Colixtan 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 Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Losartan K 50 mg, amlodipine besilate 5 mg

Indications/Uses

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

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Dosage/Direction for Use

1 tab daily. Max: 100 mg/5 mg.

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Overdosage

View Colixtan overdosage for action to be taken in the event of an overdose.

Administration

May be taken with or without food: Take w/ water.

Contraindications

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

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Special Precautions

Hypotension in patients who are intravascularly vol-depleted (eg, those treated w/ high-dose diuretics) or w/ severe aortic stenosis, symptomatic hypotension. Correct intravascular vol depletion prior to administration. Certain side effects may affect ability to drive or operate machinery. Not recommended in moderate to severe renal impairment (CrCl <20 mL/min) or patients on dialysis. Hepatic impairment. Discontinue use when pregnancy is detected. Not to be used during lactation. Not recommended in childn ≤18 yr. Elderly. Losartan: Hypersensitivity. Electrolyte/fluid imbalance in patients w/ renal impairment, w/ or w/o diabetes. Concomitant use w/ other drugs that may increase serum K; other drugs affecting renin-angiotensin system. Changes in renal function including renal failure. Amlodipine: Worsening angina & acute MI particularly in patients w/ severe obstructive CAD; increased reports of pulmonary edema in incidence of worsening heart failure.

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Use In Pregnancy & Lactation

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Adverse Reactions

Dizziness, headache.

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Drug Interactions

Concomitant use w/ other drugs affecting the RAAS. Losartan: Reduced levels of active metabolite w/ rifampin, fluconazole. May increase 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). May reduce excretion of lithium. Antihypertensive effects may be attenuated by NSAIDs including selective COX-2 inhibitors. Avoid use w/ aliskiren in patients w/ renal impairment (GFR <60 mL/min). Amlodipine: Increased systemic exposure w/ diltiazem. Plasma conc may be increased w/ strong CYP3A4 inhibitors eg, ketoconazole, itraconazole, ritonavir. Monitor for symptoms of hypotension & edema when coadministered w/ CYP3A4 inhibitors. Concomitant use w/ CYP3A4 inducers.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Colixtan detailed prescribing information

Storage

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Description

View Colixtan description for details of the chemical structure and excipients (inactive components).

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

Colixtan 50 mg/5 mg FC tab

Packing/Price

100's

Colixtan

amlodipine + losartan

Manufacturer:

Unison Pharmaceutical

Distributor:

Trumed