ncy is detected, discontinue Edarbi as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1)
INDICATIONS AND USAGE
Edarbi is an angiotensin II receptor blocker indicated for the treatment of hypertension, either alone or in combination with other antihypertensive agents. (1)
DOSAGE AND ADMINISTRATION
The recommended dose in adults is 80 mg taken once daily. Consider a starting dose of 40 mg for patients who are treated with high doses of diuretics. (2.1)
Edarbi may be administered with or without food. (2.1)
Edarbi may be administered with other antihypertensive agents. (2.1)
DOSAGE FORMS AND STRENGTHS
Tablets: 40 mg and 80 mg. (3)
CONTRAINDICATIONS
None
WARNINGS AND PRECAUTIONS
Avoid fetal or neonatal exposure. (5.1)
Correct volume or salt depletion prior to administration of Edarbi. (5.2)
Monitor for worsening renal function in patients with renal impairment. (5.3)
ADVERSE REACTIONS
The most common adverse reaction in adults was diarrhea (2%). (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-877-825-3327 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Nursing Mothers: Discontinue nursing or drug. (8.3)
Geriatric Patients: Abnormally high serum creatinine values were more likely to be reported for patients age 75 or older. No overall difference in efficacy versus younger patients, but greater sensitivity of some older individuals cannot be ruled out. (8.5)
In patients with an activated renin-angiotensin system, as by volume- or salt-depletion, renin-angiotensin-aldosterone system (RAAS) blockers such as azilsartan medoxomil can cause excessive hypotension. In susceptible patients, e.g., with renal artery stenosis, RAAS blockers can cause renal failure (5.2, 5.3).
Pediatrics: Safety and efficacy in children have not been established.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling
Revised: 02/2011
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Back to Highlights and Tabs FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed
WARNING: AVOID USE IN PREGNANCY
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dose2.2 Handling Instructions2.3 Special Populations3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Fetal/Neonatal Morbidity and Mortality5.2 Hypotension in Volume- or Salt-Depleted Patients5.3 Impaired Renal Function6 ADVERSE REACTIONS
6.1 Clinical Trials Experience6.2 Clinical Laboratory Findings7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy8.3 Nursing Mothers8.4 Pediatric Use8.5 Geriatric Use8.6 Renal Impairment8.7 Hepatic Impairment10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility13.2 Animal Toxicology and/or Pharmacology14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 General Information17.2 FDA-Approved Patient Labeling
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