Tribenzor

Name: Tribenzor

US Brand Name

  1. Tribenzor

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Aliskiren
  • Dofetilide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Aceclofenac
  • Acemetacin
  • Acetyldigoxin
  • Amiodarone
  • Amphetamine
  • Amtolmetin Guacil
  • Arsenic Trioxide
  • Aspirin
  • Atazanavir
  • Benazepril
  • Bromfenac
  • Bufexamac
  • Captopril
  • Celecoxib
  • Ceritinib
  • Choline Salicylate
  • Clarithromycin
  • Clonixin
  • Clopidogrel
  • Conivaptan
  • Cyclophosphamide
  • Cyclosporine
  • Dantrolene
  • Deslanoside
  • Dexibuprofen
  • Dexketoprofen
  • Diclofenac
  • Diflunisal
  • Digitalis
  • Digitoxin
  • Digoxin
  • Dipyrone
  • Domperidone
  • Droperidol
  • Droxicam
  • Eliglustat
  • Enalapril
  • Enalaprilat
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Felbinac
  • Fenoprofen
  • Fepradinol
  • Feprazone
  • Flecainide
  • Floctafenine
  • Flufenamic Acid
  • Flurbiprofen
  • Fosinopril
  • Ibuprofen
  • Idelalisib
  • Indomethacin
  • Ketanserin
  • Ketoprofen
  • Ketorolac
  • Lacosamide
  • Levomethadyl
  • Lisinopril
  • Lithium
  • Lornoxicam
  • Loxoprofen
  • Lumiracoxib
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Methotrexate
  • Metildigoxin
  • Moexipril
  • Morniflumate
  • Nabumetone
  • Naproxen
  • Nepafenac
  • Niflumic Acid
  • Nimesulide
  • Nimesulide Beta Cyclodextrin
  • Ouabain
  • Oxaprozin
  • Oxyphenbutazone
  • Parecoxib
  • Perindopril
  • Phenylbutazone
  • Piketoprofen
  • Piperaquine
  • Piroxicam
  • Proglumetacin
  • Propyphenazone
  • Proquazone
  • Proscillaridin
  • Quinapril
  • Ramipril
  • Rofecoxib
  • Salicylic Acid
  • Salsalate
  • Simvastatin
  • Sodium Salicylate
  • Sotalol
  • Sulindac
  • Tacrolimus
  • Tegafur
  • Telaprevir
  • Tenoxicam
  • Tiaprofenic Acid
  • Tolfenamic Acid
  • Tolmetin
  • Trandolapril
  • Trimethoprim
  • Valdecoxib

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Bepridil
  • Carbamazepine
  • Cholestyramine
  • Colesevelam
  • Ginkgo
  • Gossypol
  • Indinavir
  • Licorice
  • Topiramate

Tribenzor Drug Class

Tribenzor is part of the drug class:

  • Angiotensin II antagonists, other combinations

How should I take amlodipine, hydrochlorothiazide, and olmesartan?

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take this medicine with or without food.

Your chest pain may become worse when you first start taking this medicine or when your dose is increased. Call your doctor if your chest pain is severe or ongoing.

Your blood pressure will need to be checked often.

Vomiting, diarrhea, or heavy sweating can cause you to become dehydrated. This can lead to very low blood pressure, electrolyte disorders, or kidney failure while you are taking amlodipine, hydrochlorothiazide, and olmesartan. Drink plenty of water each day while you are taking this medication.

Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual.

If you need surgery or medical tests, tell the surgeon ahead of time that you are using this medicine.

It may take up to 2 weeks before your blood pressure improves. Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store at room temperature away from moisture and heat.

What should I avoid while taking amlodipine, hydrochlorothiazide, and olmesartan?

Do not use potassium supplements or salt substitutes while you are taking this medicine, unless your doctor has told you to.

