TWYNSTA(telmisartan/amlodipine)Tablets
TWYNSTA Rx
Generic Name and Formulations:
Telmisartan, amlodipine; 40mg/5mg, 40mg/10mg, 80mg/5mg, 80mg/10mg; tabs.
Company:
Boehringer Ingelheim Pharmaceuticals

Select therapeutic use: Hypertension
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.

Adult:
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. Renal and/or hepatic impairment: titrate slower. ≥75yrs, or hepatic impairment: not for initial use (initially use amlodipine alone, or add amlodipine 2.5mg to telmisartan).

Children:
Not established.

Contraindications:
Concomitant aliskiren in patients with diabetes.

Warnings/Precautions:
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 (Cat.D); avoid. Nursing mothers: not recommended.

Interactions:
See Contraindications. Concomitant ramipril: not recommended. Dual inhibition of the renin-angiotensin system with ARBs, ACEIs, or aliskiren may increase risk of hypotension, hyperkalemia, renal function changes; monitor closely. 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.

Pharmacological Class:
Angiotensin II receptor blocker (ARB) + calcium channel blocker (CCB).

Adverse Reactions:
Peripheral edema, dizziness, orthostatic hypotension, back pain.

Generic Availability:
NO

How Supplied:
Tabs—30