limited has changed its name to VALEANT CANADA LIMITED (VAL). 15 of 15

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