Drinking alcohol can further lower your blood pressure and may increase side effects of this medicine.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Amlodipine, hydrochlorothiazide, and olmesartan side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • worsening chest pain;

  • a light-headed feeling, like you might pass out;

  • an unusual skin rash;

  • pain or burning when you urinate;

  • severe or ongoing diarrhea with weight loss;

  • blurred vision, tunnel vision, eye pain, or seeing halos around lights;

  • signs of an electrolyte imbalance--dry mouth, increased thirst, vomiting, dizziness, feeling restless or unsteady, confusion, muscle pain or weakness, lack of energy, fast heartbeats, little or no urine; or

  • kidney problems--little or no urination, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath.

Common side effects may include:

  • dizziness;

  • headache, tired feeling;

  • swelling in your hands or feet;

  • nausea, diarrhea;

  • runny or stuffy nose, sore throat;

  • muscle spasms;

  • swollen joints; or

  • painful urination.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect amlodipine, hydrochlorothiazide, and olmesartan?

Many drugs can interact with this medicine. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

  • any other blood pressure medicines;

  • lithium;

  • a diuretic or "water pill";

  • insulin or oral diabetes medicine;

  • steroid medicine;

  • vitamin or mineral supplements that contain potassium;

  • a barbiturate--butabarbital, phenobarbital, secobarbital;

  • cholesterol-lowering medicines--simvastatin, Zocor, and others;

  • am immunosuppressant--cyclosporine, tacrolimus;

  • narcotic pain medicine--OxyContin, Vicodin, and others; or

  • NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), and others.

This list is not complete and many other drugs can interact with amlodipine, hydrochlorothiazide, and olmesartan. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Commonly used brand name(s)

In the U.S.

  • Tribenzor

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antihypertensive

Pharmacologic Class: Angiotensin II Receptor Antagonist

Chemical Class: Amlodipine

Proper Use of Tribenzor

Take this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

In addition to using this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You might have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, strokes, or kidney disease.

You may take this medicine with or without food.

If you are also using colesevelam (Welchol®), take it at least 4 hours after taking Tribenzor®.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For high blood pressure:
      • Adults—One tablet once a day. Your doctor may adjust the dose as needed. However, the dose is usually not more than olmesartan 40 milligrams (mg), amlodipine 10 mg, and hydrochlorothiazide 25 mg per day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

What do I need to tell my doctor BEFORE I take Tribenzor?

  • If you have an allergy to olmesartan, amlodipine, hydrochlorothiazide, or any other part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are taking dofetilide.
  • If you are not able to pass urine.
  • If you have kidney disease.
  • If you are taking a drug that has aliskiren in it and you also have high blood sugar (diabetes) or kidney problems. Check with your doctor or pharmacist if you are not sure if a drug you take has aliskiren in it.
  • If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with Tribenzor.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Warnings and Precautions

Fetal toxicity

Pregnancy Category D

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. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Tribenzor as soon as possible [see Use in Specific Populations (8.1].

Hypotension in Volume- or Salt-Depleted Patients

Olmesartan medoxomil. In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients (e.g., those being treated with high doses of diuretics) symptomatic hypotension may be anticipated after initiation of treatment with olmesartan medoxomil. Initiate treatment with Azor under close medical supervision. If hypotension does occur, place the patient in the supine position and, if necessary, give an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.

Amlodipine. Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension is unlikely.

Increased Angina and/or Myocardial Infarction

Amlodipine. Patients, particularly those with severe obstructive coronary artery disease, may develop increased frequency, duration, or severity of angina or acute myocardial infarction upon starting calcium channel blocker therapy or at the time of dosage increase. The mechanism of this effect has not been elucidated.

Impaired Renal Function

Tribenzor.
Impaired renal function was reported in 2.1% of subjects receiving Tribenzor compared to 0.2% to 1.3% of subjects receiving dual combination therapy of olmesartan medoxomil and amlodipine, olmesartan medoxomil and hydrochlorothiazide or amlodipine and hydrochlorothiazide.

If progressive renal impairment becomes evident consider withholding or discontinuing Tribenzor.

