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.
MIMS Class
Angiotensin II Antagonists / Calcium Antagonists
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 40/5 mg tab
Packing/Price
30's
Form
Twynsta 80/10 mg tab
Packing/Price
30's
Form
Twynsta 80/5 mg tab
Packing/Price
30's
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