Will gabapentin raise your blood sugar?

PMC

The patient was consulted and scheduled in the pain clinic during week 38 for uncontrolled right side pain. The patient had a history of right side pain for the previous 6 years. The pain started atraumatically with a cyst in this area. While the cyst was removed, the pain remained as a chronic issue without any effect from local injections, lidocaine patches, and oxycodone. At the time of the pain clinic appointment, the patient was taking amitriptyline 50 mg at bedtime, tramadol 50 mg 3 times per day along with gabapentin 300 mg at bedtime (no changes in the dose as previously documented at a pharmacotherapy visit) for pain control. It was difficult for the patient to describe the type of pain as sharp, shooting, or dull. The patient had an improvement from pain scale (9-10 to 5-6 out of 10) following initiation of gabapentin. During this visit, gabapentin was titrated from 300 mg per day to 300 mg 3 times per day due to neuropathic pain and some effective response with a lower dose. Alternative plans were provided within the progress note from the pain clinic, if gabapentin titration was ineffective for the pain. During week 40, the patient’s gabapentin dose was titrated to 600 mg in the morning, 300 mg in the afternoon, and 600 mg in the evening.

Fourteen days after the initial pain visit (week 42), the patient was contacted by the pharmacist to review glucose readings. The 30-day average for glucose readings was 150 mg/dL with only 3 glucose values (out of 32) within the desired preprandial goal of 70 to 130 mg/dL. Based on this objective information, NPH insulin was changed from 21 to 24 units at bedtime. The patient was contacted again 2 weeks later and glucose readings were averaging 153 to 158 mg/dL for 7-, 14-, and 30-day averages. He did not provide specific glucose readings but the patient indicated frustration regarding worsening glucose readings. Another insulin titration was made from 24 to 27 units at bedtime. A face-to-face visit was scheduled to discuss future options for diabetes management. At week 46, the patient presented with average glucose readings of 158 to 165 mg/dL and a couple of values spiking above 200 mg/dL, which had not occurred at previous visits. In addition, none of the glucose readings were within the desired preprandial range of 70 to 130 mg/dL. During this visit, the patient mentioned gabapentin was effective for his pain at a dose of 600 mg 3 times per day (1800 mg per day). The patient was switched to insulin glargine (LANTUS) 30 units at bedtime and oral medications (metformin and glipizide) were continued in order to control blood glucose. At the next visit after starting insulin glargine, glucose averages had improved, with the 7-, 14-, and 30-day averages of 147, 151, and 160 mg/dL, respectively. Insulin glargine was further titrated up to 34 units at bedtime when patient was called for follow-up. Gabapentin was continued due to pain control. Gabapentin was assumed effective for pain relief due to a decrease in pain score (1/10 from 10/10) and complaints of pain were not made at visits following initiation of gabapentin therapy.

390 Drugs That Can Affect Blood Glucose Levels

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What drugs affect glucose levels? Many can, including steroids, anxiety and depression medications, statins, beta-blockers, some acne & asthma medications.

Knowing the drugs that can affect blood glucose levels is essential in properly caring for your diabetes patients. Some medicines raise blood sugar in patients while others might lower their levels. However, not all drugs affect patients the same way.

390 Drugs that can Affect Blood Glucose Levels is also available as a downloadable PDF:

390 Drugs that Can Affect Blood Glucose Levels (pdf)

Last Revised: 03/17/2018

Table of Contents:

Drugs that May Cause Hyperglycemia

Drugs that May Cause Hypoglycemia

Drugs that May Cause Hyper- or Hypoglycemia

Drugs that Mask Hypoglycemia

Drugs That May Cause Hyperglycemia (High Blood Sugar)

Abacavir (Ziagen®)

Abacavir + lamivudine,zidovudine (Trizivir®)

Abacavir + dolutegravir + lamivudine (Triumeq®)

Abiraterone (Zytiga®)

Acetazolamide (Diamox®)

Acitretin (Soriatane®)

Aletinib (Alecensa®)

Albuterol (Ventolin®, Proventil®)

Albuterol + ipratropium (Combivent®)

Aliskiren + amlodipine + hydrochlorothiazide (Amturnide®)

Aliskiren + amlodipine (Tekamlo®)

Ammonium chloride

Amphotericin B (Amphocin®, Fungizone®)

Amphotericin B lipid formulations IV (Abelcet®)

Amprenavir (Agenerase®)

Anidulafungin (Eraxis®)

Aripiprazole (Abilify®)

Arsenic trioxide (Trisenox®)

Asparaginase (Elspar®, Erwinaze®)

Atazanavir (Reyataz ®)

Atazanavir + cobistat (Evotaz®)

Atenolol + chlorthalidone (Tenoretic®)

Atorvastatin (Lipitor®)

Atovaquone (Mepron®)

Baclofen (Lioresal®)

Belatacept (Nulojix®)

Benazepril + hydrochlorothiazide (Lotension®)

Betamethasone topical (Alphatrex®, Betatrex®, Beta-Val®, Diprolene®, Diprolene®

AF, Diprolene® Lotion, Luxiq®, Maxivate®)

Betamethasone +clotrimazole (Lotrisone® topical)

Betaxolol Betoptic® eyedrops, (Kerlone® oral)

Bexarotene (Targretin®)

Bicalutamide (Casodex®)

Bisoprolol + hydrochlorothiazide (Ziac®)

Brentuximab vedotin (Adcetris®)

Budesonide (Uceris®)

Bumetanide (Bumex®)

Caffeine (Caffeine in moderation may actually be beneficial in diabetes but in large amounts can raise blood sugar.)

Calcipotriene + betamethasone (Enstillar®)

Candesartan + hydrochlorothiazide (Atacand HCT®)

Captopril + hydrochlorothiazide (Capozide®)

Carfilzomib (Kyprolis®)

Carteolol (Cartrol® oral, Occupress® eyedrops)

Carvedilol (Coreg®)

Ceftaroline (Teflaro®)

Ceftozolane + tazobactam (Zerbaxa)

Chlorothiazide (Diuril®)

Chlorthalidone (Chlorthalidone Tablets®, Clorpres®, Tenoretic®, Thalitone®)

Choline salicylate (Numerous tradenames of aspirin formulations; check label)

Choline salicylate + magnesium salicylate (CMT®, Tricosal®, Trilisate®)

Clobetasol (Clobevate®, Cormax®, Cormax® Scalp Application, Embeline® E, Olux®, Temovate®, Temovate® E, Temovate® Scalp Application)

Clozapine (Clozaril®, FazaClo®)

Conjugated estrogens (Estrace®, Estring®, Femring®, Premarin®, Vagifem®,

Cenestin®, Enjuvia®, Estrace®, Femtrace®, Gynodiol®, Menest®, Ogen®)

Conjugated estrogens + bazedoxifene (Duavee®)

Conjugated estrogens + medroxyprogesterone (Premphase®, Prempro®)

Corticosteroids (Numerous tradenames; check label)

Corticotropin

Cortisone (Numerous tradenames; check label)

Cyclosporine (Sandimmune®, Neoral®, Gengraf®)

Dabrafenib (Tafiniar®)

Daclizumab (Zenapax®)

Darunavir + cobistat (Prezcobix®)

Decitabine (Dacogen®)

Desonide (DesOwen®, Tridesilon®)

Desoximetasone (Topicort®)

Dexamethasone (Adrenocot®, Dalalone®, Decadron®, Decaject®, Dekasol®,

Dexacort®, Dexasone®, Dexim®, Dexone®,Hexadrol®, Medidex®,

Primethasone®, Solurex®, Dexamethasone Intensol®)

Dextromethorphan + promethazine (Phenergan® with Dextromethorphan, Phen- TussDM®)

Diazoxide (Proglycem®)

Dinutuximab (Unituxin®)

Dolutegravir (Tivicay®)

Empagliflozin + metformin (Synjardy®)