Olmesartan medoxomil Changes in renal function occur in some individuals treated with olmesartan medoxomil as a consequence of inhibiting the renin-angiotensin-aldosterone system. In patients whose renal function may depend upon the activity of the renin-angiotensin-aldosterone system (e.g., patients with severe congestive heart failure), treatment with ACE inhibitors and angiotensin receptor antagonists has been associated with oliguria or progressive azotemia and (rarely) with acute renal failure and/or death. Similar effects may occur in patients treated with Tribenzor due to the olmesartan medoxomil component [see Drug Interactions (7.2) and Clinical Pharmacology (12.3)].

In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or blood urea nitrogen (BUN) have been reported. There has been no long-term use of olmesartan medoxomil in patients with unilateral or bilateral renal artery stenosis, but similar effects would be expected with Tribenzor because of the olmesartan medoxomil component.

Hydrochlorothiazide. Thiazides may precipitate azotemia in patients with renal disease. Cumulative effects of the drug may develop in patients with impaired renal function.

Patients with Hepatic Impairment

Amlodipine. Since amlodipine is extensively metabolized by the liver and the plasma elimination half-life (t1/2) is 56 hours in patients with severely impaired hepatic function, titrate slowly when administering to patients with severe hepatic impairment.

Electrolyte and Metabolic Imbalances

Tribenzor contains hydrochlorothiazide which can cause hypokalemia, hyponatremia and hypomagnesmia. Hypomagnesmia can result in hypokalemia which may be difficult to treat despite potassium repletion. Tribenzor also contains olmesartan, a drug that affects the RAS. Drugs that inhibit the RAS can also cause hyperkalemia.

Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides.

Hyperuricemia may occur or frank gout may be precipitated in patients receiving thiazide therapy.

Hydrochlorothiazide decreases urinary calcium excretion and may cause elevations of serum calcium. Monitor calcium levels.

Postsympathectomy Patients

The antihypertensive effects of the drug may be enhanced in the post-sympathectomy patient.

Systemic Lupus Erythematosus

Hydrochlorothiazide. Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.

Acute Myopia and Secondary Angle-Closure Glaucoma

Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.

Sprue-like Enteropathy

Olmesartan medoxomil. Severe, chronic diarrhea with substantial weight loss has been reported in patients taking olmesartan months to years after drug initiation. Intestinal biopsies of patients often demonstrated villous atrophy. If a patient develops these symptoms during treatment with olmesartan, exclude other etiologies. Consider discontinuation of Tribenzor in cases where no other etiology is identified.

Patient Counseling Information

See FDA-Approved Patient Labeling
Pregnancy: Tell female patients of childbearing age about the consequences of exposure to Azor during pregnancy. Discuss treatment options with women planning to become pregnant. Tell patients to report pregnancies to their physicians as soon as possible.

Symptomatic Hypotension: Advise patients that lightheadedness can occur, especially during the first days of therapy, and that it should be reported to the prescribing physician. Tell patients that if syncope occurs, Tribenzor should be discontinued until the physician has been consulted. Tell patients that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope.

FDA-Approved Patient Labeling
Patient Information
Tribenzor (TRY-BEN-ZOR)
(olmesartan medoxomil, amlodipine, hydrochlorothiazide) Tablets

Read the Patient Information that comes with Tribenzor before you take it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or treatment.

What is the most important information I should know about Tribenzor?

  • Tribenzor can cause harm or death to an unborn baby.
  • Talk to your doctor about other ways to lower your blood pressure if you become pregnant.
  • If you get pregnant while taking Tribenzor, tell your doctor right away.

What is Tribenzor?
Tribenzor is a prescription medicine used to lower blood pressure (hypertension). Medicines that lower blood pressure lower your chance of having a stroke or heart attack. Tribenzor is not for use as the first medicine to treat your high blood pressure.

