In the US, Brethine (terbutaline systemic) is a member of the following drug classes: adrenergic bronchodilators, tocolytic agents and is used to treat Asthma - acute, Asthma - Maintenance and Premature Labor.
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Terbutaline sulfate (a derivative of Terbutaline) is reported as an ingredient of Brethine in the following countries:
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Rubidexol may be available in the countries listed below.
Methadone hydrochloride (a derivative of Methadone) is reported as an ingredient of Rubidexol in the following countries:
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Lafol may be available in the countries listed below.
Folic Acid is reported as an ingredient of Lafol in the following countries:
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Novopulm Novolizer may be available in the countries listed below.
Budesonide is reported as an ingredient of Novopulm Novolizer in the following countries:
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Raserpamil may be available in the countries listed below.
Verapamil is reported as an ingredient of Raserpamil in the following countries:
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Reminal may be available in the countries listed below.
Enalapril is reported as an ingredient of Reminal in the following countries:
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Noreskin may be available in the countries listed below.
Azelaic Acid is reported as an ingredient of Noreskin in the following countries:
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Lorazepam Hexal may be available in the countries listed below.
Lorazepam is reported as an ingredient of Lorazepam Hexal in the following countries:
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Class: Angiotensin II Receptor Antagonists
VA Class: CV805
Chemical Name: Cyclic 2,3 carbonate 2,3 - dihydroxy - 2 - butenyl - 4 - (1 - hydroxy - 1 - methylethyl) - 1 - propyl - 1 - [p - (o - 1H - tetrazol - 5 - ylphenyl)benzyl]imidazole - 5 - carboxylate
Molecular Formula: C29H30N6O6
CAS Number: 144689-63-4
Brands: Azor (combination), Benicar, Benicar HCT
May cause fetal and neonatal morbidity and mortality if used during pregnancy.1 31 42 43 44 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)
If pregnancy is detected, discontinue the drug as soon as possible.1 31 43 44
Olmesartan is an angiotensin II type 1 (AT1) receptor antagonist.1 2 3 16 28 31 44
Olmesartan is used for management of hypertension (alone or in combination with other classes of antihypertensive agents);1 2 3 8 9 28 31 44 may be used in fixed combination with amlodipine or hydrochlorothiazide when such combined therapy is indicated.31 44
Angiotensin II receptor antagonists are one of several preferred initial therapies in hypertensive patients with chronic kidney disease, diabetes mellitus, or heart failure.30
Angiotensin II receptor antagonists can be used as monotherapy for initial management of uncomplicated hypertension; however, thiazide diuretics are preferred by JNC 7.30
Angiotensin II receptor antagonists or ACE inhibitors are first-line agents in the treatment of diabetic nephropathy† in patients with type 2 diabetes mellitus and hypertension.
Angiotensin II receptor antagonists are second-line agents in the treatment of CHF†; should be used only in those intolerant of ACE inhibitors.
Fixed-combination olmesartan/amlodipine and olmesartan/hydrochlorothiazide tablets should not be used for initial treatment of hypertension.31 44
Administer olmesartan orally once daily without regard to meals.1 2
Olmesartan is available as olmesartan medoxomil; dosage expressed in terms of the salt.1 31 44
Initially, olmesartan medoxomil 20 mg once daily in adults without intravascular volume depletion.1 Adjust dosage at approximately monthly intervals (more aggressively in high-risk patients) to achieve BP control.4 30
Usual olmesartan medoxomil dosage: 20–40 mg once daily; no additional therapeutic benefit with higher dosages1 30 or with twice-daily dosing.1 28
If BP is not adequately controlled by monotherapy with olmesartan (or another angiotensin II receptor antagonist) or amlodipine (or another dihydropyridine-derivative calcium-channel blocker), can switch to the fixed-combination preparation containing olmesartan medoxomil 20 mg and amlodipine 5 or 10 mg or, alternatively, olmesartan medoxomil 40 mg and amlodipine 5 or 10 mg.44
