Cozaar

Cozaar

losartan

Manufacturer:

Merck Sharp & Dohme

Marketer:

Transfarma Medica Indah
Full Prescribing Info
Contents
Losartan potassium.
Action
Cozaar (losartan potassium), the first of a new class of antihypertensives, is an angiotensin II receptor (type AT1) antagonist.
Indications/Uses
Treatment of hypertension.
Dosage/Direction for Use
The usual starting and maintenance dose is 50 mg once daily for most patients. The maximal antihypertensive effect is attained 3-6 weeks after initiation of therapy. Some patients may receive an additional benefit by increasing the dose to 100 mg once daily.
For patients with intravascular volume depletion (eg, those treated with high-dose diuretics), a starting dose of 25 mg once daily should be considered (see Precautions).
No initial dosage adjustment is necessary for elderly patients or for patients with mild renal impairment (ie, creatinine clearance 20-50 mL/min). For patients with moderate to severe renal impairment (ie, creatinine clearance <20 mL/min) or patients on dialysis, a lower starting dose of 25 mg once daily is recommended.
A lower dose should be considered for patients with a history of hepatic impairment (see Precautions).
Cozaar may be administered with other antihypertensive agents.
Cozaar may be administered with or without food.
Overdosage
Limited data are available with regard to overdosage in humans. The most likely manifestations of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted.
Neither losartan nor the active metabolite can be removed by hemodialysis.
Contraindications
Patients who are hypersensitive to any component of Cozaar.
Special Precautions
General: Although Cozaar is antihypertensive in all races, as with other drugs that affect the renin-angiotensin-aldosterone system, black hypertensive patients have a smaller average response to losartan monotherapy. If Cozaar is given together with thiazide-type diuretics, the blood pressure-lowering effects are approximately additive. Losartan potassium administered in doses of up to 150 mg once daily did not cause clinically important changes in fasting triglycerides, total cholesterol or HDL cholesterol in patients with hypertension. The same dose of losartan had no effect on fasting glucose levels. Cozaar should not be used with potassium-sparing diuretics.
In patients who are intravascularly volume-depleted (eg, those treated with high-dose diuretics), symptomatic hypotension may occur. These conditions should be corrected prior to administration of Cozaar, or a lower starting dose should be used (see Dosage & Administration).
Based on pharmacokinetic data which demonstrates significantly increased plasma concentrations of losartan in cirrhotic patients, a lower dose should be considered for patients with a history of hepatic impairment (see Dosage & Administration).
Other drugs that affect the renin-angiotensin system may increase blood urea and serum creatinine in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney. While not confirmed, this potentially may occur with angiotensin II receptor antagonists.
Use in pregnancy: When used in pregnancy during the 2nd and 3rd trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death in the developing fetus. When pregnancy is detected, Cozaar should be discontinued as soon as possible.
Although there is no experience with the use of Cozaar in pregnant women, animal studies with losartan potassium have demonstrated fetal and neonatal injury and death, the mechanism of which is believed to be pharmacologically mediated through effects on the renin-angiotensin system. In humans, fetal renal perfusion, which is dependent upon the development of the renin-angiotensin system, begins in the 2nd trimester; thus, risk to the fetus increases if Cozaar is administered during the 2nd or 3rd trimesters of pregnancy.
Use in lactation: It is not known whether losartan is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue Cozaar, taking into account the importance of Cozaar to the mother.
Use in children: Safety and effectiveness in children have not been established.
Use in the elderly: In clinical studies, there was no age-related difference in the efficacy or safety profile of losartan.
Use In Pregnancy & Lactation
Use in pregnancy: When used in pregnancy during the 2nd and 3rd trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death in the developing fetus. When pregnancy is detected, Cozaar should be discontinued as soon as possible.
Although there is no experience with the use of Cozaar in pregnant women, animal studies with losartan potassium have demonstrated fetal and neonatal injury and death, the mechanism of which is believed to be pharmacologically mediated through effects on the renin-angiotensin system. In humans, fetal renal perfusion, which is dependent upon the development of the renin-angiotensin system, begins in the 2nd trimester; thus, risk to the fetus increases if Cozaar is administered during the 2nd or 3rd trimesters of pregnancy.
Use in lactation: It is not known whether losartan is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue Cozaar, taking into account the importance of Cozaar to the mother.
Side Effects
Cozaar has been found to be generally well tolerated. Side effects have usually been mild and transient in nature and have not required discontinuation of therapy. The overall incidence of side effects reported with Cozaar was comparable to placebo.
In controlled clinical trials for essential hypertension, dizziness was the only side effect reported as drug related that occurred with an incidence greater than placebo in ≥1% of patients treated with Cozaar. In addition, dose-related orthostatic effects were seen in <1% of patients. Rarely, rash was reported, although the incidence in controlled clinical trials was less than placebo.
Laboratory Test Findings: In controlled clinical trials, clinically important changes in standard laboratory parameters were rarely associated with administration of Cozaar. Hyperkalemia (serum potassium >5.5 mEq/L) occurred in 1.5% of patients, but in these trials, discontinuation of losartan therapy due to hyperkalemia was not necessary. Elevations of ALT occurred rarely and usually resolved upon discontinuation of therapy.
Serum potassium should be monitored particularly in the elderly and patients with renal impairment.
Drug Interactions
No drug interactions of clinical significance have been identified. Compounds which have been studied in clinical pharmacokinetic trials include hydrochlorothiazide, digoxin, warfarin, cimetidine and phenobarbital.
Storage
Store below 30°C (86°F). Protect from light.
ATC Classification
C09CA01 - losartan ; Belongs to the class of angiotensin II receptor blockers (ARBs). Used in the treatment of cardiovascular disease.
Presentation/Packing
Tab 50 mg x 2 x 15's.
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