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Amlodipine r07-0

InvaGen Amlodipine Besylate Tablets Rev. 07-07 Flat Size 7.75 x 11 Fold Size 1.125 x 1.125 Type 5 pt. 08-13-07 TP Amlodipine Besylate Tablets
12/6 mmHg in the standing position and 13/7 mmHg in the supine position in patients with mild tomoderate hypertension. Maintenance of the blood pressure effect over the 24-hour dosing interval was observed, with little difference in peak and trough effect. Tolerance was not demonstrated inpatients studied for up to 1 year. The 3 parallel, fixed dose, dose response studies showed that the DESCRIPTION
reduction in supine and standing blood pressures was dose-related within the recommended dosing Amlodipine besylate, USP is a long-acting calcium channel blocker.
range. Effects on diastolic pressure were similar in young and older patients. The effect on systolic Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]- pressure was greater in older patients, perhaps because of greater baseline systolic pressure.
4-(2-chlorophenyl)- 1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its Effects were similar in black patients and in white patients.
molecular formula is C20H25CIN2O5•C6H6O3S, and its structural formula is: Pediatric Patients: Two-hundred sixty-eight hypertensive patients aged 6 to 17 years wererandomized first to amlodipine besylate 2.5 or 5 mg once daily for 4 weeks and then randomizedagain to the same dose or to placebo for another 4 weeks. Patients receiving 5 mg at the end of 8weeks had lower blood pressure than those secondarily randomized to placebo. The magnitude of the treatment effect is difficult to interpret, but it is probably less than 5 mmHg systolic on the 5 mgdose. Adverse events were similar to those seen in adults.
Effects in Chronic Stable Angina:The effectiveness of 5 to 10 mg/day of amlodipine besylate in exercise-induced angina has been evaluated in 8 placebo-controlled, double-blind clinical trials of up to 6 weeks duration involving 1038 patients (684 amlodipine besylate, 354 placebo) with chronic stable angina. In 5 of the 8 studies significant increases in exercise time (bicycle or treadmill) were seen with the 10 mg dose. Increasesin symptom-limited exercise time averaged 12.8% (63 sec) for amlodipine besylate 10 mg, andaveraged 7.9% (38 sec) for amlodipine besylate 5 mg. Amlodipine besylate 10 mg also increasedtime to 1 mm ST segment deviation in several studies and decreased angina attack rate. The sustained efficacy of amlodipine besylate in angina patients has been demonstrated over long-term dosing. In patients with angina there were no clinically significant reductions in blood pressures(4/1 mmHg) or changes in heart rate (+0.3 bpm).
In a double-blind, placebo-controlled clinical trial of 4 weeks duration in 50 patients, amlodipine besylate therapy decreased attacks by approximately 4/week compared with a placebo decrease of approximately 1/week (p<0.01). Two of 23 amlodipine besylate and 7 of 27 placebo patients Amlodipine besylate, USP is a white crystalline powder with a molecular weight of 567.1. It is slightly discontinued from the study due to lack of clinical improvement.
soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets are formulated as Studies in Patients with Congestive Heart Failure: white tablets equivalent to 2.5, 5 and 10 mg of amlodipine for oral administration. In addition to the Amlodipine besylate has been compared to placebo in four 8-12 week studies of patients with NYHA active ingredient, amlodipine besylate, USP, each tablet contains the following inactive ingredients: class II/III heart failure, involving a total of 697 patients. In these studies, there was no evidence of microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and worsened heart failure based on measures of exercise tolerance, NYHA classification, symptoms, or left ventricular ejection fraction. In a long-term (follow-up at least 6 months, mean 13.8 months) CLINICAL PHARMACOLOGY
placebo-controlled mortality/morbidity study of amlodipine besylate 5 to 10 mg in 1153 patients with Mechanism of Action
NYHA classes III (n=931) or IV (n=222) heart failure on stable doses of diuretics, digoxin, and ACE Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow-channel blocker) inhibitors, amlodipine besylate had no effect on the primary endpoint of the study which was the that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac combined endpoint of all-cause mortality and cardiac morbidity (as defined by life-threatening muscle. Experimental data suggest that amlodipine binds to both dihydropyridine and arrhythmia, acute myocardial infarction, or hospitalization for worsened heart failure), or on NYHA nondihydropyridine binding sites. The contractile processes of cardiac muscle and vascular smooth classification, or symptoms of heart failure. Total combined all-cause mortality and cardiac morbidity muscle are dependent upon the movement of extracellular calcium ions into these cells through events were 222/571 (39%) for patients on amlodipine besylate and 246/583 (42%) for patients on specific ion channels. Amlodipine inhibits calcium ion influx across cell membranes selectively, with placebo; the cardiac morbid events represented about 25% of the endpoints in the study.
