Edarbyclor

Edarbyclor

Manufacturer:

Celltrion Healthcare

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Per tab Azilsartan medoxomil 40 mg, chlorthalidone 12.5 mg
Indications/Uses
HTN in patients not adequately controlled w/ monotherapy & as initial therapy likely to need multiple drugs to help achieve BP goals.
Dosage/Direction for Use
Initially one 40/12.5 mg tab once daily. May be increased to 40/25 mg after 2-4 wk.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Patient w/ anuria. Concomitant use w/ aliskiren in patients w/ diabetes. Pregnancy.
Special Precautions
Severe renal (eGFR <30 mL/min/1.73 m2) & hepatic impairment. Vol- or salt-depleted patients eg, those being treated w/ high dose diuretics. Uni-/bilateral renal artery stenosis; CHF. Hypokalemia, hyperuricemia (chlorthalidone). Pregnancy (discontinue use if pregnancy is detected) & lactation. Childn <18 yr.
Adverse Reactions
Dizziness, fatigue. Azilsartan: Diarrhea, nausea, asthenia, muscle spasm, postural dizziness, cough. Chlorthalidone: Rash, headache, dizziness, GI upset & elevations of uric acid & cholesterol.
Drug 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.
MIMS Class
Angiotensin II Antagonists / Diuretics
ATC Classification
C09DA09 - azilsartan medoxomil and diuretics ; Belongs to the class of angiotensin II receptor blockers (ARBs) in combination with diuretics. Used in the treatment of cardiovascular disease.
Presentation/Packing
Form
Edarbyclor tab 40/12.5 mg
Packing/Price
2 × 14's
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