Benicar for high blood pressure

Benicar

Generic Name: olmesartan (OL me SAR tan)
Brand Names: Benicar

Medically reviewed by Sanjai Sinha, MD Last updated on Mar 4, 2019.

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What is Benicar?

Benicar (olmesartan) is an angiotensin II receptor antagonist. Olmesartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.

Benicar is used to treat high blood pressure (hypertension) in adults and children who are at least 6 years old.

Benicar is sometimes given together with other blood pressure medications.

Important Information

Do not use if you are pregnant. Stop using Benicar and tell your doctor right away if you become pregnant. Olmesartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

If you have diabetes, do not use Benicar together with any medication that contains aliskiren (a blood pressure medicine – brand names include Amturnide, Tekturna, and Tekamlo).

You may also need to avoid taking olmesartan with aliskiren if you have kidney disease.

Before taking this medicine

You should not take Benicar if you are allergic to olmesartan.

To make sure Benicar is safe for you, tell your doctor if you have ever had:

  • liver disease;

  • congestive heart failure; or

  • if you are on a low salt diet.

Do not use if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away. Olmesartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

You should not breast-feed while using this medicine.

How should I take Benicar?

Take Benicar exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

You may take Benicar with or without food.

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.

You may have very low blood pressure while taking this medication. Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual.

Your blood pressure will need to be checked often.

Store at room temperature away from moisture and heat.

Benicar dosing information

Usual Adult Dose for Hypertension:

20 mg orally once a day; may increase dose to 40 mg in two weeks if further blood pressure reduction is needed.
Maximum dose: 40 mg orally once a day

-For patients with possible intravascular volume depletion (e.g., patients treated with diuretics, especially those with impaired renal function), initiate this drug under close supervision and give consideration to a lower starting dose.
-Twice daily dosing offers no additional benefit over the same total dose give once daily.

Usual Pediatric Dose for Hypertension:

6 to 16 years:
-20 to less than 35 kg: 10 mg orally once a day; may increase dose to 20 mg in two weeks if further blood pressure reduction is needed
-35 kg or more: 20 mg orally once a day; may increase dose to 40 mg in two weeks if further blood pressure reduction is needed

-For children who cannot swallow tablets, the same dose can be given using an extemporaneous suspension.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Benicar?

Drinking alcohol can increase certain side effects of Benicar.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Benicar side effects

Get emergency medical help if you have signs of an allergic reaction to Benicar: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;

  • little or no urination;

  • fast heart rate;

  • swelling in your hands or feet; or

  • high potassium level – nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement.

Common Benicar side effects may include:

  • dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Benicar?

Tell your doctor about all your other medicines, especially a diuretic or other blood pressure medicines.

Other drugs may interact with olmesartan, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Benicar only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2020 Cerner Multum, Inc. Version: 7.01.

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CLINICAL PHARMACOLOGY

Mechanism Of Action

Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation and renal reabsorption of sodium. Olmesartan blocks the vasoconstrictor effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in vascular smooth muscle. Its action is, therefore, independent of the pathways for angiotensin II synthesis.

An AT2 receptor is found also in many tissues, but this receptor is not known to be associated with cardiovascular homeostasis. Olmesartan has more than a 12,500-fold greater affinity for the AT1 receptor than for the AT2 receptor.

Blockade of the renin-angiotensin system with ACE inhibitors, which inhibit the biosynthesis of angiotensin II from angiotensin I, is a mechanism of many drugs used to treat hypertension. ACE inhibitors also inhibit the degradation of bradykinin, a reaction also catalyzed by ACE. Because olmesartan medoxomil does not inhibit ACE (kininase II), it does not affect the response to bradykinin. Whether this difference has clinical relevance is not yet known.

Blockade of the angiotensin II receptor inhibits the negative regulatory feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and circulating angiotensin II levels do not overcome the effect of olmesartan on blood pressure.

Pharmacodynamics

Benicar doses of 2.5 mg to 40 mg inhibit the pressor effects of angiotensin I infusion. The duration of the inhibitory effect was related to dose, with doses of Benicar > 40 mg giving > 90% inhibition at 24 hours.

Plasma concentrations of angiotensin I and angiotensin II and plasma renin activity (PRA) increase after single and repeated administration of Benicar to healthy subjects and hypertensive patients. Repeated administration of up to 80 mg Benicar had minimal influence on aldosterone levels and no effect on serum potassium.

Pharmacokinetics

Absorption

Olmesartan medoxomil is rapidly and completely bioactivated by ester hydrolysis to olmesartan during absorption from the gastrointestinal tract.

Benicar tablets and the suspension formulation prepared from Benicar tablets are bioequivalent .

The absolute bioavailability of olmesartan is approximately 26%. After oral administration, the peak plasma concentration (Cmax) of olmesartan is reached after 1 to 2 hours. Food does not affect the bioavailability of olmesartan.

