Patients with impaired hepatic function: Due to the presence of amlodipine, APROVASC should be administered with caution (see Section 7). Tel: +966-12-669-3318, For Medical Information, please contact: +966-12-669-3318, ksa.medicalinformation@sanofi.com, To report any Product Technical Complaints, kindly contact: Email: quality.greatergulf@sanofi.com. heparin) may lead to increases in serum potassium and is, therefore, not recommended (see section 4.4). Hepatic impairment: CoAprovel is not indicated in patients with severe hepatic impairment. If the dose cannot be increased to 2.5mg twice a day the treatment should be withdrawn. More detailed Information on request:Refer to Summary of Product Characteristics or Date of SmPC text revision: 11 April 2019; Tritace may be used in monotherapy or in combination with other classes of antihypertensive medicinal products (see sections 4.3, 4.4, 4.5 and 5.1). temsirolimus, everolimus, sirolimus) or vildagliptin. The most commonly reported ADRs were dizziness (5.6%), fatigue (4.9%), nausea/vomiting (1.8%), and abnormal urination (1.4%). 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 The patient should be closely monitored, and the treatment should be symptomatic and supportive. ATC code: C09C A04. Tel: +966-12-669-3318, . . Therapeutic experience with clopidogrel is limited in patients with renal impairment. This website is intended exclusively for healthcare professionals residing and/or working in Oman. In hypertensive patients in whom the diuretic is not discontinued, therapy with Tritace should be initiated with a 1.25mg dose. If hypotension occurs, the patient should be placed in a supine position, with salt and volume replacements given quickly. Other antihypertensive agents: the antihypertensive effect of CoAprovel may be increased with the concomitant use of other antihypertensive agents. Sanofi, Japaul House, Plot 8, For Medical Information, please contact: +966-12-669-3318. Overdose following clopidogrel administration may lead to prolonged bleeding time and subsequent bleeding complications. 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. Irbesartan is a specific antagonist of angiotensin II receptors (subtype AT1). In elderly patients, with volume depletion (including those on treatment with diuretics), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists , including Irbesartan, can cause impaired renal function, including possible acute renal failure. In patients with diabetes and microalbuminuria: Starting dose: The recommended initial dose is 1.25mg of Tritace once daily. Pharmacotherapeutic group: platelet aggregation inhibitors excl. The combination should be administered with caution, especially in the elderly. Sanofi Biosurgery's products include: Synvisc , Synvisc-One (hylan G-F 20), Carticel (autologous cultured chondrocytes), MACI (Matrix-induced Autologous Chondrocyte Implantation . Prescribing Information - NDC#49281-511-05. By proceeding to this website, you confirm that you are a Nigeria healthcare professional. No clinically significant pharmacodynamic interactions were observedwhen clopidogrel was co-administered with atenolol, nifedipine, or both atenolol and nifedipine. Renovascular hypertension: there is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system. ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. Currently available data are described in sections 4.8, 5.1, and 5.2 but no recommendation on a posology can be made. In vitro studies have shown the increase in repaglinide exposure is due to inhibition of CYP2C8 by the glucuronide metabolite of clopidogrel. Renal function should be monitored periodically in patients receiving periodic treatment with Irbesartan and NSAIDs. 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). That's how we turn the impossible into possible. However, clopidogrel and ASA have been administered together for up to one year (see section 5.1). 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). Elderly patients and patients with renal failure: It is usually not necessary to reduce the dosage in elderly patients or in patients with impaired renal function (regardless of grade). Lithium: Increases in serum lithium concentrations and lithium toxicity have been reported with the concomitant use of Irbesartan. If prompt correction of prolonged bleeding time is required, platelet transfusion may reverse the effects of clopidogrel. Titration and maintenance dose: The daily dose is subsequently increased by doubling the dose at intervals of one to three days up to the target maintenance dose of 5mg twice daily. Nervous system disorders: dizziness, orthostatic dizziness* 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. CVRM diseases such as heart failure, cardiovascular disease, diabetes, non-alcoholic