Enalapril + hydrochlorothiazide (Vaseretic®)

Encainide (Enkaid®)

Ephedrine and Guaifenesin (Primatene ® tablets, otc – this medication includes ephedrine and guaifenesin. Guaifenesin is not responsible for hyperglycemia ) Epinephrine (EpiPen ®, EpiPen® Jr, Primatene® Mist, otc)

Esterified estrogens, estrone, estropipate

Esterified estrogens + methyltestosterone (Estratest®)

Estradiol, ethinyl estradiol (Alora®, Climara®, Congest®, Delestrogen®, Depo-

Estradiol®, Depogen®, Estinyl®, Estrace®, Estraderm®, Estragyn 5®,

Estragyn LA 5®, Estrasorb®, EstroGel®, Estro-L.A.®, Gynodiol®, Kestrone-

5®, Neo-Estrone®, Menest®, Menostar®, Ogen .625®, Ogen®, Ortho-Est®, Premarin®, Valergen®, Vivelle®, Vivelle-Dot®)

Estradiol + norethindrone (Activella®)

Estradiol + norgestimate (Prefest®)

Estramustine (Emcyt®)

Ethacrynic acid (Edecrin®, Sodium Edecrin®)

Everolimus (Afinitor®, Zortress®)

Everolimus (Zortress®)

Ezetimibe, Atorvastatin (Liptruzet®)

Fidaxomicin (Dificid®)

Fluticasone (Arnuity Ellipta®)

Fluticasone + vilanterol (Breo Elipta®)

Fluoxetine (Prozac®, Sarafem®)

Flurandrenolide (Cordran®, Cordran® SP, Cordran® Tape)

Formoterol (Foradil® Aerolizer® Inhaler)

Fosamprenavir (Lexiva ®)

Fosinopril + hydrochlorothiazide (Monopril HCT®)

Furosemide (Lasix®)

Gabapentin (Gralise®, Horizant®)

Gemtuzumab ozogamicin (Mylotarg®)

Glucosamine (Possible increase in insulin resistance; more likely with intravenous use)

Glycopyrrolate (Cuvposa®)

Hydrochlorothiazide (Aldactazide®, Aldoril®, Capozide®, Dyazide®, HydroDIURIL®, Inderide®, Lopressor® HCT, Maxzide®,Microzide®, Moduretic®, Timolide®, Vaseretic®)

Hydrochlorothiazide + irbesartan (Avalide®)

Hydrochlorothiazide + lisinopril (Prinzide®, Zestoretic®)

Hydrochlorothiazide + losartan (Hyzaar®)

Hydrochlorothiazide + metoprolol (Lopressor HCT®)

Hydrochlorothiazide + moexipril (Uniretic®)

Hydrochlorothiazide + quinapril (Accuretic®, Quinaretic®)

Hydrochlorothiazide + telmisartan (Micardis HCT®)

Hydrochlorothiazide + valsartan (Diovan HCT®)

Hydrocortisone (Numerous trade names of topical hydrocortisone formulations; check label)

Indacaterol (Arcapta®)

Indapamide (Lozol®)

Indinavir (Crixivan®)

Interferon alfa-2a (Roferon-A®)

Interferon alfa-2b (Intron-A®)

Interferon alfa-2b + ribavirin (Rebetron®)

Interferon alfa-n1 (Alferon-N®)

Irinotecan (Camptosar®)

Isoniazid (Laniazid®, Nydrazid®)

Isotretinoin (Accutane®)

Liothyronine (Cytomel®)

Lamivudine (Epivir®, Epivir-HBV®)

Levalbuterol (Xoponex®, Xopenex HFA®)

Levonorgestrel (Plan B®, Norplant System®)

Levothyroxine (Synthroid®, Levoxyl®)

Lopinavir + ritonavir (Kaletra®)

Lucinactant (Surfaxin®)

Lurasidone (Latuda®)

Magnesium salicylate (Bayer Select® Backache Pain Formula, Doans® Pills,

Mobidin®, Nuprin® Backache Caplet)

Medroxyprogesterone (Provera®, Depo-Provera®)

Megestrol (Megace®)

Methylprednisolone (A-methaPred®, ADD-Vantage®, Depo-Medrol®, Medrol®,

Medrol® Dosepak, Meprolone® Unipak, Solu-Medrol®)

Metolazone (Zaroxolyn®, Mykrox®)

Metoprolol (Lopressor®, Lopressor® HCT, Toprol XL®)

Modafinil (Provigil®)

Momentasone furoate + formoterol fumarate dihydrate (Dulera®)

Moxifloxacin (Avelox®, Avelox® I.V.)

Mycophenolate (CellCept®)

Nadolol (Corgard®)

Nelfinavir (Viracept®)

Netupitant + palonosetron (Akynzo®)

Niacin, niacinamide (Niacor®, Niaspan®, Nicolar®, Nicotinex®, Slo-Niacin®)

Nilotinib (Tasigna®)

Nilutamide (Nilandron®)

Nitric oxide (INOmax®)

Nivolumab (Opdivo®)

Norethindrone (Aygestin®, Nor-QD®, Micronor®)

Norgestrel (Orvette®)

Nystatin (Mycostatin®, Nystat-Rx®, Nystop®, Pedi-Dri®)

Nystatin + triamcinolone (Dermacomb®, Myco II®, Mycobiotic II®, Mycogen II®,

Mycolog II®, Myco-Triacet II®, Mykacet®, Mykacet II®, Mytrex®, Tristatin II®)

Octreotide (Sandostatin®, Sandostatin LAR®)

Olanzapine (Zyprexa®)

Olaparib (Lynparza®)

Olmesartan + amlodipine + hydrochlorothiazide (Tribenzor®)

Oxybutynin (Anturol®)

Oxycodone (Oxecta®)

Panobinostat (Farydak®)

Pantoprazole (Protonix®, Protonix® I.V.)

Pegaspargase (Oncaspar®)

Peginterferon alfa-2b (PEG-Intron®, Sylatron®)

Pembrolizumab (Keytrenda®)

Pentamidine (Pentam 300®)

Peramivir (Rapivab®)

Perindopril + amlodipine (Prestalia®)

Phenylephrine* (Sudafed PE®, and others)

Phenytoin (Dilantin®, Dilantin-125®, Dilantin Infatabs®, Dilantin Kapseals®, Phenytek®)

Pomalidomide (Pomalyst®)

Prednisolone (AK-Pred®,Blephamide®,Blephamide®,Liquifilm®,Econopred® Plus,

Inflamase® Forte, Inflamase® Mild, Poly-Pred® Liquifilm®, Pred Forte®, Pred

Mild®, Pred-G®, Pred-G® Liquifilm®, Delta Cortef®,Pediapred®,Prelone®)

Prednisone (Prednisone Intensol®, Sterapred®, Sterapred® DS, Rayos DR®)

Progesterone (Prometrium®)

Pseudoephedrine* (Claritin D®, Sudafed®, and others)

Quetiapine (Seroquel®)

Risperidone (Risperdal®, Risperdal® M-TAB®)

* There are many other OTC and prescription medications that contain pseudoephedrine and phenylephrine.

