Generic Azor ( Olmesartan and amlodipine )

Buy Generic Azor (Olmesartan and amlodipine) without prescription in Canada

Azor (Olmesartan and Amlodipine 20/5 mg): Comprehensive Patient Information for Canada

Basic Product Information

Mechanism of Action

In simple terms: Azor is a combination medication that contains two blood pressure-lowering medicines. Amlodipine is a calcium channel blocker that relaxes blood vessels by blocking the entry of calcium into the muscle cells of the blood vessel walls, allowing them to widen and blood to flow more easily. Olmesartan is an angiotensin receptor blocker (ARB) that works by blocking the action of angiotensin II, a natural substance in the body that causes blood vessels to narrow. By blocking angiotensin II, olmesartan helps blood vessels relax and widen. Together, these two medicines work through different mechanisms to lower blood pressure more effectively than either alone.

For specialists: Amlodipine is a dihydropyridine calcium channel blocker that directly acts on vascular smooth muscle to produce peripheral arterial vasodilation, reducing peripheral vascular resistance and blood pressure. Olmesartan medoxomil is a prodrug that is hydrolyzed during absorption from the gastrointestinal tract to olmesartan, the active metabolite. Olmesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in vascular smooth muscle and the adrenal gland. The combination targets two separate mechanisms involved in blood pressure regulation: calcium-mediated vascular smooth muscle contraction and renin-angiotensin system-mediated vasoconstriction and sodium retention.

Pharmacokinetics

• Absorption: Olmesartan is rapidly absorbed after oral administration, with peak plasma concentrations reached approximately 1.5 to 2 hours after dosing. The absolute bioavailability of olmesartan is approximately 26%. Amlodipine is slowly absorbed after oral administration, with peak plasma concentrations reached approximately 6 to 8 hours after dosing. The absolute bioavailability of amlodipine is approximately 64% to 80%. Food does not significantly affect the absorption of either component. The pharmacokinetics of amlodipine and olmesartan from the combination tablet are equivalent to those when the two drugs are administered separately.
• Metabolism: Olmesartan is not extensively metabolized. Approximately 35% to 50% of the absorbed dose is excreted in the urine and the remainder in the feces via the bile. Amlodipine is extensively metabolized in the liver, primarily by CYP3A4, to inactive metabolites.
• Distribution: Olmesartan is highly bound to plasma proteins (99.7%). Amlodipine is approximately 93% bound to plasma proteins. The volume of distribution of amlodipine is approximately 21 L/kg.
• Elimination: The effective half-life of amlodipine is approximately 45 ± 11 hours, resulting in a 2- to 3-fold accumulation with once-daily dosing. The effective half-life of olmesartan is approximately 7 ± 1 hour, with negligible accumulation. Total plasma clearance of olmesartan is 1.3 L/h, with a renal clearance of 0.6 L/h. Amlodipine is eliminated from the plasma with a terminal elimination half-life of approximately 30 to 50 hours.
• Onset of Action: Blood pressure reduction begins within 1 to 2 weeks of starting treatment, with maximal effect typically achieved after 4 to 8 weeks.
• Duration of Action: The half-life of amlodipine (approximately 45 hours) supports once-daily dosing and provides 24-hour blood pressure control.

Uses in Daily Life and Best Practice Advice

Azor is prescribed in Canada for the treatment of high blood pressure (hypertension). Your physician will determine the appropriate use and dose based on your specific medical situation.

• Typical Uses: Management of hypertension, either as monotherapy or in combination with other antihypertensive agents. It is used when treatment with a single agent is inadequate to control blood pressure, or as initial therapy in patients likely to require multiple medications to achieve blood pressure goals.
• Administration: Take the tablet orally, usually once daily, with or without food. Swallow the tablet whole with a full glass of water. Take at the same time each day to maintain a steady level of medication in your body.
• Monitoring: Your physician will monitor your blood pressure regularly and may perform periodic blood tests to check kidney function and potassium levels. If blood pressure remains high or increases, contact your healthcare provider.
• Do Not Stop Without Medical Advice: Do not stop taking this medication without consulting your physician. High blood pressure often has no symptoms, and stopping treatment abruptly may cause your blood pressure to rise to dangerous levels.

Morning vs. Evening Dosing

Azor is typically taken once daily. There is no specific clinical recommendation for morning versus evening dosing. Taking it at the same time each day helps maintain consistent blood levels. Always follow the schedule recommended by your physician.

