Drugs that act on renin-angiotensin system can cause fetal injury and death when used in 2nd and 3rd trimesters of pregnancy. Olmesartan medoxomil should be discontinued as soon as possible once pregnancy is detected. Symptomatic hypotension may occur in patients who are volume- and/or salt-depleted. May be associated with oliguria, progressive azotaemia, and acute renal failure (rare). Patients with bilateral or unilateral renal artery stenosis may have increased risk of severe hypotension and renal insufficiency.
Caution in renal impairment; monitor serum creatinine and potassium levels periodically. Avoid use in severe renal impairment (CrCl< 20 mL/min) and severe hepatic impairment. Caution in patients with aortic or mitral valve stenosis, obstructive hypertrophic cardiomyopathy. Patients with primary aldosteronism may not respond to angiotensin receptor antagonist. Not recommended in lactation.
Lactation: discontinue drug or do not nurse
Indication
Hypertension, Diabetic nephropathy
Contra Indication
Hypersensitivity to olmesartan medoxomil, hydrochlorothiazide or to other sulfonamide-derived drugs. Severe hepatic & renal impairment (CrCl <30 mL/min); cholestasis & biliary obstructive disorders; refractory hypokalemia; hypercalcemia; hyponatraemia, symptomatic hyperuricaemia; anuria. Concomitant use w/ aliskiren in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). Pregnancy (2nd & 3rd trimester) & lactation.
There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Mode of Action
Hydrochlorothiazide inhibits the reabsorption of Na and chloride in the distal tubules causing increased excretion of Na and water K and hydrogen ions.
Olmesartan is a selective and competitive angiotensin II Type 1 (AT1) receptor antagonist that blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II. As a result, olmesartan relaxes blood vessels, hence lowering BP and increases blood supply and oxygen to the heart.
Interaction
Olmesartan medoxomil: Increased risk of hypotension, hyperkalemia & changes in renal function w/ aliskiren. May result in deterioration of renal function w/ NSAIDs. May attenuate the antihypertensive effect of angiotensin II receptor antagonists. Reduces systemic exposure & peak plasma conc w/ colosevelam HCl.
Hydrochlorothiazide: Potentiation of orthostatic hypotension w/ alcohol, barbiturates or narcotics. Antidiabetic drugs. Potentiation effect w/ other antihypertensives. Reduced absorption w/ cholestyramine & colestipol resins. Intensified electrolyte depletion w/ corticosteroid, ACTH. Decreased response to pressor amines (eg norepinephrine). Increased responsiveness to skeletal muscle relaxants (eg tubocurarine). Reduce the renal clearance of lithium.
Pregnancy Category Note
Pregnancy Category: C (1st trimester); D (2nd & 3rd trimesters)
Lactation: discontinue drug or do not nurse
Adult Dose
Hypertension
Initial: 20 mg/12.5 mg PO qDay
May increase to 40 mg/25 mg after 2 weeks
Hepatic Impairment
Dose adjustment not necessary
Child Dose
Safety and efficacy not established
Renal Dose
Renal Impairment
CrCl <30 mL/min: Not recommended
Administration
May be taken with or without food.
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