Telmiget Duo

Essential HTN: As replacement therapy in patients receiving telmisartan & amlodipine besilate from separate tab; add-on therapy in patients whose BP is not adequately controlled on telmisartan or amlodipine monotherapy; initial therapy in patients who are in need of multiple drugs to achieve BP goals.

Adult Once daily. Replacement therapy Same component doses in 1 tab once daily. Add-on therapy Patients treated w/ 10 mg amlodipine who experience any dose limiting adverse reactions eg, oedema, may be switched to 40 mg/5 mg once daily. Initial therapy Initially 40 mg/5 mg once daily. Patients requiring larger BP reduc­tions may be started on 80 mg/5 mg once daily. If additional BP lowering is needed after at least 2 wk of therapy, dose may be titrated up to max 80 mg/10 mg once daily. Patient w/ mild to moderate hepatic impairment Telmisartan should not exceed 40 mg once daily.

May be taken with or without food.

Hypersensitivity to telmisartan, amlodipine or dihydropyridine derivatives. Biliary obstructive disorders; severe hepatic impairment; cardiogenic shock. Hereditary conditions that may be incompatible w/ an excipient of the product. Concomitant use w/ aliskiren in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m²). Pregnancy (2nd & 3rd trimesters) & lactation.

Symptomatic hypotension, especially after 1st dose, may occur in patients who are vol &/or Na depleted. Dual blockade of the renin-angiotensin-aldosterone system (RAAS) (eg, by adding ACE inhibitor or direct renin-inhibitor aliskiren to AIIA) is not recommended. Associated w/ acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure in patients whose vascular tone & renal function depend predominantly on the activity of RAAS (eg, patients w/ severe CHF or underlying disease, including renal artery stenosis). Telmisartan is not recommended in primary aldosteronism. No data to support use in unstable angina pectoris & during or w/in 1 mth of MI. Amlodipine was associated w/ increased reports of pulmonary oedema in patients w/ NYHA III & IV heart failure of non-ischaemic aetiology. Hyperkalaemia may occur, especially in presence of renal impairment &/or heart failure; monitoring of serum K in patients at risk is recommended. Increased risk of fatal MI & unexpected CV death in diabetic patients w/ additional CV risk (ie, DM & coexistent CAD) when treated w/ BP-lowering agents eg, ARBs or ACE inhibitors. Excessive BP reduction in patients w/ ischaemic cardiopathy or ischaemic CV disease may result in MI or stroke. Caution in patients suffering from aortic or mitral stenosis, or obstructive hypertrophy cardiomyopathy; patients w/ hepatic insufficiency. Increased risk of severe hypotension & renal insufficiency in patients w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Periodically monitor K & creatinine serum levels in patients w/ impaired renal function. No experience in patients w/ recent kidney transplant. Undesirable effects eg, syncope, somnolence, dizziness, or vertigo may be experienced during treatment; caution when driving a car or operating machinery. AIIA is not recommended during 1st trimester of pregnancy & should not be initiated during pregnancy.

Fixed dose combination: 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, diarrhea, 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 enzymes & blood uric acid. Thrombocytopenia; hypersensitivity; dyspnoea; angioedema, hyperhidrosis, urticaria. Telmisartan: UTI, URTI, sepsis including fatal outcome; anaemia, eosinophilia; anaphylactic reaction; hyperkalaemia, hypoglycaemia (in diabetic patients); visual disturbance; tachycardia; flatulence, stomach discomfort; abnormal hepatic function/liver disorder; drug eruption, toxic skin eruption; tendon pain (tendinitis like symptoms); renal impairment including acute renal failure; flu-like illness; increased blood creatinine, decreased Hb, increased blood creatine phosphokinase. Amlodipine: Leucopenia; hyperglycaemia; mood change, confusional state; extrapyramidal disorder; visual impairment; tinnitus; MI, arrhythmia, ventricular tachycardia, atrial fibrillation; vasculitis; rhinitis; change of bowel habit, pancreatitis, gastritis; hepatitis, jaundice, hepatic enzyme elevations (mostly consistent w/ cholestasis); alopecia, purpura, skin discolouration, erythema multiforme, exfoliative dermatitis, SJS, photosensitivity reaction; micturition disorder, pollakiuria; gynaecomastia; pain, increased/decreased wt.

Increased BP lowering effect w/ other antihypertensive medicinal products. Agents w/ BP lowering potential (eg, baclofen, amifostine) may potentiate hypotensive effects. Orthostatic hypotension may be aggravated by alcohol, barbiturates, narcotics, or antidepressants. Reduced antihypertensive effect w/ systemic corticosteroids. Telmisartan: Increased hypotensive effect of other antihypertensive agents. Increased median plasma trough conc of digoxin. Increased AUC_0-24 & C_max of ramipril & ramiprilat. Reversible increases in serum lithium conc & toxicity. Risk of acute renal insufficiency w/ NSAIDs in patients who are dehydrated. Compd acting on RAAS may have synergistic effects. Reduced effect w/ NSAIDs. Amlodipine: Increased bioavailability w/ grapefruit or grapefruit juice. Increased plasma conc w/ diltiazem (CYP3A4 inhibitor). Possibility of increased plasma conc w/ more potent CYP3A4 inhibitors (ie, ketoconazole, itraconazole, ritonavir). Reduced plasma conc w/ CYP3A4 inducers (eg, carbamazepine, phenobarb, phenytoin, rifampicin, St. John's wort). Increased exposure of simvastatin. Increased systemic exposure of ciclosporin or tacrolimus.

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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