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Rx Item-Olmesartan-Amlodipine-HCTZ 40-5-12.5Mg Tab 30 By Teva Pharma

NDC No.   00093-5006-56 UPC/GTIN No. 3-00935-00656-7 MPN 500656BRAND: TRIBENZOR NDC: 00093-5006-56,93500656 UPC: 3-00935-00656-7,300935006567 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Olmesartan-Amlodipine-HCTZ 40-5-12.5Mg Tab 30 By Teva Pharma

$297.11$97.14

Item No.:RX582007 NDC No.93500656 UPC No.:300935006567 NDC No. 00093-5006-56 UPC/GTIN No. 3-00935-00656-7 MPN 500656 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX Item. Rx Item No. RX582007 Olmesartan-Amlodipine-HCTZ 40-5-12.5MG TAB 30 by Teva Pharma. Generic Tribenzor Item No. 582007 NDC No. 00093500656 UPC No. 3

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TRIBENZOR- olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide tablet, film coated
Daiichi Sankyo, Inc.

WARNING: FETAL TOXICITY

When pregnancy is detected, discontinue Tribenzor as soon as possible. (5.1)
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1)
1 INDICATIONS AND USAGE



Tribenzor (olmesartan medoxomil, amlodipine, hydrochlorothiazide) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with Tribenzor.

Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program�s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
DOSAGE AND ADMINISTRATION

General Considerations
Dose once daily.

Dosage may be increased after 2 weeks. The full blood pressure lowering effects are attained within 2 weeks after a change in dose. The maximum recommended dose of Tribenzor is 40/10/25 mg. Tribenzor may be taken with or without food.

Tribenzor may be administered with other antihypertensive agents.

Renal Impairment
The usual regimens of therapy with Tribenzor may be followed if the patient�s creatinine clearance is >30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so avoid use of Tribenzor [see Warnings and Precautions (5.4)].

Elderly
Patients ? 75 years of age should start amlodipine at 2.5 mg, which is not available with Tribenzor.

Hepatic Impairment
Patients with severe hepatic impairment should start amlodipine at 2.5 mg, which is not available with Tribenzor [see Warnings and Precautions (5.5)].

Replacement Therapy
Tribenzor may be substituted for its individually titrated components.

Add-on/Switch Therapy
Tribenzor may be used to provide additional blood pressure lowering for patients not adequately controlled on maximally tolerated, labeled, or usual doses of any two of the following antihypertensive classes: angiotensin receptor blockers (ARB), calcium channel blockers (CCB), and diuretics.

A patient who experiences dose-limiting adverse reactions to an individual component while on any dual combination of the components of Tribenzor may be switched to Tribenzor containing a lower dose of that component to achieve similar blood pressure reductions.

3 DOSAGE FORMS AND STRENGTHS

Tribenzor tablets are formulated for oral administration in the following strength combinations: (olmesartan medoxomil/amlodipine/hydrochlorothiazide) 20 /5 /12.5 mg, 40 /5 / 12.5 mg, 40 /5 /25 mg, 40 /10 /12.5 mg, and 40 /10 /25 mg.

4 CONTRAINDICATIONS

Because of the hydrochlorothiazide component, Tribenzor is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.

Do not co-administer aliskiren with Tribenzor in patients with diabetes [See Drug Interactions (7.2)].

5 WARNINGS AND PRECAUTIONS

5.1 Fetal toxicity
Pregnancy Category D
DESCRIPTION

Tribenzor provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic).

Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract.

The olmesartan medoxomil component of Tribenzor is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o -1H -tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29 H30 N6 O6 .



The amlodipine besylate component of Tribenzor is chemically described as 3-ethyl-5-methyl (�)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20 H25 CIN2 O5 �C6 H6 O3 S.

The hydrochlorothiazide component of Tribenzor is chemically described as 6-chloro-3,4-dihydro-2H -1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7 H8 CIN3 O4 S2 .
Tribenzor contains olmesartan medoxomil, a white to light yellowish-white powder or crystalline powder, amlodipine besylate, a white to off-white crystalline powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution.

Each tablet of Tribenzor also contains the following 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).

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action
The active ingredients of Tribenzor target three separate mechanisms involved in blood pressure regulation. Specifically, amlodipine blocks the contractile effects of calcium on cardiac and vascular smooth muscle cells; olmesartan medoxomil blocks the vasoconstriction and sodium retaining effects of angiotensin II on cardiac, vascular smooth muscle, adrenal and renal cells; and hydrochlorothiazide directly promotes the excretion of sodium and chloride in the kidney leading to reductions in intravascular volume. For a more detailed description of the mechanisms of action for each individual component, see below.

Olmesartan medoxomil. Angiotensin II is formed from angiotensin I in a reaction catalyzed by ACE, kininase II. Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium. Olmesartan blocks the vasoconstrictor effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in vascular smooth muscle. Its action is, therefore, independent of the pathways for angiotensin II synthesis.
Amlodipine. Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Experimental data suggests that amlodipine binds to both dihydropyridine and nonhydropyridine binding sites. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. Amlodipine inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Negative inotropic effects can be detected in vitro but such effects have not been seen in intact animals at therapeutic doses. Serum calcium concentration is not affected by amlodipine. Within the physiologic pH range, amlodipine is an ionized compound (pKa=8.6), and its kinetic interaction with the calcium channel receptor is characterized by a gradual rate of association and dissociation with the receptor binding site, resulting in a gradual onset of effect.

Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.

Hydrochlorothiazide. Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts. Indirectly, the diuretic action of hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and decreases in serum potassium. The renin-aldosterone link is mediated by angiotensin II, so co-administration of an angiotensin II receptor antagonist tends to reverse the potassium loss associated with these diuretics.
PATIENT COUNSELING INFORMATION

See FDA-Approved Patient Labeling
Pregnancy: Female patients of childbearing age should be told about the consequences of exposure to Tribenzor during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.

Symptomatic Hypotension: A patient receiving Tribenzor should be cautioned 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.

Caution 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 [see Warnings and Precautions (5.2)].

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:

amlodipine, a calcium channel blocker
olmesartan medoxomil, an angiotensin receptor blocker, and
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
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.

NDC No.   00093-5006-56 UPC/GTIN No. 3-00935-00656-7 MPN 500656
RX ITEM-Olmesartan-Amlodipine-HCTZ 40-5-
NDC No. 00093-5006-56 UPC/GTIN No. 3-00935-00656-7 MPN 500656

BRAND: TRIBENZOR NDC: 00093-5006-56,93500656 UPC: 3-00935-00656-7,300935006567
Olmesartan-Amlodipine-HCTZ 40-5-12.5Mg T
BRAND: TRIBENZOR NDC: 00093-5006-56,93500656 UPC: 3-00935-00656-7,300935006567

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
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