Can use the fixed combination as a substitute for the individually titrated drugs.44 Can switch to the fixed-combination preparation containing the corresponding individual doses of olmesartan and amlodipine; alternatively, can increase the dosage of one or both components for additional antihypertensive effects.44
Adjust dosage of olmesartan/amlodipine fixed combination, up to a maximum dosage of olmesartan medoxomil 40 mg and amlodipine 10 mg daily, according to patient’s response after ≥2 weeks at the current dosage.44
If BP is not adequately controlled by monotherapy with olmesartan or hydrochlorothiazide, can switch to fixed-combination olmesartan/hydrochlorothiazide tablets.31 In patients already receiving olmesartan, initiate hydrochlorothiazide at dosage of 12.5 mg once daily; in those receiving hydrochlorothiazide, consider reducing hydrochlorothiazide dosage to 12.5 mg and initiate olmesartan medoxomil at dosage of 20 mg once daily.31 Increase dosages to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg once daily, if needed, to control BP.31
If BP is controlled with olmesartan and hydrochlorothiazide (administered separately), can switch to the fixed-combination preparation containing the corresponding individual doses for convenience.31
Adjust dosage of olmesartan/hydrochlorothiazide fixed combination according to patient’s response after 2–4 weeks at the current dosage.31
The following information addresses dosage of olmesartan in special populations. Dosages of drugs administered in fixed combination with olmesartan also may require adjustment in certain patient populations; the need for such dosage adjustments must be considered in the context of cautions, precautions, and contraindications specific to that population and drug.31 44
No adjustment of initial olmesartan dosage necessary in patients with moderate to severe hepatic impairment.1 31
Amount of amlodipine in olmesartan/amlodipine fixed combinations exceeds the recommended initial dosage of amlodipine (2.5 mg daily) in patients with hepatic impairment.44
Manufacturer states that no adjustment of initial olmesartan dosage is necessary in patients with moderate to severe renal impairment (Clcr <40 mL/minute).1 31 44 However, some clinicians recommend lower initial dosage in patients with Clcr <20 mL/minute, with maximum dosage of 20 mg once daily in such patients.10
Dosage of olmesartan in patients with end-stage renal disease not determined.29
Olmesartan/hydrochlorothiazide fixed combination not recommended in patients with severe renal impairment (Clcr ≤30 mL/minute).31 Loop diuretics are preferred to thiazides in these patients.31
No adjustment of initial olmesartan dosage is necessary.1 31
Amount of amlodipine in olmesartan/amlodipine fixed combinations exceeds the recommended initial dosage of amlodipine (2.5 mg daily) in patients ≥75 years of age.44
Correct volume and/or salt depletion prior to initiation of olmesartan therapy or initiate therapy under close medical supervision using lower initial dosage.1 31 44
Known hypersensitivity to olmesartan or any ingredient in the formulation.1 31
When olmesartan is used in fixed combination with hydrochlorothiazide or amlodipine, consider contraindications associated with the concomitant agent.31 41
Possible symptomatic hypotension with olmesartan, particularly in volume- and/or salt-depleted patients (e.g., those treated with diuretics).1 31 44 (See Volume- and/or Salt-Depleted Patients under Dosage and Administration.)
Transient hypotension is not a contraindication to additional doses; may reinstate olmesartan therapy cautiously after BP is stabilized (e.g., with volume expansion).1 31 44
Results of 2 randomized controlled trials in patients with type 2 diabetes mellitus showed an increased risk of death from cardiovascular causes (e.g., MI, sudden death, stroke) in patients receiving olmesartan compared with placebo.124 FDA is continuing to evaluate the data and has not concluded that the drug increases risk of cardiovascular death.124 Numerous controlled studies have evaluated olmesartan and other angiotensin II receptor antagonists in patients at high risk of cardiovascular events and have not suggested an increased risk of cardiovascular mortality.124 Because benefits of olmesartan in hypertensive patients continue to outweigh potential risks, FDA states that patients should continue to take the drug as prescribed unless otherwise instructed by a clinician.124