steatohepatitis (NASH) and chronic kidney disease share common and distinct mechanisms. These results indicate that clopidogrel can be administered with pantoprazole. The compatibility of ALDURAZYME in solution with other products has not been evaluated. If you wish to access one of our Group website from another country, click Proceed. Hyperkalaemia: as with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Aprovel, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/or heart failure. In patients with non- diabetic nephropathy as defined by macroproteinuria3g/day: Titration and maintenance dose: Depending on the patients tolerability to the active substance, the dose is subsequently increased. Learn about the latest trends, discover events and innovations in the changing world of cardiovascular disease. No data are available. Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors. Dual blockade of the renin-angiotensin-aldosterone system (RAAS): 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). Sanofi, Japaul House, Plot 8, Renal impairment: Due to the hydrochlorothiazide component, CoAprovel is not recommended for patients with severe renal dysfunction (creatinine clearance < 30 ml/min). This link will take you to a website to which our Privacy Policy does not apply. ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy. Symptomatic hypotension may occur, such as with ACE inhibitors, in patients with sodium/volume depletion and in those under intensive treatment with diuretics and/or salt restriction or in hemodialysis. Starting dose: Tritace should be started gradually with an initial recommended dose of 2.5mg daily. Dr. Nurudeen Olowopopo Avenue, Ikeja Central Business District, Agidingbi, Lagos, Nigeria. Aprovasc is indicated in hypertensive adult patients whose blood pressure could not be adequately controlled with Irbesartan or Amlodipine monotherapy. CoAprovel 300 mg/12.5 mg tablets. More detailed Information on request:Refer to Summary of Product Characteristics or Intravenous calcium gluconate may be of benefit in reversing the effects of calcium channel blockade. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter. In particular, they appeared less favourable in women and non-white subjects (see section 5.1). : +971 4 550 3600 | Fax: +971 4 5521050, please contact: +971 565776791 or Email: medical-information.gulf@sanofi.com, please call: +971 561747001 or Email: Gulf.pharmacovigilance@sanofi.com, To report any product technical complaints, kindly contact: Email: quality.greatergulf@sanofi.com. However, initiation of therapy with 75 mg could be considered, particularly in haemodialysed patients and in the elderly over 75 years. Date of last abbreviation of prescribing information: July 2019. . Ramipril must not be used in patients with hypotensive or haemodynamically unstable states Each tablet contains ramipril 2.5mg Hypersensitivity to the active substance or to any of the excipients listed Tritace tablets 10mg CYP2C8 substrate medicinal products: Clopidogrel has been shown to increase repaglinide exposure in healthy volunteers. Less pronounced reductions of metabolite exposure has been observed with pantoprazole orlansoprazole. For oral use.It may be given with or without food. The usual, initial, and maintenance dose of Aprovasc is one tablet once a day. Sanofi manufactures, markets and/or distributes more than 75 drugs in the U.S. A vasoconstrictor can help restore vascular tone and blood pressure, when there is no contraindication to its use. Hypertensive patients with type 2 diabetes and renal disease: the effects of irbesartan both on renal and cardiovascular events were not uniform across all subgroups, in an analysis carried out in the study with patients with advanced renal disease. Aprovel 300MG TABLETS No dosage adjustment is necessary in patients with mild to moderate hepatic impairment. The administration of activated carbon to healthy individuals immediately or up to two hours after the ingestion of 10 mg of amlodipine has shown a significant decrease in the absorption of amlodipine. The clinical relevance is unknown. Combined therapy should be started as early as possible after symptoms start and continued for at least four weeks. White to almost white oblong tablet with score line, upper stamp HMO/HMO. Date of SmPC text revision: 29 May 2015; Dose titration with the individual components (i.e. The subsequent dosage of Tritace should be adjusted according to blood pressure target. Sanofi, Japaul House, Plot 8, SANOFI, Level 3, One JLT, Jumeirah Lake Towers (JLT), DMCC, PO Box 53899, Dubai, UAE | Tel. Patients who had developed a previous allergic reaction and/or haematological reaction to one thienopyridine may have an increased risk of developing the same or