Twynsta

Twynsta

telmisartan + amlodipine

Manufacturer:

Boehringer Ingelheim

Distributor:

DKSH
Concise Prescribing Info
Contents
Per 40/5 mg tab Telmisartan 40 mg, amlodipine 5 mg. Per 40/10 mg tab Telmisartan 40 mg, amlodipine 10 mg. Per 80/5 mg tab Telmisartan 80 mg, amlodipine 5 mg. Per 80/10 mg tab Telmisartan 80 mg, amlodipine 10 mg
Dosage/Direction for Use
Adult Max: 80/10 mg once daily. Replacement therapy 1 tab once daily. Add-on therapy in patient whose BP is inadequately controlled w/ amlodipine or telmisartan alone 40/5 mg once daily. Initial therapy 40/5 mg once daily. Patient requiring larger BP reduction Initially 80/5 mg once daily, may be titrated up to max: 80/10 mg once daily if additional BP lowering is needed after at least 2 wk of therapy. Mild to moderate hepatic impairment Not to exceed telmisartan 40 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to telmisartan, amlodipine & dihydropyridine derivatives. Biliary obstructive disorders, severe hypotension, cardiogenic shock, left ventricle outflow tract obstruction, 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). Severe hepatic impairment. 2nd & 3rd trimesters of pregnancy. Lactation.
Special Precautions
Not recommended in primary aldosteronism & dual blockade of the renin-angiotensin-aldosterone system. Bilateral renal artery stenosis or artery stenosis to single functioning kidney; severe CHF or underlying renal disease including renal artery stenosis; aortic or mitral valve stenosis, obstructive hypertrophic cardiomyopathy; unstable angina pectoris, acute MI; hyperkalaemia; intercurrent events; ischaemic cardiopathy or CV disease. Patients w/ NYHA III & IV heart failure of nonischaemic aetiology; DM & coexistent CAD; biliary obstructive disorders. Correct vol &/or Na depletion prior to administration. Concomitant use of K supplements, K-containing salt substitutes, K-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, NSAIDs, heparin, immunosuppressives, trimethoprim. Fructose intolerance. Periodic monitoring of K & creatinine serum levels. May affect ability to drive & use machines. Hepatic & renal impairment or haemodialysis. Not recommended during 1st trimester of pregnancy. Not to be initiated during pregnancy. Not recommended in childn <18 yr & elderly ≥75 yr.
Adverse Reactions
Drug Interactions
Increased BP-lowering effect by other antihypertensive agents. Potentiated hypotensive effects by baclofen, amifostine. Aggravated orthostatic hypotension by alcohol, barbiturates, narcotics or antidepressants. Reduced antihypertensive effect w/ systemic corticosteroids. Telmisartan: Increased median plasma digoxin trough conc. Increased AUC & Cmax of ramipril & ramiprilat. Increased serum lithium conc & toxicity. Reduced antihypertensive effect w/ NSAIDs. Amlodipine: Increased BP-lowering effects w/ grapefruit & grapefruit juice. Increased risk of hypotension w/ strong or moderate CYP3A4 inhibitors eg, PIs, azole antifungals, erythromycin or clarithromycin, verapamil, diltiazem. Varied plasma conc w/ strong CYP3A4 inducers eg, rifampicin, Hypericum perforatum. Increased tacrolimus blood levels. Increased trough conc of cyclosporine in renal transplant patients. Increased exposure of simvastatin, mTOR inhibitors.
ATC Classification
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.
Presentation/Packing
Form
Twynsta 40/10 mg tab
Packing/Price
30's
Form
Twynsta 80/10 mg tab
Packing/Price
30's
Form
Twynsta 40/5 mg tab
Packing/Price
30's
Form
Twynsta 80/5 mg tab
Packing/Price
30's
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