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Indications & Uses
Azilpres Plus is indicated for:
Pharmacology
Azilsartan medoxomil is an angiotensin II receptor blocker (ARB). Azilsartan helps blood vessels to widen, and it also helps the body get rid of sodium and water. This combination also contains a diuretic. Chlorthalidone works in the kidneys to flush excess water and salt (sodium) out of the body. Together, these 2 medicines help lower blood pressure in people who need more than 1 medicine to treat their high blood pressure (hypertension).
Absorption: In the gastrointestinal tract, azilsartan medoxomil is rapidly hydrolyzed to azilsartan during absorption, and azilsartan is the active metabolite. Azilsartan medoxomil itself is not detected in plasma after oral administration. The estimated absolute bioavailability of azilsartan after taking azilsartan medoxomil is approximately 60%. Peak plasma concentrations (Cmax) of azilsartan are reached within 1.5 to 3 hours of an oral dose. Food does not affect the bioavailability of azilsartan.
Distribution: The volume of distribution of azilsartan is approximately 16L. Azilsartan is highly bound to human plasma proteins (>99%), mainly serum albumin. This binding stays constant even at azilsartan plasma concentrations well above the range reached with recommended doses. In whole blood, chlorthalidone is mostly bound to erythrocyte carbonic anhydrase. In plasma, approximately 75% of chlorthalidone is bound to plasma proteins, and 58% of the drug is bound to albumin.
Metabolism and Elimination: Azilsartan medoxomil: Azilsartan is metabolized to two primary metabolites. The major metabolite in plasma is formed by O-dealkylation and is called metabolite M II. The minor one is formed by decarboxylation and is called metabolite M-I. In humans, systemic exposure to the major and minor metabolites was approximately 50% and less than 1% of azilsartan, respectively. M-I and MII do not contribute to the pharmacologic activity of azilsartan medoxomil. CYP2C9 is the major enzyme responsible for azilsartan metabolism. The elimination half-life of azilsartan is approximately 11 hours, and renal clearance is approximately 2.3 mL/min. Steady-state levels of azilsartan are reached within 5 days, and with repeated once-daily dosing no accumulation in plasma occurs.
Chlorthalidone: Most of the drug is excreted unchanged by the kidneys. The nonrenal routes of elimination have yet to be clarified. Data are not available on the percentage of the dose that leaves as unchanged drug and metabolites, the concentration of the drug in body fluids, how much a particular organ or the fetus takes up, or whether it passes across the blood-brain barrier.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
The recommended starting dose of azilsartan medoxomil with chlorthalidone is 40/12.5 mg, taken by mouth once a day. Most of the blood pressure lowering shows within 1 to 2 weeks. This combination can be used to lower blood pressure further in patients who are not well controlled on an ARB or a diuretic alone.
Patients who are not controlled on azilsartan medoxomil 80 mg may see an extra clinic blood pressure reduction of 13/6 mm Hg (systolic/diastolic) when they are switched to this combination at 40/12.5 mg.
It may also be used as the first treatment if a patient is likely to need more than one drug to reach their blood pressure goals. Patients who have been titrated on the separate components (azilsartan medoxomil and chlorthalidone) can take the matching dose of this combination instead. You can take it with or without food.
Side Effects
The following potential adverse reactions are listed for Azilsartan Medoxomil + Chlorthalidone: fetal toxicity, hypotension in volume- or salt-depleted patients, impaired renal function, hypokalemia, hyperuricemia.
Cautions & Contraindications
Warnings & Precautions
Azilsartan Medoxomil + Chlorthalidone can cause excessive hypotension in patients with an activated renin-angiotensin-aldosterone system (RAAS), for example those who are volume-depleted or salt-depleted. Correct any volume or salt depletion before giving azilsartan and chlorthalidone. In patients with renal artery stenosis, Azilsartan Medoxomil + Chlorthalidone may cause renal failure. Monitor renal function in patients with renal impairment, and consider stopping the medicine if the renal impairment gets progressively worse. Take care in people with heart rhythm problems (e.g., bradycardia, QT prolongation, ventricular tachycardia), liver problems, certain uncorrected mineral imbalances (low potassium or magnesium levels), and severe kidney problems.
Pregnancy & Breastfeeding
Azilsartan Medoxomil + Chlorthalidone is Pregnancy Category D. Medicines that act on the renin-angiotensin system, when taken in the second and third trimesters, reduce the baby's kidney function in the womb. They also raise the chance of illness and death in the unborn baby and the newborn.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Storage
Store Azilsartan Medoxomil + Chlorthalidone below 30°C, and keep it away from light and moisture. Keep it out of the reach of children.
Drug Interactions
Common questions about Azilpres Plus 40 mg+12.5 mg
What is Azilpres Plus 40 mg+12.5 mg Tablet?
Azilpres Plus 40 mg+12.5 mg Tablet is a medicine that contains Azilsartan Medoxomil + Chlorthalidone. It is made by Incepta Pharmaceuticals Ltd. It belongs to the Combined antihypertensive preparations group of medicines.
What is Azilpres Plus used for?
Azilpres Plus is used for: Hypertension.
What are the side effects of Azilpres Plus?
The following potential adverse reactions are listed for Azilsartan Medoxomil + Chlorthalidone: fetal toxicity, hypotension in volume- or salt-depleted patients, impaired renal function, hypokalemia, hyperuricemia.
Can I take Azilpres Plus during pregnancy or while breastfeeding?
Azilsartan Medoxomil + Chlorthalidone is Pregnancy Category D. Medicines that act on the renin-angiotensin system, when taken in the second and third trimesters, reduce the baby's kidney function in the womb. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
How should I store Azilpres Plus?
Store Azilsartan Medoxomil + Chlorthalidone below 30°C, and keep it away from light and moisture. Keep it out of the reach of children.
Can I take other medicines with Azilpres Plus?
Some medicines can interact with Azilsartan Medoxomil + Chlorthalidone, for example: Chlorthalidone. Tell your doctor or pharmacist about every medicine you take.
Is there a cheaper medicine with the same ingredient?
Azilpres Plus is already among the lowest-priced brands of Azilsartan Medoxomil + Chlorthalidone at this strength.
Do I need a prescription for Azilpres Plus?
Azilpres Plus is a prescription (Rx) medicine. Take it as your doctor advises.