another reaction to another thienopyridine. Get a 360 view and stay up-to-date on cardiovascular disease with content selected for you. Vascular disorders: Haematoma Each tablet contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Pale red oblong tablet with score line, upper stamp 5 and company logo, lower stamp HMP and 5. The possibility of a similar effect occurring with the use of an angiotensin II receptor antagonist, including Irbesartan, cannot be excluded. This includes those individuals with measured high total cholesterol and those that self-reported as having high cholesterol. Changes in the renal function of susceptible individuals can be expected as a consequence of the inhibition of the renin-angiotensin-aldosterone system. CoAprovel 300 mg/25mg tablets. No antidote to the pharmacological activity of clopidogrel has been found. Therefore, concomitant use should be undertaken with caution (see section 4.4). Paediatric population: CoAprovel is not recommended for use in children and adolescents because the safety and efficacy have not been established. Adult patients suffering from acute coronary syndrome: 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). Second and third trimesters of pregnancy (see sections 4.4 and 4.6) As a health journey partner, we at Sanofi focus on improving quality . For patients over 75 years of age clopidogrel should be initiated without a loading dose. These technologies are also shedding new light on the biology behind many diseases, helping our teams target the root causes of disease with more precise medicines. There is an increased risk of bleeding due to the potential additive effect. For uncommon, rare and very rare side effects see full prescribing information. By continuing to browse this website, you agree to the use of such cookies. Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 or any other ACE (Angiotensin Converting Enzyme) inhibitors Each tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide. Renal function should be monitored periodically in patients receiving periodic treatment with Irbesartan and NSAIDs. The body's immune system is the first line of defense against cancer, but tumors . Aprovasc can be administered with food or fasting. Starting dose: In patients stabilized on diuretic therapy, the recommended initial dose is 1.25mg daily. Products Products Clexane Soliqua Soliqua . Usually the dose is administered once daily. For oral administration. Caution should be used when starting therapy (see section 4.4). since SSRIs affect platelet activation and increase the risk of bleeding, the concomitant administration of SSRIs with clopidogrel should be undertaken with caution. Some of these are new molecular entities while others are existing products with potential new indications, or different formulations. There are an estimated 7.1 million Australians living with hypercholesterolaemia. Hepatic impairment: Therapeutic experience is limited in patients with moderate hepatic disease who may have bleeding diatheses. In clinical studies, the pharmacokinetic of irbesartan is not affected by hydrochlorothiazide. . The effects of CYP2C9 inducers such as rifampicin on the pharmacokinetic of irbesartan have not been evaluated. With a strong focus on difficult-to-treat diseases and immunization, our R&D pipeline includes 87 clinical-stage projects, 32 of which are in phase 3 or have been submitted to regulatory authorities for approval. Blood potassium increased, Headache, dizziness, Hypotension, orthostatic blood pressure decreased, syncope, Non-productive tickling cough, bronchitis, sinusitis, dyspnoea, Gastrointestinal inflammation, digestive disturbances, abdominal discomfort, dyspepsia, diarrhoea, nausea, vomiting, Rash in particular maculo-papular, Muscle spasms, myalgia, Chest pain, fatigue. White to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2772 engraved on the other side. Excipient qs: 1tab 1tab 1tab 1tab. 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). Data sources include IBM Watson Micromedex (updated 1 Nov 2022), Cerner . Consequently, NSAIDs including Cox-2 inhibitors and clopidogrel should be co-administered with caution (see section 4.4). A lower starting dose (75 mg) should be considered for patients undergoing haemodialysis (see section 4.4). If a dose is missed: Within less than 12 hours after regular scheduled time: patients should take the dose immediately and then take the next dose at the regular scheduled time. To report an adverse event: please call: +971 561747001 or Email: Gulf.pharmacovigilance@sanofi.com. 