Losartan and its principal active metabolite block the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g., vascular smooth muscle, adrenal gland). General disorders and administration site conditions: Edema. Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended (see sections 4.5 and 5.1). The primary treatment is to discontinue drug intake as rapidly as possible. Continue reading. To make sure Cozaar is safe for you, tell your doctor if you have: an electrolyte imbalance (such as high levels of potassium in your blood); You should not breast-feed while using Cozaar. There is also an AT2 receptor found in many tissues but it is not known to be associated with cardiovascular homeostasis. Patients whose renal function may depend in part on the activity of the renin-angiotensin system (e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute renal failure on Cozaar. 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 primary endpoint was the first occurrence of cardiovascular death, nonfatal stroke, or nonfatal myocardial infarction. Hydrochlorothiazide has been shown to cause modest increases in uric acid; the combination of losartan and hydrochlorothiazide tends to attenuate the diuretic-induced hyperuricemia. In patients with mild-to-moderate hepatic impairment the recommended starting dose of Cozaar is 25 mg once daily. The most likely manifestation of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. At least 61 percent of the oral dose is eliminated unchanged within 24 hours. Generic Cozaar Availability. Protect from light. Show More Uses Losartan is used to treat high blood pressure (hypertension) and to help protect the kidneys from damage due to diabetes. . Other substances inducing hypotension like tricyclic antidepressants, antipsychotics, baclofene, amifostine: Concomitant use with these drugs that lower blood pressure, as main or side-effect, may increase the risk of hypotension. cold symptoms such as stuffy nose, sneezing, sore throat. Hypersensitivity: Angioedema, including swelling of the larynx and glottis, causing airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue has been reported rarely in patients treated with losartan; some of these patients previously experienced angioedema with other drugs including ACE inhibitors. Other drugs may interact with losartan, including prescription and over-the-counter medicines, vitamins, and herbal products. Patients with myocardial infarction or stroke within six months prior to randomization were excluded. Clinical and biological monitoring is required. Pulmonary oedema typically develops within minutes to hours after hydrochlorothiazide intake. Report a suspected side effect or falsified product to the MHRA Yellow Card scheme. The use of hydrochlorothiazide may also need to be reconsidered in patients who have experienced previous NMSC (see also section 4.8). The systemic bioavailability of losartan tablets is approximately 33%. The usual recommended starting dose is 0.7 mg per kg once daily (up to 50 mg total) administered as a tablet or a suspension [see Dosage and Administration (2.5)]. Cialis is available in a generic form called tadalafil. selective COX-2 inhibitors, acetylsalicylic acid at anti-inflammatory doses and non-selective NSAIDs), attenuation of the antihypertensive effect may occur. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. The Losartan Intervention For Endpoint reduction in hypertension (LIFE) study was a randomised, triple-blind, active-controlled study in 9193 hypertensive patients aged 55 to 80 years with ECG-documented left ventricular hypertrophy. vascular smooth muscle, adrenal gland, kidneys and the heart) and elicits several important biological actions, including vasoconstriction and the release of aldosterone. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Patients were randomized to receive once daily Cozaar 50 mg or atenolol 50 mg. Measurement of blood pressure 24 hours post-dose relative to 5-6 hours post-dose demonstrated blood pressure reduction over 24 hours; the natural diurnal rhythm was retained. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in Black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). Thiazides should be discontinued before carrying out tests for parathyroid function. In patients receiving thiazides, hypersensitivity reactions may occur with or without a history of allergy or bronchial asthma. Store in the original container in order to protect from light. After one month, investigators were instructed to titrate study drug to 100 mg once daily if the trough blood pressure goal (140/90 mmHg) was not achieved. Angiotensin II, a potent vasoconstrictor, is the primary active hormone of the renin-angiotensin system and an important determinant of the pathophysiology of hypertension. Some antipsychotics (e.g. If necessary, other antihypertensive treatments (e.g., increase in dose of hydrochlorothiazide therapy to 25 mg or addition of other diuretic therapy, calcium-channel blockers, alpha-blockers, or centrally acting agents, but not ACE inhibitors, angiotensin II antagonists, or beta-blockers) were added to the treatment regimen to reach the goal blood pressure. Both losartan and its principal active metabolite have a far greater affinity for the AT1 receptor than for the AT2 receptor. Cozaar is not approved for use by anyone younger than 6 years old. 