EDARBI- azilsartan kamedoxomil tablet

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

Azilsartan kamedoxomil (UNII: WEC6I2K1FC) (Azilsartan - UNII:F9NUX55P23)

MAH:

Azurity Pharmaceuticals, Inc.

INN:

Azilsartan kamedoxomil

composition:

Azilsartan medoxomil 40 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Edarbi is indicated for the treatment of hypertension in adults, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with Edarbi. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Edarbi may be used alone or in combination with other antihypertensive agents. Do not coadminister aliskiren-containing products with Edarbi in patients with diabetes [see Drug Interactions (7)] . Risk Summary Edarbi can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death (see Clinical Considerations ). Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. When pregnancy is detected, discontinue Edarbi as soon as possible. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly. Fetal/Neonatal adverse reactions Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension and death. Perform serial ultrasound examinations to assess the intra-amniotic environment. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to Edarbi for hypotension, oliguria, and hyperkalemia. In neonates with a history of in utero exposure to Edarbi, if oliguria or hypotension occurs, support blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function. Data Animal Data In peri- and postnatal rat development studies, adverse effects on pup viability, delayed incisor eruption and dilatation of the renal pelvis along with hydronephrosis were seen when azilsartan medoxomil was administered to pregnant and nursing rats at 1.2 times the MRHD on a mg/m2 basis. Reproductive toxicity studies indicated that azilsartan medoxomil was not teratogenic when administered at oral doses up to 1000 mg azilsartan medoxomil/kg/day to pregnant rats (122 times the MRHD on a mg/m2 basis) or up to 50 mg azilsartan medoxomil/kg/day to pregnant rabbits (12 times the MRHD on a mg/m2 basis). M-II also was not teratogenic in rats or rabbits at doses up to 3000 mg M-II/kg/day. Azilsartan crossed the placenta and was found in the fetuses of pregnant rats and was excreted into the milk of lactating rats. Risk Summary There is limited information regarding the presence of azilsartan in human milk, the effects on the breastfed infant, or the effects on milk production. Azilsartan is present in rat milk. Because of the potential for adverse effects on the nursing infant, advise a nursing woman that breastfeeding is not recommended during treatment with Edarbi. Safety and effectiveness in pediatric patients have not been established. Use of Edarbi is not recommended in children less than 2 years of age. It is not known whether post-natal use of azilsartan in patients less than 2 years of age, before maturation of kidney function is complete, has a long-term deleterious effect on the kidney. Juvenile Animal Studies In juvenile rat studies, dosing with azilsartan starting on post-natal day 14 (equivalent to a neonate with morphologically and functionally immature kidneys) resulted in increased incidence of edema of the renal papilla at the end of 4-week recovery period that was non-reversible. These findings occurred in the high-dose group (10 mg/kg) and were not observed in juvenile rats dosed starting on post-natal day 21 (equivalent to a human approximately 2 years of age) or adult rats. No dose adjustment with Edarbi is necessary in elderly patients. Of the total patients in clinical studies with Edarbi, 26% were elderly (65 years of age and older); 5% were 75 years of age and older. Abnormally high serum creatinine values were more likely to be reported for patients age 75 or older. No other differences in safety or effectiveness were observed between elderly patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out [see Clinical Pharmacology (12.3)] . Dose adjustment is not required in patients with mild-to-severe renal impairment or end-stage renal disease. Patients with moderate to severe renal impairment are more likely to report abnormally high serum creatinine values. No dose adjustment is necessary for subjects with mild or moderate hepatic impairment. Edarbi has not been studied in patients with severe hepatic impairment [see Clinical Pharmacology (12.3)].

leaflet_short:

Edarbi tablets are unscored and white to nearly white, debossed with "ASL" on one side and "40" or "80" on the other. Storage 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.

authorization_status:

New Drug Application

SPC

EDARBI- AZILSARTAN KAMEDOXOMIL TABLET
AZURITY PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EDARBI SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EDARBI.
EDARBI (AZILSARTAN MEDOXOMIL) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2011
WARNING: FETAL TOXICITY
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
WHEN PREGNANCY IS DETECTED, DISCONTINUE EDARBI AS SOON AS POSSIBLE.
(5.1, 8.1)
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH
TO THE DEVELOPING FETUS. (5.1, 8.1)
INDICATIONS AND USAGE
Edarbi is an angiotensin II receptor blocker indicated for the
treatment of hypertension in adults, to lower
blood pressure. Lowering blood pressure reduces the risk of fatal and
nonfatal cardiovascular events,
primarily strokes and myocardial infarctions. Edarbi may be used
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
Do not coadminister aliskiren-containing products with Edarbi in
patients with diabetes. (4)
WARNINGS AND PRECAUTIONS
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 AZURITY
PHARMACEUTICALS, INC. AT 1-800-
461-7449 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Dual inhibition of the renin-angiotensin system: Increased risk of
renal impairment, hypotension, and
hyperkalemia. (7)
Lithium: Increases in serum lithium