amlodipine besylate
Pharmaranks rates Amlodipine Besylate 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Amlodipine Besylate is a calcium channel blocker used to treat Variant Angina Pectoris, Coronary Artery Disease, Hypertension.
Calcium Channel Blocker · by Invagen Pharms
Generic of Norvasc
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Amlodipine Besylate
- Drug class
- Calcium Channel Blocker
- Form
- Tablet
- Strength
- Amlodipine Besylate EQ 10MG Base · Amlodipine Besylate EQ 2.5MG Base · Amlodipine Besylate EQ 5MG Base
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Invagen Pharms
- Half-life
- about 30 to 50 hours (how long it stays in your system)
- What the pharmacy pays
- ~$0.33 for 30 — not your price
- FDA application
- ANDA206367
What is Amlodipine Besylate?
From the FDA label:Amlodipine besylate, USP 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 empirical formula is C 20 H 25 CIN 2 O 5 •C 6 H 6 O 3 S, 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, USP are formulated as white tablets equivalent to 2.5 mg, 5 mg, or 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. USP dissolution test pending structure
How to use
Adult recommended starting dose: 5 mg once daily with maximum dose 10 mg once daily. ( 2.1 ) Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily. ( 2.1 ) Pediatric starting dose: 2.5 mg to 5 mg once daily. ( 2.2 ) Important Limitation: Doses in excess of 5 mg daily have not been studied in pediatric patients. ( 2.2 ) 2.1 Adults The usual initial antihypertensive oral dose of amlodipine besylate tablets is 5 mg once daily, and the maximum dose is 10 mg once daily. Small, fragile, or elderly patients, 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. Adjust dosage according to blood pressure goals. In general, wait 7 to 14 days between titration steps. Titrate more rapidly, however, if clinically warranted, provided the patient is assessed frequently. Angina : 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. Coronary artery disease: The recommended dose range for patients with coronary artery disease is 5 to10 mg once daily. In clinical studies, the majority of patients required 10 mg [see Clinical Studies ( 14.4 )]. 2.2…
Side effects
Most common adverse reaction to amlodipine is edema which occurred in a dose related manner. Other adverse experiences not dose related but reported with an incidence >1.0% are fatigue, nausea, abdominal pain, and somnolence. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Exelan Pharmaceuticals, Inc. at 1-866-604-3268 or www.exelanpharma.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Amlodipine besylate tablets have 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) at doses up to 10 mg to placebo (N=1250), discontinuation of amlodipine besylate tablets because of adverse reactions was required in only about 1.5% of patients and was not significantly different from placebo (about 1%). The most commonly reported side effects more frequent…
Warnings
Important safety information
Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. However, acute hypotension is unlikely. ( 5.1 ) Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine besylate tablets, particularly in patients with severe obstructive coronary artery disease. ( 5.2 ) Titrate slowly in patients with severe hepatic impairment. ( 5.3 ) 5.1 Hypotension Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension is unlikely. 5.2 Increased Angina or Myocardial Infarction Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine besylate tablets, particularly in patients with severe obstructive coronary artery disease. 5.3 Patients with Hepatic Failure Because 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, titrate slowly when administering amlodipine besylate tablets to patients with severe hepatic impairment.
