Twynsta

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

Essential HTN. Replacement therapy (patients receiving telmisartan & amlodipine besilate from separate tab). Add on therapy in BP not adequately controlled on monotherapy. Initial therapy in patients who are likely to need multiple drugs to achieve BP goals.

Adult Once daily. Replacement therapy Receive same component doses in 1 tab once daily. Patients treated w/ 10 mg amlodipine who experience any dose limiting AR eg, edema may be switched to 40/5 mg once daily. Initial therapy 40/5 mg once daily. Patients requiring larger BP reductions may be started on 80/5 mg once daily. If additional BP lowering is needed after at least 2 wk of therapy, the dose may be titrated up to a Max: 80/10 mg once daily. Hepatic impairment telmisartan should not exceed 40 mg once daily.

May be taken with or without food.

Hypersensitivity to telmisartan, amlodipine besilate or to dihydropyridine derivatives or excipients. Biliary obstructive disorders. Severe hepatic impairment; hypotension. Cardiogenic shock. 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). Pregnancy (2nd & 3rd trimesters) & lactation.

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/ medicinal products that affect the RAAS. Symptomatic hypotension, especially after 1st dose, may occur in patients who are vol &/or Na depleted. Hyperkalemia (monitoring of serum K is recommended). Dual blockade of RAAS. Patients w/ severe CHF or underlying renal disease, including renal artery stenosis. Not recommended in patients w/ primary aldosteronism. Patients w/ aortic & mitral stenosis, obstructive hypertrophic cardiomyopathy. Unstable angina pectoris, acute MI. Increased risk of future CV events & mortality in patients w/ CHF. Excessive reduction of BP in patients w/ ischaemic cardiopathy or ischaemic CV disease could result in MI or stroke. Not recommended for use in patients w/ hereditary fructose intolerance. DM (undergo appropriate diagnostic evaluation eg, exercise stress testing). Black patients (low-renin population). Renal impairment & kidney transplant. Hepatic impairment. May affect ability to drive or operate machines. Should not be initiated during pregnancy (1st trimester). Lactation. Increase of amlodipine dosage should take place w/ care in geriatric patients. Childn & adolescents <18 yr. 80 mg/5 mg & 80 mg/10 mg tab: Not recommended for use in patients w/ hereditary fructose intolerance due to sorbitol content.

Sepsis, 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, increased hepatic enzyme; TEN, SJS, angioedema, erythema multiforme, exfoliative dermatitis, drug eruption, toxic skin eruption, photosensitivity reaction, urticaria, eczema, erythema, rash, pruritus, alopecia, purpura, skin discolouration, hyperhidrosis; arthralgia, back pain, pain in extremity, tendon pain, joint swelling, muscle spasms, myalgia; renal impairment, nocturia, micturition disorder, pollakiuria; erectile dysfunction, gynaecomastia; chest pain, pain, oedema, peripheral oedema, asthenia, fatigue, malaise, flu like illness; increased hepatic enzyme, blood creatinine, blood creatine phosphokinase, blood uric acid & wt, decreased Hb & wt.

Increased BP lowering effect w/ other antihypertensives, baclofen, amifostine, alcohol, barbiturates, narcotics or antidepressants. Reduction of anti-hypertensive effects w/ corticosteroids. Telmisartan: Increase hypotensive effect w/ other antihypertensive agents. Increase in median plasma digoxin trough conc. Increase of AUC_0-24 & C_max of ramipril & ramiprilat. Reversible increases in serum lithium conc & toxicity. Treatment w/ NSAIDs (ie, ASA at anti-inflammatory dosage regimens, COX-2 inhibitors & non-selective NSAIDs) is associated w/ potential for acute renal insufficiency in dehydrated patients. Reduced effect of antihypertensive drugs like telmisartan by inhibition of vasodilating prostaglandins during combined treatment w/ NSAIDs. Amlodipine: Increased BP lowering effects w/ grapefruit or grapefruit juice. Strong or moderate CYP3A4 inhibitors (PIs, azole antifungals, macrolides like erythromycin or clarithromycin, verapamil or diltiazem) may increase in amlodipine exposure resulting in an increased risk of hypotension. Strong CYP3A4 inducers (eg, rifampicin, Hypericum perforatum), plasma conc of amlodipine may vary. Due to risk of hyperkalemia, coadministration w/ IV dantrolene should be avoided. Increased tacrolimus blood levels. Variable trough conc increases of cyclosporine w/ renal transplant patients. Increased exposure of mTOR inhibitors. Co-administration of multiple doses of 10 mg of amlodipine w/ simvastatin 80 mg resulted in an increase in exposure to simvastatin compared to simvastatin alone. Therefore, limit the dose of simvastatin in patients on amlodipine to 20 mg daily.

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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