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Cozaar (Losartan Potassium) - Summary

 
 



BOXED WARNING

USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, COZAAR should be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity and Mortality.

 

COZAAR SUMMARY

COZAAR 1 (losartan potassium) is an angiotensin II receptor (type AT1) antagonist.

Hypertension
COZAAR is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents, including diuretics.

Hypertensive Patients with Left Ventricular Hypertrophy
COZAAR is indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients. (See PRECAUTIONS, Race and CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Reduction in the Risk of Stroke, Race.)

Nephropathy in Type 2 Diabetic Patients
COZAAR is indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratiomg/g) in patients with type 2 diabetes and a history of hypertension. In this population, COZAAR reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end stage renal disease (need for dialysis or renal transplantation) (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects).


See all Cozaar indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Cozaar (Losartan)

Indirect treatment comparison between fixed-dose-combinations of amlodipine/losartan and amlodipine/valsartan in blood pressure control. [2014]
compared amlodipine/losartan with other FDCs... CONCLUSIONS: The BP lowering effect with amlodipine/losartan and

Comparison of the effects of amlodipine and losartan on blood pressure and diurnal variation in hypertensive stroke patients: a prospective, randomized, double-blind, comparative parallel study. [2013]
variation effects of amlodipine and losartan on acute stroke patients... CONCLUSIONS: The noninferiority of amlodipine was not confirmed by the

Comparison of the efficacy and safety of fixed-dose amlodipine/losartan and losartan in hypertensive patients inadequately controlled with losartan: a randomized, double-blind, multicenter study. [2012]
once-daily combination amlodipine/losartan versus losartan... CONCLUSION: Switching to a fixed-dose combination therapy of amlodipine/losartan

Efficacy and tolerability of fimasartan, a new angiotensin receptor blocker, compared with losartan (50/100 mg): a 12-week, phase III, multicenter, prospective, randomized, double-blind, parallel-group, dose escalation clinical trial with an optional 12-week extension phase in adult Korean patients with mild-to-moderate hypertension. [2012]
Korean patients with mild-to-moderate hypertension... CONCLUSIONS: In this study with eligible adult Korean patients who had

Effects of losartan on whole body, skeletal muscle and vascular insulin responses in obesity/insulin resistance without hypertension. [2012]
insulin-resistant subjects... CONCLUSIONS: These findings argue against the hypothesis that losartan might

more studies >>

Clinical Trials Related to Cozaar (Losartan)

Study of High Dosage of Losartan in Comparison to Low Dose of Losartan in Heart Failure Patients [Withdrawn]
The sympathetic nervous system, a part of the nervous system that stimulates the heart via release of substances, noradrenaline and adrenaline (combined called catecholamines), becomes activated in people with heart failure. As these people become sicker, the nervous system becomes more active, causing further damage to the heart. Large trials have shown that Angiotensin-converting enzyme (ACE) inhibitors reduce morbidity and mortality in patients with heart failure. Higher doses of these drugs are more effective than lower doses. Studies show that ACE-inhibitors decrease catecholamine levels. This could be why congestive heart failure (CHF) patients taking this class of drugs show improvement in heart function. There are several ways of measuring the activity of the sympathetic nervous system. The most common measurement is to test the blood for catecholamine levels. This is not very reliable or reproducible. Microneurography is a new technique used to measure sympathetic nerve activity. A small electrode (comparable to an acupuncture needle) is placed in a muscle nerve and hooked up to a stimulator and a recorder. It produces direct recordings of skeletal muscle nerve traffic. Both the rate and amplitude of the burst can be measured. The results in this technique are highly reproducible. By using this technique we get a more accurate picture of how the nervous system responds to medications given to treat heart failure. Losartan (Cozaar) is an angiotensin II type 1 (AT1) receptor blocker. It blocks the binding of angiotensin II, a hormone that constricts blood vessels. As a result the blood vessels remain relaxed, leading to a reduction in the workload of the heart. Minor decreases in blood catecholamine levels have been reported with a low dose of this drug. The purpose of this study is to see whether a high dose of losartan (200 mg) has a greater effect on the sympathetic nervous system than a low dose of losartan (50 mg) does. A total of 30 participants will be recruited. Participants will be assigned to one of two groups: high-dose, in which subjects will receive treatment of 200 mg/day of losartan, and low-dose, in which subjects will receive treatment of 50 mg/day of losartan. Via microneurography the investigators will measure the difference in sympathetic activity in subjects in high-dose vs low-dose losartan. The investigators expect to see further decrease in sympathetic activity in high-dose group than in low-dose group.