Tribenzor contains 3 different prescription medications:

  1. amlodipine, a calcium channel blocker
  2. olmesartan medoxomil, an angiotensin receptor blocker, and
  3. hydrochlorothiazide, a diuretic (water pill)

It is not known if Tribenzor is safe and works in children.

Who should not take Tribenzor?

Do not take Tribenzor if you:

  • have low or no urine output
  • are allergic to other Sulfonamide type medicines. Ask your doctor if you are not sure.
  • are taking aliskiren and have diabetes.

What should I tell my doctor before taking Tribenzor?
Before taking Tribenzor, tell your doctor if you:

  • are pregnant or plan to become pregnant. See “What is the most important information I should know about Tribenzor?”
  • are breast feeding or plan to breast feed. One of the medicines in Tribenzor can pass into your breast milk and may harm your baby. You and your doctor should decide if you will take Tribenzor or breastfeed. You should not do both.
  • are allergic to any of the ingredients in Tribenzor. See the end of the leaflet for a list of the ingredients in Tribenzor.
  • have liver problems
  • have heart problems
  • have kidney problems
  • have lupus
  • are vomiting or have a lot of diarrhea
  • have any other medical conditions

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some of your other medicines and Tribenzor could affect each other, causing serious side effects.
Especially tell your doctor if you are taking:

  • water pills (diuretics)
  • other medicines for high blood pressure or a heart problem
  • potassium supplements or using salt substitute containing potassium
  • diabetes medicine including insulin
  • narcotic pain medicine
  • sleeping pills and anti-seizure medicines called barbiturates
  • lithium, a medicine used to treat certain kinds of depression
  • medicines used to treat pain or arthritis such as aspirin or non-steroidal anti inflammatory drugs (NSAIDs)
  • steroids
  • cholesterol lowering medicines
  • tacrolimus and cyclosporine (medicines used to alter the way your immune system works)

Know the medicines you take. Keep a list of your medicines and show it to your doctor or pharmacist when you get a new medicine.

How should I take Tribenzor?

  • Take Tribenzor exactly as prescribed by your doctor. Your doctor may change your dose if needed.
  • Take Tribenzor one time a day.
  • Tribenzor can be taken with or without food.
  • If you miss a dose, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Just take the next dose at your regular time.
  • If you take too much Tribenzor, call your doctor or Poison Control Center, or go to the nearest hospital emergency room.

What should I avoid while taking Tribenzor?
Drinking alcohol. Drinking alcohol during treatment with Tribenzor can cause you to have low blood pressure. See “What are the possible side effects of Tribenzor?”

What are the possible side effects of Tribenzor?
Tribenzor may cause serious side effects, including:

  • Harm to an unborn baby causing injury or death. See “What is the most important information I should know about Tribenzor?”
  • Low Blood Pressure (hypotension). Low blood pressure may cause you to feel faint or dizzy. Lie down, if you feel faint or dizzy. Call your doctor right away.
  • Kidney problems. Kidney problems may get worse in people that already have kidney disease. Blood tests for kidney function may be done while you are taking Tribenzor and the doctor may need to lower your dose of Tribenzor. Call your doctor if you get swelling in your feet, ankles, or hands, or unexplained weight gain. If you have heart failure, your doctor should check your kidney function before prescribing Tribenzor.
  • Worsening chest pain or heart attack. Get medical help right away if you have chest pain that gets worse, or that does not go away, during treatment with Tribenzor.
  • Allergic reactions. Hydrochlorothiazide, one of the medicines in Tribenzor can cause allergic reactions.
  • Changes in body salts (such as sodium and potassium), and body fluids. Tell your doctor if you have any of these signs or symptoms during treatment with Tribenzor:
    • Dry mouth
    • thirst
    • weakness
    • tiredness or sleepiness
    • restlessness
    • confusion
    • seizures
    • muscle pains or cramps
    • muscle tiredness
    • dizziness or fainting
    • low or no urine output
    • fast heartbeat
    • nausea and vomiting
  • Eye problems. One of the medicines in Tribenzor can cause eye problems that may lead to vision loss. Symptoms of eye problems can happen within hours to weeks of starting Tribenzor. Tell your doctor right away if you have:
    • decrease in vision
    • eye pain
  • Severe diarrhea and weight loss. Severe, chronic diarrhea with considerable weight loss may develop months to years after starting Tribenzor. Tell your doctor if you are experiencing these symptoms.

