Generic Cozaar ( Losartan )

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Cozaar (losartan potassium) is an angiotensin II receptor blocker (ARB) used primarily to treat high blood pressure (hypertension), to protect the kidneys from damage in adults with type 2 diabetes who have protein in their urine and high blood pressure, and to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy. It works by selectively blocking the binding of angiotensin II—a potent hormone that narrows blood vessels and stimulates the release of aldosterone—to its AT₁ receptor, causing blood vessels to relax, reducing the workload on the heart, and lowering blood pressure over the long term.

Usual adult dose: The recommended starting dose for hypertension is 50 mg taken once daily. In patients who are volume‑depleted (e.g., those taking high‑dose diuretics), a lower starting dose of 25 mg should be considered. If blood pressure remains uncontrolled after several weeks, the dose may be increased to a maximum of 100 mg once daily. The antihypertensive effect is usually evident within 1 to 2 weeks, with maximal response achieved by 3 to 6 weeks of continuous therapy.

Dosage form: Film‑coated oral tablets: 25 mg, 50 mg, and 100 mg.

Onset of action: Losartan is rapidly absorbed, with peak plasma concentrations of the parent drug reached approximately 1 hour after dosing and the active metabolite (E‑3174) peaking at 3 to 4 hours. The antihypertensive effect begins within hours of the first dose, but clinically meaningful reductions in blood pressure are typically observed within 1 to 2 weeks, with full therapeutic effect achieved by 3 to 6 weeks.

Duration of action: Approximately 24 hours with once‑daily dosing. The active metabolite E‑3174 has a half‑life of 6 to 9 hours and contributes substantially to the sustained 24‑hour blood‑pressure‑lowering effect.

Alcohol recommendation: Alcohol consumption should be limited during treatment with Cozaar. Drinking alcohol may lower blood pressure further, causing dizziness or light‑headedness, and excessive alcohol intake can raise blood pressure, counteracting the therapeutic effect of the medication.

Most common side effects: Dizziness, upper respiratory tract infection, nasal congestion, and back pain. Other commonly reported effects include fatigue, diarrhoea, and transient, mild hypotension. In general, losartan is very well tolerated, and the incidence of dry cough—a common side effect of ACE inhibitors—is similar to placebo.

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General Information about Cozaar (Losartan)

• INN (International Nonproprietary Name): Losartan (as losartan potassium)
• Brand names available in Canada: Cozaar® (Organon Canada Inc.) is the original brand‑name product. Widely available generic versions include APO‑Losartan (Apotex Inc.), TEVA‑Losartan (Teva Canada Limited), Sandoz Losartan (Sandoz Canada Inc.), PMS‑Losartan (Pharmascience Inc.), AURO‑Losartan (Auro Pharma Inc.), JAMP‑Losartan (JAMP Pharma Corporation), MINT‑Losartan (Mint Pharmaceuticals), SANIS Losartan (Sanis Health Inc.), SIVEM Losartan (Sivem Pharmaceuticals), RAN‑Losartan (Ranbaxy Pharmaceuticals Canada Inc.), SEPTA‑Losartan (Septa Pharmaceuticals Inc.), and others.
• ATC code: C09CA01 (angiotensin II receptor blockers, plain)
• Dosage forms and strengths: Film‑coated tablets: 25 mg, 50 mg, and 100 mg of losartan potassium. Each tablet contains a small amount of potassium (4.24 mg per 50 mg tablet).
• Manufacturers in Canada: Organon Canada Inc. (Cozaar), Apotex Inc., Teva Canada Limited, Sandoz Canada Inc., Pharmascience Inc., Auro Pharma Inc., JAMP Pharma Corporation, Mint Pharmaceuticals, Sanis Health Inc., Sivem Pharmaceuticals, Ranbaxy Pharmaceuticals Canada Inc., Septa Pharmaceuticals Inc., and other generic manufacturers.
• Registration status in Canada: Approved by Health Canada. Marketed (DINs: 02182815 [25 mg], 02182874 [50 mg], 02182882 [100 mg]). First approved in Canada in 1995.
• OTC / Rx classification: Prescription only (Rx). Schedule I drug under the Controlled Drugs and Substances Act.

