Prescribing ACE Inhibitors
Total Page:16
File Type:pdf, Size:1020Kb
Load more
Recommended publications
-
Apo-Cilazapril/Hydrochlorothiazide Film Coated Tablet
New Zealand Data Sheet APO-CILAZAPRIL/HYDROCHLOROTHIAZIDE 1. PRODUCT NAME APO-CILAZAPRIL/HYDROCHLOROTHIAZIDE – cilazapril 5mg and hydrochlorothiazide 12.5mg film coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Cilazapril monohydrate 5.22mg (equivalent to Cilazapril 5mg) and Hydrochlorothiazide 12.5mg Excipient(s) with known effect HYDROCHLOROTHIAZIDE contains sulphur. APO-CILAZAPRIL/HYDROCHLOROTHIAZIDE is lactose free and gluten free. APO-CILAZAPRIL/HYDROCHLOROTHIAZIDE contains Red Ferric Oxide (orange shade # 34690). For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM APO-CILAZAPRIL/HYDROCHLOROTHIAZIDE are pink, oval biconvex film-coated tablets. Each tablet is engraved “APO” on one side and “5” bisect “12.5” on the other side. Each tablet typically weighs 92mg. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications APO-CILAZAPRIL/HYDROCHLOROTHIAZIDE is indicated for the treatment of patients with hypertension who are not adequately controlled on monotherapy. 4.2 Dose and method of administration Standard Dosage The dosage of APO-CILAZAPRIL/HYDROCHLOROTHIAZIDE is one tablet administered once daily. As food intake has no clinically significant influence on absorption, APO- CILAZAPRIL/HYDROCHLOROTHIAZIDE can be administered before or after meals. The dose should always be taken at about the same time of day. Special Populations Renal insufficiency When concomitant diuretic therapy is required in patients with severe renal impairment, a loop diuretic rather than a thiazide diuretic is preferred for use with cilazapril/hydrochlorothiazide; therefore, for patients with severe renal dysfunction (creatinine Please refer to Medsafe website (www.medsafe.govt.nz) for the most recent datasheet Page 1 of 22 APO-CILAZAPRIL/HYDROCHLOROTHIAZIDE clearance <10ml/min), APO-CILAZAPRIL/HYDROCHLOROTHIAZIDE is not recommended. -
Summary of Product Characteristics
Proposed var 24 psusa cilazapril SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT [Fosinopril sodium 10 mg, tablets] [Fosinopril sodium 20 mg, tablets] 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 or 20 mg fosinopril sodium. Excipient with known effect: Each tablet fosinopril sodium 10 mg contains 87 mg of lactose, anhydrous. Each tablet fosinopril sodium 20 mg contains 174 mg of lactose, anhydrous. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. The 10 mg tablets are white and shaped like a capsule with indents. On one side they are engraved with the letters “APO” and on the other side with “FOS-10”. The 20 mg tablets are white and their shape is oval. On one side they are engraved with the letters “APO” and on the other side with “FOS-20”. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications - Treatment of hypertension. - Treatment of symptomatic heart failure. 4.2 Posology and method of administration Posology Fosinopril sodium should be administered orally in a single daily dose. As with all other medicinal products taken once daily, it should be taken at approximately the same time each day. The absorption of fosinopril sodium is not affected by food. The dose should be individualised according to patient profile and blood pressure response (see section 4.4). Hypertension: Fosinopril sodium may be used as a monotherapy or in combination with other classes of antihypertensive medicinal products (see section 4.3, 4.4, 4.5 and 5.1). Hypertensive patients not being treated with diuretics: Starting dose The initial recommended dose is 10 mg once a day. -
Accupril® (Quinapril Hydrochloride Tablets)
