Amlodipine / Hydrochlorothiazide / Olmesartan Medoxomil

This combination medicine is used to lower high blood pressure (hypertension) in adults when more than one medication is needed.

• Tribenzor is indicated for the treatment of hypertension, alone or with other blood pressure-lowering medicines, to reduce the risk of stroke and heart attack
• Generic forms (olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets) carry the same indication for treating hypertension
• Lowering high blood pressure with this combination reduces the risk of fatal and non-fatal events like stroke and heart attack
• This is not a first-choice medicine for someone newly diagnosed with high blood pressure — it is meant for patients who already need multiple medications to control their blood pressure

This tablet combines three ingredients that each tackle blood pressure from a different angle. Olmesartan medoxomil blocks a receptor for angiotensin II — a hormone that tightens blood vessels and causes the kidneys to hold on to sodium. Amlodipine is a calcium channel blocker that prevents calcium from entering the smooth muscle cells lining blood vessels, allowing those vessels to relax and widen. Hydrochlorothiazide is a thiazide diuretic that makes the kidneys flush out more sodium and water, reducing the total fluid volume in the circulatory system. Because these three mechanisms target different pathways, the combination produces a stronger, more consistent blood pressure-lowering effect than any single agent alone.

This medicine is taken once a day by mouth, as a film-coated tablet. Food does not affect how the body absorbs it, so you can take it with or without a meal. Your prescriber selects the appropriate strength based on the medications you have taken before; the dose may be increased in two-week intervals if your blood pressure goal has not been reached. Always follow your prescriber's specific instructions — do not adjust the dose on your own.

• Take at roughly the same time each day to keep blood pressure stable
• If you miss a dose, take it as soon as you remember — unless it is almost time for your next dose; never double up

The most common side effects reported in clinical trials include:

• Dizziness (the most common reason people stopped the medicine in trials)
• Swelling in the feet or legs (peripheral edema)
• Headache
• Fatigue
• Muscle spasms
• Nausea or diarrhea
• Stuffy or runny nose (nasopharyngitis)
• Upper respiratory infections or urinary tract infections

More serious but less common reactions include fainting, significant low blood pressure, worsening kidney function, electrolyte imbalances, acute eye pain and vision changes (angle-closure glaucoma), and severe chronic diarrhea with weight loss. Contact your doctor promptly if you experience any of these.

• Fetal toxicity: This medicine can cause serious harm or death to a developing baby, especially in the second and third trimesters. Stop immediately if pregnancy is detected and contact your doctor.
• Low blood pressure (hypotension): Risk is highest if you are dehydrated, on a low-salt diet, or taking high doses of other diuretics. Lie down and seek care if you feel faint.
• Kidney function changes: This medicine can worsen kidney function, particularly in people with pre-existing kidney disease, narrowed kidney arteries, or severe heart failure. Your doctor may monitor your kidney labs.
• Electrolyte imbalances: Hydrochlorothiazide can lower potassium, sodium, and magnesium. Olmesartan can raise potassium. Routine blood tests may be needed to keep these in balance.
• Acute angle-closure glaucoma: Sudden eye pain, blurred vision, or redness shortly after starting this medicine is a medical emergency — seek care immediately.
• Sprue-like enteropathy: Severe, ongoing diarrhea and significant weight loss linked to olmesartan have been reported months to years after starting the drug. Tell your doctor if this occurs.
• Increased angina or heart attack risk: Patients with severe coronary artery disease may rarely develop worsened chest pain when starting or increasing the amlodipine dose.
• Lupus: Hydrochlorothiazide can trigger or worsen systemic lupus erythematosus.