Mechanism of Action and Pharmacology

Losartan potassium is the first orally active angiotensin II receptor blocker (ARB) developed for clinical use. Angiotensin II is the primary vasoactive hormone of the renin‑angiotensin‑aldosterone system (RAAS). It is formed from angiotensin I by angiotensin‑converting enzyme (ACE) and exerts its effects by binding to angiotensin II type 1 (AT₁) receptors located in vascular smooth muscle, the adrenal glands, the kidneys, and the heart. Losartan and its principal active metabolite (E‑3174, a carboxylic acid derivative formed by cytochrome P450 2C9 and 3A4) potently and selectively block the binding of angiotensin II to the AT₁ receptor. E‑3174 is a non‑competitive antagonist with an affinity for the AT₁ receptor 10 to 40 times greater than that of the parent drug. By inhibiting AT₁ receptor activation, losartan blocks all physiologically relevant actions of angiotensin II, including vasoconstriction, aldosterone synthesis and release, renal sodium reabsorption, cellular hypertrophy and hyperplasia, sympathetic nervous system stimulation, and vasopressin release. Unlike ACE inhibitors, losartan does not interfere with the breakdown of bradykinin, which largely explains why it does not cause the dry cough associated with ACE inhibitor therapy. Losartan has a uricosuric effect (it promotes the excretion of uric acid), an action not shared by other ARBs. After oral administration, losartan is well absorbed with a bioavailability of approximately 33%. It undergoes extensive first‑pass hepatic metabolism, primarily by CYP2C9 and to a lesser extent by CYP3A4. Peak plasma concentrations are reached at 1 hour (parent) and 3 to 4 hours (E‑3174). The terminal elimination half‑life of losartan is about 2 hours; E‑3174 has a half‑life of 6 to 9 hours. Losartan and its metabolites are excreted via both the biliary and urinary routes. Plasma protein binding is high (approximately 99%), mainly to albumin. Neither losartan nor its active metabolite is removed by haemodialysis. Food does not significantly affect the absorption of losartan.

Indications

• Hypertension: For the treatment of essential hypertension in adults and children aged 6 years and older. Losartan lowers blood pressure and reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used as monotherapy or in combination with other antihypertensive agents, most commonly thiazide diuretics.
• Hypertension with left ventricular hypertrophy: Cozaar is also indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, based on the landmark LIFE (Losartan Intervention For Endpoint reduction in hypertension) trial. The benefit does not appear to apply to Black patients.
• Renal protection in type 2 diabetes: For the delay of progression of diabetic nephropathy in adults with type 2 diabetes who have proteinuria (≥ 0.5 g/day) and elevated serum creatinine. Losartan reduces the risk of doubling of serum creatinine, end‑stage renal disease, or death.
• Off‑label uses: Losartan is sometimes prescribed off‑label for heart failure (particularly in patients intolerant to ACE inhibitors), Marfan syndrome, and for the reduction of proteinuria in chronic kidney disease from causes other than diabetes.

Important Warnings and Precautions

At‑risk groups

• Pregnancy: Cozaar is contraindicated during pregnancy. Drugs that act directly on the renin‑angiotensin system can cause injury and death to the developing foetus. When pregnancy is detected, losartan must be discontinued as soon as possible. Women of childbearing potential should use effective contraception during treatment.
• Breastfeeding: It is not known whether losartan is excreted in human breast milk. Because of the potential for adverse effects on the nursing infant, a decision must be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the medication to the mother.
• Paediatrics (≥ 6 years): Losartan is indicated for the treatment of hypertension in children aged 6 years and older. The dose is weight‑based; for children who can swallow tablets, the usual dose is 0.7 mg/kg once daily, up to a maximum of 50 mg once daily. Safety and efficacy in children under 6 years have not been established.
• Elderly: No dose adjustment is required based on age alone. Most elderly patients require the same dose as younger adults, as losartan is equally effective and well tolerated across all age groups. However, older adults are more likely to have volume depletion or renal impairment and should be monitored accordingly.
• Renal impairment: No initial dose adjustment is required in patients with mild to moderate renal impairment. In patients with severe renal impairment (creatinine clearance < 30 mL/min) or those on dialysis, a lower starting dose of 25 mg should be considered. Losartan is not removed by haemodialysis. The risk of hyperkalaemia increases as renal function declines.
• Hepatic impairment: A lower dose is recommended for patients with mild to moderate hepatic impairment, and losartan should be used with caution. A starting dose of 25 mg is recommended. Losartan is contraindicated in patients with severe hepatic impairment.
• Hypotension and electrolyte imbalance: Symptomatic hypotension may occur, particularly in patients who are volume‑depleted or sodium‑depleted (e.g., those treated with high‑dose diuretics). These conditions should be corrected before starting losartan, or a lower starting dose of 25 mg should be used. Periodic monitoring of serum electrolytes is recommended.
• Hyperkalaemia: Losartan, like other agents affecting the RAAS, may increase serum potassium. Concomitant use of potassium‑sparing diuretics, potassium supplements, potassium‑containing salt substitutes, or other drugs that increase potassium may lead to significant hyperkalaemia. Regular monitoring of serum potassium is recommended, especially in elderly patients and those with renal impairment.
• Dual blockade of the RAAS: The combination of losartan with ACE inhibitors or aliskiren is not recommended because of an increased risk of hypotension, syncope, hyperkalaemia, and acute renal failure. Co‑administration of losartan with aliskiren is contraindicated in patients with diabetes mellitus or moderate to severe renal impairment (GFR < 60 mL/min).
• Angioedema: Although less common than with ACE inhibitors, angioedema—including swelling of the larynx, glottis, face, lips, and/or tongue—has been reported in patients taking losartan. Some patients who developed angioedema with an ACE inhibitor have also experienced it with losartan. If angioedema occurs, losartan should be discontinued immediately and appropriate emergency treatment instituted.
• Heart failure and coronary artery disease: As with other antihypertensive agents, blood pressure should be lowered cautiously in patients with ischaemic heart disease, aortic stenosis, mitral stenosis, or hypertrophic cardiomyopathy to avoid myocardial ischaemia or infarction.
• Allergy: Do not take Cozaar if you have a known hypersensitivity to losartan potassium or any excipient in the formulation.