• Once Daily: The standard dose is taken once daily, with or without food.
• Consistency: Take Azor at the same time each day to ensure consistent blood pressure control.
• Missed Dose: If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not take two doses at the same time.
• Professional Guidance: Your healthcare provider may adjust the timing based on your response to treatment and other medications.

Administration With or Without Food

Azor can be taken with or without food. Food does not significantly affect the absorption of either olmesartan or amlodipine. This flexibility makes it convenient to take at any time of day.

• Swallow the tablet whole with a full glass of water.
• Azor can be taken with or without food.
• Do not crush or chew the tablet.
• Avoid salt substitutes that contain potassium unless directed by your physician, as olmesartan can increase potassium levels.
• Avoid drinking grapefruit juice while taking Azor, as it may increase the levels of amlodipine in your blood.

Interaction Warnings

Indications for Olmesartan/Amlodipine

"Off-label" means use outside the official approved indication, usually based on current medical guidelines and scientific evidence.

Dosing According to Clinical Indication

Doses should always be adjusted according to the advice of your physician and depending on your health condition, kidney function, and blood pressure response. Dosage is individualized based on blood pressure response and tolerability.

Side Effects and Safety Profile

Guidelines for Correct Use

• Take Azor exactly as prescribed by your physician. Do not change your dose without medical advice.
• Swallow the tablet whole with a full glass of water, with or without food, at the same time each day.
• Do not crush or chew the tablet.
• Avoid salt substitutes containing potassium unless directed by your physician.
• Avoid drinking grapefruit juice while taking Azor.
• Do not stop taking this medication without consulting your physician.
• Keep all medical appointments for monitoring of blood pressure, kidney function, and potassium levels.
• Inform every healthcare provider (including dentists, surgeons, and pharmacists) that you are taking Azor.
• If you are pregnant, planning to become pregnant, or breastfeeding, consult your physician before use. Azor is contraindicated during pregnancy.
• If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Do not double the dose.
• Store at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Keep out of reach of children.

Alternative Treatment Options

• Other ARB/Calcium Channel Blocker Combinations: Valsartan/amlodipine (Exforge) and telmisartan/amlodipine (Twynsta) are alternative combination products available in Canada. These may be preferred based on patient tolerance, cost, and provincial formulary coverage.
• Single-Agent ARBs: Olmesartan (Olmetec), valsartan (Diovan), losartan (Cozaar), and candesartan (Atacand) are available as single agents. These may be used alone or in combination with a separate calcium channel blocker.
• Single-Agent Calcium Channel Blockers: Amlodipine (Norvasc) and nifedipine (Adalat) are available as single agents. These may be used alone or in combination with a separate ARB.
• ACE Inhibitor/Calcium Channel Blocker Combinations: Perindopril/amlodipine (Prestalia) and benazepril/amlodipine (Lotrel) are alternative combination products. ACE inhibitors may be preferred in some patients but are associated with a higher risk of cough compared with ARBs.
• Diuretics (e.g., hydrochlorothiazide, indapamide): Often used as add-on therapy for hypertension. May be combined with an ARB or calcium channel blocker.

Comparison: Olmesartan/amlodipine is distinguished from other ARB/calcium channel blocker combinations by the specific pharmacokinetic profiles of its components. Amlodipine has a long half-life (approximately 45 hours), providing sustained 24-hour blood pressure control. Olmesartan has a shorter half-life (approximately 7 hours) but provides effective blood pressure reduction with once-daily dosing. The combination is well-established for the treatment of hypertension, with clinical trials demonstrating greater blood pressure reductions compared with either component alone. The main adverse effect of amlodipine is peripheral edema, which occurs in a dose-dependent manner. Your physician will determine the best option for your specific condition, taking into account your medical history, kidney function, and provincial formulary coverage.

Legal Status, Registration, and Coverage in Canada

• Registration: Generic olmesartan/amlodipine combination products are authorized for sale in Canada by Health Canada as prescription drugs. The brand-name Azor is not marketed in Canada, but the generic combination is available. Single-agent olmesartan (Olmetec) and amlodipine (Norvasc) are also authorized.
• Prescription Status: Prescription only in Canada.
• Coverage: Coverage varies by province and territory. In Ontario, generic olmesartan is listed on the Ontario Drug Benefit (ODB) formulary at a drug benefit price of approximately $0.3019 per tablet for the 20 mg and 40 mg strengths. The combination product may be covered under similar criteria. In Quebec, olmesartan and amlodipine are covered under the RAMQ formulary, and combination products may be covered as exceptional medications. In British Columbia, olmesartan is covered under the Reference Drug Program (RDP). Generic combination products are generally more affordable than brand-name products. Check with your provincial drug plan and private insurance provider for coverage details.
• Pharmacovigilance: Adverse reactions should be reported to Health Canada's MedEffect Canada program at 1-866-234-2345.

