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Amlife

Amlife

amlodipine + losartan

Manufacturer:

Therapharma

Distributor:

United Lab
Concise Prescribing Info
Contents
Per 50 mg/5 mg FC tab Losartan K 50 mg, amlodipine besilate 5 mg. Per 100 mg/5 mg FC tab Losartan K 100 mg, amlodipine besilate 5 mg. Per 100 mg/10 mg FC tab Losartan K 100 mg, amlodipine besilate 10 mg
Dosage/Direction for Use
Individualized dosage. One 50 mg/5 mg tab once daily, increased to 50 mg/10 mg once daily or one 100 mg/5 mg tab once daily or one 100 mg/10 mg tab once daily if BP remains uncontrolled after 2 wk.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Severe hypotension; shock (including cardiogenic shock); obstruction of the outflow tract of the left ventricle eg, high grade aortic stenosis; hemodynamically unstable heart failure after MI. Concomitant use w/ aliskiren in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). Severe hepatic impairment. Women who are pregnant, trying to get pregnant or suspect that they are pregnant. Lactation.
Special Precautions
Caution in driving & using machines. Childn. Elderly. Discontinue use as soon as possible when pregnancy is detected. Losartan: Not recommended in patients w/ primary hyperaldosteronism. Excessive hypotension in patients w/ ischemic CV & cerebrovascular disease could result in MI or stroke. Risk of severe arterial hypotension & often acute renal impairment in patients w/ heart failure w/ or w/o renal impairment. Patients whose renal function is dependent on renin-angiotensin-aldosterone system eg, those w/ severe cardiac insufficiency or pre-existing renal dysfunction; unilateral or bilateral renal artery stenosis; recent kidney transplantation; aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Correct intravascular vol-depletion (eg, patients treated w/ high-dose diuretics) prior to therapy. Monitor serum K levels in type 2 diabetic patients w/ nephropathy. Closely monitor patients w/ history of angioedema. Not recommended in concomitant use w/ K-sparing diuretics, K supplements & K-containing salt substitutes; ACE inhibitors. Not to be administered in severe hepatic impairment. Amlodipine: Worsening angina & acute MI may develop, particularly in patients w/ severe obstructive CAD after initiating or increasing dose. Possible symptomatic hypotension, particularly in patients w/ severe aortic stenosis. Patients w/ heart failure. Hepatic impairment.
Adverse Reactions
Abdominal pain; somnolence; dizziness; headache; palpitation; flushing; nausea; edema; fatigue. Losartan: Asthenia, chest pain, facial edema, fever, infection, flu-like disease, malaise, orthostatic effects, syncope, trauma; angina pectoris, 2nd degree AV block, arrhythmias including atrial fibrillation, CV accident, hypotension/orthostatic hypotension, MI, sinus bradycardia, tachycardia, ventricular tachycardia & fibrillation; diabetic neuropathy & vascular disease; anorexia, constipation, dental pain, diarrhea, dry mouth, dyspepsia, flatulence, gastritis, pancreatitis, vomiting; erectile dysfunction/impotence, nocturia, renal impairment & failure, urinary frequency, UTI; hemolysis, anemia; liver function abnormalities; anaphylactic reactions, angioedema (including swelling of larynx & glossitis); gout, hyperkalemia, hypoglycemia, hyponatremia, wt gain, elevations of ALT, BUN, serum creatinine, liver enzymes &/or bilirubin, & reductions of Hb & hematocrit; arthralgia, arthritis, fibromyalgia, joint swelling, myalgia, muscle cramps & weakness, pain (back, arm, shoulder, hip, leg, knee, musculoskeletal), stiffness, rhabdomyolysis; anxiety, anxiety disorder, ataxia, confusion, depression, dream abnormality, dysgeusia, hypesthesia, insomnia, decreased libido, memory impairment, migraine, nervousness, panic disorder, paresthesia, peripheral neuropathy, sleep disorder, tremor, vertigo; bronchitis, cough/dry cough, dyspnea, epistaxis, nasal & resp congestion, pharyngeal discomfort, pharyngitis, rhinitis, sinusitis, sinus disorder, URTI; alopecia, cellulitis, dermatitis, dry skin, ecchymosis, erythema, erythroderma, photosensitivity, pruritus, rash, sweating, superficial peeling of palms, urticaria; blurred vision, burning/stinging in eye, cataract, conjunctivitis, tinnitus, decreased visual acuity. Amlodipine: Ankle swelling.
Drug Interactions
Losartan: Increased serum lithium conc & toxicity. May increase serum K w/ K-sparing diuretics (eg, spironolactone, triamterene, amiloride), K supplements, or K-containing salt substitutes. Antihypertensive effect may be reduced w/ NSAIDs eg, selective COX-2 inhibitors & non-selective NSAIDs. May result in increased risk of worsening of renal function (including possible acute renal failure) & increase in serum K particularly in patients w/ poor pre-existing renal function w/ NSAIDs. Increased risk of hypotension, syncope, hyperkalemia & changes in renal function (including acute renal failure) in dual blockade of the RAS w/ ACE inhibitors or aliskiren. Not to be co-administered w/ aliskiren in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). May increase risk of hypotension w/ TCAs, antipsychotics, baclofene, amifostine. Decreased conc w/ rifampicin & fluconazole. Amlodipine: Bioavailability may be increased resulting in increased BP lowering effects w/ grapefruit juice. Increased systemic exposure of simvastatin. Plasma conc may be increased w/ strong or moderate CYP3A4 inhibitors eg, PIs (eg, ritonavir), azole antifungals (eg, ketoconazole, itraconazole), macrolides (eg, erythromycin, clarithromycin), verapamil or diltiazem. May result in lower plasma conc w/ CYP3A4 inducers eg, rifampicin, St. John's wort. May increase systemic exposure of ciclosporin or tacrolimus.
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
Amlife 100 mg/10 mg FC tab
Packing/Price
30's (P34.15/film-coated tab)
Form
Amlife 100 mg/5 mg FC tab
Packing/Price
30's (P29.85/film-coated tab)
Form
Amlife 50 mg/5 mg FC tab
Packing/Price
30's (P23.93/film-coated tab)
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