amlodipine and olmesartan medoxomil
Pharmaranks rates Amlodipine and Olmesartan Medoxomil 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Amlodipine and Olmesartan Medoxomil is a combination medicine containing Amlodipine Besylate and Olmesartan Medoxomil.
Amlodipine Besylate and Olmesartan Medoxomil · by Sciegen Pharms
Generic of Azor
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 and Olmesartan Medoxomil
- Form
- Tablet
- Strength
- Amlodipine Besylate EQ 10MG Base; Olmesartan Medoxomil 20MG · Amlodipine Besylate EQ 10MG Base; Olmesartan Medoxomil 40MG · Amlodipine Besylate EQ 5MG Base; Olmesartan Medoxomil 20MG · Amlodipine Besylate EQ 5MG Base; Olmesartan Medoxomil 40MG
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Sciegen 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
- ANDA209010
- FDA boxed warning
- Yes — see the boxed warning
What is Amlodipine and Olmesartan Medoxomil?
From the FDA label:Amlodipine and olmesartan medoxomil provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate, USP and the angiotensin II receptor blocker (ARB) olmesartan medoxomil, USP. The amlodipine besylate, USP component of amlodipine and olmesartan medoxomil tablets, USP 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 ClN 2 O 5 •C 6 H 6 O 3 S. Olmesartan medoxomil, USP a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil, USP component of amlodipine and olmesartan medoxomil tablets, USP is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[ p -(o-1 H -tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29 H 30 N 6 O 6 . The structural formula for amlodipine besylate, USP is: The structural formula for olmesartan medoxomil, USP is: Amlodipine and olmesartan medoxomil tablets, USP contain amlodipine besylate, USP a white or almost white powder, and olmesartan medoxomil, USP a white to off-white crystalline powder. The molecular weights of amlodipine besylate, USP and olmesartan medoxomil, USP are 567.1 and 558.59, respectively.…
How to use
The usual starting dose of amlodipine and olmesartan medoxomil tablets is 5/20 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum dose of one 10/40 mg tablet once daily as needed to control blood pressure [ see Clinical Studies (14.1) ]. Recommended starting dose: 5/20 mg once daily ( 2 ). Titrate as needed in two-week intervals up to a maximum of 10/40 mg once daily ( 2 ).
Side effects
Most common adverse reaction (incidence ≥ 3%) is edema (6.1) . To report SUSPECTED ADVERSE REACTIONS, contact ScieGen Pharmaceuticals Inc. at 1-855-724-3436 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Amlodipine and olmesartan medoxomil tablets The data described below reflect exposure to amlodipine and olmesartan medoxomil tablets in more than 1600 patients including more than 1,000 exposed for at least 6 months and more than 700 exposed for 1 year. Amlodipine and olmesartan medoxomil tablets were studied in one placebo-controlled factorial trial [ see Clinical Trials (14.1) ]. The population had a mean age of 54 years and included approximately 55% males. Seventy-one percent were Caucasian and 25% were Black. Patients received doses ranging from 5/20 mg to 10/40 mg orally once daily. The overall incidence of adverse reactions on therapy with amlodipine and olmesartan medoxomil tablets were similar to that seen with corresponding doses of the individual components of amlodipine and olmesartan medoxomil tablets, and to placebo. The reported adverse reactions were generally mild…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
When pregnancy is detected, discontinue amlodipine and olmesartan medoxomil tablets as soon as possible ( 5.1 , 8.1 ). Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus ( 5.1 , 8.1 ). WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue amlodipine and olmesartan medoxomil tablets as soon as possible ( 5.1 , 8.1 ). Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.1 , 8.1 ).
