Lapiva

Per 5 mg/80 mg FC tab Amlodipine besylate 5 mg, valsartan 80 mg. Per 5 mg/160 mg FC tab Amlodipine besylate 5 mg, valsartan 160 mg. Per 10 mg/160 mg FC tab Amlodipine besylate 10 mg, valsartan 160 mg

Essential HTN in patients whose BP is not adequately controlled by monotherapy.

1 tab daily.

May be taken with or without food.

Hypersensitivity. Patients w/ hereditary angioedema or whom angioedema developed during earlier treatment w/ ACE inhibitor or angiotensin II receptor antagonist. Concomitant use w/ aliskiren in type II diabetes. Severe hepatic impairment, biliary cirrhosis, or cholestasis. Pregnancy & lactation.

Patients w/ Na &/or vol-depletion, unilateral or bilateral renal artery stenosis, stenosis to a solitary kidney or after recent kidney transplantation, serious CHF, severe chronic heart failure or other conditions that stimulate renin-angiotensin-aldosterone system, acute MI, severe obstructive CAD; aortic & mitral stenosis or obstructive hypertrophic cardiomyopathy. Co-administration w/ agents blocking the renin-angiotensin system eg, ACE inhibitors or aliskiren. Avoid concomitant use w/ aliskiren in patients w/ GFR <30 mL/min. Discontinue if angioedema develops. Severe renal impairment (CrCl <10 mL/min), dialysis, hepatic impairment or biliary obstructive disorders. Avoid use in women planning to become pregnant, during pregnancy & while breast-feeding. Not recommended in childn <18 yr.

Nasopharyngitis, flu, headache, peripheral oedema, oedema, pitting edema, facial edema, hot flush, fatigue, flushing, asthenia, dizziness, somnolence, postural dizziness, paraesthesia, vertigo, tachycardia, palpitations, orthostatic hypotension, cough, pharyngolaryngeal pain, diarrhea, nausea, abdominal pain, constipation, dry mouth, rash, erythema, joint swelling, back pain, arthralgia. Thrombocytopenia, vasculitis, angioedema. Amlodipine: Leucocytopenia, allergic reactions, peripheral neuropathy, arrhythmia, bradycardia, atrial fibrillation, MI, pancreatitis, hepatitis, erythema multiforme, SJS, increased hepatic enzyme. Valsartan: Neutropenia, hypersensitivity eg, serum sickness, dermatitis bullous, renal failure & impairment.

Amlodipine: Increased exposure of simvastatin. Increased plasma conc w/ CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir). May increase BP lowering effects w/ grapefruit or grapefruit juice. Increased incidence of hypotension, hyperkalemia & changes in renal function w/ agents blocking the renin-angiotensin system eg, ACE inhibitors or aliskiren. Decreased antihypertensive effects w/ NSAIDs including COX-2 inhibitors. Increased plasma conc of amlodipine w/ CYP3A4 inhibitors eg, ketoconazole, itraconazole, ritonavir. Increased systemic exposure to valsartan w/ rifampin, ciclosporin or ritonavir. May increase lithium plasma conc & toxicity. Monitor serum K levels in concomitant use w/ K supplements, K-sparing diuretics, K-containing salt substitutes, drugs that increase K levels eg, heparin. CYP3A4 inducers.

Calcium Antagonists / Angiotensin II Antagonists

C09DB01 - valsartan and amlodipine ; Belongs to the class of angiotensin II receptor blockers (ARBs) and calcium channel blockers. Used in the treatment of cardiovascular disease.

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