Label: AMLODIPINE BESYLATE - amlodipine besylate tablet

  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 09/11

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    Amlodipine besylate, USP is a long-acting calcium channel blocker.
    Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (monobenzenesulphonate. Its molecular formula is C20H25CIN2O5C6H6O3S, 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.


    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 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:
    Exertional Angina: In patients with exertional angina, amlodipine besylate reduces the total peripheral resistance (afterload) against which the heart works and reduces the rate pressure product, and thus myocardial oxygen demand, at any given level of exercise.
    Vasospastic Angina: Amlodipine has been demonstrated to block constriction and restore blood flow in coronary arteries and arterioles in response to calcium, potassium epinephrine, serotonin, and thromboxane A2 analog in experimental animal models and in human coronary vessels in vitro. This inhibition of coronary spasm is responsible for the effectiveness of Amlodipine in vasospastic (Prinzmetal's or variant) angina.


    After oral administration of therapeutic doses of amlodipine besylate tablets, absorption produces peakplasma concentrations between 6 and 12 hours. Absolute bioavailability has been estimated to be between 64 and 90%. The bioavailability of amlodipine besylate is not altered by the presence of food.
    Amlodipine is extensively (about 90%) converted to inactive metabolites via hepatic metabolism with 10% of the parent compound and 60% of the metabolites excreted in the urine. Ex vivo studies have shown that approximately 93% of the circulating drug is bound to plasma proteins in hypertensive patients. Elimination from the plasma is biphasic with a terminal elimination half-life of about 30-50 hours. Steady-state plasma levels of amlodipine are reached after 7 to 8 days of consecutive daily dosing.
    The pharmacokinetics of amlodipine are not significantly influenced by renal impairment. Patients with renal failure may therefore receive the usual initial dose.
    Elderly patients and patients with hepatic insufficiency have decreased clearance of amlodipine with a resulting increase in AUC of approximately 40-60%, and a lower initial dose may be required. A similar increase in AUC was observed in patients with moderate to severe heart failure.
    Pediatric Patients: Sixty-two hypertensive patients aged 6 to 17 years received doses of amlodipine besylate between 1.25 mg and 20 mg. Weight-adjusted clearance and volume of distribution were similar to values in adults.


    Hemodynamics: Following administration of therapeutic doses to patients with hypertension, amlodipine besylate tablets produces vasodilation resulting in a reduction of supine and standing blood pressures. These decreases in blood pressure are not accompanied by a significant change in heart rate or plasma catecholamine levels with chronic dosing. Although the acute intravenous administration of amlodipine decreases arterial blood pressure and increases heart rate in hemodynamic studies of patients with chronic stable angina, chronic oral administration of amlodipine in clinical trials did not lead to clinically significant changes in heart rate or blood pressures in normotensive patients with angina.
    With chronic once daily oral administration, antihypertensive effectiveness is maintained for at least 24 hours. Plasma concentrations correlate with effect in both young and elderly patients. The magnitude of reduction in blood pressure with amlodipine besylate is also correlated with the height of pretreatment elevation; thus, individuals with moderate hypertension (diastolic pressure 105-114 mmHg) had about a 50% greater response than patients with mild hypertension (diastolic pressure 90-104 mmHg). Normotensive subjects experienced no clinically significant change in blood pressures (+1/-2 mmHg).
    In hypertensive patients with normal renal function, therapeutic doses of amlodipine besylate tablets 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.
    As with other calcium channel blockers, hemodynamic measurements of cardiac function at rest and during exercise (or pacing) in patients with normal ventricular function treated with amlodipine besylate tablets have generally demonstrated a small increase in cardiac index without significant influence on dP/dt or on left ventricular end diastolic pressure or volume. In hemodynamic studies, amlodipine besylate tablets have 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 to man. Similar findings, however, have been observed in normals or well-compensated patients with heart failure with agents possessing significant negative inotropic effects.
    Electrophysiologic Effects: Amlodipine besylate does not change sinoatrial nodal function or 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 node recovery time after pacing. Similar results were obtained in patients receiving amlodipine besylate tablets and concomitant beta blockers. In clinical studies in which amlodipine besylate tablets were administered in combination with beta-blockers to patients with either hypertension or angina, no adverse effects on electrocardiographic parameters were observed. In clinical trials with angina patients alone, amlodipine besylate tablet therapy did not alter electrocardiographic intervals or produce higher degrees of AV blocks.


