The pharmacokinetics of olmesartan medoxomil have not been investigated in patients <18 years of age.
Amlodipine and Olmesartan Medoxomil tablets were effective in treating black patients (usually a low-renin population), and the magnitude of blood pressure reduction in black patients approached that observed for non-black patients.There is no information on overdosage with Amlodipine and Olmesartan Medoxomil tablets in humans.Amlodipine and Olmesartan Medoxomil provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate, USP and the angiotensin II receptor blocker (ARB) olmesartan medoxomil.The structural formula for olmesartan medoxomil, USP is:Amlodipine and Olmesartan Medoxomil tablets contains amlodipine besylate, USP a white or almost white powder, and olmesartan medoxomil, USP a white to off-white crystalline powder. Once daily administration produced statistically significant placebo-corrected reductions in supine and standing blood pressures at 24 hours post-dose, averaging about 12/6 mmHg in the standing position and 13/7 mmHg in the supine position in patients with mild to moderate hypertension. After adjustment for BP differences this risk reduction was no longer statistically significant. Olmesartan passed across the placental barrier in rats and was distributed to the fetus.
In reproductive studies in rats, Olmesartan Medoxomil did not affect fertility and there was no evidence of a teratogenic effect. No clinically relevant gender-related differences in the pharmacokinetics of Olmesartan have been observed. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.Data from one controlled trial and an epidemiologic study have suggested that high-dose olmesartan may increase cardiovascular (CV) risk in diabetic patients, but the overall data are not conclusive. For children who weigh 77 pounds or more (35 kg or more): 20 mg taken once per day. The dosage can be increased after 1 to 2 weeks of therapy to a maximum dose of one 10/40 mg tablet once daily as needed to control blood pressure [ see Clinical Studies (14.1) ]. Limited data exist in patients ≥ 75 years of age.Amlodipine and Olmesartan Medoxomil tablets were effective in treating black patients (usually a low-renin population), and the magnitude of blood pressure reduction in black patients approached that observed for non-Black patients. olmesartan. Amlodipine & Olmesartan Medoxomil 5 mg/20 mg and 5 mg/40 mg Tablet Description Bizoran® is a combination product containing Amlodipine, a calcium channel blocker and Olmesartan, an angiotensin II receptor blocker. This composite cardiovascular endpoint included cardiovascular death in 10 (3.5%) patients receiving olmesartan versus 3 (1.1%) receiving placebo, overall mortality 19 (6.7%) versus 20 (7.0%), non-fatal stroke 8 (2.8%) versus 11 (3.9%) and non-fatal myocardial infarction 3 (1.1%) versus 7 (2.5%), respectively.The antihypertensive effects of olmesartan medoxomil in the paediatric population were evaluated in a randomized, double-blind, placebo-controlled study in 302 hypertensive patients aged 6 to 17 years. The incidence (%) of dose-related side effects was as follows:For several adverse experiences that appear to be drug- and dose-related, there was a greater incidence in women than men associated with amlodipine treatment as shown in the following table:Olmesartan medoxomil has been evaluated for safety in more than 3825 patients/subjects, including more than 3275 patients treated for hypertension in controlled trials. Patients with renal failure may therefore receive the usual initial dose.Patients with renal insufficiency have elevated serum concentrations of olmesartan compared with patients with normal renal function.
The molecular weights of amlodipine besylate and olmesartan medoxomil are 567.1 and 558.59, respectively.