Olmesartan, sold under the brand name Benicar among others, is a medication used to treat high blood pressure (hypertension). It is taken orally (swallowed by mouth). Olmesartan is administered as the prodrug olmesartan medoxomil which is hydrolyzed by esterases to the active angiotensin II receptor blocker selective for the AT1 receptor, reducing vasoconstriction and aldosterone release to lower systemic vascular resistance and blood pressure. Clinically available doses are typically 5 mg to 40 mg once daily with a usual starting dose of 20 mg once daily for most adults; doses are adjusted for age, renal function, and concomitant antihypertensives. Versions are available as the combination olmesartan/hydrochlorothiazide and olmesartan/amlodipine, with additional technical details on formulation, prodrug activation, oral bioavailability, time to peak plasma concentration, and elimination half life that guide generic formulation and fixed dose combination development. Monitoring recommendations include periodic assessment of renal function and serum electrolytes, particularly potassium, when initiating or titrating therapy or when used with other renin angiotensin aldosterone system agents.
Parent: Olmesartan
Parent: Olmesartan
Parent: Olmesartan/ Irbesartan/ Losartan
Parent: Olmesartan
Parent: Olmesartan
Parent: Olmesartan
Parent: Olmesartan
Parent: Olmesartan
Parent: Olmesartan
Parent: Olmesartan
Parent: Olmesartan
Parent: Olmesartan
Parent: Olmesartan
Parent: Olmesartan
Parent: Olmesartan
Parent: Olmesartan / Losartan / Candesartan/ Irbesartan / Zidovudine
Parent: Olmesartan
Parent: Olmesartan
Parent: Olmesartan
Parent: Olmesartan
The impurity and related compound profile for olmesartan active substance typically includes process-related residues from synthesis, medoxomil-related fragments and the deesterified active form olmesartan, isomeric variants and low-level oxidative or hydrolytic degradants; specifications in regulatory monographs and approved marketing applications commonly control individual specified impurities to low tenths of a percent and total impurities to around or below 1.0 percent by weight to ensure product quality and safety. Typical limits seen in API specifications are individual related compounds not greater than 0.2 to 0.3 percent w/w and total identified and unidentified impurities not exceeding about 1.0 percent w/w, with tighter control for any known toxic or genotoxic impurities in accordance with ICH M7 and related guidance so that permitted daily exposure thresholds are not exceeded. Residual solvents are controlled per ICH Q3C class limits and elemental impurities per ICH Q3D, and validated analytical methods such as HPLC with mass detection are used for routine release testing and stability studies.
Olmesartan is used primarily to treat hypertension as monotherapy or in fixed dose combinations to achieve blood pressure control and reduce cardiovascular risk associated with uncontrolled high blood pressure.
Avoid pregnancy, concurrent use of potassium supplements or potassium sparing diuretics without monitoring because of hyperkalemia risk, and avoid sudden volume depletion; use caution with NSAIDs which may reduce renal function when combined with renin angiotensin system blockers and monitor electrolytes and renal function as advised by a prescriber.
Olmesartan is not inherently nephrotoxic for most patients but it can reduce glomerular filtration pressure in settings such as bilateral renal artery stenosis, severe volume depletion or when combined with other drugs that affect renal perfusion, so renal function should be monitored and therapy adjusted if serum creatinine rises significantly.
Olmesartan as a molecule remains approved and available, but specific product lots or brand formulations may be discontinued for business, manufacturing or regulatory reasons including recalls, safety signal reviews or litigation; rare safety reports such as sprue like enteropathy prompted safety communications rather than a global class withdrawal, and discontinuations are typically product specific rather than a reflection that the active ingredient is universally withdrawn.