AMLODIPINE BESYLATE- amlodipine besylate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)

Available from:

St Marys Medical Park Pharmacy

INN (International Name):

AMLODIPINE BESYLATE

Composition:

AMLODIPINE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Amlodipine Besylate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Chronic Stable Angina Amlodipine besylate tablets are indicated for the symptomatic treatment of chronic stable angina. They may be used alone or in combination with other antianginal agents. Vasospastic Angina (Prinzmetal's or Variant Angina) Amlodipine Besylate tablets are indicated for the treatment of confirmed or suspected vasospastic angina. They may be used as monotherapy or in combination with other antianginal drugs. Angiographically Documented CAD In patients with recently documented CAD by angiography and without heart failure or an ejection fraction <40%, amlodipine besylate tablets are indicated to reduce the risk of hospitalization due to angina and to reduce the risk of a coronary revascularization procedure. Amlodipine besylate tablets are contraindicated in patients with known sensitivity to amlodipine.

Product summary:

Amlodipine besylate–10 mg Tablets (amlodipine besylate, USP equivalent to 10 mg of amlodipine per tablet) are supplied as white, round, flat-faced, beveled edged tablets debossed with IG on one side and 239 on the other and supplied as follows: NDC: 60760-0239-30 bottles of 30 NDC: 60760-0239-90 bottles of 90 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMLODIPINE BESYLATE- AMLODIPINE BESYLATE TABLET
ST MARYS MEDICAL PARK PHARMACY
----------
AMLODIPINE BESYLATE TABLETS
RX ONLY
DESCRIPTION
Amlodipine besylate, USP is a long-acting calcium channel blocker.
Amlodipine besylate, USP 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 molecular formula is C
H CIN O •C H O S, and its structural formula
is:
Amlodipine besylate, USP is a white crystalline powder with a
molecular weight of 567.1. It is slightly
soluble in water and sparingly soluble in ethanol. 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, USP, each tablet contains the
following inactive ingredients:
microcrystalline cellulose, dibasic calcium phosphate anhydrous,
sodium starch glycolate, and
magnesium stearate.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
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 _in vitro_ 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 ra