Pharmacogenetics: In patients who are poor CYP2C19 metabolisers, clopidogrel at recommended doses forms less of the active metabolite of clopidogrel and has a smaller effect on platelet function. Activated charcoal may be useful in the treatment of overdose. There are an estimated 7.1 million Australians living with hypercholesterolaemia. Gastrointestinal disorders: Gingival swelling When necessary, CoAprovel may be administered with another antihypertensive medicinal product (see sections 4.3, 4.4, 4.5 and 5.1). For oral administration. Experience is limited in patients with moderate hepatic disease who may have bleeding diatheses. Heart disease alone is the single leading cause of death in Australia: in 2017, almost 19,000 persons died from heart disease, with a further 1,250 deaths from ischaemic stroke. It is recommended to double the dose after one or two weeks of treatment and - after another two to three weeks - to increase it up to the target maintenance dose of 10mg Tritace once daily. Clinical and economic value of SOLIQUA - Pharmacist perspective. The maintenance dose is divided in 2 administrations per day where possible. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure (see section 4.5). Pharmacotherapeutic group: platelet aggregation inhibitors excl. please contact: +971 565776791 or Email: medical-information.gulf@sanofi.com. For oral use.It may be given with or without food. In patients suffering from acute coronary syndrome: Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction): clopidogrel treatment should be initiated with a single 300-mg loading dose and then continued at 75 mg once a day (with acetylsalicylic acid (ASA) 75 mg-325 mg daily). Apidra. The patient should be closely monitored, and the treatment should be symptomatic and supportive. It is characterised by thrombocytopenia and microangiopathic haemolytic anaemia associated with either neurological findings, renal dysfunction or fever. Hypersensitivity to the active substance or to any of the excipients listed ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. However, initiation of therapy with 75 mg could be considered, particularly in haemodialysed patients and in the elderly over 75 years. For Medical Information, please contact: +966-12-669-3318. The dose can be doubled at interval of two to four weeks to progressively achieve target blood pressure; the maximum permitted dose of Tritace is 10mg daily. Some of these are new molecular entities while others are existing products with potential new indications, or different formulations. The clinical relevance is unknown. Doubling the once daily dose to 2.5mg after two weeks and then to 5mg after a further two weeks is recommended. Data from the CAPRIE study indicate that phenytoin and tolbutamide which are metabolised by CYP2C9 can be safely coadministered with clopidogrel. Proton Pump Inhibitors (PPI): Omeprazole 80 mg once daily administered either at the same time as clopidogrel or with 12 hours between the administrations of the two drugs decreased the exposure of the active metabolite by 45% (loading dose) and 40% (maintenance dose). since SSRIs affect platelet activation and increase the risk of bleeding, the concomitant administration of SSRIs with clopidogrel should be undertaken with caution. Aliskiren-containing products or ACE-inhibitors: clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1). 1mg +1000mg, 2mg + 1000mg. Sanofi to Exit Diabetes and Cardiovascular Research - Pharma's Almanac SANOFI, Kingdom of Saudi Arabia, P.O. As a precautionary measure, breast-feeding should not be continued during treatment with Plavix. pre-existing cardiac disease (congestive heart failure, recent acute myocardial infarction, brady-cardia, heart block, ventricular arrhythmia) long QT syndrome in combination with Class IA(e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications [see Clinical Pharmacology (12.2)] 6 ADVERSE . Stay up to date and register for the latest events and view webinar recordings. Cimetidine: Co-administration of amlodipine with cimetidine did not alter amlodipine pharmacokinetics. Lithium: the combination of lithium and Aprovel is not recommended (see section 4.5). In hypertensive patients in whom the diuretic is not discontinued, therapy with Tritace should be initiated with a 1.25mg dose. Reducing hypercholesterolaemia offers the potential for significant health and economic benefits.. Science & Innovation - Sanofi There is an increased risk of bleeding due to the potential additive effect. Date of SmPC text revision: 11 April 2019; By researching the interplay and relationship between these diseases, we aim to help improve the lives of patients. This medicinal product contains hydrogenated castor oil which may cause stomach upset and diarrhoea. History of angioedema (hereditary, idiopathic or due to previous angioedema with ACE inhibitors or AIIRAs) Dr. Nurudeen Olowopopo Avenue, Ikeja Central Business District, Agidingbi, Lagos, Nigeria. Symptomatic hypotension may be expected to occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. If