a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Negative inotropic Another study (PRAISE-2) randomized patients with NYHA class III (80%) or IV (20%) heart failure effects can be detected in vitro but such effects have not been seen in intact animals at therapeutic without clinical symptoms or objective evidence of underlying ischemic disease, on stable doses of doses. Serum calcium concentration is not affected by amlodipine. Within the physiologic pH range, ACE inhibitor (99%), digitalis (99%) and diuretics (99%), to placebo (n=827) or amlodipine besylate amlodipine is an ionized compound (pKa=8.6), and its kinetic interaction with the calcium channel (n=827) and followed them for a mean of 33 months. There was no statistically significant difference receptor is characterized by a gradual rate of association and dissociation with the receptor binding between amlodipine besylate and placebo in the primary endpoint of all cause mortality (95% site, resulting in a gradual onset of effect.
confidence limits from 8% reduction to 29% increase on amlodipine besylate). With amlodipine Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause besylate there were more reports of pulmonary edema.
a reduction in peripheral vascular resistance and reduction in blood pressure.
INDICATIONS AND USAGE
The precise mechanisms by which amlodipine relieves angina have not been fully delineated, but 1. Hypertension
Amlodipine besylate is indicated for the treatment of hypertension. It may be used alone or in Exertional Angina: In patients with exertional angina, amlodipine besylate reduces the total combination with other antihypertensive agents.
peripheral resistance (afterload) against which the heart works and reduces the rate pressure 2. Coronary Artery Disease
product, and thus myocardial oxygen demand, at any given level of exercise.
Vasospastic Angina: Amlodipine besylate has been demonstrated to block constriction and restore Amlodipine besylate is indicated for the symptomatic treatment of chronic stable angina. Amlodipine blood flow in coronary arteries and arterioles in response to calcium, potassium epinephrine, besylate may be used alone or in combination with other antianginal agents.
serotonin, and thromboxane A2 analog in experimental animal models and in human coronary Vasospastic Angina (Prinzmetal’s or Variant Angina) vessels in vitro. This inhibition of coronary spasm is responsible for the effectiveness of amlodipine Amlodipine besylate is indicated for the treatment of confirmed or suspected vasospastic angina.
besylate in vasospastic (Prinzmetal’s or variant) angina.
Amlodipine besylate may be used as monotherapy or in combination with other antianginal drugs.
Pharmacokinetics and Metabolism
CONTRAINDICATIONS
After oral administration of therapeutic doses of amlodipine besylate, absorption produces peak Amlodipine besylate is contraindicated in patients with known sensitivity to amlodipine.
plasma concentrations between 6 and 12 hours. Absolute bioavailability has been estimated to bebetween 64 and 90%. The bioavailability of amlodipine besylate is not altered by the presence of WARNINGS
Increased Angina and/or Myocardial Infarction: Rarely, patients, particularly those with severe
obstructive coronary artery disease, have developed documented increased frequency, duration
Amlodipine is extensively (about 90%) converted to inactive metabolites via hepatic metabolism with and/or severity of angina or acute myocardial infarction on starting calcium channel blocker therapy 10% of the parent compound and 60% of the metabolites excreted in the urine. Ex vivo studies have or at the time of dosage increase. The mechanism of this effect has not been elucidated.
