Comment
Author: Admin | 2025-04-28
Hypotension and replacing renal function. Nursing Mother Considerations It is not known whether losartan is excreted in human milk, but significant levels of losartan and its active metabolite were shown to be present in rat milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Considerations Safety and effectiveness have not been established in pediatric patients 2. Geriatric Considerations No overall differences in effectiveness or safety were observed between elderly patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Renal Impairment Considerations No dose adjustment is necessary in patients with renal impairment unless a patient with renal impairment is also volume depleted. Hepatic Impairment Considerations The recommended initial dose of Cozaar is 25 mg in patients with mild to moderate hepatic impairment. Cozaar has not been studied in patients with severe hepatic impairment. Cozaar Pharmacokinetics Absorption The systemic bioavailability of losartan: ~33%. Mean peak concentrations of losartan: 1 hour. Distribution Volume of distribution of losartan: 34 L. Highly bound to plasma proteins (primarily albumin), with plasma free fractions of 1.3%. Elimination Fecal (~60%), renal (~35%). Half-life: ~2 hours. Cozaar Interactions Interactions See Contraindications. Hyperkalemia with concomitant other drugs that may increase serum potassium (eg, K+ supplements, K+ sparing diuretics, K+ containing salt substitutes). May be antagonized by, and renal toxicity potentiated by NSAIDs, including selective COX-2 inhibitors (monitor renal function periodically in elderly and/or volume-depleted). Monitor lithium. Dual inhibition of the renin-angiotensin system with ARBs, ACEIs, or aliskiren may increase risk of hypotension, hyperkalemia, renal function changes; monitor closely. Avoid concomitant aliskiren in renal impairment (CrCl Cozaar Adverse Reactions Adverse Reactions Upper respiratory infection, dizziness, nasal congestion, back pain; hypotension, hyperkalemia, renal failure, angioedema, cough. Cozaar Clinical Trials Clinical Trials Adult HypertensionThe antihypertensive effects of Cozaar were evaluated in 4 placebo-controlled, 6- to 12-week trials of dosages from 10–150 mg per day in patients with baseline diastolic blood pressures of 95–115. The studies allowed comparisons of two doses (50–100 mg/day) as once-daily or twice-daily regimens, comparisons of peak and trough effects, and comparisons of response by gender, age, and race. Additionally, 3 studies examined the antihypertensive effects of losartan and hydrochlorothiazide in combination.In the 4 studies of losartan monotherapy, patients were randomly assigned to several doses of losartan (n=1075) and to placebo (n=334).The 10- and 25-mg doses produced some effect at peak (6 hours after dosing) but small and inconsistent trough (24 hour) responses.Doses of 50, 100 and 150 mg once daily demonstrated statistically significant systolic/diastolic mean decreases in blood pressure, compared to placebo in the range of 5.5–10.5/3.5–7.5 mmHg, with the 150-mg dose giving no greater effect than 50–100 mg.Twice-daily dosing at 50–100 mg/day demonstrated consistently larger trough responses than once-daily dosing at the same total dose. Peak (6 hour) effects were uniformly, but moderately, larger than trough effects, with the trough-to-peak ratio for systolic and
Add Comment