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Fact Table
| Fact Table | |
|---|---|
| Formula | C44H34ClKN6O12S |
| License | FDA approved (Initial U.S. approval: 2011) |
| Bioavailability | Azilsartan approximately 60% after oral azilsartan medoxomil; no clinically significant food effect on azilsartan or chlorthalidone in Edarbyclor |
| Legal status | Prescription only (Rx) |
| Chemical Name | Azilsartan kamedoxomil (azilsartan medoxomil potassium) + chlorthalidone |
| Elimination half-life | Azilsartan approximately 11–13 hours; chlorthalidone approximately 42–45 hours |
| Dosage (Strength) | 40 mg/12.5 mg and 40 mg/25 mg oral tablets; recommended starting dose 40/12.5 mg once daily, may increase to 40/25 mg |
| Pregnancy | Boxed warning: fetal toxicity; discontinue as soon as pregnancy is detected |
| Brands | Edarbyclor |
| Protein binding | Azilsartan >99%; chlorthalidone approximately 75% in plasma |
| PubChem CID | 25210270 |
| MedlinePlus | No dedicated fixed-combination monograph identified; azilsartan component: a611028 |
| ChEBI | No unique fixed-combination ChEBI identified; components: azilsartan medoxomil CHEBI:68845, chlorthalidone CHEBI:3654 |
| ATC code | C09DA09 |
| DrugBank | No unique fixed-combination DrugBank ID clearly assigned; components: azilsartan medoxomil DB08822, chlorthalidone DB00310 |
| KEGG | D10589 |
| Routes of administration | By mouth (oral tablets) |
Edarbyclor (azilsartan medoxomil and chlorthalidone) is a combination medication used to treat high blood pressure in adults. It contains two active ingredients: azilsartan medoxomil, an angiotensin II receptor blocker (ARB), and chlorthalidone, a diuretic. Azilsartan helps blood vessels relax and widen by blocking angiotensin II receptors, while chlorthalidone works in the kidneys to remove excess water and salt from the body. Together, these two medicines can lower blood pressure more effectively than either one alone.
Directions
Edarbyclor is taken by mouth once daily, with or without food. For patients not adequately controlled on a single blood pressure medication, doctors typically start with Edarbyclor 40/12.5 mg (40 mg azilsartan medoxomil and 12.5 mg chlorthalidone) once daily. If blood pressure remains high after 2 to 4 weeks, the dose may be increased to a maximum of 40/25 mg once daily.
If a dose is missed, take it as soon as remembered unless it's close to the next scheduled dose. If that is the case, skip the missed dose and continue with the regular schedule. Don't take double doses to make up for a missed one.
Ingredients
The active ingredients in Edarbyclor are azilsartan medoxomil and chlorthalidone.
Cautions
Before using this medication, you may want to consult a healthcare provider about the following:
- Any existing health conditions
- Any allergies
- A list of all medications currently being taken
Edarbyclor can harm an unborn baby, especially during the second or third trimester. If you become pregnant while taking this medication, stop using it and contact your healthcare provider right away.
Low blood pressure may occur when starting treatment. People who are dehydrated or taking strong diuretics may experience dizziness, lightheadedness, or fainting when starting Edarbyclor.
Kidney function may worsen in some patients. This medication can affect kidney function, particularly in people with existing kidney disease, heart failure, or narrowed kidney arteries. Your healthcare provider may monitor kidney function with blood tests.
Electrolyte imbalances are possible. Edarbyclor may change levels of important minerals such as potassium or sodium in the blood. Regular blood tests may be needed to monitor electrolyte levels.
Gout may be triggered in some people. One of the ingredients (chlorthalidone) can increase uric acid levels, which may lead to gout attacks in susceptible individuals.
Certain medications may increase side effects. Taking Edarbyclor with drugs that affect potassium levels or kidney function may increase the risk of complications, so inform your healthcare provider about all medications you take.
Contraindications
Avoid taking or using this medication if any of the following apply:
- Anuria (inability to produce urine)
- Pregnancy (can cause injury and death to the developing fetus)
- Hypersensitivity to azilsartan, chlorthalidone, or any component of the medication
- Hypersensitivity to other sulfonamide-derived drugs
- Coadministration with aliskiren in patients with diabetes
Side Effects
Common side effects of Edarbyclor include:
- Dizziness
- Tiredness or fatigue
These side effects are usually mild and may occur as your body adjusts to the medication. Dizziness may be more noticeable when starting treatment or when standing up quickly. Staying well hydrated may help reduce these symptoms.
More serious side effects are less common but possible. Edarbyclor can cause low blood pressure, kidney problems, or fluid and electrolyte imbalances. Symptoms may include confusion, muscle cramps, weakness, irregular heartbeat, nausea, or unusual tiredness. Contact a healthcare provider immediately if you feel faint, pass out, notice major changes in urination, or develop severe weakness or confusion.
Frequently Asked Questions about Edarbyclor (Azilsartan-Chlorthalidone)
What is Edarbyclor (azilsartan-chlorthalidone) used for?
Edarbyclor is a prescription medicine used to treat high blood pressure in adults. It combines an angiotensin II receptor blocker with a thiazide-like diuretic and may be used when one blood pressure medicine is not enough or when a person is likely to need more than one medicine from the start.
How does Edarbyclor work?
Azilsartan relaxes blood vessels by blocking the effects of angiotensin II, while chlorthalidone helps the body remove extra salt and water through the kidneys. Together, these actions help lower blood pressure.
How is Edarbyclor usually taken?
The usual starting dose is 40 mg/12.5 mg once daily. If needed, the dose may be increased after 2 to 4 weeks to 40 mg/25 mg once daily, which is the maximum labeled dose. It can be taken with or without food.
What are the common side effects of Edarbyclor?
The most common side effects reported in the prescribing information are dizziness and fatigue. Because it contains a diuretic, some people may also notice increased urination, especially when first starting treatment.
What are the most important warnings with Edarbyclor?
The most serious boxed warning is fetal toxicity, meaning it can harm an unborn baby and should be stopped as soon as pregnancy is detected. It can also cause low blood pressure in people who are volume-depleted, kidney problems in some patients, and electrolyte changes that need monitoring.
Who should not take Edarbyclor?
Edarbyclor should not be used in people with anuria, which means the kidneys are not making urine. It also should not be used together with aliskiren in patients with diabetes.
Are there important drug interactions with Edarbyclor?
Yes. Important interactions include NSAIDs, which can reduce the blood pressure effect and raise the risk of kidney problems, lithium, which can become toxic, and other medicines that affect the renin-angiotensin system, which can increase the risk of low blood pressure, high potassium, and kidney injury.
What monitoring is usually needed while taking Edarbyclor?
Blood pressure should be checked regularly, and clinicians often monitor kidney function and blood electrolytes. This is important because the medicine can affect potassium, sodium, uric acid, and overall kidney function.
What should someone do if they miss a dose?
If a dose is missed, it should be taken as soon as remembered unless it is almost time for the next dose. The missed dose should then be skipped, and two doses should not be taken together.
Who should use Edarbyclor carefully?
Extra caution is needed in people with kidney disease, renal artery stenosis, dehydration, gout or high uric acid, or a history of major electrolyte problems. Breastfeeding is not recommended while taking Edarbyclor, and pregnancy should be avoided because of the fetal risk.
