What is Olmetrol?
Olmetrol is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. Lowering blood pressure can reduce the risk of strokes and heart attacks.
Olmetrol is an angiotensin II receptor blocker (ARB). It works by blocking a substance in the body that causes the blood vessels to tighten. As a result, Olmetrol relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.
Olmetrol is available only with your doctor's prescription.
Olmetrol indications
Olmetrol is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with Olmetrol.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
It may be used alone or in combination with other antihypertensive agents.
How should I use Olmetrol?
Use Olmetrol as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Olmetrol by mouth with or without food.
- If you cannot swallow tablets, ask your doctor or pharmacist about preparing a suspension of Olmetrol.
- If you also take colesevelam, take it at least 4 hours after you take Olmetrol.
- Take Olmetrol on a regular schedule to get the most benefit from it. Taking Olmetrol at the same time each day will help you remember to take it.
- Continue to take Olmetrol even if you feel well. Do not miss any doses.
- If you miss a dose of Olmetrol, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Olmetrol.
Uses of Olmetrol in details
Olmetrol is used to treat high blood pressure (hypertension), prevention and treatment of heart attack (Myocardial Infarction) and heart failure; when heart is unable to pump sufficient blood. It is also used in patients of diabetes with kidney failure.
Olmetrol description
Each film-coated tablet contains olmesartan medoxomil 20 mg and 40 mg, respectively. It also contains the following excipients: Titanium dioxide and ferric oxide yellow (40 mg only).
Olmetrol medoxomil, a prodrug, is hydrolyzed to Olmetrol during absorption from the gastrointestinal tract. Olmetrol is a selective AT1 subtype angiotensin II receptor antagonist. Olmetrol medoxomil is described chemically as 2,3-dihydroxy-2-butenyl 4-(1 hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-Carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6 and its molecular weight is 558.59.
Olmetrol dosage
Olmetrol Dosage
Generic name: Olmetrol MEDOXOMIL 5mg
Dosage form: tablet, film coated
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Adult Hypertension
Dosage must be individualized. The usual recommended starting dose of Olmetrol is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Olmetrol may be increased to 40 mg. Doses above 40 mg do not appear to have greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily.
No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40 mL/min) or with moderate to marked hepatic dysfunction. For patients with possible depletion of intravascular volume (e.g., patients treated with diuretics, particularly those with impaired renal function), initiate Olmetrol under close medical supervision and give consideration to use of a lower starting dose.
Olmetrol may be administered with or without food.
If blood pressure is not controlled by Olmetrol alone, a diuretic may be added. Olmetrol may be administered with other antihypertensive agents.
Pediatric Hypertension (6 to 16 years of age)
Dosage must be individualized. For children who can swallow tablets, the usual recommended starting dose of Olmetrol is 10 mg once daily for patients who weigh 20 to <35 kg (44 to 77 lb), or 20 mg once daily for patients who weigh ≥35 kg. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Olmetrol may be increased to a maximum of 20 mg once daily for patients who weigh <35 kg or 40 mg once daily for patients who weigh ≥35 kg.
Children <1 year of age must not receive Olmetrol for hypertension.
For children who cannot swallow tablets, the same dose can be given using an extemporaneous suspension as described below. Follow the suspension preparation instructions below to administer Olmetrol as a suspension.
Preparation of Suspension (for 200 mL of a 2 mg/mL suspension)
Add 50 mL of Purified Water to an amber polyethylene terephthalate (PET) bottle containing twenty Olmetrol 20 mg tablets and allow to stand for a minimum of 5 minutes. Shake the container for at least 1 minute and allow the suspension to stand for at least 1 minute. Repeat 1-minute shaking and 1-minute standing for four additional times. Add 100 mL of Ora-Sweet®* and 50 mL of Ora-Plus®* to the suspension and shake well for at least 1 minute. The suspension should be refrigerated at 2-8°C (36-46°F) and can be stored for up to 4 weeks. Shake the suspension well before each use and return promptly to the refrigerator.
* Ora-Sweet® and Ora-Plus® are registered trademarks of Paddock Laboratories, Inc.
More about Olmetrol (Olmetrol)
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Consumer resources
- Olmetrol
- Olmetrol (Advanced Reading)
Professional resources
- Olmetrol (FDA)
- Olmetrol Medoxomil (AHFS Monograph)
Other formulations
- Olmetrol HCT
Related treatment guides
- High Blood Pressure
- Migraine Prevention
Olmetrol interactions
See also:
What other drugs will affect Olmetrol?