Driving and alcohol

Cozaar may cause dizziness or drowsiness in some patients, particularly at the start of therapy or after dose increases. Patients should be cautious when driving, operating machinery, or performing activities that require mental alertness until they know how the medication affects them. Alcohol should be consumed in moderation because it can lower blood pressure further, potentially causing light‑headedness or fainting. Chronic heavy alcohol consumption can elevate blood pressure and offset the therapeutic benefits of losartan.

Dosage Instructions

• Hypertension (adults): The usual starting dose is 50 mg once daily. A lower initial dose of 25 mg once daily is recommended for patients who are volume‑depleted (e.g., those on high‑dose diuretics) or have hepatic impairment. The dose may be increased to 100 mg once daily after several weeks if adequate blood pressure control has not been achieved. Losartan may be taken with or without food and should be taken at approximately the same time each day.
• Hypertensive patients with left ventricular hypertrophy: The usual starting dose is 50 mg once daily. Hydrochlorothiazide should be added if blood pressure remains uncontrolled, and the dose of losartan may be increased to 100 mg once daily if needed.
• Diabetic nephropathy: The usual starting dose is 50 mg once daily; the dose may be increased to 100 mg once daily depending on blood pressure response.
• Paediatric hypertension (≥ 6 years): The recommended starting dose is 0.7 mg/kg once daily (up to a maximum of 50 mg). Doses above 1.4 mg/kg (or 100 mg) have not been studied in children. For patients who cannot swallow tablets, a liquid formulation may be prepared by a compounding pharmacy.
• Administration: The tablet should be swallowed whole with a glass of water. It may be taken with or without food. Consistent daily dosing at the same time is recommended.
• Missed dose: If a dose is missed, take it as soon as remembered on the same day. If it is close to the time of the next dose, skip the missed dose and resume the regular schedule. Do not double the dose.
• Discontinuation: Abrupt withdrawal of losartan has not been associated with rebound hypertension. However, patients should not discontinue the medication without consulting their physician.

Side Effects and Contraindications

• Most common side effects (incidence ≥ 2% and greater than placebo): Dizziness (3‑4%), upper respiratory tract infection (6‑8%), nasal congestion (2‑3%), and back pain (2%).
• Less common side effects: Fatigue, diarrhoea, dyspepsia, muscle cramps, insomnia, and hypotension (more common in volume‑depleted patients). Hyperkalaemia (high potassium) can occur, especially in patients with renal impairment or those taking other potassium‑elevating drugs.
• Rare but serious side effects: Angioedema (swelling of the face, lips, tongue, or throat; difficulty breathing or swallowing; requires immediate emergency medical attention), acute renal failure (especially in patients with bilateral renal artery stenosis or volume depletion), severe hypotension, and hepatotoxicity. Thrombocytopenia, vasculitis (including Henoch‑Schönlein purpura), and anaphylactic reactions have been reported in post‑marketing surveillance. Hyponatraemia has been observed rarely.
• Laboratory abnormalities: Minor increases in blood urea nitrogen (BUN) and serum creatinine may occur, particularly in volume‑depleted patients or those with renal artery stenosis. Small decreases in haemoglobin and haematocrit have been observed. Elevations in alanine aminotransferase (ALT) occur rarely and usually resolve with continued therapy or upon discontinuation.
• Contraindications: Hypersensitivity to losartan potassium or any excipient in the formulation. Concomitant use with aliskiren in patients with diabetes mellitus or moderate to severe renal impairment (GFR < 60 mL/min). Pregnancy (second and third trimesters). Severe hepatic impairment.

