Telmipin

Essential HTN. 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 likely to need multiple drugs to achieve BP goals.

Adult Replacement therapy Same component doses in 1 tab once daily. 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 adverse reactions eg, edema. Initial therapy Usual starting dose: 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 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). Rare hereditary conditions that may be incompatible w/ an excipient. Pregnancy (2nd & 3rd trimester) & lactation.

Risk of symptomatic hypotension, especially after 1st dose, in patients who are vol &/or Na depleted eg, vigorous diuretic therapy. Dual blockade of the renin-angiotensin-aldosterone system (RAAS) is not recommended. Not recommended in patients w/ primary aldosteronism. Caution in patients w/ aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Risk of fatal MI & unexpected CV death may be increased in DM patients w/ additional CV risk ie, patients w/ DM & CAD. Excessive BP reduction in patients w/ ischaemic cardiopathy or ischaemic CV disease could result in MI or stroke. 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/ renal impairment. Avoid potentially hazardous tasks eg, driving or operating machinery if patients experience syncope, somnolence, dizziness, or vertigo during treatment. Hepatic impairment. Stop immediately if pregnancy is diagnosed. Decision should be made whether to discontinue nursing or therapy. Not recommended for ped patients <18 yr. Telmisartan: Risk of hyperkalaemia, especially in patients w/ renal impairment &/or heart failure. Concomitant use w/ medicinal products that affect the RAAS eg, K-sparing diuretics, K supplements, salt substitutes containing K or other medicinal products that may increase K level. Amlodipine: Reports of pulmonary oedema in patients w/ NYHA III & IV heart failure of non-ischaemic aetiology. 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 oedema, asthenia, chest pain, fatigue, oedema, malaise; increased hepatic enzymes or blood uric acid.

Increased BP-lowering effect w/ other antihypertensives; agents w/ BP-lowering potential (eg, baclofen, amifostine). Aggravated orthostatic hypotension w/ alcohol, barbiturates, narcotics, or antidepressants. Reduction of antihypertensive effect w/ corticosteroids. Telmisartan: Increased hypotensive effect of other antihypertensive agents. Increased plasma trough conc of digoxin. Increased AUC_0-24 & C_max of ramipril & ramiprilat. Reversible increase in serum lithium conc & toxicity. Potential for acute renal insufficiency w/ NSAIDs in patients who are dehydrated. Amlodipine: Increased bioavailability resulting in increased BP lowering effects w/ grapefruit & grapefruit juice. Increased plasma conc w/ CYP3A4 inhibitors eg, ketoconazole, itraconazole, ritonavir. Reduced plasma conc w/ CYP3A4 inducers eg, carbamazepine, phenobarb, phenytoin, phosphenytoin, primidone, rifampicin, Hypericum perforatum. Increased exposure of simvastatin; ciclosporin or tacrolimus. Additive BP-lowering effect w/ sildenafil.

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.

Rx