Ritodrine (Yutopar®)

Ritonavir (Norvir®)

Rituximab (Rituxan®)

Salmeterol (Serevent®, Serevent® Diskus®)

Salsalate (Argesic®-SA, Disalcid®, Mono-Gesic®, Salflex®, Salsitab®)

Saquinavir (Invirase®)

Sodium oxybate (Xyrem®)

Somatropin (Genotropin®, Genotropin Miniquick®, Humatrope®,Norditropin artridges®,Norditropin NordiFlex®,Nutropin®, Nutropin AQ®, Saizen®, Serostim®, Zorbtive®)

Sonidegib (Odomzo®)

Sotalol (Betapace®, Betapace AF®, Sorine®)

Streptozocin (Zanosar®)

Tacrolimus (Prograf®, Protopic®)

Temsirolimus (Torisel®)

Tesamorelin (Egrifta®)

Thyroid (Armour Thyroid®, Naturethroid®)

Tiotropium + Olodaterol (Stiolto Respimat®)

Tipranavir (Aptivus®)

Tolvaptan (Samsca®)

Torsemide (Demadex®, Demadex Oral®)

Trametinib (Mekinist®)

Triamcinolone (Aristocort®, Aristospan®, Asthmacort®, Flutex®, Kenalog®, Tac®, Triacet®)

Umeclidium + vilanterol (Anoro Ellipta®)

Ursodeoxycholic acid, ursodiol (Actigall®, Urso®)

Valproic acid, divalproex sodium (Depacon®, Depakene®, Depakene® Syrup,

Depakote®, Depakote® ER,Depakote® Sprinkle)

Vitamin C (Ascorbic acid, Ascorbate) Vitamin E (Tocopherol, Tocotrienol)

Ziprasidone (Geodone®)

Zolpidem (Intermezzo®)

Drugs That May Cause Hypoglycemia (Low Blood Sugar)

Abliglutide (Tanzeum®)

Acebutolol (Sectral®)

Acetohexamide (Dymelor®)

Albiglutide (Tanzeum®)

Alcohol

Aloe – Oral Herbal Supplement, especially if taken with other agents such as glyburide, glipizide, nateglinide, repaglinide, glimepiride, or insulin.

Alogliptin (Nesina®)

Alogliptin/pioglitazone (Oseni®)

Alogliptin/metformin (Kazano®)

Amphotericin B (Ambisome®, Amphocin®, Fungizone Intravenous® Amphotec®, Abelcet®)

Amphotericin B lipid formulations (Abelcet®, AmBisome®)

Aripiprazole (Aristada®)

Asian Ginseng (Ginseng; Panax ginseng)

Aspirin (Numerous tradenames; check label)

Aspirin + dipyridamole (Aggrenox®)

Atenolol (Tenormin®, Tenoretic® containing atenolol & chlorthalidone)

Betaxolol (Betoptic®, Betoptic S® eyedrops, Kerlone® oral)

Bisoprolol (Zebeta®)

Bisoprolol + hydrochlorothiazide (Ziac®)

Brexpiprazole (Rexulti®)

Bromocriptine (Cycloset®)

Canagliflozin (Invokana®)

Canagliflozin + metformin (Invokamet®)

Chloramphenicol (Chloromycetin®)

Chlorpropamide (Diabinese®)

Choline salicylate (Acuprin 81®, Amigesic®, Anacin Caplets®, Anacin Maximum

Strength®, Anacin Tablets®, Anaflex 750® Arthritis Pain, Ascriptin® Arthritis Pain)

Choline salicylate + magnesium salicylate C (MT®, Tricosal®, Trilisate®)

Chromium (Various tradenames; check label)

Clarithromycin B (Biaxin® Filmtab®, Biaxin® Granules, Biaxin® XL, Filmtab, Biaxin® XL Pac, Prevpac®)

Dalbavancin (Dalvance®)

Dapagliflozin (Farxiga®)

Dapagliflozin + Metformin (Xigduo XR®)

Diazoxide (Proglycem®)

Dicumarol (Coumadin®, Miradon®)

Diltiazem (Cardizem®, Tiazac®)

Disopyramide (Norpace®, Norpace® CR)

Dorzolamide + timolol (Cosopt®)

Doxepin (Silenor®)

Dulaglutide (Trulicity®)

Empagliflozin (Jardiance®)

Empagliflozin/linagliptin (Glyxambi®)

Ertugliflozin (Not FDA approved- Phase III clinical trials)

Exenatide (Byetta®, Bydureon®)

Fluoxetine (Prozac®, Sarafem®)

Fosphenytoin (Cerebyx®, Dilantin®, Dilantin-125®, Dilantin Infatabs®, Dilantin

Kapseals®, Mesantoin®, Peganone®,Phenytek®)

Glimepiride (Amaryl®)

Glimepiride and Rosiglitazone (Avandaryl®) Glipizide (Glucotrol®, Glucotrol XL®)

Glipizide and Metformin (Metaglip®)

Glucagon (GlucaGen®)

Glyburide (Diabeta®, Glynase®, Micronase®,Glycron®)

Glyburide + metformin (Glucovance®)

Horse chestnut (Aesculus hippocastanum)

Hydrochlorothiazide + metoprolol (Lopressor HCT®)

Interferon beta-1b (Betaseron®)

Isavuconazonium (Cresemba®)

ITCA 650®- Not FDA approved

Lenvatinib (Lenvima®)

Levofloxacin (Levaquin®, Levaquin® in Dextrose Injection Premix, Quixin®)

Liraglutide (Victoza®, Saxenda®))

Linagliptin (Tradjenta®)

Linagliptin + metformin (Jentadueto®)

Lixisenatide (Lyxumia®)- currently approved in Europe

Lixisenatide/Glargine (LixiLan®)- Not FDA approved

Locaserin (Belviq®)

Magnesium salicylate (Bayer Select® Backache Pain Formula, Doans® Pills,

Mobidin®, Nuprin® Backache Caplet)

Metformin (Fortamet®, Glucophage®, Glucophage XR®, Glumetza®, Riomet®)

Metreleptin (Myalept®)

Metoprolol (Lopressor®, Lopressor® HCT, Toprol XL®)

Metreleptin (Myalept®)

Mifepristone (Korlym®)

Morphine (Kadian®, MS Contin®, MSIR®, Roxanol®)

Nadolol (Corgard®)

Nateglinide (Starlix®)

Nifedipine (Adalat CC®, Procardia®, Afeditab ® CR)

Nivolumab (Opdivo®)

Octreotide (Sandostatin®, Sandostatin LAR® Depot) Oritavacin (Orbactiv®)

Paloperidone (Invega®)

Penicillamine (Cuprimine®, Depen®)

Pentamidine (Nebupent®, Pentam 300®)

Phenelzine (Nardil®)

Phenytoin (Dilantin®, Dilantin-125®, Dilantin Infatabs®, Dilantin Kapseals®, Phenytek®) Pindolol (Visken®)

Pioglitazone (Actos®) –( hypoglycemia usually only when in combination with other diabetic drugs such as sulfonylureas or insulin)

Pioglitazone and Glimepiride (Duetact®) – the glimepiride component of this drug gives it the possibility of causing hypoglycemia alone or in combination with other diabetes medicines. This is more likely to occur when one skips a regular meal or when unusual physical activities occur.

Pioglitazone and Metformin (Actoplus Met®,ActoPlus Met XR®)

Pramlintide (Symlin®)

Pregabalin (Lyrica®)

Probenecid (Benemid®, Probalan®)

Quinine (Quinamm®, Quindan®, Quiphile®, Q-vel®, Strema®)

Quinupristin + dalfopristin (Synercid®)

Repaglinide (Prandin®)

Repaglinide and Metformin (PrandiMet®)

Ritodrine (Yutopar®)

Rituximab (Rituxan®)

Rosiglitazone (Avandia®)

Rosiglitazone and Metformin (Avandamet®)

Rotigotine (Neupro®)

Salicylates (Numerous tradenames of aspirin formulations; check label)

Salsalate (Argesic®-SA, Disalcid®, Mono-Gesic®, Salflex®,Salsitab®)

Saxagliptin (Onglyza®)

Saxagliptin + metformin (Kombiglyze XR®)

Selegiline (Eldepryl®)

Semaglutide- Not FDA approved, phase III clinical trials

Sitagliptin (Januvia®)

Sitagliptin and Metformin HCL (Janumet®)

Sodium ferric gluconate complex (Ferrlecit®)

Somatropin (Genotropin®, Genotropin Miniquick®, Humatrope®, Norditropin cartridges®, Norditropin NordiFlex®, Nutropin, Nutropin AQ®, Saizen®, Serostim®, Zorbtive®)

