olmesartan medoxomil

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olmesartan medoxomil

Benicar, Olmetec (UK)

Pharmacologic class: Angiotensin II type 1-receptor antagonist

Therapeutic class: Antihypertensive

Pregnancy risk category C (first trimester), D (second and third trimesters)

Pregnancy risk category C (first trimester), D (second and third trimesters)

FDA Box Warning

• When used during second or third trimester of pregnancy, drug may cause fetal harm or death. Discontinue as soon as possible when pregnancy is detected.


Selectively blocks binding of angiotensin II to specific tissue receptors in vascular smooth muscle and adrenal gland. This action blocks vasoconstrictive effects of renin-angiotensin system as well as aldosterone release, thereby reducing blood pressure and possibly preventing vascular remodeling related to arteriosclerosis.


Tablets: 5 mg, 20 mg, 40 mg

Indications and dosages


Adults and children ages 6 to 16 weighing more than 35 kg (77 lb): 20 mg P.O. once daily; may titrate to 40 mg daily after 2 weeks, if needed

Children ages 6 to 16 weighing 20 kg (44 lb) to less than 35 kg (77 lb): 10 mg P.O. daily; may titrate to 20 mg daily after 2 weeks, if needed.

Dosage adjustment

• Volume depletion


• Hypersensitivity to drug or its components


Use cautiously in:
• hepatic disease, renal dysfunction, hypovolemia, sodium depletion
• elderly patients
• pregnant patients (first trimester; not recommended in second and third trimesters)
• breastfeeding patients
• children (safety and efficacy not established).


• Give with or without food.
• Know that drug may be used alone or with other antihypertensives.

Adverse reactions

CNS: fatigue, dizziness, headache, insomnia

CV: orthostatic hypotension, chest pain, peripheral edema, syncope, tachycardia

EENT: sinusitis, rhinitis, pharyngitis

GI: nausea, diarrhea, constipation, abdominal pain, dry mouth

GU: hematuria

Hematologic: hyperglycemia

Musculoskeletal: back pain, arthritis, muscle weakness

Respiratory: upper respiratory infection symptoms, bronchitis, cough

Skin: dry skin, rash, inflammation, pruritus, alopecia, angioedema

Other: dental pain, flulike symptoms


Drug-diagnostic tests.Triglycerides: increased level

Drug-herbs.Ephedra (ma huang): antagonism of antihypertensive effect

Patient monitoring

• Monitor vital signs and cardiovascular status. Stay alert for orthostatic hypotension, syncope, and peripheral edema.
• Check temperature and watch for signs and symptoms of flu and other infections (especially respiratory and EENT infections).
• Watch for angioedema.
• In volume-depleted patient, monitor blood pressure carefully after initial dose. Transient blood pressure drop may occur.

Patient teaching

• Tell patient to take at same time each day, with or without food.
• Advise patient to promptly report signs and symptoms of infection, particularly respiratory symptoms.
• Inform patient that when he begins therapy, inadequate fluid intake, excessive perspiration, vomiting, or diarrhea may cause blood pressure to drop. Tell him to change position slowly to avoid dizziness or fainting.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.

Tell female patient to notify pre-scriber immediately if she suspects pregnancy.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the tests and herbs mentioned above.

olmesartan medoxomil

an antihypertensive agent.


An angiotensin-II receptor blocker used as a monotherapy or with other agents to manage hypertension.
Adverse effects

olmesartan medoxomil

A selective angiotensin II receptor antagonist drug used to treat high blood pressure. The drug is effective on a once-a-day dosage. It is a prodrug that is converted to olmesartan by esterases present in the intestine and portal vein blood.
References in periodicals archive ?
Compared with other ARBs, olmesartan medoxomil has distinctive pharmacokinetic properties.
Competition pattern of olmesartan medoxomil manufacturers from Menet indicates that olmesartan medoxomil produced by Beijing Winsunny Pharmaceutical Co.
Currently, olmesartan medoxomil is an angiotensin II receptor blocker approved in 32 countries worldwide and marketed in Japan under the trade name of Olmetec.
Sevikar HCT(R) is indicated as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide, taken as a dual-component (olmesartan medoxomil and amlodipine or olmesartan medoxomil and hydrochlorothiazide) and a single-component formulation ( hydrochlorothiazide or amlodipine).
Olmesartan medoxomil, Olmetec(r), is an orally active, selective angiotensin II receptor (type AT(1)) antagonist, which is one of a class of agents known more commonly as angiotensin-receptor blockers (ARBs).
May 23, 2011 /PRNewswire/ -- Data evaluating the long-term efficacy and safety of olmesartan medoxomil, amlodipine besylate, plus hydrochlorothiazide (OM/AML + HCTZ) in patients with hypertension aged <65 years and greater than or equal to 65 years, showed that the triple therapy at Week 52 was both well-tolerated and effective in maintaining the blood pressure reductions seen in the pivotal study regardless of age.
Additionally, Sankyo discovered, developed, manufactures and markets pravastatin sodium and olmesartan medoxomil, an angiotensin II receptor blocker (ARB).
Olmesartan Medoxomil Versus Losartan in Patients with Mild to
In two phase 3 studies, azilsartan medoxomil combined in a fixed-dose with CLD lowered clinic systolic blood pressure (SBP) significantly more than the fixed-dose combination of olmesartan medoxomil plus hydrochlorothiazide (HCTZ).
The olmesartan medoxomil NDA is presently under review at the FDA.
Pivotal phase 3 studies showed EDARBI (80 mg/day) was statistically superior to the highest approved doses of two commonly prescribed ARBs, olmesartan medoxomil (40 mg/day) and valsartan (320 mg/day), in lowering both clinic systolic blood pressure (SBP) and 24-hour mean SBP as measured by Ambulatory Blood Pressure Monitoring (ABPM).
Under this contract, the granting of rebates in accordance with A* 130a SGB V, Section 8 by the pharmaceutical company for all drugs with the designation A poll / vote and Vocado A plus A / Vocado A HCT with the drug Olmesarten medoxomil olmesartan medoxomil or the active compound combinations / hydrochlorothiazide, olmesartan medoxomil / amlodipine and olmesartan medoxomil / amlodipine / HCTZ.