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Tozam 100/5/Tozam 100/10

Tozam 100/5/Tozam 100/10

amlodipine + losartan

Manufacturer:

Stallion Labs

Distributor:

Torrent
Concise Prescribing Info
Contents
Per Tozam 100/5 tab Losartan K 100 mg, amlodipine besilate 5 mg. Per Tozam 100/10 tab Losartan K 100 mg, amlodipine besilate 10 mg
Indications/Uses
Essential HTN. May be used in patients whose BP is not adequately controlled on monotherapy.
Administration
May be taken with or without food: Take w/ water.
Contraindications
Hypersensitivity. Not to be administered w/ aliskiren in patients w/ diabetes.
Special Precautions
Symptomatic hypotension may occur in patients who are intravascularly vol-depleted (eg, those treated w/ high-dose diuretics) or w/ severe aortic stenosis. Reports of changes in renal function including renal failure in susceptible individuals as consequence of inhibiting the renin-angiotensin system. May increase blood urea & serum creatinine in patients w/ bilateral renal artery stenosis or stenosis of the artery to a solitary kidney. Patients w/ history of hepatic impairment. Not recommended in patients w/ moderate to severe renal impairment (CrCl <20 mL/min) or those on dialysis. Discontinue use as soon as pregnancy is detected. Do not give to nursing mothers. Neonates w/ history of in utero exposure to losartan + amlodipine. Not recommended in childn ≤18 yr. Elderly. Losartan: Angioedema. Address electrolyte imbalances in patients w/ renal impairment, w/ or w/o diabetes. Fetal toxicity. Amlodipine: Worsening angina & acute MI can develop after starting or increasing dose, particularly in patients w/ severe obstructive CAD.
Drug Interactions
Losartan: Reduced active metabolite levels w/ rifampin & fluconazole. May lead to increased 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 effect may be attenuated w/ NSAIDs including selective COX-2 inhibitors. May result in a further deterioration of renal function including possible acute renal failure w/ NSAIDs (including selective COX-2 inhibitors) in patients w/ compromised renal function eg, elderly or patients who are vol-depleted, including those on diuretics. Increased risks of hypotension, syncope, hyperkalemia, & changes in renal function (including acute renal failure) associated w/ dual blockade of the renin-angiotensin-aldosterone system w/ ACE inhibitors, or aliskiren. Active metabolite conc may be lowered w/ grapefruit juice. Amlodipine: Plasma conc may be increased w/ strong CYP3A4 inhibitors eg, ketoconazole, itraconazole, ritonavir.
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
Tozam 100/10 FC tab
Packing/Price
100's (P2,860/box)
Form
Tozam 100/5 FC tab
Packing/Price
100's (P2,860/box)
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