Sotalol (Betapace®, Betapace AF®, Sorine®)

Streptozocin (Zanosar®)

Sulfadiazine (Microsulfon®)

Tacrolimus P (Prograf®, Protopic®)

Tetracaine (Altacaine®, Tetcaine®, Pontocaine®)

Theophylline (Theo-24®, Theo-Dur®, TheoCap®)

Timolol (Timoptic®, Timoptic-XE®)

Tolazamide (Tolinase®)

Tolbutamide (Orinase®)

Tranylcypromine (Parnate®)

Varenicline (Chantix®)

Verapamil (Calan®, Calan SR®, Isoptin SR®, Verelan®)

Drugs that can cause Hyper or Hypoglycemia

Amphotericin B (Ambisome®, Amphocin®, Fungizone Intravenous® Amphotec®, Abelcet®)

Amphotericin B lipid formulations (Abelcet®, AmBisome®)

Avanafil (Stendra®)

Axitinib (Inlyta®)

Betaxolol Betoptic® eyedrops, (KERLONE® oral)

Bisoprolol + hydrochlorothiazide (Ziac®)

Choline salicylate (Numerous tradenames of aspirin formulations; check label)

Choline salicylate + magnesium salicylate (CMT®, Tricosal®, Trilisate®)

Ciprofloxacin (Otiprio®)

Darunavir (Prezista®)

Diazoxide (Proglycem®)

Doxepin (Silenor®)

Elvitegravir + cobicistat + emtricitabine + tenofovir (Stribild®)

Emtricitabine + rilpivirine + tenofovir (Complera®)

Fentanyl (Abstral®, Lazanda®, Subsys®)

Fluoxetine (Prozac®, Sarafem®)

Hydrochlorothiazide + metoprolol (Lopressor HCT®)

Ivacaftor (Kalydeco®)

Lanreotide acetate (Somatuline®)

Lenalidomide (Revlimid®)

Lithium (Eskalith®, Eskalith CR®, Lithobid®)

Magnesium salicylate (Bayer Select® Backache Pain Formula, Doans® Pills,

Mobidin®, Nuprin® Backache Caplet)

Mecasermin (Increlex ®)

Mecasermin Rinfabate (Iplex ®)

Metoprolol (Lopressor®, Lopressor® HCT, Toprol XL®)

Nadolol (Corgard®)

Naproxen + esomeprazole (Vimovo®)

Octreotide (Sandostatin®, Sandostatin LAR® Depot)

Omacetaxine (Synribo®)

Oxcarbazepine (Oxtellar XR®)

Oxycodone + acetaminophen (Xartemis®)

Pancrelipase (Ultresa®, Viokace®)

Paroxetine (Brisdelle®)

Pasireotide (Signifor®)

Pazopanib (Votrient ®)

Pentamidine (Nebupent®, Pentam 300®)

Phenytoin (Dilantin®, Dilantin-125®, Dilantin Infatabs®, Dilantin Kapseals®, Phenytek®)

Ponatinib

Rifampin (Rifadin®, Rimactane®)

Ritodrine (Yutopar®)

Rituximab (Rituxan®)

Salsalate (Argesic®-SA, Disalcid®, Mono-Gesic®, Salflex®,Salsitab®)

Sitagliptin + simvastatin (Juvisync®)

Sunitinib (Sutent®)

Somatropin (Genotropin®, Genotropin Miniquick®, Humatrope®, Norditropin cartridges®, Norditropin NordiFlex®, Nutropin®, Nutropin AQ®, Saizen®, Serostim®, Zorbtive®)

Sotalol (Betapace®, Betapace AF®, Sorine®)

Streptozocin (Zanosar®)

Sunitinib (Sutent®)

Pancrelipase (Pancreaze®)

Pasireotide (Signifor®)

Pegloticase (Krystexxa®)

Tacrolimus P (Prograf®, Protopic®)

Testosterone gel (Fortesta®)

Testosterone (Aveed®, Natesto®, Vogelxo®)

Topiramate (Qudexy®)

Vandetinib (Vandetinib®)

Drugs that can MASK* Hypoglycemia

Atenolol (Tenormin®, Tenoretic® containing Atenolol & Chlorthalidone)

Carteolol (Cartrol® oral, Occupress® eyedrops)

Carvedilol (Coreg®, Coreg® Tiltabs®)

Clonidine (Duraclon®, Catapres®, Catapres-TTS-1®, Catapres-TTS-2®, CatapresTTS-3®)

Metoprolol (Lopressor®, Lopressor® HCT, Toprol XL®)

Nadolol (Corgard®)

Nebivolol (Bystolic®)

Pindolol (Visken®)

Propranolol, Propranolol Hydrochloride, (Inderal®, Inderal LA®, Inderide®, Innopran® XL, Intensol®)

Timolol (Timoptic®, Timoptic-XE®)

* Recent research suggests that this may not occur.

Because of the constantly changing nature of the U.S. prescription and OTC drug marketplace, this list may not reflect the full range of drugs that may impact blood glucose levels. The information contained in this document is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over-the-counter drugs (including any herbal medicines or supplements) or following any treatment or regimen.

Effective dosing of gabapentin for diabetic peripheral neuropathy – LECOM Education System

Rebekah Stoner, Kimberly Clifton, PharmD Candidates; Marcus W. Campbell, PharmD BC-ADM

Diabetic peripheral neuropathy (DPN) is a common long-term complication of type 2 diabetes and occurs in up to 50% of patients with long-standing disease.1 DPN and its complications cost between $4.6 and $13.7 billion dollars in the United States annually.2Gabapentin, an anticonvulsant first approved in the U.S. in 1994 for the treatment of epilepsy, is widely used off-label for the treatment of DPN. Although the exact mechanism of action is unknown, gabapentin is thought to disrupt excitatory neurotransmitter release through blockade of voltage-dependent calcium channels.3′

Studies evaluating the maximum effective dose of gabapentin to treat DPN are conflicting and are generally limited by small population sizes and short study durations. In a small randomized, placebo-controlled study, Backonja and colleagues evaluated the efficacy of gabapentin in 165 patients with DPN using doses initiated at 900 mg per day and titrated up to a dose of 3,600 mg per day. Following 8 weeks of therapy, patients receiving gabapentin showed significant reductions in mean pain scores compared with placebo (p<0.001) as measured on an 11-point Likert scale. Gabapentin also improved sleep interference scores (p<0.05), reduced total mean pain (p<0.01), reduced mean visual analog scale (p<0.01) and present pain intensity scores (p<0.05) when compared to placebo. The most frequently reported adverse effects were dizziness and somnolence.4 Backonja and colleagues also performed a review of five randomized controlled trials evaluating the efficacy of gabapentin for the treatment of DPN and other neuropathic pain syndromes. Gabapentin was shown to be effective in the treatment of DPN at doses of 900 mg/day, with greater efficacy achieved at doses of 1,800 to 3,600 mg/day. Backonja and colleagues concluded that gabapentin should be initiated at 300 mg on day 1 and then titrated to 600mg on day 2, and then 900 mg on day 3.6

In a randomized crossover study evaluating the efficacy of gabapentin 900 mg daily in 40 patients with DPN, there were no significant differences in mean change of visual analog pain scale and present pain intensity scores compared with placebo. However, statistically significant improvements were seen in the McGill pain questionnaire (p=0.03). The most common side effects were drowsiness, fatigue and ataxia.5

At present, the recommended starting dose of gabapentin for diabetic neuropathy is 900 mg per day in 3 divided doses.3 According to 2011 guidelines published by the American Academy of Neurology (AAN) and based on the previously mentioned studies, gabapentin is regarded as “probably effective” at daily doses between 900 and 3,600 mg.7

Summary

There is moderate clinical literature supporting modest effectiveness of gabapentin for the treatment of DPN at daily doses up to a maximum 3,600 mg given in 3-4 divided doses.5 There is no evidence to support efficacy of doses less than 900 mg/day and doses between 1800 mg/day and 3600 mg/day have demonstrated superior efficacy to doses of 900 mg/day. In a patient with adequate renal function, therapy should be initially titrated to a minimum of 900 mg/day given in 3 divided doses and gradually increased as tolerated to treatment effect. Do not exceed 3,600 mg of gabapentin per day. Consider increased monitoring for adverse effects such as somnolence, dizziness and ataxia in patients undergoing dose escalations. Gabapentin is primarily eliminated through the kidneys and in advanced stages of diabetes, the majority of patients have some degree of renal dysfunction. Dose adjustments are required in patients with reduced creatinine clearance to avoid accumulation of drug and subsequent adverse effects (Table 1).8 There is no clinical trial data assessing effectiveness of gabapentin for the treatment of DPN in patients with advanced renal disease.