Possible fetal and neonatal morbidity and mortality when drugs that act directly on the renin-angiotensin system (e.g., angiotensin II receptor antagonists, ACE inhibitors) are used during the second and third trimesters of pregnancy.1 4 31 43 44 (See Boxed Warning.) ACE inhibitors also may increase the risk of major congenital malformations when administered during the first trimester of pregnancy.42 43
Discontinue olmesartan as soon as possible when pregnancy is detected, unless continued use is considered lifesaving.1 31 42 43 44 Nearly all women can be transferred successfully to alternative therapy for the remainder of their pregnancy.13
In July 2010, FDA initiated a safety review of angiotensin II receptor antagonists after a published meta-analysis found a modest but statistically significant increase in risk of new cancer occurrence in patients receiving an angiotensin II receptor antagonist compared with control.120 121 123 126 However, subsequent studies, including a larger meta-analysis conducted by FDA, have not shown such risk.126 127 128 129 Based on currently available data, FDA has concluded that angiotensin II receptor antagonists do not increase the risk of cancer.126
Anaphylactoid reactions and/or angioedema possible with angiotensin II receptor antagonists;1 2 7 14 extreme caution in patients with a history of angioedema associated with or unrelated to ACE inhibitor or angiotensin II receptor antagonist therapy.7 15 45
When olmesartan is used in fixed combination with amlodipine or hydrochlorothiazide, consider cautions, precautions, contraindications, and interactions associated with the concomitant agent.31 44 Consider cautionary information applicable to specific populations (e.g., pregnant or nursing women, individuals with hepatic or renal impairment, geriatric patients) for each drug in the fixed combination.31 44
Possible oliguria, progressive azotemia and, rarely, acute renal failure and/or death in patients with severe CHF.1 31 44
Increases in BUN and Scr possible in patients with unilateral or bilateral renal artery stenosis.1 31 44
Olmesartan: Category C (1st trimester); Category D (2nd and 3rd trimesters).1 31 44 (See Boxed Warning.)
Olmesartan is distributed into milk in rats; not known whether olmesartan is distributed into human milk.1 31 44 Discontinue nursing or the drug.1 31 44
Safety and efficacy of olmesartan alone or in fixed combination with amlodipine or hydrochlorothiazide not established.1 31 44
No substantial differences in safety or efficacy of olmesartan alone or in fixed combination with amlodipine relative to younger adults, but increased sensitivity cannot be ruled out.1 44
Insufficient experience with olmesartan given in fixed combination with hydrochlorothiazide in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults; select dosage with caution.31
Systemic exposure to olmesartan may be increased.1 31 44 (See Special Populations under Absorption, in Pharmacokinetics.)
Systemic exposure to olmesartan may be increased.1 31 44 (See Special Populations under Absorption, in Pharmacokinetics.) Some clinicians recommend initial dosage adjustment in patients with severe renal impairment.10 (See Renal Impairment under Dosage and Administration.)
Use of olmesartan in fixed combination with hydrochlorothiazide is not recommended in patients with Clcr ≤30 mL/minute.31
Deterioration of renal function may occur.1 31 44 (See Renal Effects under Cautions.)
BP reduction with olmesartan may be smaller in black patients compared with nonblack patients; use in combination with a diuretic.1 5 30 31
Olmesartan: Dizziness,1 2 3 back pain,1 bronchitis,1 2 12 diarrhea1 , headache,1 2 3 12 hematuria,1 hyperglycemia,1 hypertriglyceridemia,1 influenza-like symptoms,1 2 12 pharyngitis,1 rhinitis,1 sinusitis,1 upper respiratory tract infection.2 3 12
The following information addresses potential interactions with olmesartan. When olmesartan is used in fixed combination with hydrochlorothiazide or amlodipine, consider interactions associated with the concomitant agent.31 44
Olmesartan is not metabolized by and does not inhibit or induce CYP isoenzymes.1 2
Drug | Interaction |
|---|---|
Antacids | Pharmacokinetic interactions unlikely1 2 28 |
Digoxin | Pharmacokinetic interactions unlikely1 2 28 |
Hydrochlorothiazide | Pharmacokinetic interactions unlikely1 2 28 Additive hypotensive effects1 31 |
Warfarin | Pharmacokinetic interaction unlikely1 2 28 |
Olmesartan medoxomil (prodrug) is rapidly and completely hydrolyzed to olmesartan during absorption in the GI tract.1 31 44
Absolute bioavailability of olmesartan is about 26%.1 31 44
Peak plasma olmesartan concentration generally reached 1–2 hours following oral administration.1 31 44
