Telmefixx Plus

Telmisartan 40 mg, amlodipine besilate 5 mg

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

Adult 1 tab once daily. Replacement therapy 1 tab once daily containing same component doses to enhance convenience or compliance. Add-on therapy May be switched to 40 mg/5 mg once daily in patients treated w/ amlodipine 10 mg who experience any dose limiting AR eg, edema. Initial therapy 40 mg/5 mg once daily. Patient requiring larger BP reduction Initially 80 mg/5 mg once daily. May be titrated up to max of 80 mg/10 mg once daily if additional BP lowering is needed after at least 2 wk of therapy. 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. Biliary obstructive disorders; severe hepatic impairment; cardiogenic shock. Concomitant use w/ aliskiren in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m²). Pregnancy (2nd & 3rd trimesters) & lactation.

Renovascular HTN; increased risk of severe hypotension & renal insufficiency in patients w/ bilateral renal artery stenosis or stenosis of artery to single functioning kidney on medicinal products that affect renin-angiotensin-aldosterone system. Recent kidney transplant. Periodic monitoring of K & creatinine serum levels. Not dialyzable. Intravascular hypovolemia; symptomatic hypotension in patients who are vol &/or Na depleted by eg, vigorous diuretic therapy, dietary salt restriction, diarrhea, or vomiting. Dual blockade of renin-angiotensin-aldosterone system. Patients w/ severe CHF or underlying renal disease. Not recommended in patients w/ primary aldosteronism. Patients suffering from aortic or mitral valve stenosis, or obstructive hypertrophic cardiomyopathy. Unstable angina pectoris, acute MI. Pulmonary edema in worsening heart failure. Monitoring of serum K in patients at risk of hyperkalemia especially in presence of renal impairment &/or heart failure. Concomitant use w/ K-sparing diuretics, K supplements, salt substitutes containing K, or other medicinal products that may increase K level (eg, heparin). Increased risk of fatal MI & unexpected CV death in diabetic patients w/ additional CV risk ie, DM & coexistent CAD. Excessive reduction of BP in patients w/ ischemic cardiopathy or CV disease. Avoid potentially hazardous tasks eg, driving or operating machinery if patients experience syncope, somnolence, dizziness, or vertigo during treatment. Hepatic & renal impairment. Not recommended for ped patients <18 yr. Telmisartan: Not recommended during 1st trimester of pregnancy & not to be initiated during pregnancy. Amlodipine: Risk of prolonged delivery.

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 edema, asthenia, chest pain, fatigue, edema, malaise; increased hepatic enzymes & blood uric acid.

Increased BP lowering effect w/ other antihypertensive medicinal products. May potentiate hypotensive effects w/ baclofen, amifostine. Orthostatic hypotension may be aggravated by alcohol, barbiturates, narcotics, or antidepressants. Reduction of antihypertensive effect w/ corticosteroids (systemic route). Telmisartan: May increase hypotensive effect of other antihypertensive agents. Increase in median plasma digoxin trough conc. Increased AUC_0-24 & C_max of ramipril & ramiprilat. Reversible increases in serum lithium conc & toxicity. Potential for acute renal insufficiency in patients who are dehydrated w/ NSAIDs (ie, ASA at anti-inflammatory dosage regimens, COX-2 inhibitors & non-selective NSAIDs). Reduced effect by inhibition of vasodilating prostaglandins w/ NSAIDs. Amlodipine: Bioavailability may be increased resulting in increased BP lowering effects w/ grapefruit & grapefruit juice. Inhibited metabolism, increased plasma conc & effect w/ diltiazem. May increase plasma conc w/ potent CYP3A4 inhibitors (ie, ketoconazole, itraconazole, ritonavir). Reduced plasma conc w/ CYP3A4 inducers (eg, carbamazepine, phenobarb, phenytoin, phosphenytoin, primidone, rifampicin, Hypericum perforatum). Increase in exposure to simvastatin. May increase 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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