 The most common side effects of Tribenzor used to treat people with high blood pressure include:

  • dizziness
  • swelling (edema) of the ankles, feet, and hands
  • headache
  • tiredness
  • stuffy or runny nose and sore throat
  • muscle twitching (spasms)
  • nausea
  • upper respiratory tract infection
  • diarrhea
  • urinary tract infection
  • swelling (edema) of the joints

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all of the possible the side effects of Tribenzor. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effect to the FDA at 1-800-FDA1088.

How do I store Tribenzor?

  • Store Tribenzor at 59°F to 86°F (15°C and 30°C).
  • Keep Tribenzor and all medicines out of the reach of children.

General Information about Tribenzor
Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use Tribenzor for a condition for which it was not prescribed. Do not give Tribenzor to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about Tribenzor. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Tribenzor that is written for health professionals. For more information go to www.Tribenzor.com or call 1-877-437-7763.

What are the ingredients in Tribenzor?
Active ingredients: olmesartan medoxomil, amlodipine, and hydrochlorothiazide

Inactive ingredients: silicified microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coating contains polyvinyl alcohol, macrogol/polyethylene glycol 3350, titanium dioxide, talc, iron oxide yellow (20 /5 /12.5 mg, 40 /5 /12.5 mg, 40 /5 /25 mg, 40 /10 /12.5 mg, and 40 /10 /25 mg tablets), iron oxide red (20 /5 /12.5 mg, 40 /10 /12.5 mg, and 40 /10 /25 mg tablets), and iron oxide black (20 /5 /12.5 mg tablets).

What is high blood pressure (hypertension)?
Blood pressure is the force of blood in your blood vessels when your heart beats and when your heart rests. You have high blood pressure when the force is too much.

High blood pressure makes the heart work harder to pump blood through the body and causes damage to blood vessels. Tribenzor can help your blood vessels relax so your blood pressure is lower.

Manufactured for Daiichi Sankyo, Inc., Parsippany, New Jersey 07054
Manufactured by Daiichi Sankyo Europe GmbH, Germany

Copyright © Daiichi Sankyo, Inc. 2016. All rights reserved.

Package Label - Principal Display Panel – 90-Count Label for 20 mg/5 mg/12.5 mg Tablet

Tribenzor™
(olmesartan medoxomil, amlodipine, hydrochlorothiazide) tablets

20 mg/5 mg*/12.5 mg
*Each tablet contains 6.9 mg of amlodipine besylate

Daiichi-Sankyo           90 TABLETS

NDC 65597-114-90
Store at 25°C (77°F);
excursions permitted to
15 to 30°C (59 to 86°F)
[see USP Controlled Room
Temperature].

Manufactured for:
Daiichi Sankyo, Inc.
Parsippany, NJ 07054
Product of Germany
P1706201

Rx only
DOSAGE AND USE:
SEE PACKAGE INSERT

LOT 000000
EXP 00/00

Package Label - Principal Display Panel – 90-Count Label for 40 mg/5 mg/12.5 mg Tablet

Tribenzor™
(olmesartan medoxomil, amlodipine, hydrochlorothiazide) tablets

40 mg/5 mg*/12.5 mg
*Each tablet contains 6.9 mg of amlodipine besylate

Daiichi-Sankyo           90 TABLETS

NDC 65597-115-90
Store at 25°C (77°F);
excursions permitted to
15 to 30°C (59 to 86°F)
[see USP Controlled Room
Temperature].

