Besylon Plus

Replacement therapy for essential HTN in patients receiving telmisartan & amlodipine besilate from separate tab. Add-on therapy for essential HTN in patients whose BP is not adequately controlled on telmisartan or amlodipine monotherapy. Initial therapy for essential HTN 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 Patient treated w/ amlodipine 10 mg who experiences any dose-limiting adverse reaction eg, oedema May be switched to 40 mg/5 mg once daily. Initial therapy Initially 40 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. Patient requiring larger BP reduction May be started on 80 mg/5 mg once daily. Patient w/ mild to moderate hepatic impairment Not to exceed telmisartan 40 mg once daily.

May be taken with or without food.

Hypersensitivity to telmisartan, amlodipine or dihydropyridine derivatives. Biliary obstructive disorders. Cardiogenic shock. 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.

Not recommended in primary aldosteronism. Dual blockade of the renin-angiotensin-aldosterone system by adding ACE inhibitor or aliskiren is not recommended. Increased risk of severe hypotension & renal insufficiency in patients w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure in patients whose vascular tone & renal function depend predominantly on activity of the renin-angiotensin-aldosterone system eg, patients w/ severe CHF or underlying renal disease, including renal artery stenosis. Excessive reduction of BP in patients w/ ischaemic cardiopathy or CV disease could result in MI or stroke. Patients suffering from aortic or mitral valve stenosis, or obstructive hypertrophic cardiomyopathy; cardiac failure; DM. No data in unstable angina pectoris & during or w/in 1 mth of MI. Black patients. Periodically monitor K & creatinine serum levels in patients w/ impaired renal function. Correct vol &/or Na depletion (by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting) prior to administration. Concomitant use w/ K-sparing diuretics, K supplements, K-containing salt substitutes or other medicinal products that may increase K level eg, heparin. Avoid potentially hazardous tasks eg, driving a car or operating machinery. Patients w/ hepatic impairment. No experience in patients w/ recent kidney transplant. Not recommended during the 1st trimester of pregnancy & not to be initiated during pregnancy. Not recommended in patients <18 yr.

Cystitis; depression, anxiety, insomnia; dizziness, somnolence, migraine, headache, paresthesia, syncope, peripheral neuropathy, hypoesthesia, dysgeusia, tremor; vertigo; bradycardia, palpitations; hypotension, orthostatic hypotension, flushing; cough; abdominal pain, diarrhoea, nausea, vomiting, gingival hypertrophy, dyspepsia, dry mouth; pruritus, eczema, erythema, rash; arthralgia, muscle spasms (cramps in legs), myalgia, back pain, pain in extremity (leg pain); nocturia; erectile dysfunction; peripheral edema, asthenia (weakness), chest pain, fatigue, edema, malaise; increased hepatic enzymes & blood uric acid.

Increased BP-lowering effect w/ other antihypertensives. Hypotensive effects may be potentiated w/ baclofen, amifostine. Orthostatic hypotension may be aggravated by alcohol, barbiturates, narcotics, or antidepressants. Reduced antihypertensive effect w/ systemic corticosteroids. Telmisartan: May increase hypotensive effect of other antihypertensives. Increased median plasma trough conc of digoxin. Reversible increases in serum lithium conc & toxicity. Potential acute renal insufficiency in dehydrated patients & reduced antihypertensive effect w/ NSAIDs. Amlodipine: Bioavailability may be increased w/ grapefruit. Inhibited metabolism w/ diltiazem (CYP3A4 inhibitor). Plasma conc may be increased w/ more potent CYP3A4 inhibitors eg, ketoconazole, itraconazole, ritonavir. Plasma conc may be reduced w/ CYP3A4 inducers eg, anticonvulsants (eg, carbamazepine, phenobarb, phenytoin, phosphenytoin, primidone), rifampicin, Hypericum perforatum. Increased exposure to simvastatin. May increase systemic exposure of 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.

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