shown that approximately 93% of the circulating drug is bound to plasma proteins in hypertensive F0102nL D Ym91 0VR2 os00dZABGW445 kZnhXIgPmUHJlc patients. Elimination from the plasma is biphasic with a terminal elimination half-life of about PRECAUTIONS
30-50 hours. Steady-state plasma levels of amlodipine are reached after 7 to 8 days of consecutive General: Since the vasodilation induced by amlodipine besylate is gradual in onset, acute
hypotension has rarely been reported after oral administration. Nonetheless, caution as with any The pharmacokinetics of amlodipine are not significantly influenced by renal impairment. Patients other peripheral vasodilator, should be exercised when administering amlodipine besylate, with renal failure may therefore receive the usual initial dose.
particularly in patients with severe aortic stenosis.
Elderly patients and patients with hepatic insufficiency have decreased clearance of amlodipine with Use in Patients with Congestive Heart Failure: In general, calcium channel blockers should be
a resulting increase in AUC of approximately 40-60%, and a lower initial dose may be required. A used with caution in patients with heart failure. Amlodipine besylate (5 to 10 mg per day) has been similar increase in AUC was observed in patients with moderate to severe heart failure.
studied in a placebo-controlled trial of 1153 patients with NYHA Class III or IV heart failure (seeCLINICAL PHARMACOLOGY) on stable doses of ACE inhibitor, digoxin, and diuretics. Follow-up Pediatric Patients
was at least 6 months, with a mean of about 14 months. There was no overall adverse effect on Sixty-two hypertensive patients aged 6 to 17 years received doses of amlodipine besylate between survival or cardiac morbidity (as defined by life-threatening arrhythmia, acute myocardial infarction, 1.25 mg and 20 mg. Weight-adjusted clearance and volume of distribution were similar to values in or hospitalization for worsened heart failure). Amlodipine besylate has been compared to placebo in Amlodipine
four 8-12 week studies of patients with NYHA class II/III heart failure, involving a total of 697 patients.
Besylate
Pharmacodynamics
In these studies, there was no evidence of worsened heart failure based on measures of exercise Hemodynamics: Following administration of therapeutic doses to patients with hypertension, tolerance, NYHA classification, symptoms, or LVEF.
amlodipine besylate produces vasodilation resulting in a reduction of supine and standing blood Beta-Blocker Withdrawal: Amlodipine besylate is not a beta-blocker and therefore gives no
pressures. These decreases in blood pressure are not accompanied by a significant change in heart protection against the dangers of abrupt beta-blocker withdrawal; any such withdrawal should be by rate or plasma catecholamine levels with chronic dosing. Although the acute intravenous gradual reduction of the dose of beta-blocker.
administration of amlodipine decreases arterial blood pressure and increases heart rate inhemodynamic studies of patients with chronic stable angina, chronic oral administration of Patients with Hepatic Failure: Since amlodipine besylate is extensively metabolized by the liver
amlodipine in clinical trials did not lead to clinically significant changes in heart rate or blood and the plasma elimination half-life (t1/2) is 56 hours in patients with impaired hepatic function, pressures in normotensive patients with angina.
caution should be exercised when administering amlodipine besylate to patients with severe hepaticimpairment.
With chronic once daily oral administration, antihypertensive effectiveness is maintained for at least24 hours. Plasma concentrations correlate with effect in both young and elderly patients. The Drug Interactions: In vitro data indicate that amlodipine besylate has no effect on the human
magnitude of reduction in blood pressure with amlodipine besylate is also correlated with the height plasma protein binding of digoxin, phenytoin, warfarin, and indomethacin.
of pretreatment elevation; thus, individuals with moderate hypertension (diastolic pressure Effect of other agents on Amlodipine besylate.
105-114 mmHg) had about a 50% greater response than patients with mild hypertension (diastolic CIMETIDINE: Co-administration of amlodipine besylate with cimetidine did not alter the pressure 90-104 mmHg). Normotensive subjects experienced no clinically significant change in pharmacokinetics of amlodipine besylate.
