Drug Interaction:
Renal clearance of lithium is reduced by diuretics, such as chlorthalidone
increasing the risk of lithium toxicity .
NSAIDS increase risk of renal dysfunction and interfere with antihypertensive effect
.
Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment,
hypotension, and hyperkalemia
Indication:
EDARBYCLOR (azilsartan medoxomil and chlorthalidone) 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 EDARBYCLOR as soon as possible
Drugs that act directly on the renin-angiotensin system can cause injury and death to
the developing fetus
Drug Name- Edarbi
Active Ingredient - Azilsartan medoxomil
Treat high blood pressure (hypertension) in adults
Indication-
Treat high blood pressure (hypertension) in adults
Approved by FDA on 25-2-2011 (Ref- FDA approved List- 2011)
Adverse Reaction:
Most common adverse reactions (incidence 2%) are dizziness and fatigue
Contra-Indications:
CONTRAINDICATIONS
.
Anuria
Do not co-administer aliskiren with Edarbyclor in patients with diabetes
WARNINGS AND PRECAUTIONS
.
In patients with an activated renin-angiotensin-aldosterone system (RAAS),
such as volume- and/or salt-depleted patients, Edarbyclor can cause
excessive hypotension. Correct volume or salt depletion prior to
administration of Edarbyclor
.
In patients with renal artery stenosis, Edarbyclor may cause renal failure
.
Monitor renal function in patients with renal impairment.
Consider discontinuing Edarbyclor with progressive renal impairment
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE
Edarbyclor is an angiotensin II receptor blocker (ARB) and a thiazidelike diuretic
combination product indicated for the treatment of hypertension, to lower blood pressure:
In patients not adequately controlled with monotherapy
As initial therapy in patients likely to need multiple drugs to help
achieve blood pressure goals
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular
events, primarily strokes and myocardial infarctions
DOSAGE AND ADMINISTRATION
Starting dose is 40/12.5 mg once daily
Edarbyclor may be used to provide additional blood pressure lowering for
patients not adequately controlled on azilsartan medoxomil 80 mg or
chlorthalidone 25 mg
Dose may be increased to 40/25 mg after 2 to 4 weeks as needed to
achieve blood pressure goals
Maximal dose is 40/25 mg
May be administered with other antihypertensive agents
Edarbyclor may be administered with or without food
Replace volume in volume-depleted patients prior to use
DOSAGE FORMS AND STRENGTHS
Tablets (azilsartan/chlorthalidone): 40/12.5 mg and 40/25 mg
Patient Information:
PATIENT COUNSELING INFORMATION
Pregnancy
Tell female patients of childbearing potential about the consequences of exposure
to Edarbyclor during pregnancy. Discuss treatment options with women planning
to become pregnant. Tell patients to report pregnancies to their physicians
as soon as possible.
Symptomatic Hypotension
Advise patients to report light-headedness. Advise patients, if syncope occurs,
to have someone call the doctor or seek medical attention, and to discontinue
Edarbyclor.
Inform patients that dehydration from excessive perspiration, vomiting, or
diarrhea may lead to an excessive fall in blood pressure. Inform patients to
consult with their healthcare provider if these symptoms occur
Renal Impairment
Inform patients with renal impairment that they should receive periodic blood tests
to monitor their renal function while taking Edarbyclor.
Gout
Have patients report gout symptoms.
Pharmacology/ Pharmacokinetics:
1. Mechanism of Action
The active ingredients of Edarbyclor target two separate mechanisms involved in
blood pressure regulation. Azilsartan blocks the vasoconstriction and sodium
retaining effects of angiotensin II on cardiac, vascular smooth muscle, adrenal
and renal cells. Chlorthalidone produces diuresis with increased excretion of
sodium and chloride at the cortical diluting segment of the ascending
limb of Henle’s loop of the nephron
2. Pharmacokinetics
Edarbyclor
Following oral administration of Edarbyclor, peak plasma concentrations of
azilsartan and chlorthalidone are reached at 3 and 1 hours, respectively.
The rate (Cmax and Tmax) and extent (AUC) of absorption of azilsartan
are similar when it is administered alone or with chlorthalidone.
The extent (AUC) of absorption of chlorthalidone is similar when it is
administered alone or with azilsartan medoxomil; however, the Cmax of
chlorthalidone from Edarbyclor was 47% higher.
The elimination half-lives of azilsartan and chlorthalidone are approximately
12 hours and 45 hours, respectively.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy
Pregnancy Category D
Use of drugs that affect the renin-angiotensin system during the second and third
trimesters of pregnancy reduces fetal renal function and increases fetal and
neonatal morbidity and death.
When pregnancy is detected, discontinue Edarbyclor as soon as possible.
These adverse outcomes are usually associated with use of these drugs
in the second and third trimester of pregnancy.
2. Nursing Mothers
It is not known if azilsartan is excreted in human milk.
Because of the potential for adverse effects on the nursing infant, a decision
should be made whether to discontinue nursing or discontinue the drug,
taking into account the importance of the drug to the mother
3. Pediatric Use
Safety and effectiveness of Edarbyclor in pediatric patients under 18 years of age
have not been established
4. Geriatric Use
Edarbyclor
No dose adjustment with Edarbyclor is necessary in elderly patients.
Of the total patients in clinical studies with Edarbyclor, 24% were elderly
(65 years of age or older); 5.7% were 75 years and older.
No overall differences in safety or effectiveness were observed between
elderly patients and younger patients, but greater sensitivity of some
older individuals cannot be ruled out
.
Manufacturer Details