Amlodipine Besylate

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Overview

What is Amlodipine Besylate?

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 CHClNO • CHOS, 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 blue tablets equivalent to 2.5 mg, 5 mg 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, anhydrous; magnesium stearate; microcrystalline cellulose and sodium starch glycolate .

What does Amlodipine Besylate look like?

What are the available doses of Amlodipine Besylate?

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What should I talk to my health care provider before I take Amlodipine Besylate?

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How should I use Amlodipine Besylate?

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 section for information related to dosage and side effects.

What interacts with Amlodipine Besylate?

Amlodipine besylate tablets are contraindicated in patients with known sensitivity to amlodipine.

What are the warnings of Amlodipine Besylate?

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.

What are the precautions of Amlodipine Besylate?

General

Since the vasodilation induced by amlodipine 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, 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 (5 to 10 mg per day) has been studied in a placebo-controlled trial of 1153 patients with NYHA Class III or IV heart failure (see ) 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 has been compared to placebo in four 8 to 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

Amlodipine is not a beta-blocker and therefore gives no protection against the dangers of abrupt beta-blocker withdrawal; any such withdrawal should be by gradual reduction of the dose of beta-blocker.

Patients with Hepatic Failure

Since amlodipine is extensively metabolized by the liver and the plasma elimination half-life (t 1/2) is 56 hours in patients with impaired hepatic function, caution should be exercised when administering amlodipine to patients with severe hepatic impairment.

Drug Interactions

In vitro

Effect of Other Agents on Amlodipine

Cimetidine

Coadministration of amlodipine with cimetidine did not alter the pharmacokinetics of amlodipine.

Grapefruit Juice

Coadministration 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)

Coadministration of the antacid Maalox with a single-dose of amlodipine had no significant effect on the pharmacokinetics of amlodipine.

Sildenafil

A single 100 mg dose of sildenafil (Viagra) in subjects with essential hypertension had no effect on the pharmacokinetic parameters of amlodipine. When amlodipine and sildenafil were used in combination, each agent independently exerted its own blood pressure lowering effect.

Effect of Amlodipine on Other Agents

Atorvastatin

Coadministration of multiple 10 mg doses of amlodipine with 80 mg of atorvastatin resulted in no significant change in the steady-state pharmacokinetic parameters of atorvastatin.

Digoxin

Coadministration of amlodipine 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 had no significant effect on the pharmacokinetics of ethanol.

Warfarin

Coadministration of amlodipine with warfarin did not change the warfarin prothrombin response time.

In clinical trials, amlodipine has been safely administered with thiazide diuretics, beta-blockers, angiotensin-converting enzyme inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, non-steroidal anti-inflammatory drugs, antibiotics, and oral hypoglycemic drugs.

Drug/Laboratory Test Interactions

None known.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Rats and mice treated with amlodipine maleate in the diet for up to 2 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/m basis, similar to the maximum recommended human dose of 10 mg amlodipine/day. For the rat, the highest dose was, on a mg/m 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 (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/m basis).

Pregnancy

Teratogenic Effects. Pregnancy Category C

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/m 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.

Nursing Mothers

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.

Pediatric Use

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

Geriatric Use

Clinical studies of amlodipine 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 to 60%, and a lower initial dose may be required (see ).

What are the side effects of Amlodipine Besylate?

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:

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:

Central and Peripheral Nervous System:

Gastrointestinal:

General:

Musculoskeletal System:

Psychiatric:

Respiratory System:

Skin and Appendages:

Special Senses:

Urinary System:

Autonomic Nervous System:

Metabolic and Nutritional:

Hemopoietic:

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 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 post-marketing event has been reported infrequently where a causal relationship is uncertain: gynecomastia. In post-marketing 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, peripheral vascular disease, diabetes mellitus, and abnormal lipid profiles.

**Placebo-Controlled Studies**
Adverse Event	2.5 mgN = 275	5 mgN = 296	10 mgN = 268	PlaceboN = 520
Edema	1.8	3.0	10.8	0.6
Dizziness	1.1	3.4	3.4	1.5
Flushing	0.7	1.4	2.6	0.0
Palpitation	0.7	1.4	4.5	0.6
	AMLODIPINE (%)(N = 1730)	PLACEBO (%)(N = 1250)
Headache	7.3	7.8
Fatigue	4.5	2.8
Nausea	2.9	1.9
Abdominal Pain	1.6	0.3
Somnolence	1.4	0.6
	AMLODIPINE	PLACEBO
Adverse Event	Male = %(N = 1218)	Female = %(N = 512)	Male =%(N = 914)	Female = %(N = 336)
Edema	5.6	14.6	1.4	5.1
Flushing	1.5	4.5	0.3	0.9
Palpitations	1.4	3.3	0.9	0.9
Somnolence	1.3	1.6	0.8	0.3

What should I look out for while using Amlodipine Besylate?

Amlodipine besylate tablets are contraindicated in patients with known sensitivity to amlodipine.

What might happen if I take too much Amlodipine Besylate?

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.

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 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.

How should I store and handle Amlodipine Besylate?

