Ransys AM® is a combination of Olmesartan Medoxomil and Amlodipine Besilate. Olmesartan blocks the vasoconstrictor effects of Angiotensin II by selectively preventing its binding to the AT1 receptor in vascular smooth muscle. This action is independent of the pathways involved in Angiotensin II synthesis. Amlodipine is a calcium channel blocker that directly affects vascular smooth muscle, reducing peripheral vascular resistance and blood pressure.

Ransys AM® is indicated for the treatment of hypertension, either alone or in combination with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been observed in controlled trials with antihypertensive drugs from various pharmacological classes, including the class to which this drug belongs. However, there are no controlled trials specifically demonstrating risk reduction with Ransys AM®.
Ransys AM® may also be used as initial therapy in patients who are likely to require multiple antihypertensive agents to achieve their blood pressure goals.

General Considerations: Maximum antihypertensive effects are achieved within two weeks. Ransys AM® can be taken with or without food and may be used in combination with other antihypertensive agents. The dosage may be increased after two weeks, but the maximum recommended dose is 2 tablets (40/10 mg) once daily.
Initial Therapy: The usual starting dose of Ransys AM® is one tablet (20/5 mg) once daily. Depending on the patient's blood pressure response, the dose may be increased at 1 to 2-week intervals to two tablets of Ransys AM® (40/10 mg) once daily.
Replacement Therapy: Ransys AM® may be used as a substitute for its individually titrated components. If substituting for individual components, the dose of one or both components may be increased if blood pressure control has not been satisfactory.
Add-On Therapy: Ransys AM® may be prescribed to provide additional blood pressure reduction for patients not adequately controlled with Amlodipine (or another dihydropyridine calcium channel blocker) alone or with Olmesartan Medoxomil (or another Angiotensin Receptor Blocker) alone.
Elderly Patients: No dosage adjustment is necessary for elderly patients (≥65 years of age).
Patients with Hepatic Impairment: Initial therapy with Ransys AM® is not recommended in patients ≥75 years and in those with hepatic impairment.
Children: The safety and effectiveness of Ransys AM® in pediatric patients have not been established.
Use in Pregnancy and Lactation: Pregnancy Category D.
It is unknown whether Amlodipine or Olmesartan Medoxomil is excreted in human milk.

The overall incidence of side effects with Olmesartan and Amlodipine combination therapy is similar to that observed with the individual components and placebo. The common side effects include edema, hypotension, orthostatic hypotension, rash, pruritus, palpitations, urinary frequency, and nocturia. Long-term use of Olmesartan Medoxomil can cause sprue-like enteropathy.

The combination of Olmesartan and Amlodipine is contraindicated in patients who are hypersensitive to any component of this product or any of its ingredients.

Caution should be exercised in patients with:
Volume or salt depletion
Severe aortic stenosis
Severe obstructive coronary artery disease
Congestive heart failure
Impaired renal function and hepatic impairment
No initial dosage adjustment is recommended for patients with moderate to marked renal impairment (Creatinine Clearance <40 mL/min). However, the combination of Amlodipine and Olmesartan is not recommended in patients with Creatinine Clearance <20 mL/min.

In vitro data indicate that Amlodipine does not affect the plasma protein binding of digoxin, phenytoin, warfarin, or indomethacin. No significant drug interactions were observed when Olmesartan was co-administered with digoxin or warfarin.

In the event of a massive overdose, active cardiac and respiratory monitoring should be implemented. Frequent blood pressure measurements are essential, and treatment should be supportive.

Store at a temperature not exceeding 30 ºC in a dry place. Protect from light and moisture.
Medicine: Keep out of reach of children.
