About EDARBYCLOR
EDARBYCLOR is a prescription medicine that combines EDARBI, an angiotensin II receptor blocker (ARB), and the diuretic (water pill) chlorthalidone to treat high blood pressure (hypertension) in adults. EDARBYCLOR may be an option if you are not at goal.
What is EDARBYCLOR?
EDARBYCLOR is a prescription medicine that contains two medicines in one tablet that work to treat high blood pressure in adults. EDARBYCLOR is the first ARB (angiotensin II receptor blocker) combination medicine to use chlorthalidone, which has been shown to be effective in clinical trials to lower blood pressure.
Your doctor may prescribe EDARBYCLOR when one medicine is not enough or as the first medicine if your doctor decides you are likely to need more than one medicine. Your doctor may also prescribe other medicines for you to take along with EDARBYCLOR to treat your high blood pressure. EDARBYCLOR should be taken once a day, with or without food.
How does EDARBYCLOR work?
One component of EDARBYCLOR is EDARBI which helps your blood vessels relax. The other component is the diuretic, chlorthalidone which works in the kidney to flush excess water and salt or sodium from the body. Together these components work to help lower blood pressure. EDARBYCLOR should be taken once per day, with or without food.
EDARBYCLOR is more effective than when either EDARBI or chlorthalidone is taken alone.
Medicines that lower your blood pressure may lower your chance of having a stroke or heart attack, but they don’t work alone. It should be part of a complete treatment plan.
EDARBYCLOR was superior to BENICAR HCT in a head-to-head clinical study.
As part of a clinical study where systolic blood pressure was measured in stage 2 hypertensive patients over a 12-week period, EDARBYCLOR (40/25 mg) lowered blood pressure by 42.5 mmHg and BENICAR HCT® (40/25 mg) lowered blood pressure by 37.1 mmHg. In addition, EDARBYCLOR showed lower blood pressure readings over a 24-hour period than BENICAR HCT®.
EDARBYCLOR Safety Information
EDARBYCLOR has been evaluated for safety in more than 3,900 patients with high blood pressure. In clinical safety studies, EDARBYCLOR adverse reactions were generally mild. The most common side effects were dizziness and fatigue. To learn more, please see the EDARBYCLOR accompanying Product Information.
Call your doctor for medical advice if you have any of the above side effects or any other side effects that concern you while using EDARBYCLOR. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Important Safety Information
WARNING: EDARBI and EDARBYCLOR can cause harm or death to your unborn baby. If you become pregnant while taking EDARBI or EDARBYCLOR, tell your doctor right away. If you plan to become pregnant, talk to your doctor about other treatments to lower blood pressure.
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Before taking EDARBI or EDARBYCLOR, tell your doctor if you are breastfeeding or plan to breastfeed. Discuss with your doctor other ways to lower your blood pressure. It is not known if EDARBYCLOR passes into breast milk. You and your doctor should decide if you will take EDARBI or EDARBYCLOR and breastfeed. You should not do both.
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Do not take EDARBYCLOR if you make less urine because of kidney problems (anuria).
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Tell your doctor about all your medical conditions, including if you have heart problems or stroke, have gout, or have liver or kidney problems. Kidney problems may become worse in people that already have kidney disease. If you have kidney problems, you may need blood tests, and your doctor may need to lower your dose or may need to stop treatment with EDARBYCLOR.
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Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other medicines to treat your high blood pressure or heart problem; water pills (diuretics); lithium, a medicine used to treat some types of depression; or digoxin.
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EDARBI and EDARBYCLOR may cause serious side-effects including low blood pressure (hypotension) which may cause you to feel faint and dizzy. Vomiting and diarrhea, a low salt diet or not drinking enough fluid can also lead to low blood pressure.
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If you feel faint or dizzy, lie down and call your doctor right away. If you pass out (faint) have someone call your doctor or get medical help. Stop taking EDARBYCLOR.
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If you have fluid and body salt (electrolytes) problems, tell your doctor if you experience any of the following symptoms: dry mouth, confusion, thirst, lack of energy/weakness, drowsiness, passing very little urine or passing large amounts of urine, seizures, muscle pain/cramps, restlessness, muscle tiredness (fatigue), fast or abnormal heartbeat, nausea and vomiting, and constipation.
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People who have increased levels of uric acid in the blood may develop gout. If you already have gout tell your doctor about worsening of your gout symptoms.
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In clinical studies, the most common side effect seen with EDARBI was diarrhea.
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In clinical studies, the side effects seen with EDARBYCLOR included dizziness and tiredness.
For further information please talk to your healthcare professional and see accompanying Product Information for EDARBI and EDARBYCLOR.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Use of EDARBI and EDARBYCLOR
EDARBI and EDARBYCLOR are prescription medicines used to treat high blood pressure (hypertension). Your doctor may prescribe other medicines for you to take along with EDARBI or EDARBYCLOR to treat your high blood pressure. EDARBYCLOR is used when one medicine is not enough or as the first medicine if your doctor decides you are likely to need more than one medicine. Medicines that lower your blood pressure may lower your chances of having a stroke or heart attack, but they don’t work alone. It should be part of a complete treatment plan.