    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. 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.


    Increased Angina and/or Myocardial Infarction:Rarely, patients, particularly those with severe obstructive coronary artery disease, have developed documented increased frequency, duration and/or severity of angina or acute myocardial infarction on starting calcium channel blocker therapy or at the time of dosage increase. The mechanism of this effect has not been elucidated.


    Since the vasodilation induced by amlodipine besylate tablets is gradual in onset, acute hypotension has rarely been reported after oral administration. Nonetheless, caution as with any other peripheral vasodilator, should be exercised when administering amlodipine besylate tablets, particularly in patients with severe aortic stenosis.
    Use in Patients with Congestive Heart Failure:In general, calcium channel blockers should be used with caution in patients with heart failure. Amlodipine besylate tablets (5 to 10 mg per day) have been studied in a placebo-controlled trial of 1153 patients with NYHA Class III or IV heart failure (see CLINICAL PHARMACOLOGY) on stable doses of ACE inhibitor, digoxin, and diuretics. Follow-up was at least 6 months, with a mean of about 14 months. There was no overall adverse effect on survival or cardiac morbidity (as defined by life-threatening arrhythmia, acute myocardial infarction, or hospitalization for worsened heart failure). Amlodipine besylate tablets have been compared to placebo in four 8-12 week studies of patients with NYHA class II/III heart failure, involving a total of 697 patients. In these studies, there was no evidence of worsened heart failure based on measures of exercise tolerance, NYHA classification, symptoms, or LVEF.
    Beta-Blocker Withdrawal:
    Patients with Hepatic Failure:Since amlodipine is extensively metabolized by the liver and the plasma elimination half-life (t1/2) is 56 hours in patients with impaired hepatic function, caution should be exercised when administering amlodipine besylate tablets to patients with severe hepatic impairment.


    In vitro data indicate that amlodipine has no effect on the human plasma protein binding of digoxin, phenytoin, warfarin, and indomethacin.
    Effect of other agents on amlodipine besylate tablets.
    CIMETIDINE: Co-administration of amlodipine besylate tablets with cimetidine did not alter the pharmacokinetics of amlodipine.
    GRAPEFRUIT JUICE: Co-administration of 240 mL of grapefruit juice with a single oral dose of amlodipine 10 mg in 20 healthy volunteers had no significant effect on the pharmacokinetics of amlodipine.
    MAALOX (antacid): Co-administration of the antacid Maalox with a single dose of amlodipine besylate tablets had no significant effect on the pharmacokinetics of amlodipine.
    SILDENAFIL: A single 100 mg dose of sildenafil (Viagrain subjects with essential hypertension had no effect on the pharmacokinetic parameters of amlodipine. When amlodipine besylate tablets and sildenafil were used in combination, each agent independently exerted its own blood pressure lowering effect.
    Effect of Amlodipine besylate tablets on other agents.
    ATORVASTATIN: Co-administration of multiple 10 mg doses of amlodipine besylate tablets with 80 mg of atorvastatin resulted in no significant change in the steady state pharmacokinetic parameters of atorvastatin.
    DIGOXIN: Co-administration of amlodipine besylate tablets with digoxin did not change serum digoxin levels or digoxin renal clearance in normal volunteers.
    ETHANOL (alcohol): Single and multiple 10 mg doses of amlodipine besylate tablets had no significant effect on the pharmacokinetics of ethanol.
    WARFARIN: Co-administration of amlodipine besylate tablets with warfarin did not change the warfarin prothrombin response time.
    In clinical trials, amlodipine besylate tablets have been safely administered with thiazide diuretics, betablockers, angiotensin-converting enzyme inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, non-steroidal anti-inflammatory drugs, antibiotics, and oral hypoglycemic drugs.


    None known.


