fect was observed following the abrupt cessation of Edarbi therapy.
Edarbi was effective in reducing blood pressure regardless of the age, gender, or race of patients, but the effect, as monotherapy, was smaller, approximately half, in black patients, who tend to have low renin levels. This has been generally true for other angiotensin II antagonists and ACE inhibitors.
Edarbi has about its usual blood pressure lowering effect size when added to a calcium channel blocker (amlodipine) or a thiazide-type diuretic (chlorthalidone).
16 HOW SUPPLIED/STORAGE AND HANDLING
Edarbi tablets are unscored and white to nearly white, debossed with "ASL" on one side and "40" or "80" on the other.
Tablet NDC 64764-xxx-xx
Bottle/30 Bottle/90
40 mg 844-30 844-90
80 mg 884-30 884-90
Store at 25°C (77°F), excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from moisture and light. Do not repackage; dispense and store in original container.
17 PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (17.2).
17.1 General Information
Pregnancy: Female patients of childbearing age should be told that use of drugs like Edarbi that act on the renin-angiotensin system during pregnancy can cause serious problems in the fetus and infant including low blood pressure, poor development of skull bones, kidney failure, and death. These consequences do not appear to have resulted from intrauterine drug exposure that has been limited to the first trimester. Discuss other treatment options with female patients planning to become pregnant. Women using Edarbi who become pregnant should notify their physicians as soon as possible [see FDA-Approved Patient Labeling (17.2)].
17.2 FDA-Approved Patient Labeling
Patient Information
Edarbi (eh-DAR-bee)
(azilsartan medoxomil)
Tablets
Read this Patient Information leaflet before you start taking Edarbi and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.
What is the most important information I should know about Edarbi?
Taking Edarbi during your second and third trimester can cause harm and even death to your unborn baby. If you think that you are pregnant, stop taking Edarbi and tell your doctor right away. If you plan to become pregnant, talk to your doctor about other ways to lower your blood pressure.
What is Edarbi?
Edarbi is a prescription medicine called an angiotensin II receptor blocker (ARB) used to treat high blood pressure (hypertension) in adults.
Your doctor may prescribe other medicines for you to take along with Edarbi to treat your high blood pressure.
It is not known if Edarbi is safe and effective in children under 18 years of age.
What should I tell my doctor before taking Edarbi?
Before you take Edarbi, tell your doctor if you:
have been told that you have abnormal body salt (electrolytes) levels in your blood
are pregnant or plan to become pregnant. See "What is the most important information I should know about Edarbi?"
are breastfeeding or plan to breastfeed. It is not known if Edarbi passes into your breast milk. You and your doctor should decide if you will take Edarbi or breastfeed. You should not do both. Talk with your doctor about the best way to feed your baby if y
