Tribenzor (Olmesartan Medoxomil Amlodipine Hydrochlorothiazide Tablets) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 27, 2012

Tribenzor

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Tribenzor

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TRIBENZOR
(olmesartan medoxomil, amlodipine, hydrochlorothiazide) Tablets, for Oral Use

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-5- ylphenyl)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 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), loss of too much body water (dehydration), liver disease, gout, lupus, untreated mineral imbalance (such as high/low potassium, low magnesium, high...

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Last reviewed on RxList: 1/30/2012
This monograph has been modified to include the generic and brand name in many instances.