a patient is to undergo elective surgery and antiplatelet effect is temporarily not desirable, clopidogrel should be discontinued 7 days prior to surgery. Although the administration of clopidogrel 75 mg/day did not modify the pharmacokinetics of S-warfarin or International Normalised Ratio (INR) in patients receiving long-term warfarin therapy, coadministration of clopidogrel with warfarin increases the risk of bleeding because of independent effects on hemostasis. Irbesartan and hydrochlorothiazide (at doses up to 300 mg irbesartan/25 mg hydrochlorothiazide) have been safely administered with other antihypertensive agents including calcium channel blockers and beta-adrenergic blockers. Therefore, Aprovasc should be administered with caution in these patients. ASA did not modify the clopidogrel-mediated inhibition of ADP-induced platelet aggregation, but clopidogrel potentiated the effect of ASA on collagen-induced platelet aggregation. Monitor levels in patients receiving Irbesartan and lithium. Metformin Hydrochloride (SR),Glimepiride and Voglibose Tablets. PDF HIGHLIGHTS OF PRESCRIBING INFORMATION Pancreatitis - Sanofi General: in patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e.g. Products Our Products Clexane LEARN MORE . Plavix 75 mg film-coated tablets. As a precaution concomitant use of strong or moderate CYP2C19 inhibitors should be discouraged (see section 4.5 for a list of CYP2C19 inhibitors, see also section 5.2). Aprovel is indicated in adults for the treatment of essential hypertension. When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6). Loop diuretics are preferred to thiazides in this population. Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1). Due to the risk of bleeding and haematological adverse reactions, blood cell count determination and/or other appropriate testing should be promptly considered whenever clinical symptoms suggestive of bleeding arise during the course of treatment (see section 4.8). Co-administration of heparin had no effect on the inhibition of platelet aggregation induced by clopidogrel. Resources for healthcare providers - Sanofi U.S. Sanofi Australia & New Zealand has no control over the contents of these sites or resources, and accepts no liability or responsibility for them or for any loss or damage that may arise from your use of them. Data obtained from in vitro studies with human plasma show that amlodipine has no effect on protein binding with the medications studied (digoxin, phenytoin, warfarin, or indomethacin). Sanofi top pharma products by revenue 2017-2021 | Statista SANOFI, Kingdom of Saudi Arabia, P.O. Lactose: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter. Starting dose: In patients stabilized on diuretic therapy, the recommended initial dose is 1.25mg daily. Aprovel 300MG TABLETS If the combination proves necessary, careful monitoring of serum lithium levels is recommended. 35 Patrice Lumumba Road, Airport Residential Area, Accra. In patients with atrial fibrillation, clopidogrel should be given as a single daily dose of 75 mg. ASA (75-100 mg daily) should be initiated and continued in combination with clopidogrel (see section 5.1). It is also indicated for the treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen (see sections 4.3, 4.4, 4.5 and 5.1). ATC code: C09C A04. In patients receiving Irbesartan in clinical studies no overall differences were observed in terms of efficacy and safety in older patients (65 years or older) or in younger patients. Company will shift focus to cancer research and other more lucrative indications. Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy: as with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Please note: Sanofi provides these links as a service to its website visitors and users; however, Sanofi takes no responsibility for the information on any website but their own. No drug interaction studies have been conducted with Aprovasc and other medicinal products. Such conditions should be corrected before initiating therapy with CoAprovel. Since clopidogrel is metabolised to its active metabolite partly by CYP2C19, use of medicinal products that inhibit the activity of this enzyme would be expected to result in reduced drug levels of the active metabolite of clopidogrel. Secondary prevention after acute myocardial infarction and with heart failure: Starting dose: After 48 hours, following myocardial infarction in a clinically and haemodynamically stable patient, the starting dose is 2.5mg twice daily for three days. A starting dose of 1.25mg is recommended in such patients and the initiation of treatment should take place under medical supervision (see section 4.4). The patient should be closely monitored, and the treatment should be symptomatic and supportive. Each tablet contains ramipril 2.5mg The target daily dose is 10mg. There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). Renal impairment and kidney transplantation: when Aprovel is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended. As observed