olmesartan medoxomil, amlodipine and hydrochlorothiazide

ATC code

C09DX03

Therapeutic class

Triple antihypertensive combination · Olmesartan medoxomil, amlodipine, and hydrochlorothiazide

Forms

Oral film-coated tablet

Brand names

Balzak Plus (ES)

Overall confidence

high

Regulatory sources consulted

OpenFDA · C09DX03
AEMPS CIMA · nº registro 73437 ↗

Approved indications

Essential hypertension in adults as add-on therapy when olmesartan medoxomil and amlodipine do not adequately control blood pressure, or as replacement when the triple combination already controls it.

Contraindications

Absolute

Hypersensitivity to the active substances, dihydropyridine or sulfonamide derivatives, or excipients.
Severe renal impairment or anuria.
Refractory hypokalemia, hypercalcemia, hyponatremia, or symptomatic hyperuricemia.
Second or third trimester of pregnancy.
Severe hepatic impairment, cholestasis, or obstructive biliary disorder.
Concomitant aliskiren in patients with diabetes or GFR below 60 mL/min/1.73 m².
Shock, including cardiogenic shock; severe hypotension; severe left-ventricular outflow obstruction; or hemodynamically unstable heart failure after acute myocardial infarction.

Clinical warnings

Boxed warning · Fetal toxicity: discontinue as soon as pregnancy is detected. — openFDA set ID 45e975ff-07b1-411a-96ee-a011d1619b1e
Major warning · Monitor blood pressure, renal function, potassium, sodium, calcium, magnesium, glucose, and uric acid; correct volume or sodium depletion before initiation. — CIMA registro 73437
Major warning · Hydrochlorothiazide may cause photosensitivity and has been associated with non-melanoma skin cancer; limit sun exposure and monitor skin lesions. — CIMA registro 73437

Drug interactions

HighLithium
Mechanism: Olmesartan and the thiazide may increase lithium concentrations and toxicity.
Recommendation: Not recommended; if essential, closely monitor serum lithium.
https://cima.aemps.es/cima/dochtml/ft/73437/FT_73437.html
ModerateNSAIDs
Mechanism: May reduce antihypertensive and diuretic effects and increase the risk of renal failure.
Recommendation: Ensure hydration and monitor renal function and electrolytes.
https://cima.aemps.es/cima/dochtml/ft/73437/FT_73437.html
ModerateAlcohol, barbiturates, opioids, or antidepressants
Mechanism: May potentiate orthostatic hypotension.
Recommendation: Avoid or reduce exposure and monitor for postural symptoms.
https://cima.aemps.es/cima/dochtml/ft/73437/FT_73437.html

Adverse events

Common (≥1%)

Peripheral edema · Headache · Dizziness · Fatigue · Nasopharyngitis · Muscle spasms · Nausea · Diarrhea

Rare but serious

Acute renal failure · Severe electrolyte disturbance · Angioedema or anaphylaxis

Pregnancy and lactation

Use is not recommended in the first trimester and is contraindicated in the second and third because of olmesartan; discontinue when pregnancy is diagnosed. Do not breastfeed during treatment.