Warnings
Important safety information
Anticipate hypotension in volume-or salt-depleted patients with treatment initiation. Start treatment under close supervision ( 5.2 ). Increased angina or myocardial infarction may occur upon dosage initiation or increase ( 5.3 ). Impaired renal function: changes in renal function may occur ( 5.4 ). Sprue-like enteropathy has been reported. Consider discontinuation of amlodipine and olmesartan medoxomil tablets in cases where no other etiology is found ( 5.6 ). 5.1 Fetal Toxicity Amlodipine and olmesartan medoxomil tablets can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue amlodipine and olmesartan medoxomil tablets as soon as possible [see Use in Specific Populations (8.1) ] . 5.2 Hypotension in Volume- or Salt-Depleted Patients Olmesartan medoxomil. In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients (e.g., those being treated with high doses of diuretics) symptomatic hypotension may be anticipated after initiation of treatment with olmesartan medoxomil. Initiate treatment with amlodipine and olmesartan medoxomil tablets under close medical supervision. If hypotension does occur, place the patient in the supine position and, if necessary, give an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized. Amlodipine. Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis.Because of the gradual onset of action, acute hypotension is unlikely. 5.3 Increased Angina or Myocardial Infarction Patients, particularly those with severe obstructive coronary artery disease, may develop increased frequency, duration, 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. 5.4 Impaired Renal Function Changes in renal function may be anticipated in susceptible individuals treated with olmesartan medoxomil as a consequence of inhibiting the renin-angiotensin-aldosterone system. In patients whose renal function may depend upon the activity of the renin-angiotensin-aldosterone system (e.g., patients with severe congestive heart failure), treatment with angiotensin converting enzyme inhibitors and angiotensin receptor antagonists has been associated with oliguria or progressive azotemia and (rarely) with acute renal failure and/or death. Similar effects may occur in patients treated with amlodipine and olmesartan medoxomil tablets because of the olmesartan medoxomil component[ see Drug Interactions (7) and Clinical Pharmacology (12.3) ]. In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or blood urea nitrogen (BUN) have been reported. There has been no long-term use of olmesartan medoxomil in patients with unilateral or bilateral renal artery stenosis, but similar effects would be expected with olmesartan medoxomil and amlodipine and olmesartan medoxomil tablets. 5.5 Patients with Hepatic Impairment Patients with hepatic impairment have decreased clearance of amlodipine. Starting amlodipine or adding amlodipine at 2.5 mg in hepatically impaired patients is recommended. The lowest dose of amlodipine and olmesartan medoxomil tablets is 5/20 mg; therefore, initial therapy with amlodipine and olmesartan medoxomil tablets is not recommended in hepatically impaired patients [see Use in Specific Populations (8.6) ]. Since amlodipine is extensively metabolized by the liver and the plasma elimination half-life (t 1/2 ) is 56 hours in patients with severely impaired hepatic function, titrate slowly when administering to patients with severe hepatic impairment. 5.6 Sprue-like Enteropathy Severe, chronic diarrhea with substantial weight loss has been reported in patients taking olmesartan months to years after drug initiation. Intestinal biopsies of patients often demonstrated villous atrophy. If a patient develops these symptoms during treatment with olmesartan, exclude other etiologies. Consider discontinuation of amlodipine and olmesartan medoxomil tablets in cases where no other etiology is identified. 5.7 Electrolyte Imbalances Amlodipine and olmesartan medoxomil tablets contain olmesartan, a drug that inhibits the renin-angiotensin system (RAS). Drugs that inhibit the RAS can cause hyperkalemia.Monitor serum electrolytes periodically.
Who should not take Amlodipine and Olmesartan Medoxomil
Do not co-administer aliskiren with amlodipine and olmesartan medoxomil tablets in patients with diabetes [ See Drug Interactions (7.2) ]. Do not co-administer aliskiren with amlodipine and olmesartan medoxomil tablets in patients with diabetes (4) .