Antihypertensive effect of olmesartan is evident within 2 weeks, with maximum BP reduction after 4–6 weeks.1 3
Food does not affect bioavailability of olmesartan.1 31 44
In patients with moderate hepatic impairment, peak plasma concentration of olmesartan is increased; AUC increased by about 60%.1 31 44
In patients with severe renal impairment (Clcr <20 mL/minute), plasma concentrations and AUC of olmesartan are increased.1 31 44 After repeated dosing, AUC values are approximately triple those in patients with normal renal function.1 31 44
In women, peak plasma concentration and AUC of olmesartan are about 10–15% higher than values in men.1 31 44
Olmesartan crosses the placenta and is distributed in the fetus in animals.1 31 44
Olmesartan crosses the blood-brain barrier poorly, if at all, in animals.1 31 44
Olmesartan is distributed into milk in rats; not known whether olmesartan is distributed into human milk.1 31 44
Olmesartan: 99%.1 31 44
Olmesartan medoxomil undergoes rapid and complete ester hydrolysis to olmesartan.1 2 28 31 44 Virtually no further metabolism of olmesartan occurs; not metabolized by CYP isoenzymes.1 2 28 31 44
Olmesartan is eliminated mainly in urine (35–50%) and feces (via bile).1 2 31 44
Biphasic; terminal half-life of olmesartan is approximately 13 hours.1 31 44
In geriatric patients, renal clearance of olmesartan is decreased by approximately 30%.1 31 44
Olmesartan or olmesartan/hydrochlorothiazide fixed combination: 20–25°C.1 31
Olmesartan/amlodipine fixed combination: 25ºC (may be exposed to 15–30ºC).44
Olmesartan medoxomil (prodrug) has little pharmacologic activity until hydrolyzed to olmesartan during absorption.1 2 31 44
Olmesartan blocks the physiologic actions of angiotensin II, including vasoconstrictor and aldosterone-secreting effects.1 31 44
Olmesartan does not interfere with response to bradykinins and substance P.1 31 44
Olmesartan does not share the ACE inhibitor common adverse effect of dry cough.1
When olmesartan is used in fixed combination with hydrochlorothiazide or amlodipine, importance of advising patients of important precautionary information about the concomitant agent.31 44
Risks of use during pregnancy.1 31 42 43 44
Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.1 31 44
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1 31 44
Importance of informing patients of other important precautionary information.1 31 44 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets, film-coated | 5 mg | Benicar | Daiichi-Sankyo |
20 mg | Benicar | Daiichi-Sankyo | ||
40 mg | Benicar | Daiichi-Sankyo |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets | 20 mg with Amlodipine Besylate 5 mg (of amlodipine) | Azor | Daiichi-Sankyo |
20 mg with Amlodipine Besylate 10 mg (of amlodipine) | Azor | Daiichi-Sankyo | ||
40 mg with Amlodipine Besylate 5 mg (of amlodipine) | Azor | Daiichi-Sankyo | ||
40 mg with Amlodipine Besylate 10 mg (of amlodipine) | Azor | Daiichi-Sankyo | ||
Tablets, film-coated | 20 mg with Hydrochlorothiazide 12.5 mg | Benicar HCT | Daiichi-Sankyo | |
40 mg with Hydrochlorothiazide 12.5 mg | Benicar HCT | Daiichi-Sankyo | ||
40 mg with Hydrochlorothiazide 25 mg | Benicar HCT | Daiichi-Sankyo |
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 01/2012. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Azor 10-20MG Tablets (SANKYO): 30/$117.76 or 90/$340.05
Azor 10-40MG Tablets (SANKYO): 90/$442.99 or 270/$1,298.97
Azor 5-20MG Tablets (SANKYO): 30/$121.06 or 90/$349.97
Azor 5-40MG Tablets (SANKYO): 30/$154.35 or 90/$450.93
Benicar 20MG Tablets (SANKYO): 30/$93.99 or 90/$270.96
Benicar 40MG Tablets (SANKYO): 30/$128.99 or 90/$371.99
Benicar 5MG Tablets (SANKYO): 30/$77.99 or 90/$225.97
Benicar HCT 20-12.5MG Tablets (SANKYO): 30/$96.99 or 90/$275.96
Benicar HCT 40-12.5MG Tablets (SANKYO): 30/$131.00 or 90/$375.96
Benicar HCT 40-25MG Tablets (SANKYO): 30/$131.00 or 90/$360.98
Tribenzor 20-5-12.5MG Tablets (SANKYO): 30/$118.74 or 90/$330.31
Tribenzor 40-10-25MG Tablets (SANKYO): 30/$152.14 or 90/$433.29
Tribenzor 40-5-12.5MG Tablets (SANKYO): 30/$152.14 or 60/$304.27
Tribenzor 40-5-25MG Tablets (SANKYO): 30/$154.49 or 90/$444.01
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2012, Selected Revisions December 23, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
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2. Song JC, White CM. Olmesartan medoxomil (CS-866): an angiotensin II receptor blocker for treatment of hypertension. Formulary. 2001; 36:487-99.