Who should not take Amlodipine Besylate
Amlodipine besylate tablets are contraindicated in patients with known sensitivity to amlodipine. Known sensitivity to amlodipine ( 4 )
Overdose — what happens if you take too much
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. 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 2 basis) caused a marked peripheral vasodilation and hypotension. If massive overdose should occur, initiate active cardiac and respiratory monitoring. Frequent blood pressure measurements are essential. Should hypotension occur, provide cardiovascular support including elevation of the extremities and the judicious administration of fluids. If hypotension remains unresponsive to these conservative measures, consider administration of vasopressors (such as phenylephrine) with attention to circulating volume and urine output. As amlodipine is highly protein bound, hemodialysis is not likely to be of benefit.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Do not exceed doses greater than 20 mg daily of simvastatin. ( 7.2 ) 7.1 Impact of Other Drugs on Amlodipine CYP3A Inhibitors Co-administration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction. Monitor for symptoms of hypotension and edema when amlodipine is co-administered with CYP3A inhibitors to determine the need for dose adjustment [see Clinical Pharmacology ( 12.3 )] . CYP3A Inducers No information is available on the quantitative effects of CYP3A inducers on amlodipine. Blood pressure should be closely monitored when amlodipine is co-administered with CYP3A inducers. Sildenafil Monitor for hypotension when sildenafil is co-administered with amlodipine [see Clinical Pharmacology ( 12.2 )] . 7.2 Impact of Amlodipine on Other Drugs Simvastatin Co-administration of simvastatin with amlodipine increases the systemic exposure of simvastatin. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily [see Clinical Pharmacology ( 12.3 )]. Immunosuppressants Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co-administered. Frequent monitoring of trough blood levels of cyclosporine and tacrolimus is recommended and adjust the dose when appropriate [see Clinical Pharmacology ( 12.3 )].
How long does Amlodipine Besylate stay in your body?
The elimination half-life of amlodipine besylate is about 30 to 50 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the parent drug's terminal elimination half-life in adults with normal liver function; it is longer (about 56 hours) in people with impaired liver function, and elderly patients and those with liver problems or heart failure clear the drug more slowly (roughly 40 to 60% higher blood levels). Amlodipine's metabolites are inactive, so no active-metabolite caveat applies.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: NORVASC (amlodipine besylate) tablets — FDA prescribing information, DailyMed.
Drug class
How this class works, per Calcium Channel Blockers - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Amlodipine Besylate ranks — best-rated calcium channel blocker for:
Dosage forms
Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Amlodipine Besylate treat?
- Amlodipine Besylate (Amlodipine Besylate) may be used to treat variant angina pectoris, coronary artery disease, hypertension, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Amlodipine Besylate work?
- Amlodipine Besylate is a calcium channel blocker. Calcium channel blockers slow the flow of calcium into the muscle cells of the heart and blood vessels. With less calcium, blood vessels relax and widen and the heart pumps with less force, which lowers blood pressure and eases chest pain.
- How is Amlodipine Besylate rated?
- pharmaranks gives Amlodipine Besylate a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Amlodipine Besylate cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.33 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Amlodipine Besylate?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Amlodipine Besylate. To pay less, Amlodipine Besylate is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Amlodipine Besylate?
- Amlodipine Besylate is marketed by Invagen Pharms. You can see Invagen Pharms's full profile, rating, and other products on pharmaranks.
- Is Amlodipine Besylate a brand-name or generic drug?
- Amlodipine Besylate is a generic medication; its active ingredient is Amlodipine Besylate. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Amlodipine Besylate available over the counter?
- No. Amlodipine Besylate is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Amlodipine Besylate come in?
- Amlodipine Besylate is currently marketed as tablet, per the FDA's National Drug Code Directory.
- What class of drug is Amlodipine Besylate?
- Amlodipine Besylate is classified as calcium channel blocker, dihydropyridine calcium channel blocker, per the FDA's Established Pharmacologic Class.
- Is Amlodipine Besylate FDA-registered?
- Amlodipine Besylate is on record with the U.S. FDA under application number ANDA206367. You can verify this on its official FDA label.
- Has Amlodipine Besylate been recalled by the FDA?
- Amlodipine Besylate has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Amlodipine Besylate safe?
- There's no single safe-or-not verdict. pharmaranks gives Amlodipine Besylate a recall-safety score of 72/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Amlodipine Besylate?
- Amlodipine Besylate's side effects are taken directly from its FDA label. From the label: Most common adverse reaction to amlodipine is edema which occurred in a dose related manner. Other adverse experiences not dose related but reported with an incidence >1.0% are fatigue, nausea, abdominal pain, and somnolence. ( 6 ) To report SUSPECTED ADVERSE REACTIONS,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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72/100