for angiotensin converting enzyme inhibitors, irbesartan and the other angiotensin antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population (see section 5.1). Tel: +234 1 2710135/2800994; 14.6 ELIXA Cardiovascular Outcome Study 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied 16.2 Storage and Handling 17 PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the full prescribing information are not listed FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE Patients should be evaluated for history of hypersensitivity to thienopyridines (such as clopidogrel, ticlopidine, prasugrel) since cross-reactivity among thienopyridines has been reported (see section 4.8). More detailed Information on request:Refer to Summary of Product Characteristics or Although Sanofi has a top-selling insulin product on the market, overall its diabetes business -- and cardiovascular too -- has contributed noticeably declining percentages to the company's revenues in recent years. Based on in vitro information, no interactions are expected with drugs whose metabolism is dependent on CYP1A1, CYP1A2, CYP2A6, CYP2B6, CYP2D6, CYP2E1, or CYP3A4 cytochrome isoenzymes. By continuing to browse this website, you agree to the use of such cookies. Animal studies have shown excretion of clopidogrel in breast milk. Severe hepatic impairment, biliary cirrhosis and cholestasis For the duration of the program, eligible patients will pay $35 per 30 Day Supply. No significant pharmacokinetic or pharmacodynamic interactions were observed when irbesartan was coadministered with warfarin, a medicinal product metabolised by CYP2C9. This website is intended exclusively for healthcare professionals residing and/or working in Oman. Thiazides should be used with caution in patients with impaired hepatic function. This link will take you to a website to which our Privacy Policy does not apply. SANOFI, Level 3, One JLT, Jumeirah Lake Towers (JLT), DMCC, PO Box 53899, Dubai, UAE | Tel. Hepatic impairment: CoAprovel is not indicated in patients with severe hepatic impairment. Tel: +233 302 734772; Doubling the once daily dose to 2.5mg after two weeks and then to 5mg after a further two weeks is recommended. Pharmacotherapeutic group: ACE Inhibitors, plain. However, clopidogrel and ASA have been administered together for up to one year (see section 5.1). Combined therapy should be started as early as possible after symptoms start and continued for at least four weeks. Sanofi engages in the research, production, and distribution of pharmaceutical products. PRODUCTS PRODUCTS Amaryl Apidra Aprovel Aubagio Clexane . Lantus was Sanofi's second best-selling pharmaceutical product in 2020 according to the company's latest annual financial report. As with other oral P2Y12 inhibitors, co-administration of opioid agonists has the potential to delay and reduce the absorption of clopidogrel presumably because of slowed gastric emptying. Sanofi - Wikipedia 5.4 Increased Risk of Cardiovascular Mortality with Sulfonylureas 5.5 Macrovascular Outcomes 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 7.1 Drugs Affecting Glucose Metabolism 7.2 Miconazole 7.3 Cytochrome P450 2C9 Interactions 7.4 Concomitant Administration of Colesevelam 8 USE IN . Cardiovascular - Sanofi in Australia & New Zealand Building on Sanofis legacy of more than 60 years of fighting cardiovascular disease, we deliver innovative therapeutic solutions for cardiovascular conditions to people at high risk for cardiac events (such as a heart attack) and who need additional treatment options beyond currently available medications. Aprovel is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant. Based on a pharmacokinetic study where Irbesartan and amlodipine were administered alone or in combination, there is no pharmacokinetic interaction between Irbesartan and amlodipine. ATC code: C09DA04. Each tablet contains ramipril 10mg CoAprovel 300 mg/12.5 mg tablets. Cardiovascular, Renal and Metabolism (CVRM) - AstraZeneca Even as therapeutic solutions become more effective, we recognize that the management of these diseases is a 24/7 job. The maximum recommended dose of Aprovasc is 300 mg/10 mg daily. hypersensitivity to dihydropyridines Cardiovascular - campus.sanofi Ramiprilat, the active metabolite of ramipril is poorly removed from the general circulation by haemodialysis. More detailed Information on request:Refer to Summary of Product Characteristics or Vascular disorders: Haematoma Caution should be used when starting therapy (see section 4.4). The dual blockade of the renin angiotensin aldosterone system with the combination of Aprovasc with angiotensin-converting enzyme inhibitors (ACEIs) or with aliskiren is not recommended since there is an increased risk of hypotension, hyperkalemia, and changes in renal function compared to monotherapy. Prescribing Information - NDC#49281-510-05. Suggested measures include induction of emesis and/or gastric lavage. Each tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
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