Manufactured for:
Daiichi Sankyo, Inc.
Parsippany, NJ 07054
Product of Germany
P1706501

Rx only
DOSAGE AND USE:
SEE PACKAGE INSERT

LOT 000000
EXP 00/00

Package Label - Principal Display Panel – 90-Count Label for 40 mg/5 mg/25 mg Tablet

Tribenzor™
(olmesartan medoxomil, amlodipine, hydrochlorothiazide) tablets

40 mg/5 mg*/25 mg
*Each tablet contains 6.9 mg of amlodipine besylate

Daiichi-Sankyo           90 TABLETS

NDC 65597-116-90
Store at 25°C (77°F);
excursions permitted to
15 to 30°C (59 to 86°F)
[see USP Controlled Room
Temperature].

Manufactured for:
Daiichi Sankyo, Inc.
Parsippany, NJ 07054
Product of Germany
P1706801

Rx only
DOSAGE AND USE:
SEE PACKAGE INSERT

LOT 000000
EXP 00/00

Package Label - Principal Display Panel – 90-Count Label for 40 mg/10 mg/12.5 mg Tablet

Tribenzor™
(olmesartan medoxomil, amlodipine, hydrochlorothiazide) tablets

40 mg/10 mg*/12.5 mg
*Each tablet contains 13.9 mg of amlodipine besylate

Daiichi-Sankyo           90 TABLETS

NDC 65597-117-90
Store at 25°C (77°F);
excursions permitted to
15 to 30°C (59 to 86°F)
[see USP Controlled Room
Temperature].

Manufactured for:
Daiichi Sankyo, Inc.
Parsippany, NJ 07054
Product of Germany
P1707101

Rx only
DOSAGE AND USE:
SEE PACKAGE INSERT

LOT 000000
EXP 00/00

Package Label - Principal Display Panel – 90-Count Label for 40 mg/10 mg/25 mg Tablet

Tribenzor™
(olmesartan medoxomil, amlodipine, hydrochlorothiazide) tablets

40 mg/10 mg*/25 mg
*Each tablet contains 13.9 mg of amlodipine besylate

Daiichi-Sankyo           90 TABLETS

NDC 65597-118-90
Store at 25°C (77°F);
excursions permitted to
15 to 30°C (59 to 86°F)
[see USP Controlled Room
Temperature].

Manufactured for:
Daiichi Sankyo, Inc.
Parsippany, NJ 07054
Product of Germany
P1705901