Cozaar XQ Re-examination Study (MK-0954-349) [Completed]
This survey is conducted for preparing application material for re-examination under the Pharmaceutical Affairs Law and its Enforcement Regulation; its aim is to reconfirm the clinical usefulness of COZAAR XQ through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs.

Losartan 100 mg Tablet in Healthy Subjects Under Non-Fasting Conditions [Completed]

Losartan 100 mg Tablets in Healthy Subjects Under Fasting Conditions [Completed]

Study to Determine the Bioequivalence of Two Fixed Dose Combination (FDC) Tablet Formulations of Amlodipine and Losartan FDC5/50 and FDC5/100 Under Fasting Conditions [Completed]
This is a three-period, three sequence, reference replicated, cross-over study to determine the bioequivalence of two amlodipine and losartan FDC tablet formulations FDC5/50 and FDC5/100 (GSK2944406; 5 mg amlodipine and 50 mg and 100 mg losartan) to reference amlodipine and losartan tablets co-administered in two groups enrolling 102 healthy adult male and female subjects under fasting conditions. A description of each treatment is provided below: A (Reference) = 1 x 5 mg amlodipine tablet and 1 x 50 mg losartan tablet. B (FDC5/50) = 1 x 5 mg amlodipine and 50 mg losartan tablet C (Reference) = 1 x 5 mg amlodipine tablet and 1 x 100 mg losartan tablet D (FDC5/100) = 1 x 5 mg amlodipine and100 mg losartan tablet The treatments will be administered in accordance with the randomisation schedule as. Group 1: A → A → B or A → B → A or B → A → A Group 2: C → C → D or C → D → C or D → C → C All subjects will attend a screening visit within 28 days of their first dosing period (Day 1). The baseline assessments will be conducted the day before the first dosing. In each treatment period, subjects will be admitted to the clinic in the evening before Day 1. All subjects will receive a single oral dose of amlodipine and losartan in the morning on Day 1. All the subjects will remain in the clinical unit until completion of all assessments at 24 hours post-dose on Day 2 including collection of the 24 hour post-dose PK sample. Subjects will return to the clinic for pharmacokinetic samples at 36, 48, 72 and 96 hours post-dose. The three treatment periods will be separated by a washout period of 10-17 days. Upon completion of the last dosing period, or early withdrawal, subjects will return to the clinical unit within 14-21 days for a follow up visit.

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Reports of Suspected Cozaar (Losartan) Side Effects

Dizziness (20)Pain (19)Blood Pressure Increased (19)Asthenia (19)Somnolence (18)Nausea (18)Anaemia (18)Malaise (16)Feeling Abnormal (14)Confusional State (13)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 4 ratings/reviews, Cozaar has an overall score of 9.25. The effectiveness score is 9.50 and the side effect score is 9.50. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Cozaar review by 56 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   high blood pressure
Dosage & duration:   50 mg taken one time a day for the period of over 9 years
Other conditions:   Crohn's disease
Other drugs taken:   Boniva
  
Reported Results
Benefits:   Within a few weeks of starting, my pressure was under control and has remained that way for over 5 years.
Side effects:   I had no side effects that I noticed.
Comments:   I was diagnosed with high blood pressure (145/90) over 10 years ago, a few years after experiencing early menopause. Severe headaches were also commmon. First treatment: dietary changes and increasing daily exercise--not adequate; in fact, it increased. I was prescribed Cozaar, 50 mg/day, with the reminder that the first dosage tried was rarely the correct one. In my case, it was and I get checked now every 6 months. My blood pressure stays around 118/70 range.

 

Cozaar review by 67 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   Blood Pressure
Dosage & duration:   50 MG taken once a day for the period of 3 Months
Other conditions:   None
Other drugs taken:   None
  
Reported Results
Benefits:   Did lower my blood pressure after about 3 weeks. Remained lower during remainder of course and after the treatment ended.
Side effects:   No significant side-effects in my experience. Some mild diarrhea at the beginning of the course, nothing really after the first couple of days.
Comments:   Once a day for three months to treat high blood pressure.

 

Cozaar review by 67 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   Blood Pressure
Dosage & duration:   50 MG taken once a day for the period of 3 Months
Other conditions:   None
Other drugs taken:   None
  
Reported Results
Benefits:   Did lower my blood pressure after about 3 weeks. Remained lower during remainder of course and after the treatment ended.
Side effects:   No significant side-effects in my experience. Some mild diarrhea at the beginning of the course, nothing really after the first couple of days.
Comments:   Once a day for three months to treat high blood pressure.

See all Cozaar reviews / ratings >>

Page last updated: 2015-08-10

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