olmesartan medoxomil and amlodipine

ATC code

C09DB02

Therapeutic class

Angiotensin II receptor blocker combined with a calcium-channel blocker · Fixed-dose combination of olmesartan medoxomil and amlodipine

Forms

Oral film-coated tablet

Brand names

Balzak 20 mg/5 mg (ES)

Overall confidence

high

Regulatory sources consulted

OpenFDA · C09DB02
AEMPS CIMA · nº registro 70091 ↗

Approved indications

Essential hypertension in adults whose blood pressure is not adequately controlled with olmesartan medoxomil or amlodipine monotherapy.

Contraindications

Absolute

Hypersensitivity to the active substances, dihydropyridine derivatives, or excipients.
Second or third trimester of pregnancy.
Severe hepatic impairment or biliary obstruction.
Severe hypotension, shock, severe left-ventricular outflow obstruction, or unstable heart failure after acute infarction.

Clinical warnings

Major warning · Correct volume or sodium depletion; symptomatic hypotension may occur, particularly after the first dose. — CIMA registro 70091
Major warning · Monitor blood pressure, renal function, and potassium; dual RAAS blockade increases hypotension, hyperkalemia, and acute renal failure. — CIMA registro 70091

Drug interactions

HighLithium
Mechanism: May increase serum lithium concentration and toxicity.
Recommendation: Not recommended; if required, closely monitor serum lithium.
https://cima.aemps.es/cima/dochtml/ft/70091/FT_70091.html
ModerateNSAIDs, including COX-2 inhibitors
Mechanism: May attenuate the antihypertensive effect and increase renal impairment and potassium.
Recommendation: Ensure hydration and monitor renal function and potassium.
https://cima.aemps.es/cima/dochtml/ft/70091/FT_70091.html

Adverse events

Common (≥1%)

Peripheral edema (11.3%) · Headache (5.3%) · Dizziness (4.5%)

Rare but serious

Angioedema · Acute renal failure · Shock or severe hypotension

Pregnancy and lactation

Use is not recommended in the first trimester and is contraindicated in the second and third; switch to an alternative if pregnancy is planned or detected. During breastfeeding, a treatment with better-established safety is preferred.