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Fortzaar

Fortzaar

losartan + hydrochlorothiazide

Manufacturer:

Organon

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Losartan K 100 mg, hydrochlorothiazide 25 mg
Indications/Uses
HTN for patients in whom combination therapy is appropriate. Reduce risk of CV morbidity & mortality in hypertensive patients w/ left ventricular hypertrophy.
Dosage/Direction for Use
HTN Usual starting & maintenance dose: Losartan 50 mg/hydrochlorothiazide 12.5 mg once daily. May be increased to max of losartan 100 mg/hydrochlorothiazide 25 mg once daily in patients w/ inadequate response. Reduction of risk of CV morbidity & mortality in hypertensive patients w/ left ventricular hypertrophy Initially 50 mg losartan once daily. May be increased to losartan 100 mg/hydrochlorothiazide 12.5-25 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to losartan, hydrochlorothiazide & other sulfonamide-derived drugs. Anuria. Co-administration w/ aliskiren in patients w/ diabetes. Pregnancy.
Special Precautions
Hypersensitivity. Discontinue treatment if patient presents w/ acute resp distress; angioedema including swelling of larynx & glottis causing airway obstruction &/or swelling of face, lips, pharynx &/or tongue occur; oligohydramnios is observed. Discontinue thiazide use prior to parathyroid function test. Not to be initiated in intravascularly vol-depleted patients eg, those treated w/ high-dose diuretics. May impair glucose tolerance; decrease urinary Ca excretion & cause intermittent & slight elevation of serum Ca; increase cholesterol & triglyceride levels; precipitate hyperuricemia &/or gout. Increased risk of non-melanoma skin cancer (basal & squamous cell carcinoma) w/ increasing cumulative hydrochlorothiazide dose. Exacerbation or activation of SLE. Hyperkalemia; lethargy, nausea or vomiting. Patients w/ previous non-melanoma skin cancer. Black patients. Observe for signs of fluid or electrolyte imbalance eg, vol depletion, hyponatremia, hypochloremic alkalosis, hypomagnesemia or hypokalemia during intercurrent diarrhea or vomiting. Perform periodic determination of serum electrolytes. Reduce sun & artificial UVA exposure. Regularly check skin for new lesions. Not recommended in concomitant use w/ K supplement or K-sparing diuretics. Renal failure in susceptible individuals. May increase blood urea & serum creatinine in patients w/ renovascular disease eg, bilateral renal artery stenosis or artery stenosis to solitary kidney. Not recommended in hepatic or severe renal impairment (CrCl ≤30 mL/min). Perform serial ultrasound exam to assess intra-amniotic environment. Not recommended for routine use of diuretics in healthy pregnant women. Discontinue treatment when pregnancy is detected. Lactation. Fetal toxicity including oligohydramnios associated w/ fetal lung hypoplasia & skeletal deformations. Increased risk to fetus during 2nd or 3rd trimesters of pregnancy. Closely observe infants w/ history of in utero exposure for hypotension, oliguria & hyperkalemia. Childn. Not to be used as initial therapy in elderly.
Adverse Reactions
Dizziness, asthenia/fatigue & vertigo. Non-melanoma skin cancer (basal & squamous cell carcinoma); thrombocytopenia, anemia, aplastic & hemolytic anemia, leukopenia, agranulocytosis; anaphylactic reactions, angioedema; anorexia, hyperglycemia, hyperuricemia, electrolyte imbalance including hyponatremia & hypokalemia; insomnia, restlessness; dysgeusia, headache, migraine, paraesthesias; xanthopsia, transient blurred vision; palpitation, tachycardia; dose-related orthostatic effects, necrotizing angiitis (vasculitis & cutaneous vasculitis); cough, nasal congestion, pharyngitis, sinus disorder, upper resp infection, resp distress, pneumonitis & pulmonary edema; dyspepsia, abdominal pain, gastric irritation, cramping, diarrhea, constipation, nausea, vomiting, pancreatitis, sialadenitis; hepatitis, jaundice (intrahepatic cholestatic jaundice); rash, pruritus, purpura (including Henoch-Schonlein purpura), TEN, urticaria, erythroderma, photosensitivity, cutaneous lupus erythematosus; back pain, muscle cramps & spasm, myalgia, arthralgia; glycosuria, renal dysfunction & failure, interstitial nephritis; erectile dysfunction/impotence; chest pain, edema/swelling, malaise, fever, weakness; liver function abnormalities.
Drug Interactions
Losartan: Reduced levels of active metabolite w/ rifampin & fluconazole. Increased serum K w/ K-sparing diuretics (eg, spironolactone, triamterene, amiloride), K supplements, salt substitutes containing K or other drugs increasing serum K eg, trimethoprim-containing products. Reduced lithium excretion w/ lithium salts. Reduced effect & further renal function deterioration w/ NSAIDs including COX-2 inhibitors. Co-administration w/ aliskiren. Reduced therapeutic effect w/ grapefruit juice. Hydrochlorothiazide: Potentiation of orthostatic hypotension w/ alcohol, barbiturates or narcotics. Concomitant use w/ oral antidiabetics & insulin. Additive effect w/ other antihypertensives. Impaired absorption w/ cholestyramine & colestipol resins. Intensified electrolyte depletion particularly hypokalemia w/ corticosteroids, ACTH, or glycyrrhizin. Possible decreased response to pressor amines eg, adrenaline. Possible increased responsiveness to non-depolarizing skeletal muscle relaxants eg, tubocurarine. Reduced renal clearance of lithium. Reduced diuretic, natriuretic & antihypertensive effects w/ NSAIDs including selective COX-2 inhibitors. Interference w/ parathyroid function tests.
MIMS Class
Angiotensin II Antagonists / Diuretics
ATC Classification
C09DA01 - losartan and diuretics ; Belongs to the class of angiotensin II receptor blockers (ARBs) in combination with diuretics. Used in the treatment of cardiovascular disease.
Presentation/Packing
Form
Fortzaar tab
Packing/Price
30's
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