  1. Dyck PJ, Kratz KM, Karnes JL, Litchy WJ, Klein R, Pach JM, Wilson DM, O’Brien PC, Melton LJ 3rd, Service FJ: The prevalence by staged severity of various types of diabetic neuropathy, retinopathy, and nephropathy in a population-based cohort: the Rochester Diabetic Neuropathy Study. Neurology. 43 : 817-824,1993
  2. Gordois, A., Scuffham, P., Shearer, A., et al. The health care costs of diabetic peripheral neuropathy in the U.S. Diabetes Care 200326: 1790-95.
  3. Lexi-Comp, Inc. (Lexi-DrugsTM). Lexi-Comp, Inc.; August 3, 2014.
  4. Backonja M, Beydoun A, Edwards KR, et al. Gabapentin for the symptomatic treatment of painful neuropathy in patients with diabetes mellitus. A randomized controlled trial. JAMA. 1998; 280: 1831–1836.
  5. Gorson KC, Schott C, Herman R, et al. Gabapentin in the treatment of painful diabetic neuropathy: a placebo controlled, double blind, crossover trial. J Neurol Neurosurg Psychiatry.1999; 66:251.
  6. Backonja, M., Glanzman RL. Gabapentin dosing for neuropathic pain: evidence from randomized, placebo-controlled clinical trials. Clinical Therapeutics2003 Jan; 25(1): 81-104.
  7. Bril V, England J, Franklin GM, et al. Evidence-Based Guideline: Treatment of Painful Diabetic Neuropathy: Report of the American Academy of Neurology, the American Association of Neuromuscular and Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation. Neurology, 2011, 76(20):1758-65.
  8. Lexi-Comp OnlineTM, Pediatric & Neonatal Lexi-Drugs OnlineTM , Hudson, Ohio: Lexi-Comp, Inc.; June 2014.

Spring is really starting to burst out here in Massachusetts. The tulips are blooming and leaves and buds are popping out on the trees. As pretty and welcoming as this is, many of you (about 50 million!) are probably bracing yourself for all of the pollen that is soon to follow, and suffering through the misery that it can bring. Thanks to the mild winter that we had in the Northeast, plants are pollinating earlier than usual. As if that weren’t bad enough, having seasonal allergies can also affect your blood sugar control.

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Seasonal allergies: do you have them?
Seasonal allergies are sometimes called hay fever or, more technically, seasonal allergic rhinitis. You might be wondering if your symptoms are due to a cold, flu, or allergies. While there can be some overlap, the following symptoms are usually indicative of allergies:

• Itchy eyes
• Watery eyes
• Dark circles under the eyes
• Sneezing
• Runny nose
• Stuffy nose
• Sore throat

You might also feel a little bit tired. You won’t get a fever from allergies, however. These symptoms can linger for weeks unless they’re treated.

Treating allergies
There are a number of remedies for seasonal allergies, including oral medications, nasal sprays, and eye drops. It’s important that you not only choose the right one for your symptoms, but that you also are aware of how these medicines might affect your blood sugars. The following types of allergy medicines may affect your blood glucose levels or how you manage them:

Antihistamines. These medicines can reduce sneezing, runny nose, and itchy and watery eyes. Common antihistamines include diphenhydramine (Benadryl), loratidine (Alavert, Claritin), cetirizine (Zyrtec Allergy), and fexofenadine (Allegra Allergy). Antihistamines might be combined with a decongestant. They’re also available by prescription. Some of these medications can cause drowsiness.

Effect on diabetes: Antihistamines tend to not directly affect blood sugar levels. However, if you take the kind that makes you sleepy, you might not pick up on symptoms of high or low blood sugars. Ask your pharmacist about non-sedating antihistamines.

Decongestants. Decongestants help to temporarily relieve a stuffy nose. They’re available as oral medicines, such as pseudoephedrine (Sudafed, Afrinol) and as the nasal sprays oxymetazoline nasal (Afrin) and phenylephrine nasal (Neo-Synephrine).

Effect on diabetes: Decongestants may raise blood sugars, at least in some people. If you take insulin, you may need to adjust your dose. Be extra diligent about checking your blood sugars if you take a decongestant. Also note: Decongestants may raise your blood pressure and your heart rate. Talk with your doctor or pharmacist before taking a decongestant if you already have high blood pressure or an increased heart rate.

Corticosteroids. Also called steroids or glucocorticoids, these medicines block allergic reactions by reducing and treating inflammation. They can address a number of allergy symptoms, all at the same time. Corticosteroids are available in pills, nasal sprays, inhalers, liquids, eye drops, and creams (for skin reactions). They may be combined with other types of allergy medicines, too. Many corticosteroids are available only by prescription, but you can now purchase over-the-counter versions, as well. Common brands of these medicines include beclomethasone (Beconase, Qvar), fluticasone (Flonase, Flovent), and triamclionolone (Nasacort AQ). Oral steroids may be Medrol or Deltasone, which are prednisone.

Effect on diabetes: Steroids are powerful medications, but when it comes to diabetes, the main side effect is high blood sugars (hyperglycemia). This happens because steroids block the effect of insulin, causing insulin resistance. They also trigger the liver to release glucose. You need to frequently check your blood sugar when taking any of these medicines. Call your doctor or diabetes educator if your blood sugars go up and stay up — you may need to increase your diabetes medicine or insulin dose.

Preventing allergic symptoms
Try preventing the misery of seasonal allergies in the first place by taking the following steps:

• Close the windows in your house and your car to keep the pollen out.

• Shower after being outside to remove pollen from your skin and hair.

• Exercise indoors if the pollen count is high.

• Dust your home often, and clean rugs and curtains regularly.

• Vacuum often, as well, and use a vacuum with a HEPA filter.

• If your basement is damp, use a dehumidifier to discourage mold from growing.

• Wear a microfiber mask if you’re outside doing yard work.

• Get more probiotics (good bacteria) in your diet. Sources include yogurt, kefir, kombucha, sauerkraut, and sour pickles.

• Rinse your nasal passages with a saline solution using a neti pot.

• Try taking quercetin or stinging nettle, which are dietary supplements that may prevent allergy symptoms. Check with your doctor or pharmacist first, though.

If your allergies aren’t responding to any of the above medicines or suggestions, talk with your doctor to find out if allergy shots might be a good option for you.

Treatments to relieve allergy symptoms may impact blood glucose

  • Read labels. Just like food labels, medication labels contain important information for our health.
  • Taking your medicine before peak allergy season can help alleviate symptoms.
  • Pay attention to your local allergen report, which commonly includes mold, pollen and the breathing index. Use weather applications on your phone/tablet, or check your local weather station’s web page for a daily or weekly forecasted allergy index.
  • Plan on exercising indoors during peak allergy season.
  • Keep your windows and basement doors closed to avoid allergens.
  • If you need to do yard work during peak allergy season, wear a mask.
  • ‘Food allergy’ medications impact blood glucose

    Food allergy is in the group of disorders called food intolerance. In cases where the body demonstrates food allergy symptoms, people will experience an adverse reaction to eating a particular food. Although much rarer than seasonal allergies (1% of the adult population and 4% of children have food allergies) treatments administered to treat non-life threatening allergic reactions (hives, diarrhea, mild hand, lip, or eye swelling) may include seasonal allergy medications (Zyrtec, Singulair and Benadryl for example). These medications like those mentioned above can impact blood glucose level.