3. Neutel JM. Clinical studies of CS-866, the newest angiotensin II receptor antagonist. Am J Cardiol. 2001; 87(Suppl):37-43C.
4. National Heart, Lung, and Blood Institute National High Blood Pressure Education Program. The sixth report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VI). Bethesda, MD: National Institutes of Health; 1997 Nov. (NIH publication No. 98?4080.)
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11. Walser M. Angiotensin-Receptor Blockers, Type 2 Diabetes, and Renoprotection. N Engl J Med. 2002; 346:706.
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13. US Food and Drug Administration. Dangers of ACE inhibitors during second and third trimesters of pregnancy. FDA Med Bull. 1992; 22:2.
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17. AstraZeneca, Wayne, PA: personal communication on Candesartan 24:32.08.
18. American Diabetes Association. Treatment of hypertension in adults with diabetes. Diabetes Care. 2002; 25(Suppl 1):S71-73.
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24. Parving HH, Lehnert H, Brochner-Mortensen J et al and the Irbesartan in Patients with Type 2 Diabetes and Microalbuminuria Study Group. The effect of irbesartan on the development of diabetic nephropathy in patients with type 2 diabetes. N Engl J Med. 2001; 345:870-8. [IDIS 469608] [PubMed 11565519]
25. Walser M. Angiotensin-Receptor Blockers, Type 2 Diabetes, and Renoprotection. N Engl J Med. 2002; 346:706.
26. Unger T. Significance of angiotensin type 1 receptor blockade: why are angiotensin II receptor blockers different? Am J Cardiol. 1999; 84:9-15S.
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31. Daiichi Sankyo, Inc. Benicar HCT (olmesartan medoxomil and hydrochlorothiazide) tablets prescribing information. Parsippany, NJ; 2007 Jul.
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40. American Diabetes Association. Treatment of hypertension in adults with diabetes. Diabetes Care. 2003; 26(Suppl 1):S80-2.
41. Guidelines Committee. 2003 European Society of Hypertension–European Society of Cardiology guidelines for the management of arterial hypertension. J Hypertension. 2003; 21:1011-53.
42. Cooper WO, Hernandez-Diaz S, Arbogast PG et al. Major congenital malformations after first-trimester exposure to ACE inhibitors. N Engl J Med. 2006; 354:2443-51. [PubMed 16760444]
43. Food and Drug Administration. FDA public health advisory: angiotensin-converting enzyme inhibitor (ACE inhibitor) drugs and pregnancy. From FDA website.
44. Daiichi Sankyo, Inc. Azor (amlodipine and olmesartan medoxomil) tablets prescribing information. Parsippany, NJ; 2008 Oct.
45. Howes LG, Tran D. Can angiotensin receptor antagonists be used safely in patients with previous ACE inhibitor-induced angioedema? Drug Saf. 2002; 25:73-6.
120. Food and Drug Administration. FDA drug safety communication: ongoing safety review of the angiotensin receptor blockers and cancer. Rockville, MD; 2010 Jul 15. From FDA website ().
121. Sipahi I, Debanne SM, Rowland DY et al. Angiotensin-receptor blockade and risk of cancer: meta-analysis of randomised controlled trials. Lancet Oncol. 2010; 11:627-36. [PubMed 20542468]
122. Nissen SE. Angiotensin-receptor blockers and cancer: urgent regulatory review needed. Lancet Oncol. 2010; 11:605-6. [PubMed 20542469]
123. Sica DA. Angiotensin receptor blockers and the risk of malignancy: a note of caution. Drug Saf. 2010; 33:709-12. [PubMed 20701404]
124. Food and Drug Administration. FDA drug safety communication: ongoing safety review of Benicar and cardiovascular events. Rockville, MD; 2010 June 11. From FDA website ().