Accupril® (Quinapril Hydrochloride Tablets) WARNING: FETAL TOXICITY When pregnancy is detected, discontinue ACCUPRIL as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See Warnings: Fetal Toxicity DESCRIPTION ACCUPRIL® (quinapril hydrochloride) is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinaprilat. Quinapril hydrochloride is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[[1- (ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3- isoquinolinecarboxylic acid, monohydrochloride. Its empirical formula is C25H30N2O5 •HCl and its structural formula is: Quinapril hydrochloride is a white to off-white amorphous powder that is freely soluble in aqueous solvents. ACCUPRIL tablets contain 5 mg, 10 mg, 20 mg, or 40 mg of quinapril for oral administration. Each tablet also contains candelilla wax, crospovidone, gelatin, lactose, magnesium carbonate, magnesium stearate, synthetic red iron oxide, and titanium dioxide. CLINICAL PHARMACOLOGY Mechanism of Action: Quinapril is deesterified to the principal metabolite, quinaprilat, which is an inhibitor of ACE activity in human subjects and animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor, angiotensin II. The effect of quinapril in hypertension and in congestive heart failure (CHF) appears to result primarily from the inhibition of circulating and tissue ACE activity, thereby reducing angiotensin II formation. Quinapril inhibits the elevation in blood pressure caused by intravenously administered angiotensin I, but has no effect on the pressor response to angiotensin II, norepinephrine or epinephrine. Angiotensin II also stimulates the secretion of aldosterone from the adrenal cortex, thereby facilitating renal sodium and fluid reabsorption. -
Quinapril, an ACE Inhibitor, Reduces Markers of Oxidative Stress in the Metabolic Syndrome
Metabolic Syndrome/Insulin Resistance Syndrome/Pre-Diabetes ORIGINAL ARTICLE Quinapril, an ACE Inhibitor, Reduces Markers of Oxidative Stress in the Metabolic Syndrome 1 3 BOBBY V. KHAN, MD, PHD W. CRAIG HOOPER, PHD ing the link between inflammation, met- 1 1 SRIKANTH SOLA, MD REKHA G. MENON, MD abolic disorders, and cardiovascular 1 1 WRIGHT B. LAUTEN, BS STAMATIOS LERAKIS, MD 2 1 disease (5,6). Chronic inflammation and RAMA NATARAJAN, PHD TAREK HELMY, MD an abnormal pro-oxidant state are both found in the metabolic syndrome and may play a role in its pathogenesis (7,8). The renin-angiotensin system (RAS) plays a central role in the pathogenesis of OBJECTIVE — Patients with the metabolic syndrome often have abnormal levels of proin- atherosclerosis-related diseases. Angio- flammatory and pro-oxidative mechanisms within their vasculature. We sought to determine tensin II, the central molecule in the RAS, whether the ACE inhibitor quinapril regulates markers of oxidative stress in the metabolic syndrome. has multiple effects on inflammation, ox- idation, atherosclerotic plaque initiation, RESEARCH DESIGN AND METHODS — Forty patients with the metabolic syndrome and progression (9). In the present study, were randomized in a double-blind manner to either the ACE inhibitor quinapril (20 mg/day) or we determine potential mechanisms by matching placebo for 4 weeks. Serum markers of vascular oxidative stress were measured. which the administration of the ACE in- hibitor quinapril regulates mechanisms of RESULTS — After 4 weeks of therapy, serum 8-isoprostane was reduced by 12% in the oxidative stress in subjects with the met- Ϯ Ϯ quinapril group when compared with placebo (quinapril, 46.7 1.0; placebo, 52.7 0.9 abolic syndrome. -
"Coaprovel, INN-Irbesartan+Hydrochlorothiazide"
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT CoAprovel 150 mg/12.5 mg tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide. Excipient with known effect: Each tablet contains 26.65 mg of lactose (as lactose monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2775 engraved on the other side. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment of essential hypertension. This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone (see section 5.1). 4.2 Posology and method of administration Posology CoAprovel can be taken once daily, with or without food. Dose titration with the individual components (i.e. irbesartan and hydrochlorothiazide) may be recommended. When clinically appropriate direct change from monotherapy to the fixed combinations may be considered: . CoAprovel 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone; . CoAprovel 300 mg/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by CoAprovel 150 mg/12.5 mg. CoAprovel 300 mg/25 mg may be administered in patients insufficiently controlled by CoAprovel 300 mg/12.5 mg. Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once daily are not recommended. When necessary, CoAprovel may be administered with another antihypertensive medicinal product (see sections 4.3, 4.4, 4.5 and 5.1). -