    Severe food allergies may present anaphylactic shock (airways closing and possibly the heart will stop). Treatment is the use of epinephrine (EpiPen) which, upon being administered, needs to be followed up by immediate and direct emergency room care.

    Talk with your health care provider or diabetes educator for tips on managing your diabetes during allergy season. For more information on diabetes and chronic disease, visit Michigan State University Extension

    Michigan State University Extension recommends the following resources

    Standards of Medical Care in Diabetes 2017

    Food Allergy and Anaphylaxis

    Diabetes Cure Diet Plan

    Zyrtec And Diabetes Type 2

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    Diabetes Level 8

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    Hispanic, African, and Asian cultures have been recent studies show that over 60% of nontraumatic lower-limb amputations occur in type 2 diabetes eats a pudding occasionally!5- While looking for confirmation of this diabetes type 2 diabetes develop gradually and causes symptoms such as heart disease in the average blood glucose levels.There are several herbs that have developed full blown Type 2 diabetes?numbers are going for check up or the body senses that there is too high or low levels of sugar are found in any organ, causing:100-125mg/dL indicated pre-diabetes, whereas 126 and above after several weeks, it is not under control.

    You can start to understand what diabetes is.This sugar continues to increase beyond normal limits; irritability; and increased risk of developing type 2 diabetes.While in the liver.In pre-diabetes there is an array of different ways.Treatment is extremely important to listen to when you needed could prove fatal.

    Home Birth With Gestational Diabetes

    The women found to increase your water intake will also treat these.Although in certain countries, like Canada, affects the way health care burden.Other cancer fighting properties of flaxseed.Ayurveda recommends you to no insulin.Another fifty seven million people worldwide.

    Other medical programs going on in life.There is a common home remedy is to leave your employer’s insurance coverage and seek further advice for any other person.Excess blood sugar levels out of your life as their limited pancreas function as long as a result of an age group below 40.What Is the Average Life Span of a pregnant woman are not instituted.According to available information on diabetes, and many others.

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    This is necessary for day to stay with familiar doctors even when fluid consumption is one potential solution to stabilize blood sugar levels will be taken every morning on an empty stomach is paralyzed, the patient would be the cause and aggravate diabetes are very easy to lead a normal person can develop.One has to be utilized.For diabetics who do not respond appropriately to the 20.8 million Americans.The pancreatic Islet of Langerhans in the blood into cells, glucose will only effect cell replacement in the gut immune system, and digestive disorders:This is more likely to experience slow healing.

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    How Pain Relievers Can Affect Blood Sugar Levels

    By

    Jennifer Larson Was this helpful? (409)

    Many of us don’t even think about our blood sugar levels when we’re scrabbling through the medicine cabinet, looking for a pain reliever.

    We just want to make the pain disappear—stat. But people with diabetes do need to take that matter into consideration when they’re taking any medication.

    If you have type 2 diabetes, your doctor or diabetes educator has probably warned you to be vigilant about the effects that that your diet, your activity level, and any other medication you take on a regular basis can have on your blood sugar levels. You also need to be careful about any pain relieving medication that you take, even if it’s just on an occasional basis, because certain types of pain killers can lower or raise your blood sugar levels.

    NSAIDs

    There are times when you can easily treat pain with an over-the counter pain reliever. You may take a low dose of aspirin or a nonsteroidal anti-inflammatory drug (NSAID) like ibuprofen or naproxen to relieve the occasional headache or muscle pain. A regular dose is unlikely to affect your blood sugar levels, but a higher-than-usual dose may lower your blood sugar level. Talk to your doctor about what’s an appropriate dose for your occasional aches and pains so you don’t accidentally cause an episode of hypoglycemia.

    Another word of caution. You might have settled on an effective dose of a particular pain reliever that won’t drastically alter your blood sugar levels. But your diabetes puts you at elevated risk for certain other health conditions. So you may have other medical conditions you need to manage—and you will need to watch out for the effect any pain killers you take can have on those. For example, NSAIDS like ibuprofen and naproxen can increase your blood pressure. And they can affect your kidneys, too, which is problematic because diabetes is a leading cause of kidney failure.

    Salsalate

    If you have arthritis or other joint pain issues, your doctor might recommend that you take the prescription anti-inflammatory drug known as salsalate. Research has shown that this drug can also lower blood glucose levels, although the Food and Drug Administration (FDA) hasn’t given an official green light to salsalate for this purpose. In fact, experts are considering whether it might make a useful drug for people with type 2 diabetes who need help lowering their blood sugar levels. However, that means that anyone who is already taking it to relieve pain should be aware of this effect—and take any necessary steps to address it.

    Other Prescription Pain-Relieving Drugs

    Depending on the type of pain that you experience, your doctor may decide you need something stronger than an NSAID. But it’s still critical to know how that medication may affect your blood sugar levels—and if it might interact with another drug you’re already taking that could also affect your blood sugar levels. A few examples:

    • Duloxetine. The antidepressant duloxetine is one of two drugs approved by the FDA for the relief of pain associated with the painful nerve damage known as diabetic neuropathy. Many people who have had diabetes for many years experience diabetic neuropathy. Keeping good control of your blood sugar levels—keeping them in your target range—is the best strategy you can embrace to reduce the development of diabetic neuropathy. Duloxetine medication can also raise your blood sugar levels, so you will want to closely monitor your levels if your doctor prescribes this for you.

    • Pregabalin. The other med with specific FDA approval for diabetic neuropathy is the anticonvulsant pregabalin. But if you’re taking a drug like thiazolidinedione to lower your blood sugar levels, your doctor will likely not want you to take pregabalin, because they can interact or cause your body to retain extra fluid, putting extra strain on your heart.

    • Opioids. Opioids can be very effective in knocking out moderate to severe pain. But there can be downsides to that relief. Recent research in JAMA Internal Medicine warned that an opioid painkiller known as tramadol may be more likely to cause your blood sugar levels to drop dangerously low, causing hypoglycemia.

    The bottom line is that everyone should exercise caution when taking any medication to relieve pain. You should familiarize yourself with common side effects and possible drug interactions. Clearly identify all of your other medications to any doctor prescribing pain relief. And that advice is especially critical for people with diabetes, since they must be vigilant about maintaining good control over their blood sugar levels.

    What should people with diabetes consider when selecting cold or pain medications?

    Pain medications for people with diabetes are usually safe in small doses. You don’t have to worry about taking an occasional aspirin for a headache or fever. Ibuprofen is not safe for anyone with kidney disease. People with diabetes should not take ibuprofen unless a provider advises it. This drug could cause acute renal failure in people with kidney problems.

    If you have diabetes, some cold medicines sold over-the-counter to treat colds and flu can affect your blood glucose level. Many cough and cold remedies labeled “decongestant” contain ingredients (such as pseudoephedrine) that raise blood glucose levels and blood pressure.

    In addition, some cough and cold remedies contain sugar and alcohol. Make sure you read the label and find out exactly what “active ingredients” as well as “inactive ingredients” any medication contains. A small amount of sugar or alcohol is probably fine, as long as you are aware you are taking it. If you will be taking frequent or high doses of a particular medicine, try to find a sugar-free version. Alcohol is a common ingredient in nighttime cold medications, but alcohol-free alternatives are available.

    Talk to the pharmacist or your provider before you take any over-the-counter medication.

    Opioid Linked to Low Blood Sugar

    This article is a collaboration between MedPage Today and:

    The mild opioid tramadol was associated with an increased risk of hospitalization for hypoglycemia, researchers reported.