125. Imai E, Ito S, Haneda M et al. Olmesartan reducing incidence of endstage renal disease in diabetic nephropathy trial (ORIENT): rationale and study design. Hypertens Res. 2006; 29:703-9. [PubMed 17249526]
126. Food and Drug Administration. FDA drug safety communication: No increase in risk of cancer with certain blood pressure drugs-angiotensin receptor blockers (ARBs). Rockville, MD; 2011 Jun 2. Available from FDA website. Accessed 2011 Jun 15.
127. Bangalore S, Kumar S, Kjeldsen SE et al. Antihypertensive drugs and risk of cancer: network meta-analyses and trial sequential analyses of 324,168 participants from randomised trials. Lancet Oncol. 2011; 12:65-82. [PubMed 21123111]
128. ARB Trialists Collaboration. Effects of telmisartan, irbesartan, valsartan, candesartan, and losartan on cancers in 15 trials enrolling 138,769 individuals. J Hypertens. 2011; 29:623-35. [PubMed 21358417]
129. Pasternak B, Svanström H, Callréus T et al. Use of angiotensin receptor blockers and the risk of cancer. Circulation. 2011; 123:1729-36. [PubMed 21482967]
130. Volpe M, Morganti A. 2010 Position Paper of the Italian Society of Hypertension (SIIA): Angiotensin Receptor Blockers and Risk of Cancer. High Blood Press Cardiovasc Prev. 2011; 18:37-40. [PubMed 21612311]
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132. Haller H, Viberti GC, Mimran A et al. Preventing microalbuminuria in patients with diabetes: rationale and design of the Randomised Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) study. J Hypertens. 2006; 24:403-8. [PubMed 16508590]
In some countries, this medicine may only be approved for veterinary use.
Bacitracin methylene disalicylate (a derivative of Bacitracin) is reported as an ingredient of Robenz in the following countries:
Bacitracin zinc salt (a derivative of Bacitracin) is reported as an ingredient of Robenz in the following countries:
Chlortetracycline calcium salt (a derivative of Chlortetracycline) is reported as an ingredient of Robenz in the following countries:
Lincomycin hydrochloride monohydrate (a derivative of Lincomycin) is reported as an ingredient of Robenz in the following countries:
Oxytetracycline is reported as an ingredient of Robenz in the following countries:
Robenidine hydrochloride (a derivative of Robenidine) is reported as an ingredient of Robenz in the following countries:
Roxarsone is reported as an ingredient of Robenz in the following countries:
International Drug Name Search
Hierro Lafedar may be available in the countries listed below.
Ferrous Fumarate is reported as an ingredient of Hierro Lafedar in the following countries:
Ferrous Sulfate is reported as an ingredient of Hierro Lafedar in the following countries:
International Drug Name Search
Didanosine Delayed-Release Enteric-Coated Capsules may cause serious and sometimes fatal inflammation of the pancreas (pancreatitis). This has occurred in patients who have just started taking Didanosine Delayed-Release Enteric-Coated Capsules and in patients who have already been taking it. Contact your doctor right away if you experience sudden stomach or back pain, swelling of the stomach, fever or chills, nausea or vomiting, or fast heartbeat.
Didanosine Delayed-Release Enteric-Coated Capsules may cause severe and sometimes fatal lactic acidosis and liver problems. Fatal lactic acidosis has also occurred in pregnant women who have used Didanosine Delayed-Release Enteric-Coated Capsules along with certain other medicines for HIV (eg, stavudine). Tell your doctor if you are taking stavudine and you are pregnant or planning to become pregnant.
Treating HIV infection when used in combination with other medicines.
Didanosine Delayed-Release Enteric-Coated Capsules are a nucleoside analogue reverse transcriptase inhibitor. It works by stopping the growth of HIV-1, the virus that causes AIDS.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Didanosine Delayed-Release Enteric-Coated Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Didanosine Delayed-Release Enteric-Coated Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Didanosine Delayed-Release Enteric-Coated Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Didanosine Delayed-Release Enteric-Coated Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Didanosine Delayed-Release Enteric-Coated Capsules.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Breast enlargement; changes in body fat; darkened complexion with purple markings; diarrhea; dry mouth; headache; itching; muscle pain; skin and facial wasting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in the vomit or vomit that looks like coffee grounds; blurred vision or other vision changes; chest pain or discomfort, numbness of an arm or leg, or shortness of breath; confusion; dark urine; dizziness; fainting; fast, shallow breathing; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; lightheadedness; low body temperature; nausea or vomiting; numbness, tingling, or pain in the hands or feet; pale stools; seizures; severe muscle pain or cramping; stomach pain or swelling; tiredness; unusual bruising or bleeding; weakness; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Didanosine side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dark urine; diarrhea; pale stools; severe stomach pain with nausea and vomiting; tingling, burning, or numbness in the hands or feet; unusual fatigue; yellowing of the skin or eyes.