Angioedema After Long-Term Use of an Angiotensin-Converting Enzyme Inhibitor
J Am Board Fam Pract: first published as 10.3122/jabfm.10.5.370 on 1 September 1997. Downloaded from BRIEF REPORTS Angioedema After Long-Term Use of an Angiotensin-Converting Enzyme Inhibitor Adriana]. Pavietic, MD Angioedema is an uncommon adverse effect of cyclobenzaprine, her angioedema was initially be angiotensin-converting enzyme (ACE) inhib lieved to be an allergic reaction to this drug, and itors. Its frequency ranges from 0.1 percent in pa it was discontinued. She was also given 125 mg of tients on captopril, lisinopril, and quinapril to 0.5 methylprednisolone intramuscularly. Her an percent in patients on benazepril. l Most cases are gioedema did not improve, and she returned to mild and occur within the first week of treat the clinic the following day. She was seen by an ment. 2-4 Recent reports indicate that late-onset other physician, who discontinued lisinopril, and angioedema might be more prevalent than ini her symptoms resolved within 24 hours. Mter her tially thought, and fatal cases have been de ACE inhibitor was discontinued, she experienced scribed.5-11 Many physicians are not familiar with more symptoms and an increased frequency of late-onset angioedema associated with ACE in palpitations, but she had no change in exercise hibitors, and a delayed diagnosis can have poten tolerance. A cardiologist was consulted, who pre tially serious consequences.5,8-II scribed the angiotensin II receptor antagonist losartan (initially at dosages of 25 mg/d and then Case Report 50 mg/d). The patient was advised to report any A 57-year-old African-American woman with symptoms or signs of angioedema immediately copyright. -
THE DOSE an Estimation of Equivalent Doses Between Arbs and Aceis
THE DOSE An estimation of equivalent doses between ARBs and ACEIs ARBs still currently available as of Jan 26, 2020: Twynsta (telmisartan/amlodipine): 40/5mg. 40/10mg, 80/5mg, 80mg/ 10mg Note: ~$0.73/tablet (ODB covered) Candesartan/Hydrochlorothiazide:16mg/12.5mg, 32mg/12.5mg, 32mg/25mg Irbesartan/Hydrochlorothiazide: 150/12.5mg, 300/12.5mg, 300/25mg Olmesartan/Hydrochlorothiaizde: 20/12.5mg, 40/12.5mg Valsartan/Hydrochlorothiazide: 80/12.5mg, 160/12.5mg, 160/25mg, 320/12.5mg, 320/25mg Note: Availability changes daily. Some pharmacies are able to get candesartan (4mg, 8mg, and 32mg) and irbesartan (300mg). Considerations Patients renal function and hepatic function should be taken into consideration Patients should have blood pressure, lytes and SCr checked with rotation from ARB to ACEI as clinically indicated in 1-4 weeks ACEIs can cause a dry cough in 5-35% of patients and carry a risk of angioedema (0.1-0.2%) Comparable dosages between ACEIs and ARBs- Summary of trials Lisinopril 20mg Enalapril 20mg Perindopril 4mg Ramipril 10mg Candesartan 16mg 8mg 16mg Irbesartan 150mg Telmisartan 80mg 40-80mg 40mg ~80mg Valsartan 160mg 80mg Note: There are variations for approximate equivalent dosages between ACEIs and ARBs in clinical trials. Approximate equivalent doses of ACEI for blood pressure lowering Drug Approximate Initial Daily Dose Usual Daily Maintenance Dose Maximum Daily Duration of Dose Dose Action Equivalence Between ACEIs Cilazapril 2.5mg 2.5-5mg 2.5-5mg dailya 10mg 12-24 hr Enalapril maleate 5mg 2.5-5mg 10-40mg daily (or divided bid)a 40mg 12-24 hr Fosinopril 10mg 10mg 10-40mg daily (or divided bid)a 40mg 24hr Lisinopril 10mg 2.5-10mg 10-40mg daily 80mg 24hr Perindopril 2mg 2-4mg 4-8mg daily 8mg 24hr Quinapril 10mg 5-10mg 10-20mg dailya 40mg 24hr Ramipril 2.5mg 1.25mg-2.5mg 2.5-10mg daily (or divided bid)a 20mg ~24hr a: Some patients may experience a diminished antihypertensive effect toward the end of a 24-hour dosing interval. -
Estonian Statistics on Medicines 2016 1/41
