Olmesta M

Approved Indications:

• Essential Hypertension (Primary Hypertension):
  Indicated for the treatment of high blood pressure in patients whose blood pressure is not adequately controlled with either monotherapy of Amlodipine or Olmesartan.
• Initial Combination Therapy in Moderate to Severe Hypertension:
  Suitable for patients requiring more than one agent to achieve target blood pressure.

Clinically Accepted Off-label Uses:

• Hypertension with Left Ventricular Hypertrophy (LVH):
  Used to reduce afterload and improve cardiovascular outcomes in hypertensive patients with LVH.
• High Cardiovascular Risk Patients with Hypertension:
  Utilized to reduce long-term cardiovascular events in patients with multiple risk factors such as diabetes or chronic kidney disease.

Route of Administration: Oral
Frequency: Once daily
Dosage Forms: Film-coated tablets (various strengths)

Initial Dose Recommendations:

• If switching from monotherapy:
  Amlodipine 5 mg + Olmesartan 20 mg once daily is commonly used.
• Initial therapy (if appropriate):
  Start with the lowest available strength: Amlodipine 5 mg + Olmesartan 20 mg once daily.

Dose Titration and Maximum Doses:

• Titrate after 1–2 weeks based on blood pressure response.
• Maximum recommended dose: Amlodipine 10 mg + Olmesartan 40 mg once daily.

Special Populations:

• Elderly:
  Start at the lower end of dosing; monitor for hypotension and dizziness.
• Renal Impairment:
• Mild to moderate: Use with caution, no initial dose adjustment required.
• Severe: Not recommended.
• Hepatic Impairment:
• Mild to moderate: Start at low doses and monitor.
• Severe: Use not recommended.
• Pediatrics:
  Safety and efficacy have not been established in patients below 18 years.

Administration Tips:

• May be taken with or without food.
• Swallow tablets whole with water. Do not crush or chew.

• Amlodipine is a dihydropyridine calcium channel blocker (CCB) that inhibits the influx of calcium ions into vascular smooth muscle and cardiac muscle, leading to vasodilation and reduced peripheral resistance.
• Olmesartan is an angiotensin II receptor blocker (ARB) that selectively inhibits the binding of angiotensin II to the AT1 receptor, thereby preventing vasoconstriction, aldosterone secretion, and sodium retention.

Combined Effect:
This combination offers dual mechanisms to reduce blood pressure effectively by relaxing vascular smooth muscle and decreasing circulating volume.

Amlodipine:

• Absorption: ~60–65%, unaffected by food
• Peak Plasma Time: 6–12 hours
• Half-life: 30–50 hours
• Metabolism: Hepatic via CYP3A4
• Excretion: Mostly urine as metabolites

Olmesartan:

• Absorption: Olmesartan Medoxomil is a prodrug converted to active Olmesartan
• Peak Plasma Time: 1–3 hours
• Half-life: ~13 hours
• Metabolism: Minimal (non-CYP mediated)
• Excretion: 60% feces, 40% urine

Pregnancy:

• Contraindicated during the second and third trimesters due to fetal toxicity.
• Discontinue immediately if pregnancy is detected.

Lactation:

• Amlodipine is excreted in breast milk in low amounts.
• Olmesartan’s excretion is unknown; potential risk exists.
• Use only if clearly needed and under medical supervision.

• Therapeutic Class: Antihypertensive combination
• Subclasses:
• Amlodipine: Calcium Channel Blocker (Dihydropyridine)
• Olmesartan: Angiotensin II Receptor Blocker (ARB)

• Hypersensitivity to Amlodipine, Olmesartan, or excipients
• Pregnancy (especially after the first trimester)
• Severe hepatic impairment
• Concomitant use with Aliskiren in diabetic patients
• Cardiogenic shock or unstable hemodynamics

• Hypotension Risk: Especially in volume-depleted individuals; correct imbalance prior to use.
• Renal Impairment: Monitor renal function; may worsen in susceptible patients.
• Hyperkalemia: Risk increases with potassium supplements, salt substitutes, or potassium-sparing drugs.
• Angioedema: Rare but possible; discontinue if occurs.
• Liver Dysfunction: Use with caution in hepatic insufficiency.
• Heart Failure: Amlodipine may exacerbate angina during titration; monitor symptoms.

Common:

• Dizziness
• Peripheral edema
• Headache
• Flushing
• Fatigue
• Nausea

Less Common:

• Palpitations
• Hypotension
• Back pain
• Elevated liver enzymes
• Hyperkalemia

Rare/Serious:

• Angioedema
• Acute kidney injury
• Severe hypotension

Note: Side effects may be dose-dependent and more pronounced during dose titration.

• Potassium Supplements / Diuretics: Increased risk of hyperkalemia
• NSAIDs: May blunt antihypertensive effects and reduce renal function
• Lithium: Increased serum lithium levels and toxicity
• CYP3A4 Inhibitors (e.g., ketoconazole): May increase Amlodipine exposure
• Alcohol: Additive hypotensive effect
• Simvastatin: Limit simvastatin dose to ≤20 mg daily when used with Amlodipine

• Latest Hypertension Guidelines (ACC/AHA 2023):
  Endorse initial combination therapy for stage 2 hypertension or those with >20/10 mmHg above target BP.
• KDIGO 2021 Guidelines:
  Recommend RAAS blockers (like Olmesartan) with CCBs in CKD-related hypertension.
• Regulatory Updates:
  Reinforced contraindication during pregnancy due to fetal toxicity risk.

• Temperature: Store below 30°C
• Humidity: Protect from moisture
• Packaging: Keep in original blister or container
• Light: Protect from direct sunlight
• Refrigeration: Not required