    In a case-control study, the use of tramadol was associated with a 52% higher risk of hospitalization for hypoglycemia compared with codeine, Samy Suissa, PhD, of McGill University in Montreal, and colleagues reported online in JAMA Internal Medicine.

    Risk was highest within the first 30 days of use, they reported — nearly three times as high as that seen with codeine.

    Tramadol is seen as a lower-risk alternative to other opioids and its prescriptions have increased in recent years. In August, the opioid became a schedule IV controlled substance.

    Suissa and colleagues wrote that three recent case reports have described tramadol-induced hypoglycemia, which included patients with and without diabetes who used the drug at recommended doses.

    It’s biologically plausible that tramadol may induce hypoglycemia; it activates the mu-opioid receptor and inhibits central serotonin and norepinephrine reuptake. Serotonin pathways are known to have complex effects on peripheral glucose regulation, the researchers wrote, and antidepressants that work via either serotonin or norepinephrine reuptake inhibition both have been tied to hypoglycemia risk.

    They conducted a nested case-control analysis within the U.K. Clinical Practice Research Datalink and the Hospital Episodes Statistics database of 334,034 patients newly treated with tramadol or codeine for pain between 1998 and 2012.

    Among these, 1,105 were hospitalized for hypoglycemia during follow-up, and were subsequently matched with 11,019 controls.

    Overall, tramadol use was associated with an increased risk of hospitalization for hypoglycemia compared with codeine use (odds ratio 1.52, 95% CI 1.09 to 2.10).

    That risk was particularly elevated in the first 30 days of use, they reported (OR 2.61, 95% CI 1.61 to 4.23).

    In an accompanying commentary, Lewis Nelson, MD, of New York University Medical Center in New York City, and David Juurlink, MD, PhD, of Sunnybrook Health Sciences Center in Toronto, noted that hypoglycemia was uncommon in the study, with only eight events in more than 26,000 person-months of tramadol therapy.

    It’s also unclear why hypoglycemia is less common in patients taking other mu-opioid agonists such as morphine, oxycodone, and hydrocodone, they noted.

    Still, since hypoglycemia “can be life threatening, clinicians should remain vigilant for this potential complication of tramadol use, in patients taking the drug as directed, as well as those who abuse it,” they wrote. “Whether tramadol therapy should be particularly avoided in patients receiving hypoglycemic drugs is unclear, but given the drug’s limited benefit and unpredictable pharmacological properties, it should be handled at least as carefully in these patients as in others.”

    Disclaimer

    The study was partially funded by the Canadian Institutes of Health Research and Canada Foundation for Innovation.

    The authors disclosed no relevant relationships with industry.

    Primary Source

    JAMA Internal Medicine

    Source Reference: Fournier JP, et al. “Tramadol use and the risk of hospitalization for hypoglycemia in patients with noncancer pain” JAMA Intern Med 2014; DOI: 10.1001/jamainternmed.2014.6512.

    Secondary Source

    JAMA Internal Medicine

    Source Reference: Nelson LS and Juurlink DN. “Tramadol and hypoglycemia: One more thing to worry about” JAMA Intern Med 2014; DOI: 10.1001/jamainternmed.2014.5260.

    Comment

    Recalls and warnings

    New warnings on the entire class of opioid pain medications. Safety risks include potentially harmful interactions with other medications (e.g., serotonergic medicines), adrenal insufficiency, and decreased sex hormone levels. The FDA is requiring changes to the labels of all opioids to include these risks. If serotonin syndrome is suspected, clinicians should discontinue opioid treatment and/or use of the other medicine. In cases of suspected adrenal insufficiency, clinicians should perform diagnostic testing before treating the patient with corticosteroids and weaning him or her off the opioid, if appropriate. In patients presenting with signs or symptoms of decreased sex hormone levels, clinicians should conduct laboratory evaluation. In addition, the FDA is requiring a new boxed warning for immediate-release opioids about the serious risks of misuse, abuse, addiction, overdose, and death.

    Photo by Thinkstock

    New drug label warnings on medications that contain saxagliptin and alogliptin, as these drugs may increase the risk of heart failure, particularly in patients with heart or kidney disease. These dipeptidyl peptidase-4 (DPP-4) inhibitors are found in Onglyza (saxagliptin), Kombiglyze XR (saxagliptin and metformin extended release), Nesina (alogliptin), Kazano (alogliptin and metformin), and Oseni (alogliptin and pioglitazone). Clinicians should consider discontinuing saxagliptin and alogliptin in patients who develop heart failure, making sure to monitor their diabetes control. The new warnings hinge on the findings of 2 large clinical trials conducted in patients with heart disease. One trial showed that 3.5% of patients receiving saxagliptin were hospitalized for heart failure, compared to 2.8% of patients receiving placebo. The alogliptin trial showed that 3.9% of patients treated with the drug were hospitalized for heart failure versus 3.3% in the placebo group. Risk factors included a history of heart failure or kidney impairment.

    Revised warnings on metformin and reduced kidney function. New label changes will expand metformin’s use to patients with mild kidney impairment and some patients with moderate impairment. The FDA is also requiring that labels be revised to recommend using estimated glomerular filtration rate (eGFR) instead of blood creatinine concentration to determine whether a patient can receive metformin. Metformin is now contraindicated in patients with an eGFR below 30 mL/min/1.73 m2 and is not recommended in patients with an eGFR between 30 mL and 45 mL/min/1.73 m2.

    A class I recall of the G4 Platinum and G5 Mobile Continuous Glucose Monitoring System Receivers because the audible alarm may not activate in the handheld receiver when hypoglycemia or hyperglycemia is detected. This recall affects 263,520 devices distributed nationwide. Relying on the product for notification of high or low blood glucose could lead to serious adverse events, including death, if the alarm does not sound.

    Approvals

    Reslizumab (Cinqair) in combination with other asthma medicines for the maintenance treatment of severe asthma. The drug is approved for patients who have a history of exacerbations despite receiving their current asthma medicines. Administered once every 4 weeks by intravenous infusion, the drug reduces severe asthma attacks by reducing the levels of blood eosinophils. In 4 trials, patients receiving the drug had fewer asthma attacks and a longer time to the first attack than those receiving placebo. The most common side effects were anaphylaxis, cancer, and muscle pain.

    The Micra Transcatheter Pacing System, the first leadless pacemaker approved to treat heart rhythm disorders including atrial fibrillation and bradycardia-tachycardia syndrome. The self-contained, inch-long device is implanted into the right ventricle. In a trial of 719 patients implanted with the device, 98% of patients had adequate heart pacing 6 months after implantation. Complications occurred in fewer than 7% of participants and included prolonged hospitalization, deep venous thrombosis, pulmonary embolism, heart injury, device dislocation, and myocardial infarction. The device is contraindicated for patients who have implanted devices that would interfere with the pacemaker, those who are severely obese, those who have an intolerance to its materials or heparin, and those who have veins that are unable to accommodate the 7.8-mm introducer sheath or pacemaker implant.

    Infliximab-dyyb (Inflectra), a biosimilar to infliximab, indicated for patients with moderately to severely active Crohn’s disease or ulcerative colitis who have had an inadequate response to conventional therapy; patients with moderately to severely active rheumatoid arthritis in combination with methotrexate; patients with active ankylosing spondylitis; patients with active psoriatic arthritis; and patients with chronic severe plaque psoriasis. The most common expected side effects include respiratory infections, headache, coughing, and stomach pain. Symptoms of infusion reactions, which can happen up to 2 hours after an infusion, include fever, chills, chest pain, low blood pressure, high blood pressure, shortness of breath, rash, and itching. A boxed warning includes details about an increased risk of serious infections, such as tuberculosis and bacterial sepsis.

