Cozaar/Cozaar XQ

Cozaar/Cozaar XQ

losartan

Manufacturer:

Organon

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Cozaar tab Losartan K. Per 5/50 mg Cozaar XQ FC tab Amlodipine camsylate 7.84 mg (equiv to amlodipine 5 mg), losartan K 50 mg. Per 5/100 mg Cozaar XQ FC tab Amlodipine camsylate 7.84 mg (equiv to amlodipine 5 mg), losartan K 100 mg
Indications/Uses
Cozaar HTN. Reduction in the risk of stroke in hypertensive patients w/ left ventricular hypertrophy. Delay of renal disease progression & reduction of proteinuria. Cozaar XQ Essential hypertensive patients not adequately controlled w/ amlodipine or losartan monotherapy.
Dosage/Direction for Use
Cozaar HTN Initial & maintenance dose: 50 mg once daily, may be increased to 100 mg once daily. Patient w/ intravascular vol-depletion; moderate to severe renal impairment; on dialysis; elderly >75 yr Initially 25 mg once daily. Reduction in the risk of stroke in hypertensive patient w/ left ventricular hypertrophy Initially 50 mg once daily. A low dose of hydrochlorothiazide should be added &/or the dose of Cozaar should be increased to 100 mg once daily based on BP response. Renal protection in type 2 diabetic patient w/ proteinuria Initially 50 mg once daily, may be increased to 100 mg once daily based on BP response. May be administered w/ other antihypertensives, insulin & other commonly used hypoglycemic agents. Cozaar XQ 1 tab once daily. Recommended to be taken on a regular schedule (ie, every morning).
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Concomitant use w/ aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). Cozaar XQ Hypersensitivity to losartan or dihydropyridines. Severe aortic valvular stenosis. Patient in shock. Severe hepatic impairment. Pregnancy (or those possible to be pregnant) & lactation.
Special Precautions
Angioedema. Symptomatic hypotension must be corrected in patients w/ intravascular vol-depletion (eg, those treated w/ high-dose diuretics) prior to therapy or use a lower starting dose. Electrolyte imbalances in patients w/ renal impairment, w/ or w/o diabetes. Concomitant use of other serum K-increasing drugs. Consider a lower dose for patients w/ a history of hepatic impairment. Possible renal function changes including renal failure; may be reversible upon discontinuation. Other drugs affecting the renin-angiotensin system may increase blood urea & serum creatinine in patients w/ bilateral renal artery stenosis or stenosis of the artery to a solitary kidney. Not recommended to be combined w/ ACE inhibitors or aliskiren due to dual blockade of the renin-angiotensin-aldosterone system (RAAS). Do not concomitantly use w/ ACE inhibitors in patients w/ diabetic nephropathy. Pregnancy (2nd & 3rd trimester); reduces fetal renal function & increases fetal & neonatal morbidity & death; discontinue use as soon as pregnancy is detected. Lactation. Direct attention towards BP & renal perfusion support, if oliguria or hypotension occurs in neonates w/ history of in utero exposure to Cozaar/Cozaar XQ. Childn ≤18 yr. Elderly >75 yr. Cozaar XQ Symptomatic hypotension may occur in patients w/ severe aortic stenosis. Patients having strictly limited salt-diet. Patients w/ moderate to severe renal impairment (CrCl <20 mL/min) or those on dialysis. Patients w/ hyperkalaemia. Titrate dose slowly in patients w/ severe hepatic impairment. Amlodipine: May develop worsening angina & acute MI after starting or increasing the amlodipine dose, particularly in patients w/ severe obstructive CAD.
Adverse Reactions
Dizziness. Hypertensive patient w/ left ventricular hypertrophy: Asthenia/fatigue, vertigo. Type 2 diabetic patient w/ proteinuria: Asthenia/fatigue, hypotension, hyperkalemia. Cozaar XQ Amlodipine: Headache, edema.
Drug Interactions
Losartan: Reduced active metabolite levels by rifampin & fluconazole. Serum K may be increased w/ K-sparing diuretics (eg, spironolactone, triamterene, amiloride), K supplements or K-containing salt substitutes, or other potential serum-K increasing drugs (eg, trimethoprim-containing products). Lithium excretion may be reduced. Diuretic & antihypertensive effects may be reduced, & further renal function deterioration including possible acute renal failure in renal function compromised patients by NSAIDs including selective COX-2 inhibitors. Increased risk of hypotension, syncope, hyperkalemia & renal function changes (including acute renal failure) due to dual blockade of the RAAS w/ ACE inhibitors, or aliskiren. Amlodipine: Bioavailability may be increased by grapefruit juice. Increased systemic exposure when co-administered w/ diltiazem. Plasma conc may be increased by strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir).
MIMS Class
Angiotensin II Antagonists / Calcium Antagonists
ATC Classification
C09CA01 - losartan ; Belongs to the class of angiotensin II receptor blockers (ARBs). Used in the treatment of cardiovascular disease.
C09DB06 - losartan and amlodipine ; Belongs to the class of angiotensin II receptor blockers (ARBs) and calcium channel blockers. Used in the treatment of cardiovascular disease.
Presentation/Packing
Form
Cozaar XQ FC tab 5 mg/100 mg
Packing/Price
30's
Form
Cozaar XQ FC tab 5 mg/50 mg
Packing/Price
30's
Form
Cozaar tab 100 mg
Packing/Price
30's
Form
Cozaar tab 50 mg
Packing/Price
30's
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