Generic Name

Telmisartan + Amlodipine

Precaution

May increase frequency and/or severity of angina during treatment initiation or dosage increments. Heart failure or hepatic impairment. Avoid fetal or neonatal exposure Hypotension: Correct any volume or salt depletion before initiating therapy. Observe for signs and symptoms of hypotension. Titrate slowly in patients with hepatic or severe renal impairment Heart failure: Monitor for worsening Avoid concomitant use of an ACE inhibitor and angiotensin receptor blocker Myocardial infarction: Uncommonly, initiating a CCB in patients with severe obstructive coronary artery disease may precipitate myocardial infarction or increased angina Lactation: Discontinue drug or do not breast feed

Indication

Treatment of hypertension, alone or with other anti-hypertensive agents. It may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.

Contra Indication

Known hypersensitivity to this product or any of its components. Pregnancy & lactation. Biliary obstructive disorders, severe hepatic impairment, hypotension, cardiogenic shock, left ventricle outflow tract obstruction.

Dose

N/A

Side Effect

>10% Peripheral edema (1-11%) 1-10% Dizziness (3%),Orthostatic hypotension (6%),Syncope (2%),Back pain (2%)

Pregnancy Category

Mode of Action

Telmisartan, a non-peptide angiotensin receptor blocker (ARB), is specific angiotensin II antagonist acting on the AT1 subtype. Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium, which leads to an increase in blood pressure (hypertension). Telmisartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Therefore, Telmisartan dilates blood vessels and reduces blood pressure without affecting pulse rate. Telmisartan has much greater affinity (>3,000 fold) for the AT1 receptor than for the AT2 receptor. It does not bind or block other hormone receptors or ion channels known to be important in cardiovascular regulation. Amlodipine, a dihydropyridine calcium-channel blocker (CCB), inhibits the transmembrane influx of calcium ion into vascular smooth muscle and cardiac muscle. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.

Interaction

Amlodipine relaxes peripheral and coronary vascular smooth muscle. It produces coronary vasodilation by inhibiting the entry of Ca ions into the slow channels or select voltage-sensitive channels of the vascular smooth muscle and myocardium during depolarisation. It also increases myocardial oxygen delivery in patients w/ vasospastic angina.

Pregnancy Category Note

Pregnancy 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 Reports of hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death owing to olihydramnios Oligohydramnios in this setting has also been associated with fetal limb contractures, craniofacial deformation, and hypoplastic lung development Lactation 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 There is no information regarding the presence of telmisartan in human milk, the effects on the breastfed infant, or the effects on milk production Limited published studies report that amlodipine is present in human milk; however, there is insufficient information to determine the effects of amlodipine on the breastfed infant

Adult Dose

Hypertension Initial Therapy: Patient may be initiated on Telmisartan/Amlodipine tablets if it is unlikely that control of blood pressure would be achieved with a single agent. The usual starting dose is 40/5 mg once daily. Patients requiring larger blood pressure reductions may be started with 80/5 mg once daily. OR Substitute for individually titrated components May increase dose after at least 2 weeks, not to exceed 80 mg/10 mg qDay Dosage range: Telmisartan 20-80 mg/amlodipine 2.5-10 mg PO qDay Initial therapy with Telmisartan/Amlodipine is not recommended in patients ?75 years old or with hepatic impairment. Hepatic Impairment Severe impairment: Titrate slowly; dose adjustment not recommended May be administered concomitantly with other anti-hypertensive agents

Child Dose

N/A

Renal Dose

Mild to moderate impairment: Dose adjustment not recommended

Administration

May be taken with or without food.