Cozaar, 25 mg, are white, oval, film-coated tablets with code 951 on one side. The following less common adverse reactions have been reported: Blood and lymphatic system disorders: Anemia. creatinine clearance 30-50 ml/min). Losartan can cause injury or death to the unborn baby during your second or third trimester. Does losartan cause rapid heart rate, irregular heartbeat or low blood pressure? Table 2: Pharmacokinetic Parameters in Hypertensive Adults and Children Age 6-16 Following Multiple Dosing. Add 190 mL of the 50/50 Ora-Plus/Ora-Sweet SF mixture to the tablet and water slurry in the PET bottle and shake for 1 minute to disperse the ingredients. Ask your health care provider for advice if you are unsure about the online purchase of any medication. COZAAR 12.5 mg, 50 mg and 100 mg contain potassium in the following amounts: 1.06 mg (0.027 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq) respectively. Exacerbation or activation of systemic lupus erythematosus has been reported with the use of thiazides. tubocurarine). Cialis relaxes muscles of the blood vessels and increases blood flow to particular areas . Drug class: Angiotensin receptor blockers. Cozaar is not approved for use by anyone younger than 6 years old. Dual Blockade of the renin-angiotensin-aldosterone system (RAAS). For patients who do not respond adequately to Cozaar Comp 50 mg/12.5 mg, the dosage may be increased to one tablet of Cozaar Comp 100 mg/25 mg (losartan 100 mg/ HCTZ 25 mg) once daily. The terminal half-life of losartan is about 2 hours and of the metabolite is about 6-9 hours. Studies in rats indicate that losartan crosses the blood-brain barrier poorly, if at all. Call your doctor for medical advice about side effects. Despite these increases, antihypertensive activity and suppression of the plasma aldosterone concentration are maintained, indicating effective angiotensin II receptor blockade. The combination should be administered with caution, especially in the elderly. In patients who are hypersensitive to any component of this product. Cozaar is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: microcrystalline cellulose, lactose hydrous, pregelatinized starch, magnesium stearate, hydroxypropyl cellulose, hypromellose, and titanium dioxide. Initial dose: 0.7 mg/kg orally once a day (up to 50 mg total) Thiazides should be discontinued before carrying out tests for parathyroid function. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Risk of symptomatic hyponatraemia. Respiratory, thoracic and mediastinal disorders: Dyspnea. Further, as a result of its diuretic effect, hydrochlorothiazide increases plasma renin activity, increases aldosterone secretion, decreases serum potassium, and increases the levels of angiotensin II. alone or with other blood pressure medicines to lower high blood pressure (hypertension). Cozaar Comp may be administered with or without food. . Losartan belongs to a group of drugs called angiotensin II receptor antagonists. quinidine, hydroquinidine, disopyramide). Periodic monitoring of serum potassium and ECG is recommended when losartan/hydrochlorothiazide is administered with medicinal products affected by serum potassium disturbances (e.g. High blood pressure is the most common cause of LVH. Although not measured directly, the difference between Cozaar and placebo is compelling because there is evidence that atenolol is itself effective (vs. placebo) in reducing cardiovascular events, including stroke, in hypertensive patients. Significant lethality was observed in mice and rats after oral administration of 1000 mg/kg and 2000 mg/kg, respectively, about 44 and 170 times the maximum recommended human dose on a mg/m2 basis. The maximum dose is one tablet of Cozaar Comp 100 mg/25 mg once daily. COZAAR safely and effectively. Avoid use of aliskiren with Cozaar in patients with renal impairment (GFR <60 mL/min). With the exception of neonatal weight gain (which was affected at doses as low as 10 mg/kg/day), doses associated with these effects exceeded 25 mg/kg/day (approximately three times the maximum recommended human dose of 100 mg on a mg/m2 basis). Angiotensin II [formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE, kininase II)] is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system, and an important component in the pathophysiology of hypertension. Protect from light. Neither losartan nor its principal active metabolite exhibits any partial agonist activity at the AT1 receptor, and both have much greater affinity (about 1000-fold) for the AT1 receptor than for the AT2 receptor. Left Ventricular Hypertrophy (LVH) is an enlargement of the walls of the left chamber of the heart (the heart's main pumping chamber). Amphotericin B (parenteral), corticosteroids, ACTH, stimulant laxatives, or glycyrrhizin (found in liquorice). In nondiabetic hypertensive patients with proteinuria, the administration of losartan potassium significantly reduces proteinuria, fractional excretion of albumin and IgG. It also stimulates aldosterone secretion by the adrenal cortex. Each COZAAR 12.5 mg tablet contains 12.5 mg of losartan potassium. atropine, biperiden). Unless there is a specific reason you need the brand, the generic medication will be a better value. In general, the antihypertensive