Olmesartan

The selected single-ingredient tablets treat hypertension in adults and children aged 6 years or older, alone or with other antihypertensives. Lowering BP reduces cardiovascular risk generally; the label states that no controlled trial demonstrates cardiovascular risk reduction specifically with this product.

Effectiveness below age 6 has not been demonstrated; use below age 1 is not recommended because RAS blockade can affect kidney development. BPH, diabetic nephropathy prevention, HFrEF-specific therapy and olmesartan/HCTZ or amlodipine combinations are not dose indications supplied by this monograph.

Treatment combines individualized BP control with lifestyle and broader cardiovascular-risk management. The current 2025adult guideline supports home BP monitoring and, for stage 2 hypertension, two first-line agents, often in one pill. This does not change the single-product label or its pediatric dose limits.

Start 20 mg once daily in a patient who is not volume-contracted. If further lowering is needed after 2 weeks, increase to 40 mg once daily. Above 40 mg shows no greater BP effect; twice-daily administration has no advantage over the same daily total. In possible volume depletion, use close supervision and consider a lower start. Food does not affect bioavailability.

For a child unable to swallow tablets, the label permits the same dose as its specific 2 mg/mL suspension. Preparation of 200 mL: put twenty 20 mg tablets in an amber PET bottle, add 50 mL purified water and stand at least 5 minutes. Shake at least 1 minute and stand at least 1 minute, then repeat that shaking/standing cycle four more times. Add 100 mL Ora-Sweet and 50 mL Ora-Plus; shake at least 1 minute. Refrigerate at 2–8°C for up to 4 weeks; shake well before every dose and return promptly to the refrigerator. This is a pharmacy preparation recipe, not a licensed ready-to-use solution or permission to substitute vehicles.

The selected label requires no initial adjustment for moderate-to-marked renal impairment (CrCl below 40 mL/min) or moderate-to-marked hepatic dysfunction. This does not eliminate monitoring or override a lower supervised start for volume depletion. Severe renal impairment increases exposure; hemodialysis PK has not been studied. No dialysis supplement or validated pediatric renal-adjustment table is supplied.

Use the prescribed tablets or accurately measured labeled suspension. At 2 mg/mL, 10 mg equals 5 mL and 20 mg equals 10 mL; confirm concentration and use an oral dosing device. Do not double a missed dose or independently change treatment. Other manufacturers and fixed combinations require their own identifiers and instructions.

Do not coadminister aliskiren with olmesartan in patients with diabetes. This is the formal contraindication in the selected U.S. label; pregnancy is covered by the fetal-toxicity boxed warning. Serious hypersensitivity still requires immediate assessment and discontinuation advice.

Fetal toxicity: stop olmesartan medoxomil as soon as pregnancy is detected. Medicines acting directly on the RAS can injure or kill the developing fetus. Arrange an alternative before planned pregnancy.

Dizziness was the principal common reaction in adult placebo-controlled trials. Postmarketing reports include angioedema or anaphylaxis, vomiting, enteropathy, hyperkalemia, acute renal failure, increased creatinine, rhabdomyolysis and skin/hair reactions. Frequencies and causal attribution of voluntary reports are uncertain.

The label describes an inconclusive cardiovascular-risk signal from high-dose 40 mg studies in diabetic patients. It does not establish universal cardiovascular harm or make diabetes alone a contraindication. This product is not labeled to prevent diabetic microalbuminuria.

Potassium-sparing diuretics, supplements, potassium salt substitutes or other potassium-raising drugs can cause hyperkalemia. In general, avoid combining RAS inhibitors because additional benefit is limited while hypotension, hyperkalemia and kidney injury increase. Aliskiren is contraindicated with diabetes and should be avoided with renal impairment (GFR below 60 mL/min).

NSAIDs/COX-2 inhibitors can blunt BP response and worsen renal function, especially with dehydration, older age or CKD; monitor renal function. ARBs can raise lithium concentrations and cause toxicity; monitor lithium if combined.

Colesevelam reduces olmesartan exposure; consider giving olmesartan at least 4 hours before it. Olmesartan is not metabolized by CYP enzymes and does not affect them. No significant interaction was found with digoxin or warfarin in healthy-volunteer studies; these observations do not exclude unrelated clinical risks from other medicines.

Second/third-trimester RAS blockade can cause oligohydramnios, fetal renal failure, lung/skull abnormalities and death; first-trimester safety is not established by these data. Stop when pregnancy is detected and evaluate exposed pregnancies/neonates appropriately. Human milk data are unavailable. The label’s lactation section calls for deciding between nursing and therapy; its counseling section advises not breastfeeding during treatment. Arrange an alternative feeding or medication plan.

Use is labeled from age 6 with the weight-specific chart; no under 20 kg regimen is supplied. Children younger than 6 have no demonstrated efficacy, and under 1 year use is not recommended. Older adult trials did not show overall safety/efficacy differences, but increased individual sensitivity remains possible.

No initial organ-impairment adjustment is specified for the labeled moderate-to-marked categories, despite increased exposure. Assess renal function and potassium particularly after interacting drugs or dehydration; dialysis PK is unknown. The label reports a smaller average BP response in Black patients, without barring use or replacing individualized assessment.

Olmesartan selectively blocks angiotensin II AT1 receptors, reducing vasoconstrictor signaling. It does not inhibit ACE or directly prevent bradykinin breakdown. RAS feedback increases renin and angiotensin levels without overcoming the BP effect.

The prodrug rapidly hydrolyzes to olmesartan during gastrointestinal absorption. Bioavailability is about 26%; peak levels occur in 1–2 hours, without a food effect. Protein binding is about 99%. There is virtually no further metabolism; absorbed drug leaves through urine and biliary/fecal routes. Terminal half-life is about 13 hours, and steady state is reached within 3–5 days. Tablets and the label-specific suspension are bioequivalent.

Track baseline/follow-up BP, kidney function and potassium, with extra assessment after titration, interacting medicines or volume depletion. Monitor dizziness/orthostasis and adherence. Current adult guidance supports standardized cuff-based home readings with clinician feedback; do not rely on cuffless watches for accurate readings. Pediatric assessment follows age/weight and clinical needs.

Discuss pregnancy planning; report pregnancy immediately and stop promptly. Avoid potassium products without clinician advice. Report severe or persistent diarrhea, weight loss, fainting or reduced urine. Seek emergency care for swelling affecting breathing. Follow exact suspension shaking/refrigeration instructions and measured doses.

Limited human overdose data suggest hypotension and tachycardia, with possible bradycardia. Obtain prompt medical or poison-control advice; symptomatic hypotension requires supportive care. Olmesartan dialyzability is unknown, so no dialysis rescue or numerical antidote regimen is provided.

Appearance

White to off-white, round, film-coated

Debossing

OLM · 20 on opposite sides

Example package

NDC 60290-010-01 · bottle of 30

Distributor

Umedica Laboratories USA Inc.

Selected tablets contain 5, 20 or 40 mg olmesartan medoxomil. The 5 mg tablet is round with O and a plain reverse; 40 mg is oval with OLM and 40. The selected label includes a 2 mg/mL extemporaneous suspension made from 20 mg tablets. Benicar is a brand reference; current brand supply and other manufacturer identifiers are not established by this generic label. Fixed combinations require separate dosing.

Store tablets at 20–25°C and dispense in a tight, light-resistant container with a child-resistant closure. The label-specific suspension requires 2–8°C refrigeration, use within 4 weeks, shaking before each dose and prompt return to the refrigerator. Do not apply tablet storage to the suspension.