Edarbyclor 40mg/12.5mg Tablets
Azilsartan + Chlorthalidone
"40mg, 12.5mg"
TAKEDA PHARMACEUTICALS U.S.A., INC.
| Pack size | 28's (7's Blister x 4) |
|---|---|
| Dispensing mode | POM |
| Source | USA |
| Agent | Modern Pharmaceutical Co. |
| Retail Price | 131.50 AED |
Available as:
Indications
Edarbyclor 40mg/12.5mg Tablets is used for:
Hypertension, Treatment of hypertension in patients not adequately controlled with monotherapy or as initial therapy in patients likely to need multiple drugs to help achieve blood pressure goals
Adult Dose
Adult
Oral
Hypertension
1 tab (40 mg/12.5 mg) once daily.
May increase to 40 mg/25 mg after 2-4 weeks as needed to achieve blood pressure goals; not to exceed 40 mg/25 mg daily
Switching from ARB or diuretic monotherapy: Initiate with 40 mg/12.5 mg PO qDay
Hepatic impairment
Mild-to-moderate: No dose adjustment required for azilsartan
Severe: Azilsartan has not been studied in patients with severe hepatic impairment
Chlorthalidone may cause mild alterations of fluid and electrolyte balance that may precipitate hepatic coma in patients with impaired hepatic function or progressive liver disease
Child Dose
Safety and efficacy not established
Renal Dose
Renal impairment
Mild-to-moderate (eGFR 30 mL/min/1.73 sq.meter or greater): No dose adjustment required
Severe (eGFR <30 mL/min/1.73 sq.meter): Safety and effectiveness not established
Chlorthalidone may precipitate azotemia
Administration
May be taken with or without food.
Contra Indications
Hypersensitivity. Patient w/ anuria. Concomitant use w/ aliskiren in patients w/ diabetes. Pregnancy.
Precautions
Hyperuricemia
Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving chlorthalidone or other thiazide diuretics
Fetal toxicity
When pregnancy is detected, discontinue as soon as possible; drugs affecting renin-angiotensin system causing oligohydramnios, which may result in fetal injury and/or death
Hypotension in volume or salt depleted patients
Electrolytes
Hypokalemia is a dose-dependent adverse reaction that may develop with chlorthalidone; Edarbyclor attenuates chlorthalidone-associated hypokalemia
Coadministration of digitalis may exacerbate adverse effects of hypokalemia
Thiazide diuretics can cause hyponatremia and hypokalemia; drugs that inhibit the renin angiotensin system can cause hyperkalemia; monitor serum electrolytes periodically
Lactation: Unknown whether azilsartan distributed in breast milk, thiazide-like diuretics are excreted in human milk; consider alternate antihypertensive therapy or do not breastfeed
Pregnancy-Lactation
Pregnancy Category: D
Discontinue as soon as possible when pregnancy is detected; use during second and third trimesters affects renin-angiotensin system causing oligohydramnios, which may result in fetal injury and/or death (see Black Box Warnings and Cautions)
Lactation: Unknown whether azilsartan distributed in breast milk, thiazide-like diuretics are excreted in human milk; consider alternate antihypertensive therapy or do not breastfeed
Interactions
Elderly, vol-depleted patients or w/ compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, w/ angiotensin II receptor antagonists (including azilsartan) may result in deterioration of renal function, including possible acute renal failure. Dual blockade of the renin angiotensin system w/ angiotensin receptor blockers, ACE inhibitors or aliskiren is associated w/ increased risks of hypotension, hyperkalemia & changes in renal function (including acute renal failure). Concomitant use w/ aliskiren. Reduced lithium clearance by diuretics eg, chlorthalidone increasing the risk of lithium toxicity.
Adverse Effects
Side effects of Azilsartan + Chlorthalidone :
1-10%
Dizziness (8.9%)
Fatigue (2%)
Hypotension (1.7%)
<1%
Syncope (0.3%)
Mechanism of Action
Angiotensin II blocker; displaces angiotensin II from AT1 receptor and may lower blood pressure by antagonizing AT1-induced vasoconstriction, aldosterone release, catecholamine release, arginine vasopressin release, water absorption, and hypertrophic responses
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
Note
Edarbyclor 40mg/12.5mg "40mg, 12.5mg" Tablets manufactured by TAKEDA PHARMACEUTICALS U.S.A., INC.. Its generic name is Azilsartan + Chlorthalidone. Edarbyclor 40mg/12.5mg is availble in United Arab Emirates.
Farmaco UAE drug index information on Edarbyclor 40mg/12.5mg Tablets is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.