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Tribenzor

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Tribenzor

TRIBENZOR
(olmesartan medoxomil, amlodipine, hydrochlorothiazide) Tablets

WARNING

FETAL TOXICITY

  • When pregnancy is detected, discontinue Tribenzor as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

DRUG 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-5ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6.

The amlodipine besylate component of Tribenzor is chemically described as 3-ethyl-5methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5•C6H6O3S.

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 C7H8CIN3O4S2.

The structural formula for olmesartan medoxomil is:

olmesartan medoxomil - Structural Formula Illustration

The structural formula for amlodipine besylate is:

Amlodipine besylate - Structural Formula Illustration

The structural formula for hydrochlorothiazide is:

Hydrochlorothiazide - Structural Formula Illustration

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).

What are the possible side effects of amlodipine, hydrochlorothiazide, and olmesartan (Tribenzor)?

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

Call your doctor at once if you have:

  • eye pain, vision problems;
  • a light-headed feeling, like you might pass out;
  • swelling in your hands, ankles, or feet;
  • little or no urinating;
  • pain or burning when you urinate;
  • joint pain or swelling with fever, swollen glands, muscle aches, unusual thoughts or behavior, patchy skin color, red...

Read All Potential Side Effects and See Pictures of Tribenzor »

What are the precautions when taking olmesartan medoxomil amlodipine hydrochlorothiazide tablets (Tribenzor)?

Before taking this product, tell your doctor or pharmacist if you are allergic to either olmesartan, amlodipine, or hydrochlorothiazide; or to other angiotensin receptor blockers (such as losartan); or to ACE inhibitors (such as lisinopril); or to other calcium channel blockers (such as nifedipine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease (such as renal artery stenosis, anuria), severe loss of body water and/or minerals (volume depletion, dehydration), liver disease, gout, lupus, untreated mineral imbalance (such as high/low...

Read All Potential Precautions of Tribenzor »

Last reviewed on RxList: 6/27/2014
This monograph has been modified to include the generic and brand name in many instances.

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Tribenzor - User Reviews

Tribenzor User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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