    Rats and mice treated with amlodipine maleate in the diet for up to two years, at concentrations calculated to provide daily dosage levels of 0.5, 1.25, and 2.5 amlodipine mg/kg/day showed no evidence of a carcinogenic effect of the drug. For the mouse, the highest dose was, on a mg/m2 basis, similar to the maximum recommended human dose of 10 mg amlodipine/day*). For the rat, the highest dose, was on a mg/m2 basis, about twice the maximum recommended human dose*.
    Mutagenicity studies conducted with amlodipine maleate revealed no drug related effects at either the gene or chromosome level.
    There was no effect on the fertility of rats treated orally with amlodipine maleate (males for 64 days and females for 14 days prior to mating) at doses up to 10 mg amlodipine/kg/day (8 times* the maximum recommended human dose of 10 mg/day on a mg/m2 basis).


    No evidence of teratogenicity or other embryo/fetal toxicity was found when 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 of 10 mg on a mg/m2 basis) during their respective periods of major organogenesis. However, litter size was significantly decreased (by about 50%) and the number of intrauterine deaths was significantly increased (about 5-fold) in rats receiving amlodipine maleate at a dose equivalent to 10 mg amlodipine/kg/day for 14 days before mating and throughout mating and gestation. Amlodipine maleate has been shown to prolong both the gestation period and the duration of labor in rats at this dose. There are no adequate and well-controlled studies in pregnant women. Amlodipine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
    *Based on patient weight of 50 kg.


    It is not known whether amlodipine is excreted in human milk. In the absence of this information, it is recommended that nursing be discontinued while amlodipine is administered.


    The effect of amlodipine on blood pressure in patients less than 6 years of age is not known.


    Clinical studies of amlodipine besylate tablets did not include sufficient numbers of subjects 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 younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Elderly patients have decreased clearance of amlodipine with a resulting increase of AUC of approximately 40-60%, and a lower initial dose may be required (see DOSAGE AND ADMINISTRATION).


    Amlodipine besylate has been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials. In general, treatment with amlodipine besylate tablets was well-tolerated at doses up to 10 mg daily. Most adverse reactions reported during therapy with amlodipine besylate tablets were of mild or moderate severity. In controlled clinical trials directly comparing amlodipine besylate tablets (N=1730) in doses up to 10 mg to placebo (N=1250), discontinuation of amlodipine besylate tablets 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:
    Adverse Event2.5mg N=27550mg N=29610.0mg N=268Placebo N=520Edema1. adverse experiences which were not clearly dose related but which were reported with an incidence greater than 1.0% in placebo-controlled clinical trials include the following:
    Placebo-Controlled StudiesAMLODIPINE (%) (N=1730)PLACEBO (%) (N=1250)Headache7.37.8Fatigue4.52.8Nausea2.91.9Abdominal Pain1.60.3Somnolence1.40.6For 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:
    AMLODIPINEPLACEBOMale=%Female=%Male=%Famale=%Adverse Event(N=1218)(N=512)(N=914)(N=336)Edema5.614.61.45.1Flushing1.
    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 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 besylate tablet 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.
    In the CAMELOT and PREVENT studies (see CLINICAL PHARMACOLOGYClinical StudiesStudies in Patients with Coronary Artery Disease) the adverse event profile was similar to that reported previously (see above), with the most common adverse event being peripheral edema.
    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 besylate tablets have 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.


    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 hypotension and possibly a reflex tachycardia. In humans, experience with intentional overdosage of amlodipine besylate tablets is limited. Reports of intentional overdosage include a patient who ingested 250 mg and was asymptomatic and was not hospitalized; another (120 mg) was hospitalized, underwent gastric lavage and remained normotensive; the third (105 mg) was hospitalized and had hypotension (90/50 mmHg) which normalized following plasma expansion. A case of accidental drug overdose has been documented in a 19-month-old male who ingested 30 mg amlodipine (about 2 mg/kg). During the emergency room presentation, vital signs were stable with no evidence of hypotension, but a heart rate of 180 bpm. Ipecac was administered 3.5 hours after ingestion and on subsequent observation (overnight) no sequelae were noted.
    If massive overdose should occur, active cardiac and respiratory monitoring should be instituted.
    Frequent blood pressure measurements are essential. Should hypotension occur, cardiovascular support including elevation of the extremities and the judicious administration of fluids should be initiated. If hypotension remains unresponsive to these conservative measures, administration of vasopressors (such as phenylephrine) should be considered with attention to circulating volume and urine output.
    Intravenous calcium gluconate may help to reverse the effects of calcium entry blockade. As amlodipine is highly protein bound, hemodialysis is not likely to be of benefit.


