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Cardea

Cardea

amlodipine + losartan

Manufacturer:

Globela Pharma

Distributor:

Corbridge
Concise Prescribing Info
Contents
Per 50 mg/5 mg FC tab Losartan K 50 mg, amlodipine besilate 5 mg
Indications/Uses
Essential HTN in adults whose BP is not adequately controlled on monotherapy.
Dosage/Direction for Use
1 tab daily. Max recommended dose: 100 mg/5 mg. Patient w/ intravascular vol depletion Initially losartan 25 mg once daily (as monotherapy). Elderly Initially 2.5 mg amlodipine daily (as monotherapy).
Administration
May be taken with or without food: Take w/ water.
Contraindications
Hypersensitivity. Should not be administered w/ aliskiren in patients w/ diabetes.
Special Precautions
Symptomatic hypotension may occur w/ patients who are intravascularly vol-depleted (eg, those treated w/ high-dose diuretics) or w/ severe aortic stenosis. Closely monitor BP, renal function & electrolytes. Certain side effects may affect patients' ability to drive or operate machinery. Not recommended for patients w/ moderate to severe renal impairment (ie, CrCl <20 mL/min) or patients on dialysis. Avoid use of aliskiren in patients w/ renal impairment (GFR <60 mL/min). Pregnancy. Not recommended in childn ≤18 yr. Neonates w/ history of in utero exposure to amlodipine & losartan K tab. Losartan: In cases where lower dose (ie, 25 mg once daily) is required for patients w/ history of hepatic impairment, administration of amlodipine & losartan K tab is not recommended. Electrolyte imbalances in patients w/ renal impairment, w/ or w/o diabetes. Changes in renal function including renal failure in susceptible individuals. Hyperkalaemia in concomitant use of other drugs that may increase serum K. Fetal toxicity (2nd & 3rd trimesters of pregnancy). Discontinue therapy when pregnancy is detected. Amlodipine: Worsening angina & acute MI can develop after starting or increasing dose, particularly in patients w/ severe obstructive CAD. Increased pulmonary edema in patients w/ heart failure. Titrate slowly when administering to patients w/ severe hepatic impairment.
Adverse Reactions
Insomnia; asthenia; chest pain. Losartan: Headache, dizziness; fatigue. Amlodipine: Arrhythmia (including ventricular tachycardia & atrial fibrillation), bradycardia, peripheral ischemia, syncope, tachycardia, vasculitis; hypoesthesia, peripheral neuropathy, paresthesia, tremor, vertigo; anorexia, constipation, dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia; allergic reaction, back pain, hot flushes, malaise, pain, rigors, gain/decrease wt; arthralgia, arthrosis, muscle cramps, myalgia; sexual dysfunction (male & female), nervousness, depression, abnormal dreams, anxiety, depersonalization; dyspnea, epistaxis; angioedema, erythema multiforme, pruritus, rash, erythematous/maculo-papular rash; abnormal vision, conjunctivitis, diplopia, eye pain, tinnitus; micturition frequency/disorder, nocturia; dry mouth, increased sweating; hyperglycemia, thirst; leukopenia, purpura, thrombocytopenia.
Drug Interactions
Losartan: Increased serum K w/ K-sparing diuretics (eg, spironolactone, triamterene, amiloride), K supplements, salt substitutes containing K, or other drugs that may increase serum K (eg, trimethoprim-containing products). Excretion of lithium may be reduced. Antihypertensive effect may be attenuated by NSAIDs including selective COX-2 inhibitors.
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
Cardea 50 mg/5 mg FC tab
Packing/Price
100's (P12/film-coated tab)
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