Drug Interactions

• Agents that increase serum potassium (major interaction): Co‑administration with potassium‑sparing diuretics (spironolactone, eplerenone, triamterene, amiloride), potassium supplements, or potassium‑containing salt substitutes may lead to significant hyperkalaemia. Monitor serum potassium closely.
• Non‑steroidal anti‑inflammatory drugs (NSAIDs) including COX‑2 inhibitors (moderate interaction): NSAIDs may reduce the antihypertensive effect of losartan by inhibiting prostaglandin synthesis and causing sodium and water retention. In patients who are elderly, volume‑depleted, or have compromised renal function, co‑administration of NSAIDs with losartan may precipitate acute renal failure. Renal function should be monitored periodically.
• Lithium (moderate interaction): Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of ARBs. Serum lithium levels should be monitored carefully.
• Dual RAAS blockade (major interaction): The combination of losartan with ACE inhibitors or aliskiren increases the risk of hypotension, syncope, hyperkalaemia, and acute kidney injury. Concomitant use of losartan and aliskiren is contraindicated in patients with diabetes or renal impairment. Combined use of two RAAS inhibitors is generally not recommended.
• Rifampin and fluconazole (moderate interaction): Rifampin (a CYP2C9 inducer) may decrease the metabolic conversion of losartan to its active metabolite, potentially reducing efficacy. Fluconazole (a CYP2C9 inhibitor) may decrease active metabolite formation, though the clinical impact is modest.
• Diuretics and other antihypertensives (minor interaction): Additive blood‑pressure‑lowering effects may occur. Losartan is often safely combined with a thiazide diuretic (e.g., hydrochlorothiazide) for enhanced blood pressure control; the fixed‑dose combination product Hyzaar is available in Canada.
• Alcohol: Moderate alcohol intake may cause additive blood‑pressure‑lowering effects, while heavy drinking may counteract the antihypertensive benefit.

Practical Advice

• Administration: Take Cozaar exactly as prescribed. The tablet can be taken with or without food. Establish a regular time of day for dosing (e.g., each morning) to help maintain consistency. Swallow the tablet whole with a glass of water; do not crush or chew.
• Monitoring: Blood pressure should be checked regularly, especially during the first few weeks of therapy and after dose adjustments. Serum potassium levels should be monitored periodically, particularly in patients with renal impairment, diabetes, or those taking potassium‑elevating medications. Renal function (serum creatinine, BUN) should be assessed before and during therapy, especially in patients with pre‑existing renal disease or those taking NSAIDs. Liver function tests may be considered in patients with hepatic impairment.
• Storage: Store at room temperature (15‑30 °C) in a dry place, protected from moisture and light. Keep the container tightly closed. Do not store in the bathroom or near a sink. Keep out of the reach and sight of children.
• Lifestyle: Losartan is most effective as part of a comprehensive approach to cardiovascular health. Follow a low‑sodium, heart‑healthy diet (rich in fruits, vegetables, and whole grains), maintain a healthy body weight, exercise regularly, limit alcohol consumption, and avoid smoking. Rise slowly from sitting or lying down to minimise the risk of dizziness from lowered blood pressure.
• Missed dose: If you forget a dose, take it as soon as you remember on the same day. If it is close to the time of your next dose, skip the missed dose and return to your regular schedule. Never take two doses at once.
• When to seek medical review: Contact your doctor if you experience symptoms of low blood pressure (severe dizziness, fainting, light‑headedness), signs of hyperkalaemia (weakness, muscle cramps, slow or irregular heartbeat, numbness or tingling in the hands or feet), or signs of angioedema (swelling of the face, eyes, lips, tongue, or throat; difficulty breathing or swallowing). Seek emergency medical attention immediately for signs of a serious allergic or anaphylactic reaction. If you become pregnant, stop taking losartan and inform your doctor right away.
• Disposal: Return unused or expired medication to a pharmacy for safe disposal. Do not flush down the toilet or discard in household waste.