No significant drug interactions were reported in studies in which Olmetrol was co-administered with digoxin or warfarin in healthy volunteers.
The bioavailability of Olmetrol was not significantly altered by the co-administration of antacids [Al(OH)].
Olmetrol medoxomil is not metabolized by the cytochrome P450 system and has no effects on P450 enzymes; thus, interactions with drugs that inhibit, induce, or are metabolized by those enzymes are not expected.
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 Olmetrol 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 Olmetrol medoxomil and NSAID therapy.
The antihypertensive effect of angiotensin II receptor antagonists, including Olmetrol 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 Olmetrol and other agents that affect the RAS.
Do not co-administer aliskiren with Olmetrol in patients with diabetes. Avoid use of aliskiren with Olmetrol in patients with renal impairment (GFR < 60 ml/min).
Colesevelam Hydrochloride
Concurrent administration of bile acid sequestering agent colesevelam hydrochloride reduces the systemic exposure and peak plasma concentration of Olmetrol. Administration of Olmetrol at least 4 hours prior to colesevelam hydrochloride decreased the drug interaction effect. Consider administering Olmetrol at least 4 hours before the colesevelam hydrochloride dose.
Lithium
Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists, including Olmetrol. Monitor serum lithium levels during concomitant use.
Olmetrol side effects
See also:
What are the possible side effects of Olmetrol?
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.
Adult Hypertension
Olmetrol has been evaluated for safety in more than 3825 patients/subjects, including more than 3275 patients treated for hypertension in controlled trials. This experience included about 900 patients treated for at least 6 months and more than 525 for at least 1 year. Treatment with Olmetrol was well tolerated, with an incidence of adverse reactions similar to placebo. Events generally were mild, transient and had no relationship to the dose of Olmetrol.
The overall frequency of adverse reactions was not dose-related. Analysis of gender, age and race groups demonstrated no differences between Olmetrol and placebo-treated patients. The rate of withdrawals due to adverse reactions in all trials of hypertensive patients was 2.4% (i.e., 79/3278) of patients treated with Olmetrol and 2.7% (i.e., 32/1179) of control patients. In placebo-controlled trials, the only adverse reaction that occurred in more than 1% of patients treated with Olmetrol and at a higher incidence versus placebo was dizziness (3% vs. 1%).
The following adverse reactions occurred in placebo-controlled clinical trials at an incidence of more than 1% of patients treated with Olmetrol, but also occurred at about the same or greater incidence in patients receiving placebo: back pain, bronchitis, creatine phosphokinase increased, diarrhea, headache, hematuria, hyperglycemia, hypertriglyceridemia, influenza-like symptoms, pharyngitis, rhinitis and sinusitis.
The incidence of cough was similar in placebo (0.7%) and Olmetrol (0.9%) patients.
Other potentially important adverse reactions that have been reported with an incidence of greater than 0.5%, whether or not attributed to treatment, in the more than 3100 hypertensive patients treated with Olmetrol monotherapy in controlled or open-label trials are listed below.
Body as a Whole: chest pain, peripheral edema
Central and Peripheral Nervous System: vertigo
Gastrointestinal: abdominal pain, dyspepsia, gastroenteritis, nausea
Heart Rate and Rhythm Disorders: tachycardia
Metabolic and Nutritional Disorders: hypercholesterolemia, hyperlipemia, hyperuricemia
Musculoskeletal: arthralgia, arthritis, myalgia
Skin and Appendages: rash
Facial edema was reported in five patients receiving Olmetrol. Angioedema has been reported with angiotensin II antagonists.
Laboratory Test Findings: In controlled clinical trials, clinically important changes in standard laboratory parameters were rarely associated with administration of Olmetrol.
Hemoglobin and Hematocrit: Small decreases in hemoglobin and hematocrit (mean decreases of approximately 0.3 g/dL and 0.3 volume percent, respectively) were observed.
Liver Function Tests: Elevations of liver enzymes and/or serum bilirubin were observed infrequently. Five patients (0.1%) assigned to Olmetrol and one patient (0.2%) assigned to placebo in clinical trials were withdrawn because of abnormal liver chemistries (transaminases or total bilirubin). Of the five Olmetrol patients, three had elevated transaminases, which were attributed to alcohol use, and one had a single elevated bilirubin value, which normalized while treatment continued.
Pediatric Hypertension
No relevant differences were identified between the adverse experience profile for pediatric patients aged 1 to16 years and that previously reported for adult patients.
