No overall differences in effectiveness or safety were observed between elderly patients and younger patients. Lesser effects, 4% and 15% reduction in Cmax and AUC respectively, were observed when olmesartan medoxomil was administered 4 hours prior to colesevelam hydrochloride [see No significant drug interactions were reported in studies in which olmesartan medoxomil was co-administered with digoxin or warfarin in healthy volunteers.The bioavailability of olmesartan was not significantly altered by the co-administration of antacids [Al(OH)Olmesartan 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.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. It is practically insoluble in water and sparingly soluble in methanol. For children who can swallow tablets, the usual recommended starting dose of Benicar 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.
Benicar is sometimes given together with other blood pressure medications.If you have diabetes, do not use Benicar together with any medication that contains You may also need to avoid taking olmesartan with aliskiren 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:You should not breast-feed while using this medicine.Take Benicar exactly as prescribed by your doctor. Olmesartan passed across the placental barrier in rats and was distributed to the fetus. Administration of olmesartan at least 4 hours prior to colesevelam hydrochloride decreased the drug interaction effect. Revised: Oct 2019Because 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.Benicar has been evaluated for safety in more than 3825 patients/subjects, including more than 3275 patients treated for hypertension in controlled trials. ACE inhibitors also inhibit the degradation of bradykinin, a reaction also catalyzed by ACE. Drugs that inhibit the renin angiotensin system can cause hyperkalemia. skeletal deformations, including skull hypoplasia, hypotension and death. 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.
Consider alternative antihypertensive therapy during pregnancy.The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
Olmesartan was distributed to milk at low levels in rats.Following the rapid and complete conversion of olmesartan medoxomil to olmesartan during absorption, there is virtually no further metabolism of olmesartan.
A total of 2693 patients (2145 Benicar; 548 placebo) with essential hypertension were studied. 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. Monitor renal function periodically in patients receiving olmesartan medoxomil and NSAID therapy.The antihypertensive effect of angiotensin II receptor antagonists, including olmesartan medoxomil, may be attenuated by NSAIDs including selective COX-2 inhibitors.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. These effects are usually reversible. The pharmacokinetics of olmesartan in patients undergoing hemodialysis has not been studied [see 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.
The trial met its primary endpoint, delayed onset of microalbuminuria, but olmesartan had no beneficial effect on decline in glomerular filtration rate (GFR).