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. These studies demonstrate that the incidence of cough associated with losartan therapy, in a population that all had cough associated with ACE-inhibitor therapy, is similar to that associated with hydrochlorothiazide or placebo therapy. Exacerbation or activation of systemic lupus erythematosus has been reported with the use of thiazides. Anaphylactic reactions have been reported. Unless there is a specific reason you need the brand, the generic medication will be a better value. As with other medicines which affect the excretion of sodium, lithium excretion may be reduced. Tell your doctor about all of your medical conditions including if you: Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. When the low dose of losartan was randomly withdrawn, the rise in trough diastolic blood pressure was the same in patients receiving placebo and in those continuing losartan, again suggesting that the lowest dose did not have significant antihypertensive efficacy. The following additional adverse reactions have been reported in postmarketing experience with Cozaar. Dosage adjustment is not usually necessary for the elderly. Plasma clearance of losartan and its active metabolite is about 600 ml/min and 50 ml/min, respectively. This is not a complete list of side effects. Mean peak concentrations of losartan and its active metabolite are reached in 1 hour and in 3-4 hours, respectively. Medicinal products affected by serum potassium disturbances. Next to these effects, there are further adverse reactions reported after the introduction of the product to the market as follows: The adverse reactions that have been seen with one of the individual components and may be potential adverse reactions with losartan potassium/hydrochlorothiazide are the following: The following adverse reactions have been reported for losartan in clinical studies and in post-marketing experience: anaemia, Henoch-Schnlein purpura, ecchymosis, haemolysis, hypotension, orthostatic hypotension, sternalgia, angina pectoris, grade II-AV block, cerebrovascular event, myocardial infarction, palpitation, arrhythmias (atrial fibrillations, sinus bradycardia, tachycardia, ventricular tachycardia, ventricular fibrillation), blurred vision, burning/stinging in the eye, conjunctivitis, decrease in visual acuity, abdominal pain, nausea, diarrhea, dyspepsia, constipation, dental pain, dry mouth, flatulence, gastritis, vomiting, obstipation, General disorders and administration site conditions. Thiazides in high doses causing intense diuresis can inhibit the milk production. VA NEPHRON-D was a study in patients with type 2 diabetes mellitus and diabetic nephropathy. Hydrochlorothiazide is a thiazide diuretic. Dilutional hyponatraemia may occur in oedematous patients in hot weather. This was mainly attributable to a reduction of the incidence of stroke. In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists (including losartan) may result in deterioration of renal function, including possible acute renal failure. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. In addition, blood pressure reductions in both treatment groups were consistent between Black and non-Black patients. 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. Company: Organon Pharma (UK) Limited See contact details. The adverse reactions below are classified where appropriate by system organ class and frequency according to the following convention: very common ( 1/10); common ( 1/100, < 1/10); uncommon ( 1/1,000, < 1/100); rare ( 1/10,000, < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data). No initial dosage adjustment is necessary in patients with moderate renal impairment (i.e. Possible increased responsiveness to the muscle relaxant. Hydrochlorothiazide may intensify electrolyte imbalance, particularly hypokalaemia. kidney problems - little or no urination, rapid weight gain, painful or difficult urination, swelling in your hands, feet, or ankles. Such conditions should be corrected before the administration of Cozaar Comp tablets (see sections 4.2 and 4.3). Reporting suspected adverse reactions after authorisation of the medicinal product is important. Patients were followed for a mean duration of 3.4 years. Doctors prescribe it to treat erectile dysfunction and benign prostatic hyperplasia. Following oral administration, plasma concentrations of losartan and its active metabolite decline polyexponentially with a terminal half-life of about 2 hours and 6-9 hours, respectively. Drug class: angiotensin receptor blockers. Therefore, losartan/hydrochlorothiazide should not be administered to children and adolescents. Cozaar; Descriptions. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Therapy with Cozaar Comp should be discontinued and the patient observed closely. Rifampicin and fluconazole have been reported to reduce levels of active metabolite. -Doses above 1.4 mg/kg (or 100 mg) daily have not been studied in pediatric patients. Last updated on May 2, 2023. It keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Jersey City, NJ 07302, USA, For patent information: www.organon.com/our-solutions/patent/. This is not a complete list of side effects and others may occur. The AUC of active metabolite following oral losartan was not affected by erythromycin, an inhibitor of P450 3A4, but the AUC of losartan was increased by 30%. Store in the original package in order to protect from light and moisture. The usual starting dose of Cozaar is 50 mg once daily. An increased risk of non-melanoma skin cancer (NMSC) [basal cell carcinoma (BCC) and squamous cell carcinoma (SCC)] with increasing cumulative dose of hydrochlorothiazide exposure has been observed in two epidemiological studies based on the Danish National Cancer Registry. Choroidal effusion, acute myopia and secondary angle-closure glaucoma: Sulfonamide or sulfonamide derivative drugs can cause an idiosyncratic reaction resulting in choroidal effusion with visual field defect, transient myopia and acute angle-closure glaucoma. As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. 