In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients:anhydrous dibasic calcium phosphate, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium … No clinically relevant changes were noted in serum potassium, serum glucose, total triglycerides, total cholesterol, HDL cholesterol, uric acid, blood urea nitrogen, or creatinine.
Effects in various subgroups are shown in Figure 2.In an angiographic substudy (n=274) conducted within CAMELOT, there was no significant difference between amlodipine and placebo on the change of atheroma volume in the coronary artery as assessed by intravascular ultrasound.Another study (PRAISE-2) randomized patients with NYHA Class III (80%) or IV (20%) heart failure without clinical symptoms or objective evidence of underlying ischemic disease, on stable doses of ACE inhibitors (99%), digitalis (99%), and diuretics (99%), to placebo (n=827) or amlodipine (n=827) and followed them for a mean of 33 months.
Normotensive subjects experienced no clinically significant change in blood pressures (+1/–2 mmHg). The incidence (%) of side effects that occurred in a dose related manner are as follows:arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, peripheral ischemia, syncope, tachycardia, vasculitis.hypoesthesia, neuropathy peripheral, paresthesia, tremor, vertigo. Patients with renal failure may therefore receive the usual initial dose. Morris & Dickson Company, LTD. Protect from light.Store at 20° to 25°C (68° to 77°F). Due to inconsistencies between the drug labels on DailyMed and the pill images provided by
Protect from light.Store at 20° to 25°C (68° to 77°F). 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. However, strong inhibitors of CYP3A (e.g., itraconazole, clarithromycin) may increase the plasma concentrations of amlodipine to a greater extent Amlodipine is a weak inhibitor of CYP3A and may increase exposure to CYP3A substrates.Co-administered amlodipine does not affect the exposure to atorvastatin, digoxin, ethanol and the warfarin prothrombin response time.
There is no available information on the effects of amlodipine on milk production.Single oral doses of amlodipine maleate equivalent to 40 mg amlodipine/kg and 100 mg amlodipine/kg in mice and rats, respectively, caused deaths. 68180-750-09, The usual initial antihypertensive oral dose of Norvasc is 5 mg once daily, and the maximum dose is 10 mg once daily. However, a 3-fold increase in plasma exposure to tacrolimus in a renal transplant patient (CYP3A5 non-expresser) upon initiation of amlodipine for the treatment of post-transplant hypertension resulting in reduction of tacrolimus dose has been reported.
To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or www.lupinpharmaceuticals.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Vasospastic Angina (Prinzmetal's or Variant Angina) Disease-associated maternal and/or embryo/fetal risk USP dissolution test for Amlodipine besylate tablets is pending.Figure 1 - Kaplan-Meier Analysis of Composite Clinical Outcomes for Amlodipine versus PlaceboFigure 2 - Effects on Primary Endpoint of Amlodipine versus Placebo across Sub-GroupsTable 1. Morris & Dickson Company, LTD.
(Most common adverse reaction to amlodipine is edema which occurred in a dose related manner. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X.If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. Once daily administration produced statistically significant placebo-corrected reductions in supine and standing blood pressures at 24 hours postdose, averaging about 12/6 mmHg in the standing position and 13/7 mmHg in the supine position in patients with mild to moderate hypertension. Tell your doctor about any prescription and non-prescription medicines you are taking, including natural or herbal remedies. [See USP Controlled Room Temperature.]
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