Generic Name and Formulations:
Telmisartan, amlodipine; 40mg/5mg, 40mg/10mg, 80mg/5mg, 80mg/10mg; tabs.
Boehringer Ingelheim Pharmaceuticals
Indications for TWYNSTA:
Hypertension, as monotherapy or with other antihypertensives. As initial therapy in patients likely to need multiple drugs to achieve blood pressure goals.
Take once daily. Initial therapy: 40/5mg or 80/5mg; may titrate at 2-week intervals to max 80/10mg. Add-on therapy: may be used if not controlled on monotherapy; if dose-limiting adverse reactions with amlodipine 10mg, switch to 40/5mg tab. Replacement therapy: may be substituted for the titrated components. Severe renal impairment: titrate slower. ≥75yrs, or hepatic impairment: not for initial use (initially use amlodipine alone, or add amlodipine 2.5mg to telmisartan; titrate slowly).
Concomitant aliskiren in patients with diabetes.
Fetal toxicity may develop; discontinue if pregnancy is detected. Salt/volume depletion; correct before starting therapy or monitor closely. Severe CHF. Severe aortic stenosis. Biliary obstruction. Hepatic or severe renal dysfunction. Renal artery stenosis. Severe obstructive coronary disease. Monitor BP, electrolytes and renal function. Neonates. Pregnancy; avoid. Nursing mothers: not recommended.
See Contraindications. Dual inhibition of the renin-angiotensin system with ARBs, ACEIs, or aliskiren may increase risk of hypotension, hyperkalemia, renal function changes; avoid. Avoid concomitant aliskiren in renal impairment (CrCl <60mL/min). May be antagonized by, and renal toxicity potentiated by NSAIDs (including COX-2 inhibitors): monitor renal function in elderly and/or volume-depleted. Hyperkalemia with K+ supplements, K+ sparing diuretics, K+ containing salt supplements. May potentiate digoxin, lithium, immunosuppressants (eg, cyclosporine, tacrolimus); monitor levels. Concomitant simvastatin: max simvastatin dose 20mg/day. May be potentiated by strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir); monitor.
Angiotensin II receptor blocker (ARB) + calcium channel blocker (CCB).
Peripheral edema, dizziness, orthostatic hypotension, back pain.