Indications
Olmesartan Medoxomil is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
Dosage and Administration
Dosage must be individualized. The usual recommended starting dose of Olmesartan Medoxomil 20 mg once daily when
used as monotherapy in patients who are not volumecontracted. For patients requiring further reduction in blood pressure
after 2 weeks of therapy, the dose of Olmesartan Medoxomil may be increased to 40 mg. Doses above 40 mg do not appear
to have greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily.
Hepatic Impairment
Dose should not exceed 20 mg daily in moderate impairment. Manufacturer advises avoid in severe impairment—no
information available.
Renal Impairment
Max. 20 mg daily if eGFR 20–60 mL/minute/1.73 m2
. Avoid if eGFR less than 20 mL/minute/1.73 m2
Contraindications
Olmesartan Medoxomil is contraindicated in patients who are hypersensitive to any component of this product.
Special Warnings and Precautions
Fetal/Neonatal Morbidity and Mortality
Drugs that act directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered
to pregnant women. Several dozen cases have been reported in the world literature of patients who were taking angiotensin
converting enzyme inhibitors. When pregnancy is detected, Olmesartan Medoxomil should be discontinued as soon as
possible.
Hypotension in Volume- or Salt-Depleted Patients
In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients (e.g., those being
treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with Olmesartan
Medoxomil. Treatment should start under close medical supervision. If hypotension does occur, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline.
Drug Interactions
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)3/Mg(OH)2]. 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.
Use during Pregnancy and Lactation
Pregnancy
Pregnancy Categories C (first trimester) and D (second and third trimesters).
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first
trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded. Whilst
there is no controlled epidemiological data on the risk with angiotensin II antagonists, similar risks may exist for
this class of drugs. Unless continued angiotensin receptor blocker therapy is considered essential, patients
planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established
safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with angiotensin II antagonists
should be stopped immediately, and, if appropriate, alternative therapy should be started.
Angiotensin II antagonists therapy exposure during the second and third trimesters is known to induce human
fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal
failure, hypotension, hyperkalemia).
Should exposure to angiotensin II antagonists have occurred from the second trimester of pregnancy, ultrasound
check of renal function and skull is recommended. Infants whose mothers have taken angiotensin II antagonists
should be closely observed for hypotension.
Lactation
It is not known whether Olmesartan is excreted in human milk, but Olmesartan is secreted at low concentration
in the milk of lactating rats. Because of the potential for adverse effects on the nursing infant, a decision should
be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug
to the mother.
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