GRAPEFRUIT JUICE: Co-administration of 240 mL of grapefruit juice with a single oral dose of In hypertensive patients with normal renal function, therapeutic doses of amlodipine besylate amlodipine 10 mg in 20 healthy volunteers had no significant effect on the pharmacokinetics of resulted in a decrease in renal vascular resistance and an increase in glomerular filtration rate and effective renal plasma flow without change in filtration fraction or proteinuria.
MAALOX (antacid): Co-administration of the antacid Maalox with a single dose of amlodipine As with other calcium channel blockers, hemodynamic measurements of cardiac function at rest and besylate had no significant effect on the pharmacokinetics of amlodipine besylate.
during exercise (or pacing) in patients with normal ventricular function treated with amlodipine SILDENAFIL: A single 100 mg dose of sildenafil (Viagra®) in subjects with essential hypertension besylate have generally demonstrated a small increase in cardiac index without significant influence had no effect on the pharmacokinetic parameters of amlodipine besylate. When amlodipine besylate on dP/dt or on left ventricular end diastolic pressure or volume. In hemodynamic studies, amlodipine and sildenafil were used in combination, each agent independently exerted its own blood pressure besylate has not been associated with a negative inotropic effect when administered in the therapeutic dose range to intact animals and man, even when co-administered with beta-blockers toman. Similar findings, however, have been observed in normals or well-compensated patients with Effect of Amlodipine besylate on other agents.
heart failure with agents possessing significant negative inotropic effects.
ATORVASTATIN: Co-administration of multiple 10 mg doses of amlodipine besylate with 80 mg of Electrophysiologic Effects: Amlodipine besylate does not change sinoatrial nodal function or atorvastatin resulted in no significant change in the steady state pharmacokinetic parameters of atrioventricular conduction in intact animals or man. In patients with chronic stable angina, intravenous administration of 10 mg did not significantly alter A-H and H-V conduction and sinus DIGOXIN: Co-administration of amlodipine besylate with digoxin did not change serum digoxin levels node recovery time after pacing. Similar results were obtained in patients receiving amlodipine or digoxin renal clearance in normal volunteers.
besylate and concomitant beta blockers. In clinical studies in which amlodipine besylate was ETHANOL (alcohol): Single and multiple 10 mg doses of amlodipine besylate had no significant administered in combination with beta-blockers to patients with either hypertension or angina, no effect on the pharmacokinetics of ethanol.
adverse effects on electrocardiographic parameters were observed. In clinical trials with angina WARFARIN: Co-administration of amlodipine besylate with warfarin did not change the warfarin patients alone, amlodipine besylate therapy did not alter electrocardiographic intervals or produce In clinical trials, amlodipine besylate has been safely administered with thiazide diuretics, beta- Clinical Studies
blockers, angiotensin-converting enzyme inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, non-steroidal anti-inflammatory drugs, antibiotics, and oral hypoglycemic drugs.
Adult Patients: The antihypertensive efficacy of amlodipine besylate has been demonstrated in atotal of 15 double-blind, placebo-controlled, randomized studies involving 800 patients on amlodipine Drug/Laboratory Test Interactions: None known.
besylate and 538 on placebo. Once daily administration produced statistically significant placebo- Carcinogenesis, Mutagenesis, Impairment of Fertility: Rats and mice treated with amlodipine
corrected reductions in supine and standing blood pressures at 24 hours postdose, averaging about maleate in the diet for up to two years, at concentrations calculated to provide daily dosage levels of InvaGen Amlodipine Besylate Tablets Rev. 07-07 Flat Size 7.75 x 11 Fold Size 1.125 x 1.125 Type 5 pt. 08-13-07 TP 0.5, 1.25, and 2.5 amlodipine mg/kg/day showed no evidence of a carcinogenic effect of the drug.
lavage and remained normotensive; the third (105 mg) was hospitalized and had hypotension For the mouse, the highest dose was, on a mg/m2 basis, similar to the maximum recommended (90/50 mmHg) which normalized following plasma expansion. A case of accidental drug overdose human dose of 10 mg amlodipine/day*). For the rat, the highest dose, was on a mg/m2 basis, about has been documented in a 19-month-old male who ingested 30 mg amlodipine (about 2 mg/kg).
twice the maximum recommended human dose*.
