Olmesartan - Warnings and Precautions

5 WARNINGS AND PRECAUTIONS Hypotension: Correct volume or salt depletion prior to administration.

Monitor renal function and potassium in susceptible patients.

Increased angina or myocardial infarction with calcium channel blockers may occur upon dosage initiation or increase .

Observe for signs of fluid or electrolyte imbalance .

Exacerbation or activation of systemic lupus erythematosus .

Acute angle-closure glaucoma .

Sprue-like enteropathy has been reported.

Consider discontinuation of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets in cases where no other etiology is found 5.1 Fetal Toxicity Olmesartan medoxomil .

Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets can cause fetal harm when administered to a pregnant woman.

Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.

Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations.

Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death.

When pregnancy is detected, discontinue olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets as soon as possible [ see Use in specific Populations ].

Thiazides cross the placental barrier and appear in cord blood.

Adverse reactions include fetal or neonatal jaundice and thrombocytopenia [see Use in Specific Populations ].

5.2 Hypotension in Volume- or Salt-Depleted Patients Olmesartan medoxomil.

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 be anticipated after initiation of treatment with olmesartan medoxomil.

Initiate treatment with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets under close medical supervision.

If hypotension does occur, place the patient in the supine position and, if necessary, give an intravenous infusion of normal saline.

A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.

Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis.

Because of the gradual onset of action, acute hypotension is unlikely.

5.3 Increased Angina and/or Myocardial Infarction Amlodipine.

Patients, particularly those with severe obstructive coronary artery disease, may develop increased frequency, duration, or severity of angina or acute myocardial infarction upon starting calcium channel blocker therapy or at the time of dosage increase.

The mechanism of this effect has not been elucidated.