Twynsta (Telmisartan Amlodipine Tablets) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 27, 2012

Twynsta

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Twynsta

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TWYNSTA®
(telmisartan/amlodipine)

WARNING

FETAL TOXICITY

When pregnancy is detected, discontinue TWYNSTA as soon as possible [see WARNINGS AND PRECAUTIONS].
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

TWYNSTA is a fixed dose combination of telmisartan and amlodipine.

TWYNSTA tablets contain telmisartan, a non-peptide angiotensin II receptor (type AT₁) antagonist. Telmisartan is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Telmisartan is chemically described as 4'-[(1,4'-dimethyl-2'-propyl [2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its empirical formula is C₃₃H₃₀N₄O₂ and its structural formula is:

Telmisartan Structural Formula Illustration

TWYNSTA tablets contain the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate's chemical name is 3-Ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its empirical formula is C₂₀H₂₅ClN₂O₅•C₆H₆O₃S and its structural formula is:

Amlodipine Structural Formula Illustration

TWYNSTA tablets are formulated in four strengths for oral administration with a combination of amlodipine besylate, equivalent to 5 mg or 10 mg of amlodipine free-base, with 40 mg, or 80 mg of telmisartan provided in the following four combinations: 40/5 mg, 40/10 mg, 80/5 mg, and 80/10 mg.

TWYNSTA tablets also contain the following inactive ingredients: sodium hydroxide, povidone, meglumine, sorbitol, magnesium stearate, microcrystalline cellulose, pregelatinized starch, corn starch, colloidal silicon dioxide, ferric oxide black, ferric oxide yellow and FD&C blue #1.

TWYNSTA tablets are hygroscopic and require protection from moisture.

TWYNSTA tablets require protection from light.

What are the precautions when taking telmisartan amlodipine tablets (Twynsta)?

Before taking this product, tell your doctor or pharmacist if you are allergic to either telmisartan or amlodipine; or to other angiotensin receptor blockers (such as losartan); or to other calcium channel blockers (such as nifedipine); or to ACE inhibitors (such as lisinopril); 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), liver disease, high levels of potassium in the blood (hyperkalemia), loss of too much body water (dehydration), heart disease (such as aortic stenosis, heart failure), bile duct...

Read All Potential Precautions of Twynsta »

Last reviewed on RxList: 4/12/2012
This monograph has been modified to include the generic and brand name in many instances.