During the emergency room presentation, vital signs were stable with no evidence of hypotension, Mutagenicity studies conducted with amlodipine maleate revealed no drug related effects at either but a heart rate of 180 bpm. Ipecac was administered 3.5 hours after ingestion and on subsequent observation (overnight) no sequelae were noted.
There was no effect on the fertility of rats treated orally with amlodipine maleate (males for 64 days If massive overdose should occur, active cardiac and respiratory monitoring should be instituted.
and females for 14 days prior to mating) at doses up to 10 mg amlodipine/kg/day (8 times* the Frequent blood pressure measurements are essential. Should hypotension occur, cardiovascular maximum recommended human dose of 10 mg/day on a mg/m2 basis).
support including elevation of the extremities and the judicious administration of fluids should beinitiated. If hypotension remains unresponsive to these conservative measures, administration of Pregnancy Category C: No evidence of teratogenicity or other embryo/fetal toxicity was found when
vasopressors (such as phenylephrine) should be considered with attention to circulating volume and pregnant rats and rabbits were treated orally with amlodipine maleate at doses up to 10 mg amlodipine/kg/day (respectively 8 times* and 23 times* the maximum recommended human dose of10 mg on a mg/m2 basis) during their respective periods of major organogenesis. However, litter size Intravenous calcium gluconate may help to reverse the effects of calcium entry blockade. As was significantly decreased (by about 50%) and the number of intrauterine deaths was significantly amlodipine besylate is highly protein bound, hemodialysis is not likely to be of benefit.
increased (about 5-fold) in rats receiving amlodipine maleate at a dose equivalent to 10 mg DOSAGE AND ADMINISTRATION
amlodipine/kg/day for 14 days before mating and throughout mating and gestation. Amlodipine Adults: The usual initial antihypertensive oral dose of amlodipine besylate is 5 mg once daily with
maleate has been shown to prolong both the gestation period and the duration of labor in rats at this a maximum dose of 10 mg once daily. Small, fragile, or elderly individuals, or patients with hepatic dose. There are no adequate and well-controlled studies in pregnant women. Amlodipine should be insufficiency may be started on 2.5 mg once daily and this dose may be used when adding used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
amlodipine besylate to other antihypertensive therapy.
Dosage should be adjusted according to each patient’s need. In general, titration should proceed Nursing Mothers: It is not known whether amlodipine is excreted in human milk. In the absence of
over 7 to 14 days so that the physician can fully assess the patient’s response to each dose level.
this information, it is recommended that nursing be discontinued while amlodipine besylate is Titration may proceed more rapidly, however, if clinically warranted, provided the patient is assessed Pediatric Use: The effect of amlodipine besylate on blood pressure in patients less than 6 years of
The recommended dose for chronic stable or vasospastic angina is 5 to 10 mg, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Most patients will require 10 mg Geriatric Use: Clinical studies of amlodipine besylate did not include sufficient numbers of subjects
for adequate effect. See ADVERSE REACTIONS section for information related to dosage and side
aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and The recommended dose range for patients with coronary artery disease is 5 to 10 mg once daily. In younger patients. In general, dose selection for an elderly patient should be cautious, usually starting clinical studies the majority of patients required 10 mg (see CLINICAL PHARMACOLOGY, Clinical
at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or Studies).
cardiac function, and of concomitant disease or other drug therapy. Elderly patients have decreased Children: The effective antihypertensive oral dose in pediatric patients ages 6-17 years is 2.5 mg to
clearance of amlodipine with a resulting increase of AUC of approximately 40-60%, and a lower 5 mg once daily. Doses in excess of 5 mg daily have not been studied in pediatric patients. See initial dose may be required (see DOSAGE AND ADMINISTRATION).