Distribution

The volume of distribution of olmesartan is approximately 17 L. Olmesartan is highly bound to plasma proteins (99%) and does not penetrate red blood cells. The protein binding is constant at plasma olmesartan concentrations well above the range achieved with recommended doses.

In rats, olmesartan crossed the blood-brain barrier poorly, if at all. Olmesartan passed across the placental barrier in rats and was distributed to the fetus. Olmesartan was distributed to milk at low levels in rats.

Metabolism And Excretion

Following the rapid and complete conversion of olmesartan medoxomil to olmesartan during absorption, there is virtually no further metabolism of olmesartan. Total plasma clearance of olmesartan is 1.3 L/h, with a renal clearance of 0.6 L/h. Approximately 35% to 50% of the absorbed dose is recovered in urine while the remainder is eliminated in feces via the bile.

Olmesartan appears to be eliminated in a biphasic manner with a terminal elimination half-life of approximately 13 hours. Olmesartan shows linear pharmacokinetics following single oral doses of up to 320 mg and multiple oral doses of up to 80 mg. Steady-state levels of olmesartan are achieved within 3 to 5 days and no accumulation in plasma occurs with once-daily dosing.

Geriatric

The pharmacokinetics of olmesartan were studied in the elderly ( ≥ 65 years). Overall, maximum plasma concentrations of olmesartan were similar in young adults and the elderly. Modest accumulation of olmesartan was observed in the elderly with repeated dosing; AUCss,τ, was 33% higher in elderly patients, corresponding to an approximate 30% reduction in CLR .

Pediatric

The pharmacokinetics of olmesartan were studied in pediatric hypertensive patients aged 1 to16 years. The clearance of olmesartan in pediatric patients was similar to that in adult patients when adjusted by the body weight .

Olmesartan pharmacokinetics have not been investigated in pediatric patients less than 1 year of age .

Gender

Minor differences were observed in the pharmacokinetics of olmesartan in women compared to men. AUC and Cmax were 10-15% higher in women than in men.

Hepatic Insufficiency

Increases in AUC0-∞ and Cmax were observed in patients with moderate hepatic impairment compared to those in matched controls, with an increase in AUC of about 60% .

Renal Insufficiency

In patients with renal insufficiency, serum concentrations of olmesartan were elevated compared to subjects with normal renal function. After repeated dosing, the AUC was approximately tripled in patients with severe renal impairment (creatinine clearance < 20 mL/min). The pharmacokinetics of olmesartan in patients undergoing hemodialysis has not been studied .

Drug Interactions

Bile Acid Sequestering Agent Colesevelam

Concomitant administration of 40 mg olmesartan medoxomil and 3750 mg colesevelam hydrochloride in healthy subjects resulted in 28% reduction in Cmax and 39% reduction in AUC of olmesartan. Lesser effects, 4% and 15% reduction in Cmax and AUC respectively, were observed when olmesartan medoxomil was administered 4 hours prior to colesevelam hydrochloride .

Animal Toxicology And/Or Pharmacology

Reproductive Toxicology Studies

No teratogenic effects were observed when olmesartan medoxomil was administered to pregnant rats at oral doses up to 1000 mg/kg/day (240 times the maximum recommended human dose of olmesartan medoxomil on a mg/m² basis) or pregnant rabbits at oral doses up to 1 mg/kg/day (half the MRHD on a mg/m² basis; higher doses could not be evaluated for effects on fetal development as they were lethal to the does). In rats, significant decreases in pup birth weight and weight gain were observed at doses ≥ 1.6 mg/kg/day, and delays in developmental milestones (delayed separation of ear auricula, eruption of lower incisors, appearance of abdominal hair, descent of testes, and separation of eyelids) and dose-dependent increases in the incidence of dilation of the renal pelvis were observed at doses ≥ 8 mg/kg/day. The no observed effect dose for developmental toxicity in rats is 0.3 mg/kg/day, about one-tenth the MRHD of 40 mg/day.

Clinical Studies

Adult Hypertension

The antihypertensive effects of Benicar have been demonstrated in seven placebo controlled studies at doses ranging from 2.5 mg to 80 mg for 6 to 12 weeks, each showing statistically significant reductions in peak and trough blood pressure. A total of 2693 patients (2145 Benicar; 548 placebo) with essential hypertension were studied. Benicar once daily lowered diastolic and systolic blood pressure. The response was dose-related, as shown in the following graph. A Benicar dose of 20 mg daily produces a trough sitting BP reduction over placebo of about 10/6 mmHg and a dose of 40 mg daily produces a trough sitting BP reduction over placebo of about 12/7 mmHg. Benicar doses greater than 40 mg had little additional effect. The onset of the antihypertensive effect occurred within 1 week and was largely manifest after 2 weeks.

Data above are from seven placebo-controlled studies (2145 Benicar patients, 548 placebo patients). The blood pressure lowering effect was maintained throughout the 24-hour period with Benicar once daily, with trough-to-peak ratios for systolic and diastolic response between 60 and 80%.

