Twynsta

Per 40/5 mg tab Telmisartan 40 mg, amlodipine 5 mg. Per 80/5 mg tab Telmisartan 80 mg, amlodipine 5 mg

Replacement, add-on or initial therapy for essential HTN.

Adult Initially 40/5 mg once daily. May be started on 80/5 mg once daily if patient requires larger BP reductions. May be titrated up to max 80/10 mg once daily if needed after at least 2 wk of therapy. Mild to moderate hepatic impairment Not to exceed telmisartan 40 mg once daily.

May be taken with or without food.

Hypersensitivity to telmisartan, amlodipine or dihydropyridine derivatives. Biliary obstructive disorders; severe hypotension; shock (including cardiogenic shock); obstruction of the outflow tract of the left ventricle (eg, high grade aortic stenosis); haemodynamically unstable heart failure after acute MI. Concomitant use w/ aliskiren in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m²). Severe hepatic impairment. 2nd & 3rd trimesters of pregnancy. Lactation.

Not to be used in patients w/ diabetic nephropathy. Not recommended in primary aldosteronism. Dual blockade of the renin-angiotensin-aldosterone system is not recommended. Increased risk of severe hypotension & renal insufficiency in patients w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Patients w/ severe CHF or underlying renal disease including renal artery stenosis; aortic or mitral valve stenosis, obstructive hypertrophic cardiomyopathy; unstable angina pectoris & during or w/in 1 mth of MI; cardiac failure; DM & coexistent CAD. Black patients (low renin population). Periodically monitor K & creatinine serum levels. Correct vol &/or Na depletion prior to administration. Concomitant use w/ K-sparing diuretics, K supplements, K-containing salt substitutes or other medicinal products that may increase K level (eg, heparin). Caution when driving a car or operating machinery. Hepatic impairment. Renal impairment; recent kidney transplant. Not to be initiated during pregnancy. Not recommended in childn <18 yr. 80/5 mg tab: Not recommended in patients w/ hereditary fructose intolerance.

Cystitis; depression, anxiety, insomnia; dizziness, somnolence, migraine, headache, paraesthesia, syncope, peripheral neuropathy, hypoaesthesia, dysgeusia, tremor; vertigo; bradycardia, palpitations; hypotension, orthostatic hypotension, flushing; cough; abdominal pain, diarrhoea, nausea, vomiting, gingival hypertrophy, dyspepsia, dry mouth; pruritus, eczema, erythema, rash; arthralgia, muscle spasms, myalgia, back pain, pain in extremity; nocturia; erectile dysfunction; peripheral oedema, asthenia, chest pain, fatigue, oedema, malaise; increased hepatic enzyme & blood uric acid.

Increased BP-lowering effect w/ other antihypertensives. Hypotensive effects may be potentiated w/ baclofen, amifostine. Orthostatic hypotension may be aggravated by alcohol, barbiturates, narcotics or antidepressants. Reduced antihypertensive effect w/ systemic corticosteroids. Telmisartan: May increase hypotensive effect of other antihypertensives. Increased median plasma digoxin trough conc. Reversible increase in serum lithium conc & toxicity. Reduced antihypertensive effect w/ NSAIDs. Higher frequency of adverse events w/ combined use of ACE inhibitors, AIIA or aliskiren. Amlodipine: May increase exposure w/ strong or moderate CYP3A4 inhibitors eg, PIs, azole antifungals, macrolides (eg, erythromycin or clarithromycin), verapamil or diltiazem. Plasma conc may vary w/ CYP3A4 inducers eg, rifampicin, Hypericum perforatum. Increased exposure to simvastatin. Risk of increased tacrolimus blood levels. May increase exposure of mTOR inhibitors eg, sirolimus, temsirolimus & everolimus. Not recommended: Grapefruit or grapefruit juice (bioavailability may be increased). Dantrolene infusion (risk of hyperkalemia in patients susceptible to malignant hyperthermia).

Angiotensin II Antagonists / Calcium Antagonists

C09DB04 - telmisartan and amlodipine ; Belongs to the class of angiotensin II receptor blockers (ARBs) and calcium channel blockers. Used in the treatment of cardiovascular disease.

POM