DESCRIPTION

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displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Amlodipine besylate 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 molecular formula is C20H25ClN2O5•C6H6O3S, 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. 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: dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.

INDICATIONS AND USAGE

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displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

1. Hypertension: Amlodipine Besylate Tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.2. Coronary Artery Disease (CAD): Chronic Stable Angina: Amlodipine Besylate Tablets are indicated for the symptomatic treatment of chronic stable angina. Amlodipine Besylate Tablets 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. Amlodipine Besylate Tablets may be used as monotherapy or in combination with other antianginal drugs.

CONTRAINDICATIONS

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displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Amlodipine Besylate Tablets are contraindicated in patients with known sensitivity to amlodipine.

ADVERSE REACTIONS

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displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

Amlodipine has been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials. In general, treatment with amlodipine was well-tolerated at doses up to 10 mg daily. Most adverse reactions reported during therapy with amlodipine were of mild or moderate severity. In controlled clinical trials directly comparing amlodipine (N=1730) in doses up to 10 mg to placebo (N=1250), discontinuation of amlodipine due to adverse reactions was required in only about 1.5% of patients and was not significantly different from placebo (about 1%). The most common side effects are headache and edema. The incidence (%) of side effects which occurred in a dose related manner are as follows:

Other adverse experiences which were not clearly dose related but which were reported with an incidence greater than 1% in placebo-controlled clinical trials include the following:Placebo-Controlled Studies

For several adverse experiences that appear to be drug and dose related, there was a greater incidence in women than men associated with amlodipine treatment as shown in the following table:

The following events occurred in <1% but >0.1% of patients in controlled clinical trials or under conditions of open trials or marketing experience where a causal relationship is uncertain; they are listed to alert the physician to a possible relationship:Cardiovascular: arrhythmia (including ventricular tachycardia and atrial fibrilla tion), bradycardia, chest pain, hypotension, peripheral ischemia, syncope, tachycardia, postural dizziness, postural hypotension, vasculitis.Central and Peripheral Nervous System: hypoesthesia, neuropathy peripheral, paresthesia, tremor, vertigo.Gastrointestinal: anorexia, constipation, dyspepsia,** dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia.General: allergic reaction, asthenia,** back pain, hot flushes, malaise,pain, rigors, weight gain, weight decrease.Musculoskeletal System: arthralgia, arthrosis, muscle cramps, **myalgia.Psychiatric: sexual dysfunction (male** and female), insomnia, nervousness, depression, abnormal dreams, anxiety, depersonalization.Respiratory System: dyspnea,**epistaxis.Skin and Appendages: angioedema, erythema multiforme, pruritus, **rash, ** rash erythematous, rash maculopapular. **These events occurred in less than 1% in placebo-controlled trials, but the incidence of these side effects was between 1% and 2% in all multiple dose studies.Special Senses: abnormal vision, conjunctivitis, diplopia, eye pain, tinnitus.Urinary System: micturition frequency, micturition disorder, nocturia.Autonomic Nervous System: dry mouth, sweating increased.Metabolic and Nutritional: hyperglycemia, thirst.Hemopoietic: leukopenia, purpura, thrombocytopeniaThe following events occurred in <0.1% of patients: cardiac failure, pulse irregularity, extrasystoles, skin discoloration, urticaria, skin dryness, alopecia, dermatitis, muscle weakness, twitching, ataxia, hypertonia, migraine, cold and clammy skin, apathy, agitation, amnesia, gastritis, increased appetite, loose stools, coughing, rhinitis, dysuria, polyuria, parosmia, taste perversion, abnormal visual accommodation, and xerophthalmia.Other reactions occurred sporadically and cannot be distinguished from medications or concurrent disease states such as myocardial infarction and angina.Amlodipine therapy has not been associated with clinically significant changes in routine laboratory tests. No clinically relevant changes were noted in serum potassium, serum glucose, total triglycerides, total cholesterol, HDL cholesterol, uric acid, blood urea nitrogen, or creatinine.The following postmarketing event has been reported infrequently where a causal relationship is uncertain: gynecomastia. In postmarketing experience, jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis) in some cases severe enough to require hospitalization have been reported in association with use of amlodipine.Amlodipine has been used safely in patients with chronic obstructive pulmonary disease, well-compensated congestive heart failure, coronary artery disease, peripheral vascular disease, diabetes mellitus, and abnormal lipid profiles.

HOW SUPPLIED

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displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Amlodipine Besylate Tablets are supplied as white, round, biconvex tablets. The 2.5 mg tablets are debossed with product identification “54 513” on one side and plain on the other side. The 5 mg tablets are debossed with product identification “54 771” on one side and plain on the other side. The 10 mg tablets are debossed with product identification “54 233” on one side and plain on the other side.They are supplied by State of Florida DOH Central Pharmacy as follows:

Storage

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displayName: STORAGE AND HANDLING SECTION
FDA Article Code: 44425-7

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].1 MAALOX® is a registered trademark of Novartis Pharmaceuticals Corporation.2 Viagra® is a registered trademark of Pfizer, Inc.Roxane Laboratories, Inc.Columbus, Ohio 43216 This Product was Repackaged By:State of Florida DOH Central Pharmacy

104-2 Hamilton Park Drive
Tallahassee, FL 32304
United States

SUMMARY OF INFORMATION ABOUT AMLODIPINE BESYLATE TABLETS

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displayName: SPL PATIENT PACKAGE INSERT SECTION
FDA Article Code: 42230-3

Read this information carefully before you start amlodipine besylateand each time you refill your prescription.There may be new information. This information does not replace talkingwith your doctor. If you have any questions about amlodipine besylate,ask your doctor. Your doctor will know if amlodipine besylate is right for you.

Label Image for 10mg

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displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4