Cozaar XQ

Cozaar XQ

Manufacturer:

Hanmi Pharmaceutical

Distributor:

Organon
Concise Prescribing Info
Contents
Per 50 mg/5 mg FC tab Losartan K 50 mg, amlodipine camsylate 7.8 mg (equiv to amlodipine 5 mg). Per 100/5 mg tab Losartan K 100 mg, amlodipine camsylate 7.8 mg (equiv to amlodipine 5 mg)
Dosage/Direction for Use
1 tab daily. Max dose: 100 mg/5 mg daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Co-administration of aliskiren in patients w/ diabetes.
Special Precautions
Symptomatic hypotension may occur in patients who are intravascularly vol-depleted (eg, those treated w/ high-dose diuretics) or w/ severe aortic stenosis. Electrolyte imbalances. Concomitant use of other drugs that may increase serum K may lead to hyperkalemia. Other drugs that affect 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. History of hepatic impairment. Not recommended in patients w/ moderate to severe renal impairment or those on dialysis. Pregnancy (2nd & 3rd trimesters); discontinue therapy as soon as pregnancy is detected. Lactation. Neonates w/ history of in utero exposure to losartan + amlodipine. Not recommended in childn ≤18 yr. Elderly. Amlodipine: Worsening angina & acute MI may develop after starting or increasing the dose in patients w/ severe obstructive CAD.
Adverse Reactions
Dizziness, headache. Palpitation. Losartan: Abdominal pain, asthenia/fatigue, chest pain, edema/swelling; tachycardia; diarrhea, dyspepsia, nausea; back pain, muscle cramps; insomnia; cough, nasal congestion, pharyngitis, sinus disorder, URTI. Amlodipine: Edema, flushing.
Drug Interactions
Losartan: Reduced active metabolite levels w/ rifampin & fluconazole. Increased serum K w/ K-sparing diuretics (eg, spironolactone, triamterene, amiloride), K supplements, K containing salt substitutes or other drugs that may increase serum K (eg, trimethoprim-containing products). Reduced lithium excretion. Reduced effect w/ NSAIDs including selective COX-2 inhibitors. May result in a further deterioration of renal function including possible acute renal failure w/ NSAIDs in patients w/ compromised renal function (eg, elderly, vol-depleted patients including those on diuretic therapy). Increased risk of hypotension, syncope, hyperkalemia & changes in renal function w/ drugs that affect RAAS eg, angiotensin receptor blockers, ACE inhibitors or aliskiren. Reduced therapeutic effect w/ grapefruit juice. Amlodipine: May increase plasma conc w/ strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir).
MIMS Class
Angiotensin II Antagonists / Calcium Antagonists
ATC Classification
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 100/5 mg film-coated tab
Packing/Price
30's (P1,027.4/box)
Form
Cozaar XQ 50/5 mg film-coated tab
Packing/Price
30's (P795.3/box)
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