Amtera-BP

Amtera-BP

telmisartan + amlodipine

Manufacturer:

Evertogen

Distributor:

HLM Pharma
Concise Prescribing Info
Contents
Per 40 mg/10 mg tab Telmisartan 40 mg, amlodipine 10 mg
Indications/Uses
HTN, alone or w/ other antihypertensive agents. Initial therapy in patients who are likely to need multiple drugs to achieve BP goals.
Dosage/Direction for Use
Individualized dosage. Effective dose: Telmisartan 20-80 mg once daily, amlodipine 2.5-10 mg. May be increased after at least 2 wk. Max: 80/10 mg once daily. Patient receiving amlodipine & telmisartan from separate tab Same component doses in 1 tab once daily. Patient treated w/ amlodipine 10 mg who experiences any dose-limiting adverse reactions eg, edema & patient whose BP is unlikely to be controlled w/ a single agent 40/5 mg once daily. Patient requiring larger BP reduction May be started on 80/5 mg once daily.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Correct imbalances of intravascular vol- or salt-depletion before initiating therapy, or start treatment under close medical supervision w/ reduced dose. Initial therapy w/ telmisartan + amlodipine is not recommended in patients w/ hepatic impairment or elderly ≥75 yr. Titrate slowly in patients w/ hepatic impairment, patients w/ severe renal impairment, & elderly ≥75 yr. Discontinue treatment as soon as possible when pregnancy is detected. Closely observe infants w/ histories of in utero exposure to telmisartan + amlodipine for hypotension, oliguria & hyperkalemia. Discontinue nursing during treatment. Telmisartan: Hyperkalemia may occur, particularly in patients w/ advanced renal impairment, heart failure, on renal replacement therapy or K supplements, K-sparing diuretics, K-containing salt substitutes or other drugs that increase K levels. Patients w/ biliary obstructive disorders or hepatic insufficiency can be expected to have reduced clearance. Anticipate changes in renal function in susceptible individuals. Closely monitor renal function in dual blockade of the renin angiotensin-aldosterone system (eg, by adding an ACE inhibitor to AIIA). Concomitant use w/ ramipril is not recommended. Amlodipine: Closely observe patients w/ severe aortic stenosis. Risk of MI or increased angina, particularly in patients w/ severe obstructive CAD. Closely monitor patients w/ heart failure. Reports of pulmonary edema. Decreased clearance in patients w/ hepatic impairment.
Adverse Reactions
Peripheral edema, dizziness, back pain, edema, hypotension.
Drug Interactions
Telmisartan: Increased digoxin peak plasma conc & trough conc. Reversible increases in serum lithium conc & toxicity. May result in renal function deterioration, including possible acute renal failure, w/ NSAIDs including selective COX-2 inhibitors in patients who are elderly, vol-depleted, or w/ compromised renal function. Attenuated hypertensive effects w/ NSAIDs including selective COX-2 inhibitors. Increased Cmax & AUC of ramipril & ramiprilat. Decreased Cmax & AUC, & possible additive pharmacodynamic effects w/ ramipril & ramiprilat. Amlodipine: Increased exposure to simvastatin.
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
Amtera-BP 40 mg/10 mg tab
Packing/Price
30's