Estonian Statistics on Medicines 2016 ATC code ATC group / Active substance (rout of admin.) Quantity sold Unit DDD Unit DDD/1000/ day A ALIMENTARY TRACT AND METABOLISM 167,8985 A01 STOMATOLOGICAL PREPARATIONS 0,0738 A01A STOMATOLOGICAL PREPARATIONS 0,0738 A01AB Antiinfectives and antiseptics for local oral treatment 0,0738 A01AB09 Miconazole (O) 7088 g 0,2 g 0,0738 A01AB12 Hexetidine (O) 1951200 ml A01AB81 Neomycin+ Benzocaine (dental) 30200 pieces A01AB82 Demeclocycline+ Triamcinolone (dental) 680 g A01AC Corticosteroids for local oral treatment A01AC81 Dexamethasone+ Thymol (dental) 3094 ml A01AD Other agents for local oral treatment A01AD80 Lidocaine+ Cetylpyridinium chloride (gingival) 227150 g A01AD81 Lidocaine+ Cetrimide (O) 30900 g A01AD82 Choline salicylate (O) 864720 pieces A01AD83 Lidocaine+ Chamomille extract (O) 370080 g A01AD90 Lidocaine+ Paraformaldehyde (dental) 405 g A02 DRUGS FOR ACID RELATED DISORDERS 47,1312 A02A ANTACIDS 1,0133 Combinations and complexes of aluminium, calcium and A02AD 1,0133 magnesium compounds A02AD81 Aluminium hydroxide+ Magnesium hydroxide (O) 811120 pieces 10 pieces 0,1689 A02AD81 Aluminium hydroxide+ Magnesium hydroxide (O) 3101974 ml 50 ml 0,1292 A02AD83 Calcium carbonate+ Magnesium carbonate (O) 3434232 pieces 10 pieces 0,7152 DRUGS FOR PEPTIC ULCER AND GASTRO- A02B 46,1179 OESOPHAGEAL REFLUX DISEASE (GORD) A02BA H2-receptor antagonists 2,3855 A02BA02 Ranitidine (O) 340327,5 g 0,3 g 2,3624 A02BA02 Ranitidine (P) 3318,25 g 0,3 g 0,0230 A02BC Proton pump inhibitors 43,7324 A02BC01 Omeprazole -
Patient Information Leaflet
Package leaflet: Information for the user Accuretic® 10/12.5 mg film-coated tablets quinapril and hydrochlorothiazide Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Accuretic is and what it is used for 2. What you need to know before you take Accuretic 3. How to take Accuretic 4. Possible side effects 5. How to store Accuretic 6. Contents of the pack and other information 1. What Accuretic is and what it is used for Accuretic contains the active substances quinapril and hydrochlorothiazide. Quinapril belongs to a group of medicines called angiotensin converting enzyme (ACE) inhibitors. ACE inhibitors work by widening blood vessels in the body, which can help to reduce the pressure in the vessels. Hydrochlorothiazide belongs to a group of medicines called diuretics. Diuretics help the body to get rid of extra fluid and are used in patients with high blood pressure. Because they get rid of fluid diuretics are sometimes called ‘water tablets’. Accuretic is used to treat high blood pressure. You must talk to a doctor if you do not feel better or if you feel worse. -
Angiotensin-Converting Enzyme (ACE) Inhibitors
Angiotensin-Converting Enzyme (ACE) Inhibitors Summary Blood pressure reduction is similar for the ACE inhibitors class, with no clinically meaningful differences between agents. Side effects are infrequent with ACE inhibitors, and are usually mild in severity; the most commonly occurring include cough and hypotension. Captopril and lisinopril do not require hepatic conversion to active metabolites and may be preferred in patients with severe hepatic impairment. Captopril differs from other oral ACE inhibitors in its rapid onset and shorter duration of action, which requires it to be given 2-3 times per day; enalaprilat, an injectable ACE inhibitor also has a rapid onset and shorter duration of action. Pharmacology Angiotensin Converting Enzyme Inhibitors (ACE inhibitors) block the conversion of angiotensin I to angiotensin II through competitive inhibition of the angiotensin converting enzyme. Angiotensin is formed via the renin-angiotensin-aldosterone system (RAAS), an enzymatic cascade that leads to the proteolytic cleavage of angiotensin I by ACEs to angiotensin II. RAAS impacts cardiovascular, renal and adrenal functions via the regulation of systemic blood pressure and electrolyte and fluid balance. Reduction in plasma levels of angiotensin II, a potent vasoconstrictor and negative feedback mediator for renin activity, by ACE inhibitors leads to increased plasma renin activity and decreased blood pressure, vasopressin secretion, sympathetic activation and cell growth. Decreases in plasma angiotensin II levels also results in a reduction in aldosterone secretion, with a subsequent decrease in sodium and water retention.[51035][51036][50907][51037][24005] ACE is found in both the plasma and tissue, but the concentration appears to be greater in tissue (primarily vascular endothelial cells, but also present in other organs including the heart). -