The blood pressure lowering effect of Benicar, with and without hydrochlorothiazide, was maintained in patients treated for up to 1 year. There was no evidence of tachyphylaxis during long-term treatment with Benicar or rebound effect following abrupt withdrawal of olmesartan medoxomil after 1 year of treatment.

The antihypertensive effect of Benicar was similar in men and women and in patients older and younger than 65 years. The effect was smaller in black patients (usually a low renin population), as has been seen with ACE inhibitors, beta-blockers and other angiotensin receptor blockers. Benicar had an additional blood pressure lowering effect when added to hydrochlorothiazide.

There are no trials of Benicar demonstrating reductions in cardiovascular risk in patients with hypertension, but at least one pharmacologically similar drug has demonstrated such benefits.

Pediatric Hypertension

The antihypertensive effects of Benicar in the pediatric population were evaluated in a randomized, double-blind study involving 302 hypertensive patients aged 6 to 16 years. The study population consisted of an all black cohort of 112 patients and a mixed racial cohort of 190 patients, including 38 blacks. The etiology of the hypertension was predominantly essential hypertension (87% of the black cohort and 67% of the mixed cohort). Patients who weighed 20 to < 35 kg were randomized to 2.5 or 20 mg of Benicar once daily and patients who weighed ≥ 35 kg were randomized to 5 or 40 mg of Benicar once daily. At the end of 3 weeks, patients were re-randomized to continuing Benicar or to taking placebo for up to 2 weeks. During the initial dose-response phase, Benicar significantly reduced both systolic and diastolic blood pressure in a weight-adjusted dose-dependent manner. Overall, the two dose levels of Benicar (low and high) significantly reduced systolic blood pressure by 6.6 and 11.9 mmHg from the baseline, respectively. These reductions in systolic blood pressure included both drug and placebo effect. During the randomized withdrawal to placebo phase, mean systolic blood pressure at trough was 3.2 mmHg lower and mean diastolic blood pressure at trough was 2.8 mmHg lower in patients continuing Benicar than in patients withdrawn to placebo. These differences were statistically different. As observed in adult populations, the blood pressure reductions were smaller in black patients.

In the same study, 59 patients aged 1 to 5 years who weighed ≥ 5 kg received 0.3 mg/kg of Benicar once daily for three weeks in an open label phase and then were randomized to receiving Benicar or placebo in a double-blind phase. At the end of the second week of withdrawal, the mean systolic/diastolic blood pressure at trough was 3/3 mmHg lower in the group randomized to Benicar; this difference in blood pressure was not statistically significant (95% C.I. -2 to 7/-1 to 7).

Blood Pressure Medication Benicar Can Have Serious Side Effects

July 31, 2014 8:46 am | Tags: benicar, high blood pressure, medication, side effects | Categorised in: Defective Drugs, Personal Injury

No drug is a good drug. It is always better to live off medication rather than on medication. But some medical conditions demand medical attention and many times demand drug therapy to control the negative health condition present without the medication. One such condition is high blood pressure (HBP). HBP is a common and growing problem in American, and fortunately there are a lot of solutions. The most common and easiest solution is to take a consistent and therapeutic dose of blood pressure medication. The problem becomes which one to take. There are lots of solid and well documented safe choices on the market.

One choice that has proven to be less than safe is Benicar (also called Olmesartan Medomoxil). Benicar is one of the popular blood pressure drug therapy choices that people have. The problem with Benicar is that there is a terrible side effect that the drug can cause called “sprue-like enteropathy.” Only a small number of Benicar users will experience sprue-like enterpathy, but for those numbers the situation is terrible. Instead of helping, the medication turns deadly and literally attacks the food-absorbing cells in the small intestine and kills them. Those people experiencing this will suffer a number of side effects, starting with weight loss and dehydration, but also going onto chronic diarrhea and long term malnutrition, which can lead to liver and kidney/renal failure.

There are many Benicar users who don’t understand what is happening to their bodies and who continue to suffer from this condition. They can’t figure out what is wrong and that it is their own blood pressure medication causing them such problems.

We are working with victims of Benicar to file lawsuits on their behalf. One man was on Benicar for more than 4 years before his gastroenterologist recognized it was the Benicar that was the thing causing this poor man’s terrible symptoms. The problem is that this was unknown until June 2012 when the medical study from the Mayo Clinic was published. This study provided the link between Benicar and these awful symptoms. Once this was known there was an adverse events report that was published in July 2013. We have reviewed that adverse events report as set out by the Food and Drug Administration (FDA). In that report the FDA forced the Benicar Company to re-label their produce and add a legible warning to warn about the horrible side effects of Benicar that cause chronic diarrhea, massive weight loss, dehydration, vomiting and overall malnutrition.

If you or a loved one took Benicar and now have some of these negative symptoms, do not wait. Seek help immediately.

Image courtesy of freedigitalphotos.net by amenic181

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