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. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. Cozaar Comp 100 mg/12.5 mg contains 8.48 mg (0.216 mEq) of potassium. Animal studies are insufficient. Hepatic Insufficiency: 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-times and about 1.7-times those in young male volunteers. Add 10 mL of Purified Water USP to an 8 ounce (240 mL) amber polyethylene terephthalate (PET) bottle containing ten 50 mg Cozaar tablets. Photosensitising actions of hydrochlorothiazide could act as a possible mechanism for NMSC. Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists. 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. Suggested measures include induction of emesis if ingestion is recent, and correction of dehydration, electrolyte imbalance, hepatic coma and hypotension by established procedures. About Medicine. High blood pressure often has no symptoms. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Others (e.g. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure: General Disorders and Administration Site Conditions: Malaise. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. COZAAR (losartan potassium) tablets, for oral use. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. When losartan is administered orally, about 4% of the dose is excreted unchanged in the urine, and about 6% of the dose is excreted in the urine as active metabolite. If diagnosis of ARDS is suspected, Cozaar Comp should be withdrawn and appropriate treatment given. Cialis relaxes muscles of the blood vessels and increases blood flow to particular areas . Because losartan decreases uric acid, losartan in combination with hydrochlorothiazide attenuates the diuretic-induced hyperuricemia. Active Ingredient: hydrochlorothiazide, losartan potassium. The principal pharmacokinetic parameters in adults and children are shown in the table below. Cozaar 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively. Significant levels of losartan and its active metabolite were shown to be present in rat fetal plasma during late gestation and in rat milk. The favorable effects of Cozaar were seen in patients also taking other anti-hypertensive medications (angiotensin II receptor antagonists and angiotensin converting enzyme inhibitors were not allowed), oral hypoglycemic agents and lipid-lowering agents. Cozaar (losartan potassium) is an angiotensin II receptor blocker acting on the AT1 receptor subtype. This medicinal product contains lactose. 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. Use in patients with intravascular volume depletion. cyclophosphamide, methotrexate). Can you eat bananas when taking losartan? White, oval film-coated tablets marked 745 on one side and plain on the other. 6 Years or Older: The primary endpoint was the composite of cardiovascular morbidity and mortality as measured by a reduction in the combined incidence of cardiovascular death, stroke and myocardial infarction. Comments: Does Losartan block the receptor used by the Coronavirus? It helps relieve erectile dysfunction by. For people who already have kidney problems, you may see a worsening in how well your kidneys work. Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, as it may cause intrahepatic cholestasis, and since minor alterations of fluid and electrolyte balance may precipitate hepatic coma. In patients with heart failure, with or without renal impairment, there is - as with other drugs acting on the renin-angiotensin system - a risk of severe arterial hypotension, and (often acute) renal impairment. ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) was a study designed to test the benefit of adding aliskiren to a standard therapy of an ACE-inhibitor or an angiotensin II receptor blocker in patients with type 2 diabetes mellitus and chronic kidney disease, cardiovascular disease, or both. Your doctor may change your dose if needed. About 14% of an orally-administered dose of losartan is converted to the active metabolite. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. Cozaar Comp 100 mg/12.5 mg also contains: titanium dioxide (E171) and carnauba wax (E903). If oligohydramnios is observed, discontinue Cozaar, unless it is considered lifesaving for the mother. 2022 Organon group of companies. If calcium supplements must be prescribed, serum calcium levels should be monitored and calcium dosage should be adjusted accordingly. Do not take Cozaar if you are allergic to any of the ingredients in Cozaar. Light yellow, oval film-coated tablets marked 747 on one side and plain on the other. There was no evidence of teratogenicity in rats or rabbits treated with the losartan/hydrochlorothiazide combination. Losartan/HCTZ tablets must not be used in patients with severe renal impairment (i.e. Drug class: Angiotensin receptor blockers. 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