Store Didanosine Delayed-Release Enteric-Coated Capsules at room temperature, between 59 and 77 degrees F (15 and 25 degrees C), in a tightly closed container. Brief storage at temperatures of up to 86 degrees F (30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Didanosine Delayed-Release Enteric-Coated Capsules out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Didanosine Delayed-Release Enteric-Coated Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Losartan Cinfa may be available in the countries listed below.
Losartan potassium salt (a derivative of Losartan) is reported as an ingredient of Losartan Cinfa in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
Rec.INN
0000111-30-8
C5-H8-O2
100
Antiseptic
Disinfectant
Antiviral agent
Pentanedial
International Drug Name Search
Glossary
| JAN | Japanese Accepted Name |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Vispazine may be available in the countries listed below.
Tiemonium Methylsulfate is reported as an ingredient of Vispazine in the following countries:
International Drug Name Search
Uni Dose may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Metrifonate is reported as an ingredient of Uni Dose in the following countries:
International Drug Name Search
RIF may be available in the countries listed below.
Rifampicin is reported as an ingredient of RIF in the following countries:
Rifamycin is reported as an ingredient of RIF in the following countries:
International Drug Name Search
Ritemed Gliclazide may be available in the countries listed below.
Gliclazide is reported as an ingredient of Ritemed Gliclazide in the following countries:
International Drug Name Search
Cohemin Depot may be available in the countries listed below.
Hydroxocobalamin acetate (a derivative of Hydroxocobalamin) is reported as an ingredient of Cohemin Depot in the following countries:
International Drug Name Search
Regulin may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Melatonin is reported as an ingredient of Regulin in the following countries:
International Drug Name Search
In the US, Niferex (iron polysaccharide systemic) is a member of the drug class iron products and is used to treat Iron Deficiency Anemia.
US matches:
Ferrous Glycine Sulfate is reported as an ingredient of Niferex in the following countries:
Polyferose is reported as an ingredient of Niferex in the following countries:
International Drug Name Search
Adipex may be available in the countries listed below.
Phentermine resinate (a derivative of Phentermine) is reported as an ingredient of Adipex in the following countries:
International Drug Name Search
Sulphytrim may be available in the countries listed below.
Sulfamethoxazole is reported as an ingredient of Sulphytrim in the following countries:
Trimethoprim is reported as an ingredient of Sulphytrim in the following countries:
International Drug Name Search
Trétinoïne may be available in the countries listed below.
Trétinoïne (DCF) is known as Tretinoin in the US.
International Drug Name Search
Glossary
| DCF | Dénomination Commune Française |
Viskoferm may be available in the countries listed below.
Acetylcysteine is reported as an ingredient of Viskoferm in the following countries:
International Drug Name Search
Megalac Hydrotalcit may be available in the countries listed below.
Hydrotalcite is reported as an ingredient of Megalac Hydrotalcit in the following countries:
International Drug Name Search
Covorit may be available in the countries listed below.
Folinic Acid is reported as an ingredient of Covorit in the following countries:
International Drug Name Search
Nasobol Xylo may be available in the countries listed below.
Xylometazoline hydrochloride (a derivative of Xylometazoline) is reported as an ingredient of Nasobol Xylo in the following countries:
International Drug Name Search
Ortho may be available in the countries listed below.
Ethinylestradiol is reported as an ingredient of Ortho in the following countries:
Norethisterone is reported as an ingredient of Ortho in the following countries:
International Drug Name Search
Reconil may be available in the countries listed below.
Chloroquine phosphate (a derivative of Chloroquine) is reported as an ingredient of Reconil in the following countries:
Hydroxychloroquine sulfate (a derivative of Hydroxychloroquine) is reported as an ingredient of Reconil in the following countries:
International Drug Name Search
Coopertet may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Oxytetracycline is reported as an ingredient of Coopertet in the following countries:
International Drug Name Search
Metagem may be available in the countries listed below.
