Duowell

Telmisartan: Essential HTN. Reduce risk of death from MI, stroke & CV disease in patients ≥55 yr at high risk of developing major CV events who are intolerant to ACE inhibitors. High risk CV events including evidence of CAD, peripheral arterial disease, stroke, transient ischemic attack or DM w/ evidence of end-organ damage. Rosuvastatin: Adjunct to diet for patients w/ primary dysbetalipoproteinemia (type III); primary hypercholesterolemia (type IIa including heterozygous familial hypercholesterolemia & combined hyperlipidemia (type IIb); HoFH. Adjunct to slow progression of atherosclerosis in hypercholesterolemia patients to lower total-C & LDL-C to target levels. Reduce risk of CV disease, stroke, MI & arterial revascularization.

Adult Essential HTN Telmisartan 40 mg once daily, may be increased to max: 80 mg once daily. CV disease Telmisartan 80 mg once daily. Primary hypercholesterolemia (type IIa including heterozygous familial hypercholesterolemia), combined hyperlipidemia (type IIb), primary dysbetalipoproteinemia (type III) & HoFH Initially rosuvastatin 5 mg once daily. Maintenance dose: 10 mg once daily. Max: 20 mg daily. Predisposing factors to myopathy, Asian patient Recommended starting dose: Rosuvastatin 5 mg. Moderate hepatic impairment Not to exceed telmisartan 40 mg once daily.

May be taken with or without food.

Hypersensitivity. Cholestasis, biliary obstructive disorders; active liver disease including unexplained, persistent elevations of serum transaminases >3 x ULN. Patients w/ myopathy, hereditary angioedema or history of angioedema from ACE inhibitor or AIIAs. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Concomitant use w/ cyclosporine; aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m²). Severe hepatic & renal (CrCl <30 mL/min) impairment. Women of childbearing potential. Pregnancy & lactation. Rosuvastatin: Predisposing factors for myopathy/rhabdomyolysis eg, hypothyroidism, personal or family history of hereditary muscular disorders, previous history of muscular toxicity w/ another HMG-CoA reductase inhibitor or fibrate, situations where increase plasma levels may occur, Asian patients, alcohol abuse, concomitant use of fibrates, moderate renal impairment (CrCl <60 mL/min).

Discontinue use if creatine kinase (CK) levels are markedly elevated (>5 x ULN), ILD develops, severe skin reactions appear. Not to be used in acute, serious condition suggestive of myopathy or predisposing to development of renal failure secondary to rhabdomyolysis. Not recommended in dual blockade of renin-angiotensin-aldosterone system & primary aldosteronism. Hyperkalemia or predisposing factors for high K levels in blood; secondary hypercholesterolaemia caused by hypothyroidism or nephrotic syndrome; aortic or mitral stenosis, obstructive hypertrophic cardiomyopathy; ischaemic cardiomyopathy or CV disease, CVA; gastroduodenal diseases eg, active gastric or duodenal ulcer; severe hypotension; bilateral renal artery stenosis or artery stenosis to single functioning kidney; proteinuria; intravascular hypovolemia; diabetes w/ additional risk for CV disease. Perform LFTs & measure CK levels prior to initiation. Monitor AST & ALT levels prior to & periodically during administration. Discontinue use 24 hr prior to surgery. Genetic polymorphism. Not recommended in combination w/ gemfibrozil. May affect ability to drive & use machines. History of hepatic disease, mild & moderate hepatic impairment. Recent kidney transplantation, renal insufficiency. Ped patients <18 yr. Elderly.

Increased ALT, AST & creatine phosphokinase, dizziness & pruritus. Rosuvastatin: DM; headache; constipation, abdominal pain; myalgia; asthenia.

Telmisartan: Increased risk of hypotension, syncope, hyperkalemia & renal function changes w/ ARB, ACE inhibitor or aliskiren. Increased BP-lowering effect of other hypotensives. Increased digoxin median peak plasma & trough conc. Increased ramipril & ramiprilat AUC & C_max. Reversible increased serum lithium conc & toxicity. Aggravated orthostatic hypotension w/ baclofen, amifostine, alcohol, barbiturates, antidepressants. Reduced antihypertensive effect w/ NSAIDs ie, ASA >3 g daily, COX-2 inhibitors, non-selective NSAIDs; corticosteroids. Significant increased serum K w/ K-sparing diuretics, K supplements or K-containing salt substitutes. Vol depletion & risk of hypotension w/ high-dose diuretics. Rosuvastatin: Increased AUC w/ ciclosporin, darolutamide, regorafenib, atazanavir/ritonavir, velpatasvir, ombitasvir/paritaprevir/ritonavir/dasabuvir, elbasvir/grazoprevir, glecaprevir/pibrentasvir, lopinavir/ritonavir, clopidogrel, gemfibrozil, eltrombopag, darunavir/ritonavir, tipranavir/ritonavir, dronedarone, itraconazole, ezetimibe. Decreased AUC w/ erythromycin, baicalin. Decreased plasma conc w/ Al- & Mg hydroxide-containing antacids. Increased INR w/ vit K antagonists eg, warfarin, another coumarin anticoagulant. Increased risk of myopathy by gemfibrozil, fenofibrates, other fibrates, niacin ≥1 g daily. Increased ethinylestradiol & norgestrel AUC.

Angiotensin II Antagonists / Dyslipidaemic Agents

C10BX20 - rosuvastatin and telmisartan ; Belongs to the class of HMG CoA reductase inhibitors, other combinations.

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