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amlodipine besylate
Overview
What is Norvasc?
NORVASC is the besylate salt of amlodipine, a long-acting calcium channel blocker.
Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C
H
CIN
O
•C
H
O
S, and its structural formula is:
Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. NORVASC (amlodipine besylate) Tablets are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate.
What does Norvasc look like?
What are the available doses of Norvasc?
Tablets: 2.5 mg white, diamond, flat-faced, beveled edged, with "NORVASC" on one side and "2.5" on the other Tablets: 5 mg white, elongated octagon, flat-faced, beveled edged, with "NORVASC" on one side and "5" on the other Tablets: 10 mg white, round, flat-faced, beveled edge, with "NORVASC" on one side and "10" on the other
What should I talk to my health care provider before I take Norvasc?
How should I use Norvasc?
NORVASC
is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including NORVASC.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
NORVASC may be used alone or in combination with other antihypertensive agents.
The usual initial antihypertensive oral dose of NORVASC is 5 mg once daily, and the maximum dose is 10 mg once daily.
Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily and this dose may be used when adding NORVASC to other antihypertensive therapy.
Adjust dosage according to blood pressure goals. In general, wait 7 to 14 days between titration steps. Titrate more rapidly, however, if clinically warranted, provided the patient is assessed frequently.
What interacts with Norvasc?
Sorry No Records found
What are the warnings of Norvasc?
Sorry No Records found
What are the precautions of Norvasc?
Sorry No Records found
What are the side effects of Norvasc?
Sorry No records found
What should I look out for while using Norvasc?
NORVASC is contraindicated in patients with known sensitivity to amlodipine.
What might happen if I take too much Norvasc?
Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia. In humans, experience with intentional overdosage of NORVASC is limited.
Single oral doses of amlodipine maleate equivalent to 40 mg amlodipine/kg and 100 mg amlodipine/kg in mice and rats, respectively, caused deaths. Single oral amlodipine maleate doses equivalent to 4 or more mg amlodipine/kg or higher in dogs (11 or more times the maximum recommended human dose on a mg/m
basis) caused a marked peripheral vasodilation and hypotension.
If massive overdose should occur, initiate active cardiac and respiratory monitoring. Frequent blood pressure measurements are essential. Should hypotension occur, provide cardiovascular support including elevation of the extremities and the judicious administration of fluids. If hypotension remains unresponsive to these conservative measures, consider administration of vasopressors (such as phenylephrine) with attention to circulating volume and urine output. As NORVASC is highly protein bound, hemodialysis is not likely to be of benefit.
How should I store and handle Norvasc?
StorageStore bottles at controlled room temperature, 59° to 86°F (15° to 30°C) and dispense in tight, light-resistant containers (USP).StorageStore bottles at controlled room temperature, 59° to 86°F (15° to 30°C) and dispense in tight, light-resistant containers (USP).Atorvastatin calcium tablets of 10 mg are white to off-white, capsule shaped, biconvex, film coated tablets debossed ‘RDY’ on one side and ‘121’ on other side and are supplied in bottles of 30’s, 60’s, 90’s, 500's and 1000’s.Atorvastatin calcium tablets of 20 mg are white to off-white, capsule shaped, biconvex, film coated tablets debossed ‘RDY’ on one side and ‘122’ on other side and are supplied in bottles of 30’s, 60’s, 90’s, 500's and 1000’s.55700-548-3055700-548-90Atorvastatin calcium tablets of 40 mg are white to off-white, capsule shaped, biconvex, film coated tablets debossed ‘RDY’ on one side and ‘123’ on other side and are supplied in bottles of 30’s, 60’s, 90’s, 500's and 1000’s.Storage Store atorvastatin calcium tablets at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].Atorvastatin calcium tablets of 10 mg are white to off-white, capsule shaped, biconvex, film coated tablets debossed ‘RDY’ on one side and ‘121’ on other side and are supplied in bottles of 30’s, 60’s, 90’s, 500's and 1000’s.Atorvastatin calcium tablets of 20 mg are white to off-white, capsule shaped, biconvex, film coated tablets debossed ‘RDY’ on one side and ‘122’ on other side and are supplied in bottles of 30’s, 60’s, 90’s, 500's and 1000’s.55700-548-3055700-548-90Atorvastatin calcium tablets of 40 mg are white to off-white, capsule shaped, biconvex, film coated tablets debossed ‘RDY’ on one side and ‘123’ on other side and are supplied in bottles of 30’s, 60’s, 90’s, 500's and 1000’s.Storage Store atorvastatin calcium tablets at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].Atorvastatin calcium tablets of 10 mg are white to off-white, capsule shaped, biconvex, film coated tablets debossed ‘RDY’ on one side and ‘121’ on other side and are supplied in bottles of 30’s, 60’s, 90’s, 500's and 1000’s.Atorvastatin calcium tablets of 20 mg are white to off-white, capsule shaped, biconvex, film coated tablets debossed ‘RDY’ on one side and ‘122’ on other side and are supplied in bottles of 30’s, 60’s, 90’s, 500's and 1000’s.55700-548-3055700-548-90Atorvastatin calcium tablets of 40 mg are white to off-white, capsule shaped, biconvex, film coated tablets debossed ‘RDY’ on one side and ‘123’ on other side and are supplied in bottles of 30’s, 60’s, 90’s, 500's and 1000’s.Storage Store atorvastatin calcium tablets at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].Atorvastatin calcium tablets of 10 mg are white to off-white, capsule shaped, biconvex, film coated tablets debossed ‘RDY’ on one side and ‘121’ on other side and are supplied in bottles of 30’s, 60’s, 90’s, 500's and 1000’s.Atorvastatin calcium tablets of 20 mg are white to off-white, capsule shaped, biconvex, film coated tablets debossed ‘RDY’ on one side and ‘122’ on other side and are supplied in bottles of 30’s, 60’s, 90’s, 500's and 1000’s.55700-548-3055700-548-90Atorvastatin calcium tablets of 40 mg are white to off-white, capsule shaped, biconvex, film coated tablets debossed ‘RDY’ on one side and ‘123’ on other side and are supplied in bottles of 30’s, 60’s, 90’s, 500's and 1000’s.Storage Store atorvastatin calcium tablets at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].Atorvastatin calcium tablets of 10 mg are white to off-white, capsule shaped, biconvex, film coated tablets debossed ‘RDY’ on one side and ‘121’ on other side and are supplied in bottles of 30’s, 60’s, 90’s, 500's and 1000’s.Atorvastatin calcium tablets of 20 mg are white to off-white, capsule shaped, biconvex, film coated tablets debossed ‘RDY’ on one side and ‘122’ on other side and are supplied in bottles of 30’s, 60’s, 90’s, 500's and 1000’s.55700-548-3055700-548-90Atorvastatin calcium tablets of 40 mg are white to off-white, capsule shaped, biconvex, film coated tablets debossed ‘RDY’ on one side and ‘123’ on other side and are supplied in bottles of 30’s, 60’s, 90’s, 500's and 1000’s.Storage Store atorvastatin calcium tablets at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].Atorvastatin calcium tablets of 10 mg are white to off-white, capsule shaped, biconvex, film coated tablets debossed ‘RDY’ on one side and ‘121’ on other side and are supplied in bottles of 30’s, 60’s, 90’s, 500's and 1000’s.Atorvastatin calcium tablets of 20 mg are white to off-white, capsule shaped, biconvex, film coated tablets debossed ‘RDY’ on one side and ‘122’ on other side and are supplied in bottles of 30’s, 60’s, 90’s, 500's and 1000’s.55700-548-3055700-548-90Atorvastatin calcium tablets of 40 mg are white to off-white, capsule shaped, biconvex, film coated tablets debossed ‘RDY’ on one side and ‘123’ on other side and are supplied in bottles of 30’s, 60’s, 90’s, 500's and 1000’s.Storage Store atorvastatin calcium tablets at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].Atorvastatin calcium tablets of 10 mg are white to off-white, capsule shaped, biconvex, film coated tablets debossed ‘RDY’ on one side and ‘121’ on other side and are supplied in bottles of 30’s, 60’s, 90’s, 500's and 1000’s.Atorvastatin calcium tablets of 20 mg are white to off-white, capsule shaped, biconvex, film coated tablets debossed ‘RDY’ on one side and ‘122’ on other side and are supplied in bottles of 30’s, 60’s, 90’s, 500's and 1000’s.55700-548-3055700-548-90Atorvastatin calcium tablets of 40 mg are white to off-white, capsule shaped, biconvex, film coated tablets debossed ‘RDY’ on one side and ‘123’ on other side and are supplied in bottles of 30’s, 60’s, 90’s, 500's and 1000’s.Storage Store atorvastatin calcium tablets at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow-channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Experimental data suggest that amlodipine binds to both dihydropyridine and nondihydropyridine binding sites. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. Amlodipine inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Negative inotropic effects can be detected
but such effects have not been seen in intact animals at therapeutic doses. Serum calcium concentration is not affected by amlodipine. Within the physiologic pH range, amlodipine is an ionized compound (pKa=8.6), and its kinetic interaction with the calcium channel receptor is characterized by a gradual rate of association and dissociation with the receptor binding site, resulting in a gradual onset of effect.
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.
The precise mechanisms by which amlodipine relieves angina have not been fully delineated, but are thought to include the following:
Non-Clinical Toxicology
NORVASC is contraindicated in patients with known sensitivity to amlodipine.Concomitant administration of vancomycin and anesthetic agents has been associated with erythema and histamine-like flushing (see ) and anaphylactoid reactions (see ).
Monitor renal function in patients receiving vancomycin and concurrent and/or sequential systemic or topical use of other potentially neurotoxic and/or nephrotoxic drugs, such as amphotericin B, aminoglycosides, bacitracin, polymixin B, colistin, viomycin, or cisplatin.
Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension is unlikely.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Interactions
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