effect is attained within three to four weeks after initiation of therapy. thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol). -Antihypertension is substantially present within 1 week but in some studies the maximal effect occurred in 3 to 6 weeks. At the end of study or at the last visit before a primary endpoint, 77% of the group treated with Cozaar and 73% of the group treated with atenolol were still taking study medication. In patients with left ventricular failure, 25 mg and 50 mg doses of losartan produced positive haemodynamic and neurohormonal effects characterized by an increase in cardiac index and decreases in pulmonary capillary wedge pressure, systemic vascular resistance, mean systemic arterial pressure and heart rate and a reduction in circulating levels of aldosterone and norepinephrine, respectively. Following an intravenous dose of 14C-labeled losartan, about 45% of radioactivity is recovered in the urine and 50% in the feces. Losartan has no effect on autonomic reflexes and no sustained effect on plasma norepinephrine. Dosage adjustment is not usually necessary for the elderly. The Risk Reduction is adjusted for baseline Framingham risk score and level of electrocardiographic left ventricular hypertrophy. Removal of the negative feedback of angiotensin II causes a doubling to tripling in plasma renin activity and consequent rise in angiotensin II plasma concentration in hypertensive patients. Does losartan cause rapid heart rate, irregular heartbeat or low blood pressure? Renal Insufficiency: Following oral administration, plasma concentrations and AUCs of losartan and its active metabolite are increased by 50-90% in patients with mild (creatinine clearance of 50 to 74 mL/min) or moderate (creatinine clearance 30 to 49 mL/min) renal insufficiency. Untreated acute angle-closure glaucoma can lead to permanent vision loss. Cozaar can cause fetal harm when administered to a pregnant woman. However, the AUC of the carboxylic acid metabolite (E-3174) appears to be different between the two groups, with an approximately 1.5fold higher exposure in Japanese subjects than in non-Japanese subjects. Clinical trial data have shown that dual blockade of the renin-angiotensin-aldosterone system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia, and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4, and 5.1). Metabolism: Losartan is an orally active agent that undergoes substantial first-pass metabolism by cytochrome P450 enzymes. The renin-aldosterone link is mediated by angiotensin II and therefore co-administration of an angiotensin II receptor antagonist tends to reverse the potassium loss associated with thiazide diuretics. As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Photosensitising actions of hydrochlorothiazide could act as a possible mechanism for NMSC. Although the LIFE study favored Cozaar over atenolol with respect to the primary endpoint (p=0.021), this result is from a single study and, therefore, is less compelling than the difference between Cozaar and placebo. Hypertensive type II diabetic patients with proteinuria 0.5 g/day, Reduction in the risk of stroke in hypertensive patients with left ventricular hypertrophy documented by ECG. While blood pressure was reduced in all racial subgroups examined, too few non-White patients were enrolled to compare the dose-response of losartan in the non-White subgroup. Because no information is available regarding the use of Cozaar Comp during breastfeeding, Cozaar Comp is not recommended and alternative treatments with better established safety profiles during breastfeeding are preferable, especially while nursing a new-born or preterm infant. Table 3 shows the results for the primary composite endpoint and the individual endpoints. -To reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy. At least 61 percent of the oral dose is eliminated unchanged within 24 hours. Patients with primary aldosteronism generally will not respond to antihypertensive drugs acting through inhibition of the renin-angiotensin system. If you take too much Cozaar, call your doctor or Poison Control Center, or go to the nearest hospital emergency room right away. Two large randomised, controlled trials (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) have examined the use of the combination of an ACE-inhibitor with an angiotensin II receptor blocker. Uses; Warnings; Before taking; Side effects; Interactions; Dosage; FAQ; What is Cialis? Subgroup analyses can be difficult to interpret and it is not known whether these represent true differences or chance effects. Keep the bottle tightly closed in order to protect from moisture. Other clinical endpoints of the LIFE study were: total mortality, hospitalization for heart failure or angina pectoris, coronary or peripheral revascularization procedures, and resuscitated cardiac arrest. Cozaar is not recommended in pediatric patients less than 6 years of age or in pediatric patients with estimated glomerular filtration rate less than 30 mL/min/1.73 m2 [see Use in Specific Populations (8.4), Clinical Pharmacology (12.3), and Clinical Studies (14)]. Closely observe neonates with histories of in utero exposure to Cozaar for hypotension, oliguria, and hyperkalemia. Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, post-partum hemorrhage). The antihypertensive effect of Cozaar Comp is sustained for a 24-hour period. The primary endpoint of the study was the time to first occurrence of any one of the following events: doubling of serum creatinine, end-stage renal disease (ESRD) (need for dialysis or transplantation), or death. Following oral administration in patients with mild to moderate alcoholic cirrhosis of the liver, plasma concentrations of losartan and its active metabolite were, respectively, 5-fold and 1.7-fold greater than those seen in young male volunteers. Treatment with Cozaar reduced the risk of stroke by 25% relative to atenolol (p=0.001) (see Figure 2 and Table 3). Cardiac disorders: Palpitations, syncope, atrial fibrillation, CVA. Foetal toxicity in rats, as evidenced by a slight increase in supernumerary ribs in the F1 generation, was observed when females were treated prior to and throughout gestation. The mean age was 67 with 5704 (62%) age 65. As with all antihypertensive therapy, symptomatic hypotension may occur in some patients. When pregnancy is detected, discontinue Cozaar as soon as possible. The relationship of these findings to drug-treatment is uncertain since there was no effect at these dosage levels on implants/pregnant female, percent post-implantation loss, or live animals/litter at parturition. Distribution: The volume of distribution of losartan and the active metabolite is about 34 liters and 12 liters, respectively. Losartan selectively blocks the AT1 receptor. Rifampicin and fluconazole have been reported to reduce levels of active metabolite. Treatment is symptomatic and supportive. Given the difficulty in interpreting subset differences in large trials, it cannot be known whether the observed difference is the result of chance. Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Inhibitors (AIIRAs), similar risks may exist for this class of drugs. Report a suspected side effect or falsified product to the MHRA Yellow Card scheme. Minimal conversion of losartan to its active metabolite was seen in about one percent of individuals studied. Almost all of the patients (96.6%) had a history of hypertension, and the patients entered the trial with a mean serum creatinine of 1.9 mg/dL and mean proteinuria (urinary albumin/creatinine) of 1808 mg/g at baseline. In this study, renal clearance was reduced by 55-85% for both losartan and its active metabolite in patients with mild or moderate renal insufficiency. Both losartan and its principal active metabolite have a far greater affinity for the AT1 receptor than for the AT2 receptor. The incidence of cough is shown in Table 1 below. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter. Cozaar has been evaluated for safety in more than 3300 adult patients treated for essential hypertension and 4058 patients/subjects overall. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Clinical and biological monitoring is required. Analysis of age, gender, and race subgroups of patients showed that men and women, and patients over and under 65, had generally similar responses. What should I tell my doctor before taking Cozaar? While maximum plasma concentrations of losartan and its active metabolite are approximately equal, the AUC (area under the curve) of the metabolite is about 4 times as great as that of losartan. You have high blood pressure when the force is too much. This effect is thought to be a result of the complimentary actions of both components. Cozaar Comp 50 mg/12.5 mg - PVC/PE/PVDC blister packages with aluminium foil lidding in cartons containing 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98, or 280 tablets and unit-dose packages of 28, 56 and 98 tablets for hospital use. Disease-associated Maternal and/or Embryo/Fetal Risk. Intensified electrolyte depletion, particularly hypokalaemia. Usual Adult Dose for Diabetic Nephropathy: Initial dose: 50 mg orally once a day After oral use, diuresis begins within 2 hours, peaks in about 4 hours and lasts about 6 to 12 hours the antihypertensive effect persists for up to 24 hours. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. The trademarks depicted herein are owned by their respective companies. The mechanism of the antihypertensive effect of thiazide diuretics is not fully known. Because the study was designed to achieve equal blood pressure control in both groups, other antihypertensive agents (diuretics, calcium-channel blockers, alpha- or beta-blockers, and centrally acting agents) could be added as needed in both groups. (59-86F) [see USP Controlled Room Temperature]. The adverse reactions were restricted to those which were formerly observed with losartan potassium salt and/or hydrochlorothiazide. Therefore, serum lithium levels should be monitored carefully if lithium salts are to be co-administered with angiotensin II receptor antagonists. Consumption of grapefruit juice should be avoided while taking losartan tablets. Losartan has been shown to have a mild and transient uricosuric effect. Of the total number of patients receiving Cozaar in controlled clinical studies for hypertension, 391 patients (19%) were 65 years and over, while 37 patients (2%) were 75 years and over. 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