    Adults:The usual initial antihypertensive oral dose of amlodipine besylate tablets is 5 mg once daily with a maximum dose of 10 mg once daily. Small, fragile, or elderly individuals, or patients with hepatic insufficiency may be started on 2.5 mg once daily and this dose may be used when adding amlodipine besylate tablets to other antihypertensive therapy.
    Dosage should be adjusted according to each patient's need. In general, titration should proceed over 7 to 14 days so that the physician can fully assess the patient's response to each dose level. Titration may proceed more rapidly, however, if clinically warranted, provided the patient is assessed frequently.
    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 for adequate effect. See ADVERSE REACTIONSsection for information related to dosage and side effects.
    The recommended dose range for patients with coronary artery disease is 5 to 10 mg once daily. In clinical studies the majority of patients required 10 mg (see CLINICAL PHARMACOLOGY, Clinical Studies).
    Children: The effective antihypertensive oral dose in pediatric patients ages 6 to 17 years is 2.5 mg to 5 mg once daily. Doses in excess of 5 mg daily have not been studied in pediatric patients. See CLINICAL PHARMACOLOGY.
    Co-administration with Other Antihypertensive and/or Antianginal Drugs:Amlodipine besylate tablets have been safely administered with thiazides, ACE inhibitors, beta-blockers, long-acting nitrates, and/or sublingual nitroglycerin.


    2.5 mg Tablets
    Amlodipine Besylate Tablets - 2.5 mg (amlodipine besylate equivalent to 2.5 mg of amlodipine per tablet) are supplied as white to off-white, triangle-shaped, flat-beveled debossed withWon one side and421on the other side and supplied as follows:
    NDC 64679-421-01 Bottle of 90 tablets
    NDC 64679-421-02 Bottle of 1000 tablets
    NDC 64679-421-03 Unit dose package of 100 tablets
    NDC 64679-421-04 Bottle of 100 tablets
    5 mg Tablets
    Amlodipine Besylate Tablets - 5 mg (amlodipine besylate equivalent to 5 mg of amlodipine per tablet) are supplied as white to off-white, caplet, flat-beveled, debossed withWon one side and422on the other side and supplied as follows:
    NDC 64679-422-01 Bottle of 90 tablets
    NDC 64679-422-02 Bottle of 1000 tablets
    NDC 64679-422-03 Unit dose package of 100 tablets
    NDC 64679-422-04 Bottle of 100 tablets
    NDC 64679-422-05 Bottle of 300 tablets
    10 mg Tablets
    Amlodipine Besylate Tablets - 10 mg (amlodipine besylate equivalent to 10 mg of amlodipine per tablet) are supplied as white to off-white, round, flat-beveled, debossed withWon one side and plain on the other side and supplied as follows: 423

    NDC 64679-423-01 Bottle of 90 tablets
    NDC 64679-423-02 Bottle of 1000 tablets
    NDC 64679-423-03 Unit dose package of 100 tablets
    NDC 64679-423-04 Bottle of 100 tablets


    Store at 20to 25(68to 77(USP Controlled Room Temperature) and dispense in tight, light-resistant containers (USP).


    Amlodipine Besylate Tablets
    Read this information carefully before you start taking amlodipine besylate tablets and each time you refill your prescription. There may be new information. This information does not replace talking with your doctor. If you have any questions about amlodipine besylate tablets, ask your doctor. Your doctor will know if amlodipine besylate tablets are right for you.

    What are amlodipine besylate tablets?
    Amlodipine besylate tablets are a type of medicine known as a calcium channel blocker (CCB). It is used to treat high blood pressure (hypertension) and a type of chest pain called angina. It can be used by itself or with other medicines to treat these conditions.

    High Blood Pressure (hypertension)
    High blood pressure comes from blood pushing too hard against your blood vessels. Amlodipine besylate tablets relaxes your blood vessels, which lets your blood flow more easily and helps lower your blood pressure. Drugs that lower blood pressure lower your risk of having a stroke or heart attack.