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). Plavix contains lactose. Amlodipine is a calcium dihydropyridine antagonist. Tests are available to identify a patient's CYP2C19 genotype. over-the-counter medicines and natural products. Titration and maintenance dose: Depending on the patients tolerability to the active substance, the dose should be gradually increased. irbesartan and hydrochlorothiazide) may be recommended. If possible, the diuretic should be discontinued 2 to 3 days before beginning therapy with Tritace (see section 4.4). ESH - ISH 2021/ Sanofi Hypertension Symposium - Case Based Scenarios. The optimal duration of treatment has not been formally established. No specific information is available on the treatment of overdose with Aprovel. The tablet can be divided into equal halves. 500mg+1mg + 0.2mg, 500mg + 2mg + 0.3mg. Amaryl MV. Cyclosporine: Pharmacokinetic studies with cyclosporine have shown that amlodipine does not significantly modify its pharmacokinetics. Sanofi and the Heart Foundation are looking at why people with CVD appear to be more vulnerable to severe outcomes, and how we can better treat the cardiac complications of COVID-19. Hypotension may occur following initiation of therapy with TRITACE; this is more likely in patients who are being treated concurrently with diuretics. Dr. Nurudeen Olowopopo Avenue, Ikeja Central Business District, Agidingbi, Lagos, Nigeria. The concomitant administration of medicinal products associated with bleeding risk should be undertaken with caution (see section 4.4). In view of the lack of data, clopidogrel cannot be recommended during the first 7 days after acute ischaemic stroke. Learn about the latest trends, discover events and innovations in the changing world of cardiovascular disease. Suggested measures include gastric lavage. Randys Story: Ill never forget hearing my doctor say, We need to talk about your cholesterol.. Safety and efficacy in pediatric patients have not been established. 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. Furthermore, the pharmacodynamic activity of clopidogrel was not significantly influenced by the coadministration of phenobarbital or oestrogen. . For further Medical Information: please contact: 800 MEDICAL Toll-Free Number, Email: medical-information.gulf@sanofi.com, To report an adverse event: please call: +971 561747001 or. Manifest glomerular non diabetic nephropathy as defined by macroproteinuria 3g/day (see section 5.1). Each tablet contains ramipril 5mg Tel: +233 302 734772; ALDURAZYME must not be administered with other medicinal products in the same infusion. discover events and innovations in the changing world of cardiovascular disease. Sanofi Office, 2nd Floor Yekeima Square, This website is intended exclusively for healthcare professionals residing and/or working in the UAE. Close monitoring of serum potassium in patients at risk is . Close monitoring of serum potassium in patients at risk is recommended (see section 4.5). This website is restricted to healthcare professionals of Nigeria. Lantus was Sanofi's second best-selling pharmaceutical product in 2020 according to the company's latest annual financial report. 4 CONTRAINDICATIONS mTOR inhibitors or vildagliptin: An increased risk of angioedema is possible in patients taking concomitant medications such as mTOR inhibitors (e.g. The plasma concentrations of the active metabolite was 20% reduced (loading dose) and 14% reduced (maintenance dose) during concomitant treatment with pantoprazole 80 mg once daily. Active pathological bleeding such as peptic ulcer or intracranial haemorrhage. For Pharmacovigilance (reporting adverse events), please contact: ng-gh.pv@sanofi.com. Grapefruit juice: Simultaneous administration of 240 mL of grapefruit juice with a single oral dose of 10 mg of amlodipine in 20 healthy volunteers had no significant effect on amlodipine pharmacokinetics. From a neighborhood or school community to a network with a shared bond of life-changing experiences like a medical diagnosis, being part of a community can foster feelings of connection. Medicinal products that are strong or moderate CYP2C19 inhibitors include, for example, omeprazole and esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, carbamazepine, and efavirenz. Each tablet contains 300 mg of irbesartan. 