Europe — EMA
Olmesartán/Amlodipino Kern Pharma (Olmesartan Medoxomil, Amlodipine)
GNH USA supplies Olmesartán/Amlodipino (Olmesartan Medoxomil and Amlodipine), a combination antihypertensive for essential hypertension.
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What is Olmesartan Medoxomil, Amlodipine?
Olmesartan Medoxomil and Amlodipine, the active ingredient in Olmesartán/Amlodipino Kern Pharma, is a combination antihypertensive presented as a tablet for oral use. It is indicated for the treatment of hypertension in adult patients, including those who require additional blood pressure control beyond monotherapy.
GNH USA supplies Olmesartán/Amlodipino Kern Pharma as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Olmesartan Medoxomil, Amlodipine used for?
Olmesartan/Amlodipine is a fixed‑dose combination that addresses elevated blood pressure through two complementary mechanisms. It is employed in the following clinical situations: - Essential hypertension: provides superior blood pressure reduction when single‑agent therapy is insufficient. - Hypertension with concomitant cardiovascular risk: helps achieve target pressures in patients with additional risk factors such as dyslipidaemia or smoking. - Hypertension in patients requiring once‑daily dosing: simplifies regimen adherence by combining an ARB and a calcium‑channel blocker.
What are the side effects of Olmesartan Medoxomil, Amlodipine?
Common Side Effects: - Dizziness: mild to moderate light‑headedness, especially after the first dose. - Headache: transient tension‑type headache. - Peripheral edema: swelling of ankles or lower legs. - Flushing: warm sensation and reddening of skin. - Fatigue: general tiredness without specific cause. - Palpitations: awareness of heartbeat.
Serious or Rare Side Effects: - Angioedema: rapid swelling of face, lips, tongue, or throat requiring emergency care. - Severe hypotension: marked drop in blood pressure leading to fainting. - Hepatic dysfunction: abnormal liver enzymes or jaundice. - Myocardial infarction: chest pain indicative of heart attack. - Acute renal impairment: sudden decrease in kidney function. - Severe allergic reactions: rash, itching, or anaphylaxis.
What precautions apply to Olmesartan Medoxomil, Amlodipine?
Before initiating therapy, clinicians should consider the following precautions: - Blood pressure monitoring: ensure adequate control and avoid excessive hypotension. - Renal function assessment: adjust therapy in patients with impaired kidney function. - Hepatic status: use cautiously in severe liver disease. - Electrolyte balance: monitor potassium and sodium levels, especially with concomitant diuretics. - Pregnancy and lactation: avoid use during pregnancy; discontinue if pregnancy is confirmed. - Store at ambient temperature: keep tablets in the original container, protect from moisture and direct sunlight.
What does Olmesartan Medoxomil, Amlodipine interact with?
Major Interactions (Avoid): - ACE inhibitors or aliskiren: combined use may increase risk of hyperkalemia and renal dysfunction. - Potassium‑sparing diuretics: additive effect on serum potassium leading to hyperkalaemia. - Strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin): may raise amlodipine concentrations and cause hypotension. - NSAIDs: can blunt antihypertensive effect and affect renal function. - Dual renin‑angiotensin system blockade: heightened risk of adverse renal outcomes.
Moderate Interactions (Monitor Closely): - Other antihypertensives (beta‑blockers, diuretics): may require dose adjustment to prevent excessive blood pressure drop. - CYP3A4 inducers (rifampin, carbamazepine): may reduce amlodipine levels, diminishing efficacy. - Lithium: concurrent use may increase lithium levels, necessitating monitoring.