Rx only
DOSAGE AND USE:
SEE PACKAGE INSERT

LOT 000000
EXP 00/00

Tribenzor 
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65597-114
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 20 mg
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 5 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN  
CELLULOSE, MICROCRYSTALLINE  
CROSCARMELLOSE SODIUM  
MAGNESIUM STEARATE  
SILICON DIOXIDE  
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code C51
Contains     
Packaging
# Item Code Package Description
1 NDC:65597-114-30 30 TABLET, FILM COATED in 1 BOTTLE
2 NDC:65597-114-90 90 TABLET, FILM COATED in 1 BOTTLE
3 NDC:65597-114-10 10 BLISTER PACK in 1 BOX
3 10 TABLET, FILM COATED in 1 BLISTER PACK
4 NDC:65597-114-07 7 TABLET, FILM COATED in 1 BOTTLE
5 NDC:65597-114-70 7 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA200175 07/31/2010
Tribenzor 
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65597-115
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 40 mg
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 5 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN  
CELLULOSE, MICROCRYSTALLINE  
CROSCARMELLOSE SODIUM  
MAGNESIUM STEARATE  
SILICON DIOXIDE  
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 10mm
Flavor Imprint Code C53
Contains     
Packaging
# Item Code Package Description
1 NDC:65597-115-30 30 TABLET, FILM COATED in 1 BOTTLE
2 NDC:65597-115-90 90 TABLET, FILM COATED in 1 BOTTLE
3 NDC:65597-115-10 10 BLISTER PACK in 1 BOX
3 10 TABLET, FILM COATED in 1 BLISTER PACK
4 NDC:65597-115-07 7 TABLET, FILM COATED in 1 BOTTLE
5 NDC:65597-115-70 7 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA200175 07/31/2010
Tribenzor 
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65597-116
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 40 mg
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 5 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN  
CELLULOSE, MICROCRYSTALLINE  
CROSCARMELLOSE SODIUM  
MAGNESIUM STEARATE  
SILICON DIOXIDE  
Product Characteristics
Color YELLOW Score no score
Shape OVAL Size 15mm
Flavor Imprint Code C54
Contains     
Packaging
# Item Code Package Description
1 NDC:65597-116-30 30 TABLET, FILM COATED in 1 BOTTLE
2 NDC:65597-116-90 90 TABLET, FILM COATED in 1 BOTTLE
3 NDC:65597-116-10 10 BLISTER PACK in 1 BOX
3 10 TABLET, FILM COATED in 1 BLISTER PACK
4 NDC:65597-116-07 7 TABLET, FILM COATED in 1 BOTTLE
5 NDC:65597-116-70 7 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA200175 07/31/2010
Tribenzor 
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65597-117
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 40 mg
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 10 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN  
CELLULOSE, MICROCRYSTALLINE  
CROSCARMELLOSE SODIUM  
MAGNESIUM STEARATE  
SILICON DIOXIDE  
Product Characteristics
Color RED Score no score
Shape ROUND Size 10mm
Flavor Imprint Code C55
Contains     
Packaging
# Item Code Package Description
1 NDC:65597-117-30 30 TABLET, FILM COATED in 1 BOTTLE
2 NDC:65597-117-90 90 TABLET, FILM COATED in 1 BOTTLE
3 NDC:65597-117-10 10 BLISTER PACK in 1 BOX
3 10 TABLET, FILM COATED in 1 BLISTER PACK
4 NDC:65597-117-07 7 TABLET, FILM COATED in 1 BOTTLE
5 NDC:65597-117-70 7 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA200175 07/31/2010
Tribenzor 
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65597-118
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 40 mg
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 10 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN  
CELLULOSE, MICROCRYSTALLINE  
CROSCARMELLOSE SODIUM  
MAGNESIUM STEARATE  
SILICON DIOXIDE  
Product Characteristics
Color RED Score no score
Shape OVAL Size 15mm
Flavor Imprint Code C57
Contains     
Packaging
# Item Code Package Description
1 NDC:65597-118-30 30 TABLET, FILM COATED in 1 BOTTLE
2 NDC:65597-118-90 90 TABLET, FILM COATED in 1 BOTTLE
3 NDC:65597-118-10 10 BLISTER PACK in 1 BOX
3 10 TABLET, FILM COATED in 1 BLISTER PACK
4 NDC:65597-118-07 7 TABLET, FILM COATED in 1 BOTTLE
5 NDC:65597-118-70 7 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA200175 07/31/2010
Labeler - Daiichi Sankyo, Inc. (068605067)
Establishment
Name Address ID/FEI Operations
Daiichi Sankyo Europe GmbH 551338593 MANUFACTURE(65597-114, 65597-115, 65597-116, 65597-117, 65597-118), ANALYSIS(65597-114, 65597-115, 65597-116, 65597-117, 65597-118)
Revised: 01/2017   Daiichi Sankyo, Inc.

What should I avoid while taking Tribenzor?

Do not use potassium supplements or salt substitutes while you are taking this medicine, unless your doctor has told you to.