Post-Marketing Experience
The following adverse reactions have been reported in post-marketing experience. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Body as a Whole: Asthenia, angioedema, anaphylactic reactions
Gastrointestinal: Vomiting, sprue-like enteropathy
Metabolic and Nutritional Disorders: Hyperkalemia
Musculoskeletal: Rhabdomyolysis
Urogenital System: Acute renal failure, increased blood creatinine levels
Skin and Appendages: Alopecia, pruritus, urticaria
Data from one controlled trial and an epidemiologic study have suggested that high-dose Olmetrol may increase cardiovascular (CV) risk in diabetic patients, but the overall data are not conclusive. The randomized, placebo-controlled, double-blind ROADMAP trial (Randomized Olmetrol And Diabetes MicroAlbuminuria Prevention trial, n=4447) examined the use of Olmetrol, 40 mg daily, vs. placebo in patients with type 2 diabetes mellitus, normoalbuminuria, and at least one additional risk factor for CV disease. The trial met its primary endpoint, delayed onset of microalbuminuria, but Olmetrol had no beneficial effect on decline in glomerular filtration rate (GFR). There was a finding of increased CV mortality (adjudicated sudden cardiac death, fatal myocardial infarction, fatal stroke, revascularization death) in the Olmetrol group compared to the placebo group (15 Olmetrol vs. 3 placebo, HR 4.9, 95% confidence interval [CI], 1.4, 17), but the risk of non-fatal myocardial infarction was lower with Olmetrol (HR 0.64, 95% CI 0.35, 1.18).
The epidemiologic study included patients 65 years and older with overall exposure of > 300,000 patient-years. In the sub-group of diabetic patients receiving high-dose Olmetrol (40 mg/d) for > 6 months, there appeared to be an increased risk of death (HR 2.0, 95% CI 1.1, 3.8) compared to similar patients taking other angiotensin receptor blockers. In contrast, high-dose Olmetrol use in non-diabetic patients appeared to be associated with a decreased risk of death (HR 0.46, 95% CI 0.24, 0.86) compared to similar patients taking other angiotensin receptor blockers. No differences were observed between the groups receiving lower doses of Olmetrol compared to other angiotensin blockers or those receiving therapy for < 6 months.
Overall, these data raise a concern of a possible increased CV risk associated with the use of high-dose Olmetrol in diabetic patients. There are, however, concerns with the credibility of the finding of increased CV risk, notably the observation in the large epidemiologic study for a survival benefit in non-diabetics of a magnitude similar to the adverse finding in diabetics.
Olmetrol contraindications
See also:
What is the most important information I should know about Olmetrol?
Stop using this medication and tell your doctor right away if you become pregnant. Olmetrol can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.
You should not use this medication if you are allergic to Olmetrol.
Drinking alcohol can further lower your blood pressure and may increase certain side effects of Olmetrol.
Do not use potassium supplements or salt substitutes while you are taking Olmetrol, unless your doctor has told you to.
Your blood pressure will need to be checked often. Visit your doctor regularly.
Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.
Active ingredient matches for Olmetrol:
Olmesartan in India.
| Unit description / dosage (Manufacturer) | Price, USD |
| OLMETROL tab 20 mg x 10's (Ikon) | $ 1.01 |
| OLMETROL tab 40 mg x 10's (Ikon) | $ 1.56 |
List of Olmetrol substitutes (brand and generic names): | |
| OLMETIME | |
| Olmetime 40mg Tablet (Mankind Pharma Ltd) | $ 0.10 |
| OLMETUS | |
| OLMETUS 20MG TABLET 1 strip / 10 tablets each (Aretaeus Pharmaceuticals) | $ 0.94 |