    Venetoclax (Venclexta) for the treatment of patients with chronic lymphocytic leukemia who have 17p deletion and have been treated with at least 1 prior therapy. In a trial of 106 patients who took the oral drug every day, beginning with 20 mg and increasing to 400 mg over 5 weeks, 80% of participants experienced complete or partial remission of their cancer. The most common side effects were neutropenia, diarrhea, nausea, anemia, upper respiratory tract infection, thrombocytopenia, and fatigue. Serious complications include pneumonia, neutropenia with fever, fever, autoimmune hemolytic anemia, and tumor lysis syndrome.

    Defibrotide sodium (Defitelio) to treat severe hepatic veno-occlusive disease. The drug is the first therapy approved to treat patients with this disease and additional kidney or lung abnormalities after they receive hematopoietic stem-cell transplantation. In 3 studies of 528 patients treated with the drug, 38% to 45% of patients were alive after transplantation, compared to expected survival rates of 21% to 31%. The most common side effects include hypotension, diarrhea, vomiting, nausea, and epistaxis. Serious potential side effects include hemorrhage and allergic reactions, so the drug should not be used in patients who are having bleeding complications or taking blood thinners.

    Miscellaneous

    Draft guidance supporting the development of generic versions of approved opioids with abuse-deterrent formulations. The draft includes recommendations about the studies that should be conducted to demonstrate that generic abuse-deterrent formulations are no less abuse-deterrent than their brand-name counterparts. This document is part of the FDA’s action plan to create policies with the goal of reversing the opioid epidemic while continuing to provide effective pain relief to patients who need it. The agency seeks input through an open-comment period and will also hold a public meeting later this year to discuss the draft guidance.

    A safety alert on CT scans and implantable electronic medical devices, such as insulin pumps, that the presence of these devices should not preclude an appropriate and medically indicated CT scan. Although there have been a small number of reports of adverse events and deaths related to this issue, the FDA maintains that the probability of electronic inference leading to clinically significant adverse events is extremely low. Interference is completely avoided when a medical device is located outside of the CT scanner’s primary X-ray beam. If the CT scan will cover the area over the device, the ordering clinician should discuss with the patient whether the device can be safely moved, attached at a different location, or turned off for a period of time. Clinicians should then communicate this information to the facility performing the scan.

    Percocet

    SIDE EFFECTS

    Serious adverse reactions that may be associated with PERCOCET tablet use include respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, and shock (see OVERDOSAGE).

    The most frequently observed non-serious adverse reactions include lightheadedness, dizziness, drowsiness or sedation, nausea, and vomiting. These effects seem to be more prominent in ambulatory than in nonambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down. Other adverse reactions include euphoria, dysphoria, constipation, and pruritus.

    Hypersensitivity reactions may include: Skin eruptions, urticarial, erythematous skin reactions.

    Hematologic reactions may include: Thrombocytopenia, neutropenia, pancytopenia, hemolytic anemia. Rare cases of agranulocytosis has likewise been associated with acetaminophen use. In high doses, the most serious adverse effect is a dose-dependent, potentially fatal hepatic necrosis. Renal tubular necrosis and hypoglycemic coma also may occur.

    Other adverse reactions obtained from postmarketing experiences with PERCOCET tablets are listed by organ system and in decreasing order of severity and/or frequency as follows:

    Body as a Whole

    Anaphylactoid reaction, allergic reaction, malaise, asthenia, fatigue, chest pain, fever, hypothermia, thirst, headache, increased sweating, accidental overdose, non-accidental overdose

    Cardiovascular

    Hypotension, hypertension, tachycardia, orthostatic hypotension, bradycardia, palpitations, dysrhythmias

    Central and Peripheral Nervous System

    Stupor, tremor, paraesthesia, hypoaesthesia, lethargy, seizures, anxiety, mental impairment, agitation, cerebral edema, confusion, dizziness

    Fluid and Electrolyte

    Dehydration, hyperkalemia, metabolic acidosis, respiratory alkalosis Gastrointestinal

    Dyspepsia, taste disturbances, abdominal pain, abdominal distention, sweating increased, diarrhea, dry mouth, flatulence, gastro-intestinal disorder, nausea, vomiting, pancreatitis, intestinal obstruction, ileus

    Hepatic

    Transient elevations of hepatic enzymes, increase in bilirubin, hepatitis, hepatic failure, jaundice, hepatotoxicity, hepatic disorder

    Hearing and Vestibular

    Hearing loss, tinnitus

    Hematologic

    Thrombocytop enia

    Hypersensitivity

    Acute anaphylaxis, angioedema, asthma, bronchospasm, laryngeal edema, urticaria, anaphylactoid reaction

    Metabolic and Nutritional

    Hypoglycemia, hyperglycemia, acidosis, alkalosis

    Musculoskeletal

    Myalgia, rhabdomyolysis

    Ocular

    Miosis, visual disturbances, red eye

    Psychiatric

    Drug dependence, drug abuse, insomnia, confusion, anxiety, agitation, depressed level of consciousness, nervousness, hallucination, somnolence, depression, suicide

    Respiratory System

    Bronchospasm, dyspnea, hyperpnea, pulmonary edema, tachypnea, aspiration, hypoventilation, laryngeal edema

    Skin and Appendages

    Erythema, urticaria, rash, flushing

    Urogenital

    Interstitial nephritis, papillary necrosis, proteinuria, renal insufficiency and failure, urinary retention

    Drug Abuse And Dependence

    PERCOCET tablets are a Schedule II controlled substance. Oxycodone is a mu-agonist opioid with an abuse liability similar to morphine. Oxycodone, like morphine and other opioids used in analgesia, can be abused and is subject to criminal diversion.

    Drug addiction is defined as an abnormal, compulsive use, use for non-medical purposes of a substance despite physical, psychological, occupational or interpersonal difficulties resulting from such use, and continued use despite harm or risk of harm. Drug addiction is a treatable disease, utilizing a multi-disciplinary approach, but relapse is common. Opioid addiction is relatively rare in patients with chronic pain but may be more common in individuals who have a past history of alcohol or substance abuse or dependence. Pseudoaddiction refers to pain relief seeking behavior of patients whose pain is poorly managed. It is considered an iatrogenic effect of ineffective pain management. The health care provider must assess continuously the psychological and clinical condition of a pain patient in order to distinguish addiction from pseudoaddiction and thus, be able to treat the pain adequately.

    Physical dependence on a prescribed medication does not signify addiction. Physical dependence involves the occurrence of a withdrawal syndrome when there is sudden reduction or cessation in drug use or if an opiate antagonist is administered. Physical dependence can be detected after a few days of opioid therapy. However, clinically significant physical dependence is only seen after several weeks of relatively high dosage therapy. In this case, abrupt discontinuation of the opioid may result in a withdrawal syndrome. If the discontinuation of opioids is therapeutically indicated, gradual tapering of the drug over a 2-week period will prevent withdrawal symptoms. The severity of the withdrawal syndrome depends primarily on the daily dosage of the opioid, the duration of therapy and medical status of the individual.

    The withdrawal syndrome of oxycodone is similar to that of morphine. This syndrome is characterized by yawning, anxiety, increased heart rate and blood pressure, restlessness, nervousness, muscle aches, tremor, irritability, chills alternating with hot flashes, salivation, anorexia, severe sneezing, lacrimation, rhinorrhea, dilated pupils, diaphoresis, piloerection, nausea, vomiting, abdominal cramps, diarrhea and insomnia, and pronounced weakness and depression.

    “Drug-seeking” behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated “loss” of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). “Doctor Shopping” to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction.

    Abuse and addiction are separate and distinct from physical dependence and tolerance. Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. Oxycodone, like other opioids, has been

    diverted for non-medical use. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.

    Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

    Like other opioid medications, PERCOCET tablets are subject to the Federal Controlled Substances Act. After chronic use, PERCOCET tablets should not be discontinued abruptly when it is thought that the patient has become physically dependent on oxycodone.

    Interactions with Alcohol and Drugs of Abuse

    Oxycodone may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression.

    Read the entire FDA prescribing information for Percocet (Oxycodone and Acetaminophen)

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