Vascace Plus, INN-Cilazapril/Hydrochlorthiazid
SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Vascace Plus and associated names (see Annex I) 5 mg/12.5 mg film-coated tablets [See Annex I - To be completed nationally] 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains: 5.22 mg cilazapril equivalent to 5 mg cilazapril anhydrous and 12.5 mg hydrochlorothiazide Excipients with known effects: Each tablet contains 119.18 mg lactose monohydrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Pale red, oval, biconvex film-coated tablets with a score on one side and imprinted "CIL+" and underneath "5 + 12.5" on the other side. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Vascace Plus is indicated for the treatment of hypertension in adult patients whose blood pressure is not adequately controlled with cilazapril alone. 4.2 Posology and method of administration Posology Patients with renal impairment When concomitant diuretic therapy is required in patients with severe renal impairment, a loop diuretic rather than a thiazide diuretic is preferred for use with cilazapril. Therefore, Vascace Plus is not recommended for patients with severe renal impairment (see section 4.3). Patients with liver cirrhosis Because significant hypotension may occur in patients with liver cirrhosis treated with standard doses of ACE inhibitors, cautious dose titration of each individual component is needed if patients with liver cirrhosis should require treatment with cilazapril and hydrochlorothiazide (see section 4.4). Older people In clinical studies, the efficacy and tolerability of cilazapril and hydrochlorothiazide administered concomitantly was similar in both elderly and younger hypertensive patients, although pharmacokinetic data show that clearance of both components in elderly patients was reduced (see section 5.2). -
Switching Ace-Inhibitors
Switching Ace-inhibitors http://www.ksdl.kamsc.org.au/dtp/switching_ace_inhibitors.html Change to → Enalapril Quinapril Ramipril Change from ↓ (Once daily dosing) (Once daily dosing) (Once daily dosing) Captopril Captopril 12.5mg daily Enalapril 2.5mg1 Quinapril 2.5mg Ramipril 1.25mg Captopril 25mg daily Enalapril 5mg1 Quinapril 5mg Ramipril 1.25-2.5mg Captopril 50mg daily Enalapril 7.5mg1 Quinapril 10mg Ramipril 2.5-5mg Captopril 100mg daily Enalapril 20mg1 Quinapril 20mg Ramipril 5-10mg2 Captopril 150mg daily Enalapril 40mg Quinapril 40mg Ramipril 10mg Fosinopril Fosinopril 5mg daily Enalapril 5mg Quinapril 5mg Ramipril 1.25mg Fosinopril 10mg daily Enalapril 10mg Quinapril 10mg Ramipril 2.5mg Fosinopril 20mg daily Enalapril 20mg Quinapril 20mg Ramipril 5mg Fosinopril 40mg daily Enalapril 40mg Quinapril 40mg Ramipril 10mg Lisinopril Lisinopril 5mg daily Enalapril 5mg Quinapril 5mg Ramipril 1.25mg Lisinopril 10mg daily Enalapril 10mg Quinapril 10mg Ramipril 2.5mg Lisinopril 20mg daily Enalapril 20mg Quinapril 20mg Ramipril 5mg Lisinopril 40mg Enalapril 40mg Quinapril 40mg Ramipril 10mg Perindopril Perindopril 2mg daily Enalapril 5-10mg Quinapril 5-10mg Ramipril 2.5mg Perindopril 4mg daily Enalapril 10mg-20mg Quinapril 10mg-20mg Ramipril 5mg Perindopril 8mg daily Enalapril 20-40mg Quinapril 20-40mg Ramipril 10mg Trandolapril Trandolapril 0.5mg d Enalapril 5mg Quinapril 5mg Ramipril 1.25mg Trandolapril 1mg daily Enalapril 10mg Quinapril 10mg Ramipril 2.5mg Trandolapril 2mg daily Enalapril 20mg Quinapril 20mg Ramipril 5mg Trandolapril 4mg daily Enalapril 40mg Quinapril 40mg Ramipril 10mg There are few studies comparing equivalent doses of ACE-inhibitors, for specific indications. Therefore, the above recommendations are based on clinical experiences and are not specific for any indication.