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Protect from light.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Protect from light.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Protect from light.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Amlodipine Besylate 2.5 mg tablets (amlodipine besylate, USP equivalent to 2.5 mg of amlodipine per tablet) are supplied as white, round, flat-faced, beveled edged tables debossed with on one side and on the other side. 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 tables debossed with on one side and on the other side.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 tables debossed with on one side and on the other side. They are supplied by as follows:This product was Manufactured By: InvaGen Pharmaceuticals, Inc.And Repackaged By:State of Florida DOH Central PharmacyStore at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]Amlodipine Besylate 2.5 mg tablets (amlodipine besylate, USP equivalent to 2.5 mg of amlodipine per tablet) are supplied as white, round, flat-faced, beveled edged tables debossed with on one side and on the other side. 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 tables debossed with on one side and on the other side.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 tables debossed with on one side and on the other side. They are supplied by as follows:This product was Manufactured By: InvaGen Pharmaceuticals, Inc.And Repackaged By:State of Florida DOH Central PharmacyStore at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]Amlodipine Besylate 2.5 mg tablets (amlodipine besylate, USP equivalent to 2.5 mg of amlodipine per tablet) are supplied as white, round, flat-faced, beveled edged tables debossed with on one side and on the other side. 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 tables debossed with on one side and on the other side.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 tables debossed with on one side and on the other side. They are supplied by as follows:This product was Manufactured By: InvaGen Pharmaceuticals, Inc.And Repackaged By:State of Florida DOH Central PharmacyStore at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]Amlodipine Besylate 2.5 mg tablets (amlodipine besylate, USP equivalent to 2.5 mg of amlodipine per tablet) are supplied as white, round, flat-faced, beveled edged tables debossed with on one side and on the other side. 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 tables debossed with on one side and on the other side.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 tables debossed with on one side and on the other side. They are supplied by as follows:This product was Manufactured By: InvaGen Pharmaceuticals, Inc.And Repackaged By:State of Florida DOH Central PharmacyStore at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]Amlodipine Besylate 2.5 mg tablets (amlodipine besylate, USP equivalent to 2.5 mg of amlodipine per tablet) are supplied as white, round, flat-faced, beveled edged tables debossed with on one side and on the other side. 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 tables debossed with on one side and on the other side.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 tables debossed with on one side and on the other side. They are supplied by as follows:This product was Manufactured By: InvaGen Pharmaceuticals, Inc.And Repackaged By:State of Florida DOH Central PharmacyStore at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]Amlodipine Besylate 2.5 mg tablets (amlodipine besylate, USP equivalent to 2.5 mg of amlodipine per tablet) are supplied as white, round, flat-faced, beveled edged tables debossed with on one side and on the other side. 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 tables debossed with on one side and on the other side.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 tables debossed with on one side and on the other side. They are supplied by as follows:This product was Manufactured By: InvaGen Pharmaceuticals, Inc.And Repackaged By:State of Florida DOH Central PharmacyStore at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]Amlodipine Besylate 2.5 mg tablets (amlodipine besylate, USP equivalent to 2.5 mg of amlodipine per tablet) are supplied as white, round, flat-faced, beveled edged tables debossed with on one side and on the other side. 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 tables debossed with on one side and on the other side.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 tables debossed with on one side and on the other side. They are supplied by as follows:This product was Manufactured By: InvaGen Pharmaceuticals, Inc.And Repackaged By:State of Florida DOH Central PharmacyStore at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]Amlodipine Besylate 2.5 mg tablets (amlodipine besylate, USP equivalent to 2.5 mg of amlodipine per tablet) are supplied as white, round, flat-faced, beveled edged tables debossed with on one side and on the other side. 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 tables debossed with on one side and on the other side.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 tables debossed with on one side and on the other side. They are supplied by as follows:This product was Manufactured By: InvaGen Pharmaceuticals, Inc.And Repackaged By:State of Florida DOH Central PharmacyStore at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]Amlodipine Besylate 2.5 mg tablets (amlodipine besylate, USP equivalent to 2.5 mg of amlodipine per tablet) are supplied as white, round, flat-faced, beveled edged tables debossed with on one side and on the other side. 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 tables debossed with on one side and on the other side.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 tables debossed with on one side and on the other side. They are supplied by as follows:This product was Manufactured By: InvaGen Pharmaceuticals, Inc.And Repackaged By:State of Florida DOH Central PharmacyStore at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]

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Clinical Information

Chemical Structure

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Clinical 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

Amlodipine besylate tablets are contraindicated in patients with known sensitivity to amlodipine.

In vitro

Since the vasodilation induced by amlodipine 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, particularly in patients with severe aortic stenosis.

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:

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:

Central and Peripheral Nervous System:

Gastrointestinal:

General:

Musculoskeletal System:

Psychiatric:

Respiratory System:

Skin and Appendages:

Special Senses:

Urinary System:

Autonomic Nervous System:

Metabolic and Nutritional:

Hemopoietic:

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 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 post-marketing event has been reported infrequently where a causal relationship is uncertain: gynecomastia. In post-marketing 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, peripheral vascular disease, diabetes mellitus, and abnormal lipid profiles.

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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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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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