Alternative Medications

• Other angiotensin II receptor blockers (ARBs): Candesartan (Atacand), irbesartan (Avapro), telmisartan (Micardis), valsartan (Diovan), eprosartan (Teveten), and olmesartan (Olmetec) belong to the same class and share a similar mechanism of action. Differences among ARBs relate mainly to potency, half‑life, and the presence or absence of ancillary properties (e.g., losartan has a uricosuric effect; telmisartan has PPAR‑γ agonist activity).
• Angiotensin‑converting enzyme (ACE) inhibitors: Ramipril (Altace), lisinopril (Zestril), enalapril (Vasotec), perindopril (Coversyl), and others also block the RAAS but via a different mechanism (inhibition of ACE). ACE inhibitors are equally effective but are more frequently associated with dry cough. ARBs such as losartan are often preferred in patients intolerant of ACE inhibitors because of cough or angioedema.
• Calcium channel blockers (CCBs): Amlodipine (Norvasc) is a first‑line antihypertensive that dilates blood vessels by blocking calcium entry into vascular smooth‑muscle cells. CCBs are often combined with an ARB or ACE inhibitor for additive blood‑pressure‑lowering effects.
• Thiazide and thiazide‑like diuretics: Hydrochlorothiazide (Microzide), chlorthalidone (Thalitone), and indapamide (Lozide) lower blood pressure by reducing sodium and water reabsorption. They are often used as first‑line therapy and are frequently combined with losartan (e.g., Hyzaar is the fixed‑dose combination of losartan and hydrochlorothiazide).
• Beta‑blockers: Metoprolol (Lopressor), bisoprolol (Monocor), and others reduce heart rate and cardiac output. They are particularly useful in patients with ischaemic heart disease, heart failure, or those who have had a heart attack.
• Non‑pharmacological approaches: Dietary Approaches to Stop Hypertension (DASH) eating plan, reducing dietary sodium, increasing potassium‑rich foods (unless contraindicated by renal impairment), regular aerobic exercise (at least 150 minutes per week), weight loss in overweight or obese individuals, smoking cessation, and stress management techniques are effective lifestyle interventions.

Clinical Efficacy

The efficacy of losartan for the treatment of hypertension has been established in multiple randomised, double‑blind, placebo‑controlled trials. Doses of 50 mg, 100 mg, and 150 mg once daily produced statistically significant reductions in systolic and diastolic blood pressure compared with placebo, with the 50 mg dose achieving a placebo‑subtracted reduction of approximately 10/6 mm Hg. The landmark LIFE (Losartan Intervention For Endpoint reduction in hypertension) study, which randomised over 9,000 patients with hypertension and left ventricular hypertrophy to losartan‑based or atenolol‑based therapy, demonstrated that losartan reduced the primary composite endpoint of cardiovascular death, myocardial infarction, and stroke by 13% (p = 0.021), driven primarily by a 25% reduction in the risk of fatal and nonfatal stroke.

The RENAAL (Reduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan) study, involving over 1,500 patients with type 2 diabetes and nephropathy, showed that losartan reduced the risk of doubling of serum creatinine, end‑stage renal disease, or death by 16% compared with placebo when added to conventional antihypertensive therapy. In this study, losartan reduced the incidence of end‑stage renal disease by 28%. The ELITE‑II trial demonstrated that losartan was as effective as captopril in improving outcomes in patients with heart failure, with significantly better tolerability. Losartan is unique among ARBs in possessing a uricosuric property that lowers serum uric acid levels, a potentially beneficial effect in patients with gout or hyperuricaemia. Clinical guidelines from Hypertension Canada (2024) and the Canadian Cardiovascular Harmonized National Guideline Endeavour (C‑CHANGE) recommend ARBs, including losartan, as first‑line agents for the treatment of hypertension, either as monotherapy or in combination with a thiazide diuretic or calcium channel blocker. Losartan has established efficacy in a wide variety of patient populations, including the elderly, those with diabetes, and patients with renal impairment, and is supported by decades of post‑marketing experience confirming its safety and tolerability.

Important:

Cozaar (losartan) is a prescription medication that should be used only under the supervision of a qualified healthcare professional. It can cause injury or death to the developing foetus when taken during pregnancy. If you become pregnant, stop taking Cozaar immediately and contact your doctor. Do not take Cozaar if you are also taking aliskiren and have diabetes or kidney disease. This medicine can cause serious side effects, including angioedema (swelling of the face, lips, tongue, or throat) which is a medical emergency requiring immediate hospital treatment; severe hypotension, particularly in patients who are dehydrated; and hyperkalaemia, which can be life‑threatening. Have your blood pressure and blood tests (potassium, kidney function) checked regularly as advised by your doctor. Do not stop taking this medication without consulting your physician. Avoid excessive alcohol intake during treatment. This information is not a substitute for professional medical advice, diagnosis, or treatment.

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