| OLMINOR | |
| OLMINOR 20MG TABLET 1 strip / 10 tablets each (Elinor Pharmaceuticals Pvt Ltd) | $ 0.72 |
| Olmistal | |
| Olmistal 10mg Tablet (Stallion Laboratories Pvt Ltd) | $ 0.05 |
| Olmistal 20mg Tablet (Stallion Laboratories Pvt Ltd) | $ 0.09 |
| OLMO | |
| OLMO 20 MG TABLET 1 strip / 10 tablets each (Knoll Pharmaceuticals Ltd) | $ 1.01 |
| OLMO 40 MG TABLET 1 strip / 10 tablets each (Knoll Pharmaceuticals Ltd) | $ 1.79 |
| Olmo 20mg Tablet (Knoll Pharmaceuticals Ltd) | $ 0.10 |
| Olmo 40mg Tablet (Knoll Pharmaceuticals Ltd) | $ 0.18 |
| OLMORE | |
| OLMORE 20 MG TABLET 1 strip / 10 tablets each (Morepen Laboratories Ltd) | $ 1.01 |
| OLMORE 40MG TABLET 1 strip / 10 tablets each (Morepen Laboratories Ltd) | $ 1.20 |
| Olmore 20mg Tablet (Morepen Laboratories Ltd) | $ 0.10 |
| Olmore 40mg Tablet (Morepen Laboratories Ltd) | $ 0.12 |
| OLRAAS | |
| OLRAAS 40 MG TABLET 1 strip / 10 tablets each (RPG LS) | $ 1.48 |
| OLRAAS tab 20 mg x 10's (RPG LS) | $ 0.72 |
| OLRAAS tab 40 mg x 10's (RPG LS) | $ 1.35 |
| Olraas 40mg Tablet (RPG LS) | $ 0.15 |
| OLSAC | |
| OLSAC CAPSULE 1 strip / 10 capsules each (Maxamus International) | $ 1.33 |
| OLSAM (India) | |
| OLSAM film-coated tab 20 mg x 10's (Alde Medi) | |
| OLSAM film-coated tab 40 mg x 10's (Alde Medi) | |
| OLSAVAS | |
| OLSAVAS 20 MG TABLET 1 strip / 10 tablets each (Orchid Chemicals & Pharmaceuticals Ltd) | $ 0.81 |
| OLSAVAS 40 MG TABLET 1 strip / 10 tablets each (Orchid Chemicals & Pharmaceuticals Ltd) | $ 1.45 |
| Olsavas 20mg Tablet (Orchid Chemicals & Pharmaceuticals Ltd) | $ 0.08 |
| Olsavas 40mg Tablet (Orchid Chemicals & Pharmaceuticals Ltd) | $ 0.14 |
| Olsem | |
| Olsem 20mg Tablet (Alde Medi Impex Ltd) | $ 0.09 |
| Olsem 40mg Tablet (Alde Medi Impex Ltd) | $ 0.12 |
| Olsem CH 40mg/12.5mg Tablet (Alde Medi Impex Ltd) | $ 0.14 |
| OLSERTAIN ACTIVE | |
| OLSERTAIN ACTIVE 20 MG TABLET 1 strip / 30 tablets each (Dr Reddy's Laboratories Ltd) | $ 1.36 |
| OLSERTAIN ACTIVE 40 MG TABLET 1 strip / 30 tablets each (Dr Reddy's Laboratories Ltd) | $ 2.31 |
| Olsertain Active 40mg Tablet (Dr Reddy's Laboratories Ltd) | $ 0.08 |
| OLSI | |
| OLSI 40 MG TABLET 1 strip / 10 tablets each (C M R Life Sciences) | $ 1.52 |
| OLSTAN | |
| Olstan 40mg Tablet (Biochem Pharmaceutical Industries) | $ 0.11 |
| Olstan H Tablet (Elder Pharmaceuticals Ltd) | $ 0.29 |
| OLTAS | |
| OLTAS 20 MG TABLET 1 strip / 10 tablets each (Tas Med India Pvt Ltd) | $ 0.71 |
| OLTAS 40 MG TABLET 1 strip / 10 tablets each (Tas Med India Pvt Ltd) | $ 0.98 |
| Oltas 20mg Tablet (Tas Med India Pvt Ltd) | $ 0.07 |
| Oltas 40mg Tablet (Tas Med India Pvt Ltd) | $ 0.10 |
| OLVANCE | |
| 20 mg x 10's (Ranbaxy Laboratories Ltd.,) | $ 0.98 |
| 40 mg x 10's (Ranbaxy Laboratories Ltd.,) | $ 1.75 |
| Olvance 20 mg Tablet (Ranbaxy Laboratories Ltd.,) | $ 0.10 |
| Olvance 40 mg Tablet (Ranbaxy Laboratories Ltd.,) | $ 0.17 |
| Olvance 20mg TAB / 10 (Ranbaxy Laboratories Ltd.,) | $ 0.98 |
See 184 substitutes for Olmetrol | |
References
- PubChem. "Olmesartan". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "Olmesartan". http://www.drugbank.ca/drugs/DB00275 (accessed September 17, 2018).
- DTP/NCI. "Olmesartan: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Olmetrol are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Olmetrol. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported useful
No survey data has been collected yetConsumer reported price estimates
No survey data has been collected yetConsumer reported time for results
No survey data has been collected yet2 consumers reported age
| Users | % | ||
|---|---|---|---|
| > 60 | 2 | 100.0% | |
Consumer reviews
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Information checked by Dr. Sachin Kumar, MD Pharmacology
