Classes
DEA Class; Rx
Common Brand Names; Twynsta
- ARB/CCB Combos;
- Antianginal Agents;
- Calcium Channel Blockers, Dihydropyridine
Description
Angiotensin II antagonist (telmisartan) combined with dihydropyridine calcium-channel blocker (amlodipine) for treatment of hypertension.
Indications
Indicated for treatment of hypertension
Contraindications
Hypersensitivity
Do not coadminister with aliskiren in patients with diabetes mellitus
Adverse Effects
Peripheral edema (1-11%)
Dizziness (3%)
Orthostatic hypotension (6%)
Syncope (2%)
Back pain (2%)
Most common reported include headache, asthenia, coughing, nausea, fatigue, hypoglycemia (in patients with diabetes), and angioedema (with fatal outcome), upper respiratory tract infection; gynecomastia, jaundice and hepatic enzyme elevations, extrapyramidal disorder
Warnings
Discontinue immediately with pregnancy; increased fetal/neonatal morbidity and mortality (see Black Box Warnings)
May cause hypotension, particularly if volume or salt depleted (correct before initiating)
Symptomatic hypotension with or without syncope may occur
Titrate slowly in patients with hepatic or severe renal impairment
May increase serum creatinine or BUN in patients w/ renal artery stenosis
Monitor for hyperkalemia
Use caution in heart failure, severe aortic stenosis (amlodipine), hepatic impairment, renal artery stenosis, or hypertrophic cardiomyopathy
Dual blockade of the renin angiotensin system with ARBs, ACE inhibitors, or aliskiren associated with increased risk for hypotension, hyperkalemia, and renal function changes (including acute renal failure) compared to monotherapy
Monitor for worsening heart failure; may lead to oliguria or progressive azotemia
Initiating calcium channel blockers in patients with severe obstructive coronary artery disease may precipitate MI or increase angina
Pregnancy and Lactation
Can cause fetal harm when administered to a pregnant woman; discontinue drug when pregnancy is dectected and treat hypertension according to guidelines during pregnancy
Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death
Because of the potential for serious adverse reactions in the breastfed infant including hypotension, hyperkalemia and renal impairment, advise a nursing woman not to breastfeed during treatment with telmisartan/amlodipine
Maximum Dosage
80 mg/day PO telmisartan and 10 mg/day PO amlodipine.
80 mg/day PO telmisartan and 10 mg/day PO amlodipine.
Safe and effective use has not been established.
Safe and effective use has not been established.
How supplied
Telmisartan/amlodipine
tablet
- 40mg/5mg
- 40mg/10mg
- 80mg/5mg
- 80mg/10mg