Drinking alcohol can further lower your blood pressure and may increase certain side effects of this medicine.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

For the Consumer

Applies to amlodipine / hydrochlorothiazide / olmesartan: oral tablet

Along with its needed effects, amlodipine / hydrochlorothiazide / olmesartan may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking amlodipine / hydrochlorothiazide / olmesartan:

More common
  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • rapid weight gain
  • tingling of the hands or feet
  • unusual weight gain or loss
Less common
  • Bladder pain
  • bloody or cloudy urine
  • body aches or pain
  • cough
  • difficult, burning, or painful urination
  • difficulty with breathing
  • fainting
  • frequent urge to urinate
  • headache
  • loss of voice
  • lower back or side pain
  • swelling of the joints
  • unusual tiredness or weakness

Some side effects of amlodipine / hydrochlorothiazide / olmesartan may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Diarrhea
  • muscle aches or spasms
  • nausea

Highlights for Tribenzor

Tribenzor is an oral drug that’s used to lower your blood pressure. This reduces your risk of having a stroke or heart attack. This drug is used after other medications have failed to control your blood pressure.

This drug comes as a tablet that you take by mouth. It’s available as the brand-name drug Tribenzor. It’s also available as a generic drug.

More common side effects can include dizziness, headache, tiredness, stuffy or runny nose, or sore throat. Side effects can also include muscle twitching, nausea, upper respiratory tract infection, diarrhea, urinary tract infection, and swelling of your ankles, feet, hands, or joints. 

This drug shouldn’t be used during pregnancy. It can seriously harm or even end a pregnancy. If you’re pregnant, talk with your doctor about other ways to lower your blood pressure. If you get pregnant while taking this drug, tell your doctor right away.

This drug is typically started at a low dose. Your doctor may increase your dose slowly every 2 weeks to a maximum dose of 40 mg olmesartan/10 mg amlodipine/25 mg hydrochlorothiazide once per day. Your doctor will change your dose based on your blood pressure goals.

IMPORTANT INFORMATION
  • FDA warning See Details

  • Low blood pressure See Details

  • Chest pain or heart attack See Details

  • Kidney problems See Details

What is Tribenzor?

This drug is a prescription drug. It comes in the form of a tablet you take by mouth.

Tribenzor is a brand-name version of the drug olmesartan/amlodipine/hydrochlorothiazide. This drug is also available in a generic form. Generic drugs usually cost less. In some cases, they may not be available in every strength or form as the brand-name version.

This medication is a combination drug. It contains 3 drugs in a single form: olmesartan, amlodipine, and hydrochlorothiazide. It’s important to know about all the drugs in the combination because each drug may affect you in a different way.

This medication may be used as part of a combination therapy. This means you may need to take it with other drugs that treat high blood pressure.

Why it's used

This drug is used to lower blood pressure levels. This reduces your risk of stroke or heart attack. This drug is used after other medications have failed to control your blood pressure.

How it works

This drug contains three medications. Each of these belongs to a different class of drugs. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

More Details

Tribenzor Side Effects

More Common Side Effects

The more common side effects that can occur with use of Tribenzor include:

  • dizziness

  • swelling of your ankles, feet, hands, or joints

  • headache

  • tiredness

  • stuffy or runny nose

  • sore throat

  • upper respiratory tract infection

  • muscle twitching

  • nausea

  • diarrhea

  • urinary tract infection

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious Side Effects

Call your doctor right away if you have serious side effects. Call 9-1-1 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

  • Hypotension (low blood pressure). Symptoms can include:

    • feeling faint or dizzy, especially when you stand up
    • tiredness
    • feeling lightheaded
  • Eye problems. Symptoms can include:

    • vision problems
    • eye pain
  • Kidney problems. Symptoms can include:

    • tiredness
    • swelling, especially of your hands, feet, or ankles
    • shortness of breath
  • Heart attack. Symptoms of heart attack can include:

    • chest pain
    • shortness of breath
    • discomfort in your upper body
  • Eye problems. Symptoms can include:

    • vision problems
    • eye pain
  • Kidney problems. Symptoms can include:

    • tiredness
    • swelling, especially of your hands, feet, or ankles
    • shortness of breath
  • Heart attack. Symptoms of heart attack can include:

    • chest pain
    • shortness of breath
    • discomfort in your upper body
  • Hyperkalemia (high potassium levels). Symptoms can include:

    • abnormal heart rhythm
    • weakness
    • paralysis
Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.
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