Cozaar XQ Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Side Effects Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Per 5/50 mg tab Amlodipine camsylate 5 mg, losartan K 50 mg. Per 5/100 mg tab Amlodipine camsylate 5 mg, losartan K 100 mg

Indications/Uses

Essential HTN in adult patients whose BP is not adequately controlled on either monotherapy.

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Dosage/Direction for Use

1 tab daily. HTN 5/50 mg in patient whose BP is not adequately controlled w/ amlodipine 5 mg or losartan 50 mg alone, or 5/100 mg in patient whose BP is not adequately controlled w/ losartan 100 mg or 5/50 mg dose. Max recommended dose: 5/100 mg.

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Overdosage

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Administration

May be taken with or without food.

Contraindications

Hypersensitivity. Not to be used w/ aliskiren in diabetic patients.

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Special Precautions

Intravascular vol-depletion (eg, those treated w/ high-dose diuretics), severe aortic stenosis, symptomatic hypotension. May affect ability to drive & use machines. Not recommended in moderate to severe renal impairment (CrCl <20 mL/min) or patients on dialysis. Hepatic impairment. Not to be used during pregnancy & lactation. Not recommended in childn ≤18 yr. Elderly. Losartan: Hypersensitivity. Bilateral renal artery stenosis or artery stenosis to solitary kidney; electrolyte/fluid imbalance. Amlodipine: Patients w/ severe obstructive CAD, NYHA III & IV heart failure.

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Use In Pregnancy & Lactation

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Adverse Reactions

Dizziness, headache. Losartan: Asthenia/fatigue; vertigo; hypotension; hyperkalemia. Amlodipine: Edema.

Drug Interactions

Losartan: Reduced levels of active metabolite w/ rifampin & fluconazole. Increased serum K w/ K-sparing diuretics (eg, spironolactone, triamterene, amiloride), K supplements, K-containing salt substitutes or other drugs increasing serum K (trimethoprim-containing products). Reduced lithium excretion. Attenuated antihypertensive effects w/ NSAIDs including selective COX-2 inhibitors. Avoid use w/ aliskiren. Other drugs affecting renin-angiotensin-aldosterone system. Amlodipine: Increased plasma conc w/ strong CYP3A4 inhibitors eg, ketoconazole, itraconazole, ritonavir. Lowered active metabolite conc w/ grapefruit juice.

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Storage

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Description

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Action

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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.

Regulatory Classification

Presentation/Packing

Form

Cozaar XQ 5/100 mg FC tab

Packing/Price

30's

Form

Cozaar XQ 5/50 mg FC tab

Packing/Price

30's

Cozaar XQ

Manufacturer:

Organon

Distributor:

Zuellig Pharma