Recent Research and Clinical Guidelines (2022–2026)

• Canadian clinical practice guidelines, including those from Hypertension Canada, recommend combination therapy with an ARB and a calcium channel blocker as an effective strategy for achieving blood pressure targets in patients who do not respond adequately to monotherapy. The combination of olmesartan and amlodipine is specifically recognized in the Hypertension Canada guidelines as a preferred combination.
• The COACH trial (Combination of Olmesartan medoxomil and Amlodipine besylate in Controlling High blood pressure) demonstrated that the combination of olmesartan and amlodipine produced significantly greater blood pressure reductions compared with the component monotherapies in patients with mild to severe hypertension.
• A randomized, double-blind trial published in 2013 found that the fixed-dose combination of olmesartan/amlodipine was superior in central aortic blood pressure reduction compared with perindopril/amlodipine, with a significantly higher rate of blood pressure normalization.
• Research continues to explore the role of olmesartan/amlodipine in various patient populations, including those with difficult-to-treat hypertension and chronic kidney disease.
• Current evidence supports the use of olmesartan/amlodipine combination therapy as an effective and well-tolerated option for the management of hypertension, with a safety profile consistent with the individual components.

Availability and Supply in Canada

Prices and availability may vary by province, territory, and pharmacy. Generic olmesartan/amlodipine combination products are available in Canada and are generally more affordable than the brand-name Azor. Coverage is subject to provincial/territorial formulary criteria. Check with your local pharmacy for current pricing and availability.

Frequently Asked Questions (FAQ)

1. What is Azor used for?
   Azor is a combination medication used to treat high blood pressure (hypertension). It contains two active ingredients: olmesartan, an angiotensin receptor blocker (ARB), and amlodipine, a calcium channel blocker. It is used when a single medication is not enough to control blood pressure, or as initial therapy in patients likely to need multiple medications.
2. How does Azor work?
   Azor works by relaxing blood vessels through two different mechanisms. Amlodipine blocks calcium from entering the muscle cells of blood vessel walls, allowing them to widen. Olmesartan blocks the action of angiotensin II, a natural substance that causes blood vessels to narrow. Together, these actions lower blood pressure and improve blood flow.
3. What is the correct dose of Azor?
   The usual starting dose is olmesartan 20 mg/amlodipine 5 mg once daily. The dose may be increased after 1 to 2 weeks of therapy, up to a maximum of olmesartan 40 mg/amlodipine 10 mg per day. Your physician will determine the appropriate dose for your condition.
4. Can I take Azor with food?
   Yes. Azor can be taken with or without food. Food does not significantly affect the absorption of the medication.
5. What should I do if I miss a dose?
   If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not take two doses at the same time.
6. Can I drink alcohol while taking Azor?
   Avoid excessive alcohol consumption while taking Azor, as alcohol may increase the blood pressure-lowering effect and worsen dizziness.
7. What are the serious side effects of Azor?
   Serious side effects include sprue-like enteropathy (severe chronic diarrhea with weight loss), angioedema (swelling of the face, lips, tongue, or throat), severe allergic reactions, and kidney impairment. Seek immediate medical attention if you experience these symptoms.
8. Is Azor safe during pregnancy?
   No. Azor is contraindicated during pregnancy. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. Discontinue as soon as possible when pregnancy is detected and consult your physician immediately.
9. Is Azor safe during breastfeeding?
   Breastfeeding is not recommended during treatment with Azor. It is unknown if olmesartan is excreted in human breast milk. Consult your physician before use if breastfeeding.
10. Are there alternatives to Azor?
    Yes. Alternatives include other ARB/calcium channel blocker combinations (valsartan/amlodipine, telmisartan/amlodipine), single-agent ARBs, single-agent calcium channel blockers, ACE inhibitor/calcium channel blocker combinations, and diuretics. Your physician will determine the best option for your specific condition.
11. Is Azor covered by Canadian health insurance?
    Coverage varies by province and territory. In Ontario, generic olmesartan is listed on the ODB formulary. In Quebec, olmesartan and amlodipine are covered under the RAMQ formulary. In British Columbia, olmesartan is covered under the Reference Drug Program. Check with your provincial drug plan and private insurance provider for coverage details.