Overdose — what happens if you take too much
There is no information on overdosage with amlodipine and olmesartan medoxomil tablets in humans. Amlodipine. 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. 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. 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. Olmesartan medoxomil. Limited data…
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
Amlodipine ( 7.1 ): If simvastatin is co-administered with amlodipine, do not exceed 20 mg daily of simvastatin. Increased exposure of cyclosporine and tacrolimus. Increased exposure of amlodipine when coadministered with CYP3A inhibitors. Olmesartan medoxomil ( 7.2 ): Nonsteroidal anti-inflammatory drugs (NSAIDS) may lead to increased risk of renal impairment and loss of antihypertensive effect. Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia. Colesevelam hydrochloride: Consider administering olmesartan at least 4 hours before colesevelam hydrochloride dose. Lithium: Increases in serum lithium concentrations and lithium toxicity. 7.1 Drug Interactions with Amlodipine 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) ]. CYP3A Inhibitors : Co-administration of amlodipine 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. 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. 7.2 Drug Interactions with Olmesartan Medoxomil Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors): In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including olmesartan medoxomil, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving olmesartan medoxomil and NSAID therapy. The antihypertensive effect of angiotensin II receptor antagonists, including olmesartan medoxomil may be attenuated by NSAIDs including selective COX-2 inhibitors. Dual Blockade of the Renin-Angiotensin System (RAS): Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on amlodipine and olmesartan medoxomil tablets and other agents that affect the RAS. Do not co-administer aliskiren with amlodipine and olmesartan medoxomil tablets in patients with diabetes [ see Contraindications (4) ]. Avoid use of aliskiren with amlodipine and olmesartan medoxomil tablets in patients with renal impairment (GFR <60 ml/min). Use with Colesevelam Hydrochloride: Concurrent administration of bile acid sequestering agent colesevelam hydrochloride reduces the systemic exposure and peak plasma concentration of olmesartan. Administration of olmesartan at least 4 hours prior to colesevelam hydrochloride decreased the drug interaction effect. Consider administering olmesartan at least 4 hours before the colesevelam hydrochloride dose [see Clinical Pharmacology (12.3) ] . Lithium: Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists, including amlodipine and olmesartan medoxomil tablets. Monitor serum lithium levels during concomitant use.
How long does Amlodipine Besylate and Olmesartan Medoxomil stay in your body?
The elimination half-life of amlodipine besylate and olmesartan medoxomil 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.
Dosage forms
Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- How is Amlodipine and Olmesartan Medoxomil rated?
- pharmaranks gives Amlodipine and Olmesartan Medoxomil a composite score of 3.5 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 and Olmesartan Medoxomil 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 and Olmesartan Medoxomil?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Amlodipine and Olmesartan Medoxomil. To pay less, Amlodipine and Olmesartan Medoxomil 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 and Olmesartan Medoxomil?
- Amlodipine and Olmesartan Medoxomil is marketed by Sciegen Pharms. You can see Sciegen Pharms's full profile, rating, and other products on pharmaranks.
- Is Amlodipine and Olmesartan Medoxomil a brand-name or generic drug?
- Amlodipine and Olmesartan Medoxomil is a generic medication; its active ingredient is Amlodipine Besylate and Olmesartan Medoxomil. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Amlodipine and Olmesartan Medoxomil available over the counter?
- No. Amlodipine and Olmesartan Medoxomil 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 and Olmesartan Medoxomil come in?
- Amlodipine and Olmesartan Medoxomil is currently marketed as tablet, per the FDA's National Drug Code Directory.
- Is Amlodipine and Olmesartan Medoxomil FDA-registered?
- Amlodipine and Olmesartan Medoxomil is on record with the U.S. FDA under application number ANDA209010. You can verify this on its official FDA label.
- Has Amlodipine and Olmesartan Medoxomil been recalled by the FDA?
- Amlodipine and Olmesartan Medoxomil 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 and Olmesartan Medoxomil safe?
- There's no single safe-or-not verdict. pharmaranks gives Amlodipine and Olmesartan Medoxomil a recall-safety score of 70/100, 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 and Olmesartan Medoxomil?
- Amlodipine and Olmesartan Medoxomil's side effects are taken directly from its FDA label. From the label: Most common adverse reaction (incidence ≥ 3%) is edema (6.1) . To report SUSPECTED ADVERSE REACTIONS, contact ScieGen Pharmaceuticals Inc. at 1-855-724-3436 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.… 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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amlodipine and olmesartan medoxomil
70/100