    Angina is a pain or discomfort that keeps coming back when part of your heart does not get enough blood. Angina feels like a pressing or squeezing pain, usually in your chest under the breastbone. Sometimes you can feel it in your shoulders, arms, neck, jaws, or back. Amlodipine besylate tablets can relieve this pain.

    Who should not use amlodipine besylate tablets?
    Do not use amlodipine besylate tablets if you are allergic to amlodipine (the active ingredient in amlodipine besylate tablets), or to the inactive ingredients. Your doctor or pharmacist can give you a list of these ingredients.

    What should I tell my doctor before taking amlodipine besylate tablets?
    Tell your doctor about any prescription and non-prescription medicines you are taking, including natural or herbal remedies. Tell your doctor if you:
         ever had heart disease
         ever had liver problems
         are pregnant, or plan to become pregnant. Your doctor will decide if amlodipine besylate tablets are the best treatment for you.
         are breast-feeding. Do not breast-feed while taking amlodipine besylate tablets. You can stop breast-feeding or take a different medicine.
    How should I take amlodipine besylate tablets?
         Take amlodipine besylate tablets once a day, with or without food. You can take amlodipine besylate tablets with most drinks, including grapefruit juice.
         It may be easier to take your dose if you do it at the same time every day, such as with breakfast or dinner, or at bedtime. Do not take more than one dose of amlodipine besylate tablets at a time.
         If you miss a dose, take it as soon as you remember. Do not take amlodipine besylate tablets if it has been more than 12 hours since you missed your last dose. Wait and take the next dose at your regular time.
         Other medicines:You can use nitroglycerin and amlodipine besylate tablets together. If you take nitroglycerin for angina, don't stop taking it while you are taking amlodipine besylate tablets.
         While you are taking amlodipine besylate tablets, do not stop taking your other prescription medicines, including any other blood pressure medicines, without talking to your doctor.
         If you took too much amlodipine besylate tablets, call your doctor or Poison Control Center, or go to the nearest hospital emergency room right away.
    What should I avoid while taking amlodipine besylate tablets?
         Do not breast-feed. It is not known if amlodipine besylate tablets will pass through your milk.
         Do not start any new prescription or non-prescription medicines or supplements, unless you check with your doctor first.
    What are the possible side effects of amlodipine besylate tablets?
    Amlodipine besylate tablets
    may cause the following side effects. Most side effects are mild or moderate:
         swelling of your legs or ankles
         tiredness, extreme sleepiness
         stomach pain, nausea
         flushing (hot or warm feeling in your face)
         arrhythmia (irregular heartbeat)
         heart palpitations (very fast heartbeat)
    It is rare, but when you first start taking amlodipine besylate tablets or increase your dose, you may have a heart attack or your angina may get worse. If that happens, call your doctor right away or go directly to a hospital emergency room.

    Tell your doctor if you are concerned about any side effects you experience. These are not all the possible side effects of amlodipine besylate tablets. For a complete list, ask your doctor or pharmacist.

    How do I store amlodipine besylate tablets?
    Keep amlodipine besylate tablets away from children. Store amlodipine besylate tabletsat 20to 25(68to 77(USP Controlled Room Temperature). Keep amlodipine besylate tablets out of the light. Do not store in the bathroom. Keep amlodipine besylate tablets in a dry place.

    General advice about amlodipine besylate tablets
    Sometimes, doctors will prescribe a medicine for a condition that is not written in the patient information leaflets. Only use amlodipine besylate tablets the way your doctor told you to. Do not give amlodipine besylate tablets to other people, even if they have the same symptoms you have. It may harm them.

    You can ask your pharmacist or doctor for information about amlodipine besylate tablets, or call 1-800-346-6854.


    DRUG: Amlodipine Besylate
    GENERIC: Amlodipine Besylate
    NDC: 49349-509-23
    STRENGTH:10 mg
    COLOR: white
    SCORE: No score
    SIZE: 11 mm
    IMPRINT: 180
    QTY: 180


    amlodipine besylate tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49349-509(NDC:64679-422)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Inactive Ingredients
    Ingredient Name Strength
    Product Characteristics
    Color white Score no score
    Shape ROUND (TABLET) Size 11mm
    Flavor Imprint Code W;422
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49349-509-23 180 in 1 CANISTER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA078500 09/14/2011
    Labeler - REMEDYREPACK INC. (829572556)