This medicine interacts with several common drugs and substances — let your prescriber and pharmacist know everything you take:

• NSAIDs (ibuprofen, naproxen, COX-2 inhibitors) — can reduce blood pressure control and increase the risk of kidney damage, especially in older or dehydrated patients
• Aliskiren — must not be combined in patients with diabetes; avoid in patients with reduced kidney function due to risk of low blood pressure, high potassium, and kidney failure
• ACE inhibitors or other angiotensin receptor blockers — using two renin-angiotensin system blockers together raises risk of low blood pressure, high potassium, and kidney problems
• Lithium — olmesartan can raise lithium blood levels, increasing the risk of lithium toxicity
• Simvastatin — amlodipine raises simvastatin exposure; the simvastatin dose should be limited when used together
• Cyclosporine or tacrolimus — amlodipine can increase levels of these immune-suppressing drugs
• CYP3A inhibitors (certain antifungals, some antibiotics) — may increase amlodipine exposure
• Colesevelam or cholestyramine/colestipol — these cholesterol medicines can reduce absorption; take olmesartan at least 4 hours before colesevelam
• Antidiabetic medicines — hydrochlorothiazide can affect blood sugar; your diabetes medication dose may need adjustment
• Alcohol, barbiturates, or narcotic pain medicines — may worsen dizziness or low blood pressure when standing up

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

• Pregnancy: Do not take this medicine if you are pregnant. Stop it immediately if you become pregnant and call your doctor — it can cause serious fetal harm or death.
• Breastfeeding: Not recommended. Components of this medicine are present in breast milk, and the risk to a nursing infant is unknown.
• Children: Safety and effectiveness in patients under 18 have not been established.
• Adults 75 and older: The recommended starting dose of amlodipine for this age group (2.5 mg) is not available in this fixed-combination tablet — discuss with your prescriber.
• Severe kidney disease: Avoid use if your creatinine clearance is 30 mL/min or less.
• Severe liver disease: The appropriate lower starting dose of amlodipine is not available in this combination tablet — use requires caution and prescriber guidance.
• Diabetes: Cannot be combined with aliskiren; hydrochlorothiazide may affect blood sugar control.
• Sulfonamide or penicillin allergy: May increase the risk of a rare eye reaction (acute angle-closure glaucoma) from the hydrochlorothiazide component.
• Lupus: Tell your doctor — hydrochlorothiazide can worsen or trigger systemic lupus erythematosus.
• Gout or high uric acid: Hydrochlorothiazide can raise uric acid levels and may trigger gout attacks.
• Anuria (inability to produce urine): This medicine is contraindicated in patients with this condition.

Taking too much of this medicine could cause severely low blood pressure, rapid or slow heart rate, excessive fluid loss, and dangerous shifts in electrolytes like potassium and sodium. If you suspect an overdose, call 911 or Poison Control (1-800-222-1222) immediately. Supportive care — lying flat, IV fluids, and blood pressure monitoring — is the main approach; hemodialysis is not expected to be helpful for the amlodipine component due to its high protein binding.

Each of the three components measurably lowers blood pressure by a different mechanism. Olmesartan blocks the blood pressure-raising effect of angiotensin II at its receptor, an effect that lasts over 24 hours with adequate dosing. Amlodipine relaxes peripheral blood vessels, lowering blood pressure without significantly changing heart rate; its effect is proportional to how elevated the blood pressure was before treatment — people with higher baseline pressures see larger reductions. Hydrochlorothiazide starts producing a diuretic (urine-producing) effect within about 2 hours of an oral dose, peaking around 4 hours and lasting 6 to 12 hours, reducing blood volume and blood pressure.

After swallowing a tablet, peak blood levels of olmesartan and hydrochlorothiazide are reached within about 1.5 to 3 hours, while amlodipine peaks more slowly at 6 to 8 hours. Food does not affect how much of any component is absorbed. Olmesartan is completely converted to its active form as it is absorbed from the gut, then eliminated partly in urine and partly in bile, with a half-life of about 13 hours. Amlodipine is extensively broken down by the liver and has a much longer half-life of 30 to 50 hours, which is why it takes 7 to 8 days of daily dosing to reach steady blood levels. Hydrochlorothiazide is not metabolized — the kidneys clear it unchanged, so people with significant kidney impairment can accumulate higher levels of it.

Stored at 20° to 25°C (68° to 77°F) .