CLINICAL PHARMACOLOGY.
ADVERSE REACTIONS
Co-administration with Other Antihypertensive and/or Antianginal Drugs: Amlodipine besylate
Amlodipine besylate has been evaluated for safety in more than 11,000 patients in U.S. and foreign has been safely administered with thiazides, ACE inhibitors, beta-blockers, long-acting nitrates, clinical trials. In general, treatment with amlodipine besylate was well-tolerated at doses up to 10 mg daily. Most adverse reactions reported during therapy with amlodipine besylate were of mild or HOW SUPPLIED
moderate severity. In controlled clinical trials directly comparing amlodipine besylate (N=1730) in Amlodipine besylate 2.5 mg Tablets (amlodipine besylate, USP equivalent to 2.5 mg of amlodipine doses up to 10 mg to placebo (N=1250), discontinuation of amlodipine besylate due to adverse per tablet) are supplied as white, round, flat-faced, beveled edged tablets debossed with IG on one
reactions was required in only about 1.5% of patients and was not significantly different from placebo side and 237 on the other and supplied as follows:
(about 1%). The most common side effects are headache and edema. The incidence (%) of sideeffects which occurred in a dose related manner are as follows: Amlodipine besylate 5 mg Tablets (amlodipine besylate, USP equivalent to 5 mg of amlodipine per tablet) are supplied as white, round, flat-faced, beveled edged tablets debossed with IG on one side
and 238 on the other and supplied as follows:
Amlodipine besylate 10 mg Tablets (amlodipine besylate, USP equivalent to 10 mg of amlodipine per Other adverse experiences which were not clearly dose related but which were reported with an tablet) are supplied as white, round, flat-faced, beveled edged tablets debossed with IG on one side
incidence greater than 1% in placebo-controlled clinical trials include the following: and 239 on the other and supplied as follows:
Placebo-Controlled Studies
Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature].
For several adverse experiences that appear to be drug and dose related, there was a greaterincidence 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 underconditions of open trials or marketing experience where a causal relationship is uncertain; they arelisted to alert the physician to a possible relationship: Cardiovascular: arrhythmia (including ventricular tachycardia and atrial fibrillation), 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, thrombocytopenia.
The 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 visualaccommodation, and xerophthalmia.
Other reactions occurred sporadically and cannot be distinguished from medications or concurrentdisease states such as myocardial infarction and angina.
Amlodipine besylate therapy has not been associated with clinically significant changes in routinelaboratory tests. No clinically relevant changes were noted in serum potassium, serum glucose, totaltriglycerides, total cholesterol, HDL cholesterol, uric acid, blood urea nitrogen, or creatinine.
The following postmarketing event has been reported infrequently where a causal relationship isuncertain: gynecomastia. In postmarketing experience, jaundice and hepatic enzyme elevations(mostly consistent with cholestasis or hepatitis) in some cases severe enough to requirehospitalization have been reported in association with use of amlodipine.
Amlodipine besylate 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.
OVERDOSAGE
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/m2 basis) caused a marked peripheral vasodilation and
hypotension.
Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotensionand possibly a reflex tachycardia. In humans, experience with intentional overdosage of amlodipinebesylate is limited. Reports of intentional overdosage include a patient who ingested 250 mg andwas asymptomatic and was not hospitalized; another (120 mg) was hospitalized, underwent gastric

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Doi:10.1016/j.jpba.2005.02.033

Journal of Pharmaceutical and Biomedical Analysis 38 (2005) 781–784Stable isotopic composition of the active pharmaceuticalA.M. Wokovich , J.A. Spencer , B.J. Westenberger , L.F. Buhse , J.P. Jasper a Food and Drug Administration, Center for Drug Evaluation and Research, Division of Pharmaceutical Analysis, St. Louis, MO 63101, USA b Molecular Isotope Technologies, LLC, 8 Old Oak Lane, Nia

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