Trimetazidine dihydrochloride (a derivative of Trimetazidine) is reported as an ingredient of Metagem in the following countries:
International Drug Name Search
Ceelin may be available in the countries listed below.
Ascorbic Acid is reported as an ingredient of Ceelin in the following countries:
Ascorbic Acid sodium salt (a derivative of Ascorbic Acid) is reported as an ingredient of Ceelin in the following countries:
International Drug Name Search
Midazolam Injection may be available in the countries listed below.
Midazolam is reported as an ingredient of Midazolam Injection in the following countries:
International Drug Name Search
Ectaprim may be available in the countries listed below.
Sulfamethoxazole is reported as an ingredient of Ectaprim in the following countries:
Trimethoprim is reported as an ingredient of Ectaprim in the following countries:
International Drug Name Search
Ro-A-Vit may be available in the countries listed below.
Retinol palmitate (a derivative of Retinol) is reported as an ingredient of Ro-A-Vit in the following countries:
International Drug Name Search
Dedlor may be available in the countries listed below.
Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Dedlor in the following countries:
International Drug Name Search
Lansoptol may be available in the countries listed below.
Lansoprazole is reported as an ingredient of Lansoptol in the following countries:
International Drug Name Search
Caproamin Fides may be available in the countries listed below.
Aminocaproic Acid is reported as an ingredient of Caproamin Fides in the following countries:
International Drug Name Search
ox-i-bu-BUE-ti-nin KLOR-ide
In the U.S.
Available Dosage Forms:
Therapeutic Class: Urinary Antispasmodic
Pharmacologic Class: Oxybutynin
Oxybutynin is used to treat symptoms of an overactive bladder, such as incontinence (loss of bladder control) or a frequent need to urinate.
Oxybutynin belongs to the group of medicines called antispasmodics. It helps decrease muscle spasms of the bladder and the frequent urge to urinate caused by these spasms.
Oxybutynin extended-release tablets is also used to treat children 6 years of age and older who have an overactive bladder caused by a certain nerve disorder (e.g., spina bifida).
oxybutynin is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For oxybutynin, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to oxybutynin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of oxybutyninextended-release tablet in children 6 years of age and older. However, oxybutynin extended-release tablet is not recommended in children who cannot swallow it whole without breaking, chewing, or crushing; or in children younger than 6 years of age.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oxybutynin in the elderly.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | B | Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus. |
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking oxybutynin, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using oxybutynin with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using oxybutynin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of oxybutynin. Make sure you tell your doctor if you have any other medical problems, especially:
It is very important that you use oxybutynin only as directed. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.
oxybutynin is usually taken with water on an empty stomach. However, your doctor may want you to take it with food or milk to lessen stomach upset.
For patients taking the extended-release tablets:
The dose of oxybutynin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of oxybutynin. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of oxybutynin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
It is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to take it.
oxybutynin may cause a serious type of allergic reaction called angioedema. Angioedema may be life-threatening and requires immediate medical attention. Stop using oxybutynin and seek medical attention right away if you or your child have a rash; itching; a large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs; trouble with breathing; or chest tightness while you are using oxybutynin.
Oxybutynin may cause anxiety, confusion, irritability, sleepiness or unusual drowsiness, or hallucinations (seeing, hearing, or feeling things that are not there). These symptoms are more likely to occur when you begin taking oxybutynin, or when the dose is increased. If you or your child have these symptoms, stop using oxybutynin and tell your doctor right away.
oxybutynin will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you or your child are using oxybutynin.
oxybutynin may cause your eyes to become more sensitive to light than they are normally. Wearing sunglasses and avoiding too much exposure to bright light may help lessen the discomfort.
oxybutynin may cause some people to become dizzy, drowsy, or have blurred vision. Make sure you know how you react to oxybutynin before you drive, use machines, or do anything else that could be dangerous if you are dizzy, not alert, or not able to see well.
Oxybutynin may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you or your child are taking oxybutynin, since overheating may result in heat stroke. Also, hot baths or saunas may make you feel dizzy or faint while you or your child are taking oxybutynin.
Your mouth, nose, and throat may feel very dry while you or your child are taking oxybutynin. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Get emergency help immediately if any of the following symptoms of overdose occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: oxybutynin side effects (in more detail)
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