Twynsta

Per 40/5 mg tab Telmisartan 40 mg, amlodipine besilate 5 mg. Per 80/5 mg tab Telmisartan 80 mg, amlodipine besilate 5 mg. Per 80/10 mg tab Telmisartan 80 mg, amlodipine besilate 10 mg

Essential HTN as replacement therapy in patients receiving telmisartan & amlodipine from separate tab; add-on therapy in patients whose BP is inadequately controlled on telmisartan or amlodipine monotherapy; initial therapy in patients who need multiple drugs to achieve BP goals.

Adult Replacement therapy 1 tab once daily equiv to telmisartan & amlodipine as separate tab. Add on therapy 40/5 mg once daily in patients treated w/ 10 mg amlodipine who experience dose limiting adverse reactions. Initial therapy Initially 40/5 mg once daily. Patients requiring larger BP reductions May start w/ 80/5 mg once daily. May titrate up to max of 80/10 mg once daily if additional BP lowering is needed after at least 2 wk. Mild to moderate hepatic impairment Max telmisartan dose: 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; left ventricle outflow tract obstruction (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. Pregnancy (2nd & 3rd trimesters) & lactation.

Discontinue treatment immediately in case of swelling face, tongue & larynx; dyspnoea occurs. Not recommended in patients w/ primary aldosteronism. Increased risk of severe hypotension & renal insufficiency in patients w/ bilateral renal artery stenosis or artery stenosis to single functioning kidney. Symptomatic hypotension especially after 1st dose in patients who are vol &/or Na depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Acute hypotension, hyperazotaemia, oliguria, or acute renal failure in patients whose vascular tone & renal function depend predominantly on activity of the renin-angiotensin-aldosterone system. Unstable angina pectoris & during or w/in 1 mth of MI. Hyperkalaemia in the presence of renal impairment &/or heart failure. Excessive BP reduction in patients w/ ischaemic cardiopathy or CV disease. Patients w/ aortic or mitral stenosis or obstructive hypertrophic cardiomyopathy; severe heart failure (NYHA class III & IV); CHF; DM & coexistent CAD. Correct vol &/or Na depletion before treatment. Monitor serum K in patients at risk of hyperkalaemia. Perform diagnostic evaluation eg, exercise stress test in patients w/ DM to detect & treat CAD before treatment initiation. Test CPK level if patients experience tired out & fatigued easily after normal exercise. Not recommended to use concomitantly w/ ACE inhibitor or aliskiren. Concomitant use w/ K-sparing diuretics, K supplements, K containing salt substitutes or other medicinal products that may increase K level eg, heparin. Not to be taken by patients w/ fructose intolerance. Avoid driving or operating machinery if syncope, somnolence, dizziness or vertigo occasionally occur. Periodic monitoring of K & creatinine serum levels in patients w/ renal impairment. Biliary obstructive disorders or hepatic insufficiency; liver function impairment (mild to moderate). Not recommended during 1st trimester & not to be initiated during pregnancy. Discontinue treatment during pregnancy & lactation. Not recommended in paed patients <18 yr. Elderly.

Sepsis including fatal outcome, URTI, UTI, cystitis; leukopenia, thrombocytopenia, anaemia, eosinophilia; anaphylactic reaction, hypersensitivity; hyperkalaemia, hypoglycaemia (in diabetic patients), hyperglycaemia, hyponatraemia; depression, anxiety, confusional state, insomnia, altered mood; syncope, somnolence, dizziness, extrapyramidal disorder, hypertonia, migraine, headache, peripheral neuropathy, paraesthesia, hypoaesthesia, dysgeusia, tremor; visual impairment, diplopia; vertigo, tinnitus; MI, ventricular tachycardia, arrhythmia, atrial fibrillation, bradycardia, tachycardia, palpitations; hypotension, orthostatic hypotension, flushing, vasculitis; dyspnoea, cough, rhinitis; pancreatitis, gastritis, abdominal pain, diarrhoea, vomiting, gingival hypertrophy, dyspepsia, constipation, nausea, dry mouth, flatulence, abdominal discomfort, change of bowel habit; hepatitis, jaundice, abnormal hepatic function/liver disorder; increased hepatic enzyme; TEN, SJS, angioedema, erythema multiforme, exfoliative dermatitis, drug & toxic skin eruption, photosensitivity reaction, urticaria, eczema, erythema, rash, pruritus, alopecia, purpura, skin discolouration, hyperhidrosis; arthralgia, back & tendon pain (tendonitis like symptoms), pain in extremity (leg pain), joint swelling, muscle spasms (cramps in legs), myalgia; renal impairment including acute kidney injury, nocturia, micturition disorder, pollakiuria; erectile dysfunction, gynaecomastia; chest pain, pain, oedema, peripheral oedema, asthenia, fatigue, malaise, flu-like illness; increased hepatic enzyme, wt, blood creatinine, creatine phosphokinase & uric acid, decreased Hb & wt.

Increased BP lowering effect w/ other antihypertensive medicinal products. Potentiated hypotensive effects w/ baclofen, amifostine. Aggravated orthostatic hypotension w/ alcohol, barbiturates, narcotics or antidepressants. Reduced antihypertensive effect w/ systemic corticosteroids. Telmisartan: May increase hypotensive effect of other hypertensive agents. Increased median plasma digoxin trough conc. Increased AUC_0-24 & C_max of ramipril & ramiprilat. Reversible increase in serum lithium conc & toxicity. Potential for acute renal insufficiency in dehydrated patients; reduced antihypertensive effect w/ NSAIDs. Amlodipine: Increased bioavailability & BP lowering effects w/ grapefruit or grapefruit juice. Increased exposure w/ strong or moderate CYP3A4 inhibitors (PIs, azole antifungals, macrolides [eg, erythromycin or clarithromycin], verapamil or diltiazem). Concomitant use w/ strong CYP3A4 inducers eg, rifampicin, Hypericum perforatum. Hyperkalaemia-associated lethal ventricular fibrillation & CV collapse w/ verapamil & IV dantrolene. Risk of increased tacrolimus blood levels. May increase exposure of mTOR inhibitors eg, sirolimus, temsirolimus & everolimus. Increased exposure to simvastatin.

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.

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