Azilsartan Medoxomil (an angiotensin II receptor blocker) and Chlorthalidone (thiazide-like diuretic) is indicated for the treatment of hypertension, to lower blood pressure. This combination may be used in patients whose blood pressure is not adequately controlled on monotherapy. This combination may be used as initial therapy if a patient is likely to need multiple drugs to achieve blood pressure goals. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefts have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including thiazide-like diuretics such as chlorthalidone and ARBs such as azilsartan medoxomil.

Azilsartan medoxomil is an angiotensin II receptor blocker (ARB). Azilsartan helps blood vessels to dilate. It also helps to excrete of Sodium and water from body. This combination also contains a diuretic. Chlorthalidone works in the kidneys to flush excess water and salt (sodium) from the body. Together, these 2 medicines work to help lower blood pressure in people who need more than 1 medicine to treat their high blood pressure (hypertension).

For the treatment of hypertension, to lower blood pressure:

• In patients not adequately controlled with ARB monotherapy
• As initial therapy in patients likely to need multiple drugs to help

To achieve blood pressure goals and to reduce the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

The recommended starting dose is 40/12.5 mg taken orally once daily. Most of the antihypertensive effect is apparent within 1 to 2 weeks. This combination may be used to provide additional blood pressure lowering for patients not adequately controlled on ARB or diuretic monotherapy treatment. Patients not controlled with azilsartan medoxomil 80 mg may have an additional systolic/diastolic clinic blood pressure reduction of 13/6 mm Hg when switched to this combination 40/12.5 mg.

This combination may be used as initial therapy if a patient is likely to need multiple drugs to achieve blood pressure goals. Patients titrated to the individual components (azilsartan medoxomil and chlorthalidone) may instead receive the corresponding dose of This combination.

This is contraindicated in patients with anuria.

The following potential adverse reactions are-

• Fetal toxicity
• Hypotension in Volume- or Salt-Depleted Patients
• Impaired Renal Function
• Hypokalemia Hyperuricemia

• In patients with an activated renin-angiotensin-aldosterone system (RAAS), such as volume- and/or salt-depleted patients, this combination can cause excessive hypotension. Correct volume or salt depletion prior to administration of azilsartan and chlorthalidone.
• In patients with renal artery stenosis, This combination may cause renal failure.
• Monitor renal function in patients with renal impairment. Consider discontinuing this combination with progressive renal impairment.
• Heart rhythm problems (e.g., bradycardia, QT prolongation, ventricular tachycardia), liver problems, certain uncorrected mineral imbalances (low potassium/magnesium levels), severe kidney problems.

Pregnancy & Lactation

Pregnancy Category D. Use of drugs that affect the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.