Olmesartan Medoxomil / Amlodipine Besylate / Hydrochlorothiazide

Olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide is a three-ingredient oral tablet used to lower blood pressure in adults.

• Treats high blood pressure (hypertension), alone or alongside other blood pressure medicines
• Lowers blood pressure to reduce the risk of stroke and heart attack
• Tribenzor is indicated for hypertension when blood pressure is not controlled on fewer medicines
• Not indicated as initial (first-ever) therapy for high blood pressure — this combination is used after simpler regimens have been tried

This tablet targets three separate pathways that control blood pressure. Olmesartan blocks angiotensin II — a hormone that normally tightens blood vessels and causes the body to hold onto sodium — from binding to its receptor (called the AT1 receptor) in blood vessel walls. Amlodipine prevents calcium from entering vascular muscle cells, which allows blood vessels to relax and widen. Hydrochlorothiazide acts in the kidneys to flush out extra sodium and water, shrinking the volume of fluid the heart must pump. Because each ingredient works at a different site, the combination lowers blood pressure more effectively than any single ingredient alone.

These tablets are taken once daily by mouth and can be taken with or without food. Your prescriber will personalize your dose based on how you responded to previous blood pressure medicines. Dose changes, if needed, are typically made no more often than every two weeks.

• Take at the same time each day to keep blood pressure steady
• If you miss a dose, take it as soon as you remember — but skip it if it is almost time for your next dose; never double up
• Do not stop taking this medicine without talking to your doctor first

The most common side effects reported in clinical trials include:

• Dizziness (most common reason people stop this medicine)
• Swelling in the feet or ankles (peripheral edema)
• Headache
• Fatigue
• Nausea
• Muscle spasms or cramps
• Diarrhea
• Stuffy nose or cold symptoms (nasopharyngitis)

More serious reactions to act on immediately include fainting, sudden chest pain, significant decrease in urination, sudden eye pain or vision loss, and severe ongoing diarrhea with weight loss — contact your doctor or get emergency help if any of these occur.

• Fetal toxicity (pregnancy risk): This medicine can cause serious kidney damage and death in an unborn baby. Stop it immediately if you become pregnant and call your doctor.
• Low blood pressure (hypotension): Especially likely if you are dehydrated, on a low-salt diet, or already taking diuretics. Dizziness or fainting when standing are warning signs.
• Kidney function: This combination can worsen kidney function in some people, particularly those with existing kidney disease or severe heart failure. Kidney labs should be monitored.
• Electrolyte imbalances: The hydrochlorothiazide component can lower potassium, sodium, and magnesium levels. The olmesartan component can raise potassium. Watch for muscle weakness, cramps, or irregular heartbeat.
• Sprue-like enteropathy: Severe chronic diarrhea and significant weight loss have been reported with olmesartan, sometimes starting months or years after beginning the drug. Tell your doctor if this develops.
• Acute angle-closure glaucoma: A rare but sudden eye emergency — eye pain, blurred vision, or redness — can occur with the hydrochlorothiazide component. Seek care immediately.
• Worsening angina or heart attack: People with severe coronary artery disease may experience increased chest pain or a heart attack when starting amlodipine or increasing its dose.

Several medicines, foods, and substances can interact with this combination tablet — tell your prescriber and pharmacist about everything you take:

• NSAIDs (ibuprofen, naproxen, celecoxib) — can blunt blood pressure control and increase the risk of kidney damage, especially in older adults or those with kidney disease
• Aliskiren (Tekturna) — must not be combined in patients with diabetes; should be avoided in patients with kidney disease
• ACE inhibitors or other ARBs — combining multiple drugs that act on the renin-angiotensin system raises the risk of low blood pressure, high potassium, and kidney failure
• Lithium — olmesartan can cause lithium to build up to toxic levels in the blood
• Simvastatin — limit the daily dose of simvastatin when taken with amlodipine to avoid muscle side effects
• Cyclosporine or tacrolimus — amlodipine can raise blood levels of these immunosuppressants
• CYP3A inhibitors (certain antifungals, antibiotics, and others) — can increase amlodipine exposure in the body
• Alcohol, sedatives, or narcotic pain medicines — can worsen dizziness or low blood pressure, especially upon standing
• Antidiabetic medicines — hydrochlorothiazide can affect blood sugar; dose adjustment of diabetes medicines may be needed
• Cholestyramine or colestipol (cholesterol binders) — can reduce the absorption of hydrochlorothiazide; timing of doses matters

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 use this medicine if you are pregnant. If you become pregnant while taking it, stop immediately and call your doctor.
• Breastfeeding: Breastfeeding is not recommended while taking this medicine.
• Severe kidney disease: Avoid this combination if your creatinine clearance is 30 mL/min or less.
• Severe liver disease: Use with caution — amlodipine is processed by the liver and stays in the body much longer when liver function is impaired. A lower starting amlodipine dose (2.5 mg) is recommended for severe hepatic impairment, but that dose is not available in this combination tablet.
• Dehydration or low-salt diet: Correct fluid or salt deficits before starting — you may be at high risk for a dangerous drop in blood pressure.
• Diabetes: This medicine should not be combined with aliskiren if you have diabetes. Also, hydrochlorothiazide can raise blood sugar.
• Sulfonamide or penicillin allergy: May increase the risk of the rare eye reaction (acute angle-closure glaucoma) from the hydrochlorothiazide component.
• Severe aortic stenosis or coronary artery disease: Use with caution — amlodipine may worsen angina in some patients with these conditions.
• Older adults (75+): The recommended starting dose of amlodipine for patients 75 and older (2.5 mg) is not available in this fixed-dose combination tablet — discuss this with your prescriber.
• Children: Safety and effectiveness have not been established in pediatric patients.

Taking too much of this combination tablet could cause a dangerous drop in blood pressure, dizziness, fainting, or a rapid or slow heart rate. With the amlodipine component specifically, severe overdose can cause marked low blood pressure and reflex fast heart rate. With the hydrochlorothiazide component, overdose can cause dehydration and electrolyte loss (especially low potassium and sodium). If you suspect an overdose, call 911 or Poison Control immediately and seek emergency care — do not try to manage this at home.

All three ingredients work together to lower both sitting and standing blood pressure without causing a significant increase in heart rate during chronic use. Amlodipine's blood pressure-lowering effect is sustained for at least 24 hours after a once-daily dose, and its effect is greater in people with higher pre-treatment blood pressure levels. Hydrochlorothiazide begins producing a diuretic effect within about 2 hours of an oral dose, peaking around 4 hours and lasting 6 to 12 hours. Together, the three components complement each other — the olmesartan component also tends to offset the potassium loss that hydrochlorothiazide would otherwise cause.

After swallowing a tablet, peak blood levels of olmesartan are reached in about 1.5 to 3 hours, amlodipine in 6 to 8 hours, and hydrochlorothiazide in 1.5 to 2 hours. Food does not affect how much of any of the three ingredients is absorbed. Amlodipine is heavily processed by the liver and has a very long half-life of roughly 30 to 50 hours, meaning it stays in the body for days — steady-state levels build up after about 7 to 8 days of daily dosing. Olmesartan is eliminated partly through the kidneys and partly through the bile, while hydrochlorothiazide is cleared almost entirely by the kidneys unchanged. Kidney or liver impairment can significantly increase how much of these drugs accumulate in the body.

Stored at 20° to 25°C (68° to 77°F) .