Olmesartan-Hydrochlorothiazide (olmesartan medoxomil/hydrochlorothiazide)

Olmesartan is available as olmesartan medoxomil; dosages are expressed in terms of the salt. Dosage of olmesartan medoxomil must be individualized.

Dosage of hydrochlorothiazide should be individualized according to the patient's requirements and response. The lowest dosage necessary to produce the desired clinical effect should be used. If hydrochlorothiazide is added to the regimen of a patient stabilized on a potent hypotensive agent, dosage of the hypotensive agent should initially be reduced to avoid the possibility of severe hypotension.

Olmesartan medoxomil is administered orally without regard to meals. Twice-daily dosing offers no therapeutic advantage over the same total dose given once daily.

Olmesartan medoxomil is commercially available as a film-coated tablet. It is also commercially available in fixed-combination tablets containing olmesartan medoxomil with hydrochlorothiazide, olmesartan medoxomil with amlodipine and hydrochlorothiazide, and olmesartan medoxomil with amlodipine; see the full prescribing information of these products for administration information.

Store olmesartan tablets at 20-25degreesC.

For pediatric patients unable to swallow tablets, olmesartan may be administered orally as an extemporaneously prepared suspension. An extemporaneous suspension containing olmesartan medoxomil 2 mg/mL can be prepared in the following manner. First, 50 mL of purified water is added to an amber polyethylene terephthalate (PET) bottle containing twenty 20-mg tablets of olmesartan medoxomil, and the contents allowed to stand for a minimum of 5 minutes. The container should then be shaken for at least 1 minute and allowed to stand for at least 1 minute; this step of alternating shaking and standing should be repeated 4 additional times. The concentrated suspension should then be diluted with 100 mL of syrup (Ora-Sweet(R)) and 50 mL of a suspending vehicle (Ora-Plus(R)) and the container shaken well for at least 1 minute to disperse the ingredients. The suspension should be shaken well before dispensing each dose. The extemporaneous suspension is stable for up to 4 weeks when stored at 2-8degreesC. Olmesartan medoxomil tablets and the extemporaneously prepared oral suspension of the drug are bioequivalent.

Hydrochlorothiazide is administered orally.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Concomitant therapy with aliskiren in patients with diabetes mellitus.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

In placebo-controlled studies, the only adverse effect that occurred in more than 3% of adults receiving olmesartan, and at an incidence greater than with placebo, was dizziness. The incidence of adverse effects was not affected by age, gender, or race.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

Safety and efficacy of olmesartan have been established in a randomized, double-blind, placebo-controlled trial in pediatric patients 6-16 years of age with hypertension. Similar to adults, smaller blood pressure reductions have been observed in Black pediatric patients compared with non-Black pediatric patients. Adverse effects generally were similar to those observed in adults.

Olmesartan has also been studied in 59 patients who were 1-5 years of age; treatment with olmesartan medoxomil (0.3 mg/kg once daily) in this age group did not result in a statistically significant reduction in blood pressure compared with placebo. The manufacturer states that olmesartan has not been shown to be effective for hypertension in patients <6 years of age. Olmesartan has not been evaluated in infants <1 year of age; because of the possibility of abnormal kidney development, the drug must not be used in this age group.

Pharmacokinetics of olmesartan have been evaluated in pediatric patients 1-16 years of age; clearance of the drug (adjusted for body weight) in these pediatric patients was similar to that observed in adults.

Olmesartan may cause fetal and neonatal morbidity and mortality when administered to a pregnant woman. Olmesartan should be discontinued as soon as possible when pregnancy is detected. Alternative antihypertensive agents should be considered during pregnancy.

Untreated hypertension during pregnancy is associated with an increased risk of maternal preeclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section and risk of post-partum hemorrhage). Hypertension also increases the risk of fetal growth restriction in utero, and intrauterine death.

In pregnant women who receive olmesartan during pregnancy, serial ultrasound examinations should be performed along with fetal testing, based on gestational age. Oligohydramnios may not appear, however, until the fetus has sustained irreversible injury.

In infants with exposure to olmesartan in utero, carefully observe for hypotension, oliguria, and hyperkalemia, and use appropriate measures to maintain adequate blood pressure and renal perfusion. Exchange transfusions or dialysis may be required.

Olmesartan is distributed into milk in rats; it is not known whether the drug is distributed into milk in humans. The effects of olmesartan on the breast-fed child or on milk production are not known. Because of the potential for serious adverse reactions to olmesartan in breast-feeding infants, a decision should be made whether to discontinue breast-feeding or the drug, taking into account the importance of the drug to the woman.

The manufacturer states that no adjustment in initial olmesartan medoxomil dosage is necessary in geriatric patients.

No overall differences in safety and efficacy of olmesartan have been observed in geriatric patients >=65 years of age relative to younger adults, but increased sensitivity to the drug cannot be ruled out.

Modest accumulation of olmesartan has been observed in geriatric patients following repeated doses.