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 . Tritace tablets 2.5mg Aluminum/magnesium (antacid): Simultaneous administration of an aluminum/magnesium antacid with a single dose of amlodipine had no significant effect on amlodipine pharmacokinetics. We focus, and we push our limits. General disorders and administration site conditions: fatigue The maximum recommended dose of Aprovasc is 300 mg/10 mg daily. The Sanofi Managed Care Digest Series (available at www.managedcaredigest.com) includes the Hospitals/Systems Digest, the Public Payer Digest, the HMO-PPO Rx Digest and robust patient-level chronic disease-specific claims data.The Series continues to be a trusted source for the most reliable health care data and analysis, and provides detailed, local-level information about all stakeholders . No dosage adjustment is necessary in patients with renal impairment whose renal creatinine clearance is 30 ml/min (see sections 4.3 and 4.4). TTP is a potentially fatal condition requiring prompt treatment including plasmapheresis. In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke. ATC code: C09DA04. Sildenafil: When using amlodipine and sildenafil in combination, each agent independently exerted its own blood pressure reductive effect. Due to the risk of increased plasma concentrations, concomitant administration of clopidogrel and drugs primarily cleared by CYP2C8 metabolism (e.g., repaglinide, paclitaxel) should be undertaken with caution (see section 4.4). Caprini risk assessment model. Vascular disorders: Orthostatic hypotension Cardiovascular disease and associated risk factors significantly affect peoples quality of life and that of their families, and put a rising medical and economic burden on health systems worldwide., Cost of ACS to Governments, Individuals and Families. The clinical relevance of this interaction is uncertain. 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. 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. Therefore, the use of Aprovel is not recommended. For uncommon, rare and very rare side effects see full prescribing information. ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy. In addition, increases in blood urea nitrogen (BUN) (2.3%), creatine kinase (1.7%) and creatinine (1.1%) were also commonly observed in the trials. Patients with a strongly activated renin-angiotensin-aldosterone system may experience an excessive drop in blood pressure following the initial dose. Nervous system disorders: Dizziness, headache, somnolence You are leaving the www.sanofi.com.au website If the initial 2.5mg dose is not tolerated a dose of 1.25mg twice a day should be given for two days before increasing to 2.5mg and 5mg twice a day. Jul 27, 2022. By clicking on this link, you will be leaving Campus Sanofi website and going to another, entirely independent website. Cardiovascular disease and associated risk factors significantly affect peoples quality of life and that of their families, and put a rising medical and economic burden on health systems worldwide. The demonstration of renal benefit of Aprovel in hypertensive type 2 diabetic patients is based on studies where irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure (see sections 4.3, 4.4, 4.5 and 5.1). We're determined to find answers for patients, and to develop medicines and vaccines with the potential to improve people's lives. cardiogenic shock, clinically significant aortic stenosis, unstable angina (excluding Prinzmetals angina) A pharmacodynamic interaction between clopidogrel and acetylsalicylic acid is possible, leading to increased risk of bleeding. Doubling the daily dose to 5mg Tritace after one or two weeks and then to 10mg Tritace after a further two or three weeks is recommended. 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). Clinical and economic value of SOLIQUA - Pharmacist perspective. There are certain watershed moments in every person's life that propel them to find a community. Box 9874, Jeddah 21423, K.S.A. 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). The combination of Aprovasc with medications containing aliskiren is contraindicated in patients with diabetes mellitus or with moderate to severe renal failure (glomerular filtration rate (GFR) <60 mL/min/1.73 m2) and is not recommended in other patients.Angiotensin-converting enzyme inhibitors (ACE inhibitors): Use of Aprovasc in combination with ACE inhibitors is contraindicated in patients with diabetic nephropathy and is not recommended in other patients. If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure. Each tablet contains: The long-acting insulin (glargine), used to . Medical practices and regulations can be different from one country to another. Sanofi engages in the research, production, and distribution of pharmaceutical products. AVAPRO 150 mg is a white to off-white, biconvex oval, lm-coated tablet debossed with a heart on one side and 2872 on the other. The use of Factor IX products has been associated with the development of thromboembolic complications. Therefore, this combination is not recommended (see section 4.4). As a precaution concomitant use of strong or moderate CYP2C19 inhibitors should be discouraged (see sections 4.4 and 5.2). If a patient is to undergo elective surgery and antiplatelet effect is temporarily not desirable, clopidogrel should be discontinued 7 days prior to surgery.
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