"The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of selexipag (Uptravi, Actelion Registration Ltd) for the treatment of adults with pulmonary arterial hypertension (PAH)./"...
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].
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:
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:
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 possible side effects of amlodipine and telmisartan (Twynsta)?
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.
In rare cases, amlodipine and telmisartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.
Call your doctor at once if you have:
- feeling like you might pass...
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 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: liver disease, high levels of potassium in the blood (hyperkalemia), loss of too much body water and/or minerals (dehydration), heart disease (such as aortic stenosis, heart failure), bile duct blockage.
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you...
Last reviewed on RxList: 12/30/2014
This monograph has been modified to include the generic and brand name in many instances.
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