Twynsta

Essential HTN.

Adult Replacement therapy Patients receiving telmisartan & amlodipine from separate tab can instead receive Twynsta containing the same component doses in 1 tab once daily. Add-on therapy May be used in patients whose BP is not adequately controlled w/ amlodipine or telmisartan monotherapy (eg, patients treated w/ amlodipine 10 mg who experience any dose-limiting AR eg, oedema may be switched to Twynsta 40 mg/5 mg once daily). Initial therapy 40 mg/5 mg once daily. Patient requiring larger BP reduction Initially 80 mg/5 mg once daily. Dose may be titrated up to a max of 80 mg/10 mg once daily if additional BP lowering is needed after 2 wk of therapy. Mild to moderate hepatic impairment Max: 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. In case of rare hereditary conditions that may be incompatible w/ an excipient. 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.

Possible hyperkalaemia; monitor serum K in patients at risk. Concomitant use w/ K-sparing diuretics, K supplements, K-containing salt substitutes or other drugs that may increase K level (eg, heparin). Symptomatic hypotension (especially after 1st dose) may occur in patients who are vol &/or Na depleted (eg, vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting). Possible renovascular HTN; increased risk of severe hypotension & renal insufficiency when patients w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated w/ drugs affecting renin-angiotensin-aldosterone system (RAAS). Dual blockade of RAAS through combined use of ACE inhibitors, ARBs or aliskiren is not recommended; not to be used concomitantly w/ ACE inhibitors in patients w/ diabetic nephropathy. Patients w/ severe CHF or underlying renal disease including renal artery stenosis. Not recommended for patients w/ primary aldosteronism. Patients suffering from aortic & mitral valve stenosis, obstructive hypertrophic cardiomyopathy. Unstable angina pectoris, acute MI. Patients w/ cardiac failure; may increase risk of future CV events & mortality. Contains sorbitol; not recommended for use in patients w/ hereditary fructose intolerance. Patients w/ DM & coexisting CAD. Excessive BP reduction in patients w/ ischaemic cardiopathy or CV disease could result in MI or stroke. May experience adverse events (eg, syncope, somnolence, dizziness, or vertigo) during treatment; avoid potentially hazardous tasks (eg, driving or operating machinery). Patients w/ biliary obstructive disorders or hepatic insufficiency. Mild to moderate hepatic impairment. Patients w/ impaired renal function; periodically monitor serum K & creatinine serum levels. Patients w/ recent kidney transplant; telmisartan is not removed from blood by hemofiltration & is not dialyzable; amlodipine is not dialyzable. Not recommended during 1st trimester & not to be initiated during pregnancy. Not recommended for childn <18 yr. Elderly.

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

BP lowering effect can be increased by concomitant use of other antihypertensives. May potentiate hypotensive effect w/ baclofen, amifostine. May aggravate orthostatic hypotension by alcohol, barbiturates, narcotics or antidepressants. Reduction of antihypertensive effect w/ corticosteroids (systemic route). Telmisartan: May increase hypotensive effect of other antihypertensives. Co-administration w/ digoxin, ramipril, lithium, NSAIDs. Do not co-administer w/ aliskiren in patients w/ DM; avoid aliskiren in patients w/ renal impairment (GFR <60 mL/min). Amlodipine: May increase BP lowering effects w/ grapefruit or its juice. Significantly increase exposure w/ strong or moderate CYP3A4 inhibitors (eg, PIs, azole antifungals, macrolides like erythromycin or clarithromycin, verapamil or diltiazem). Plasma conc may vary w/ CYP3A4 inducers (eg, rifampicin, Hypericum perforatum). Co-administration w/ dantrolene (infusion). Increased simvastatin exposure. May increase tacrolimus blood levels. Consider monitoring of cyclosporine levels in renal transplant patients. May increase exposure of mechanistic target of rapamycin inhibitors (eg, sirolimus, temsirolimus, & everolimus).

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