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Telmisartan
Overview
What is Telmisartan?
Telmisartan, USP is a non-peptide angiotensin II receptor (type AT) antagonist.
Telmisartan, USP 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 CHNO, its molecular weight is 514.63, and its structural formula is:
Telmisartan, USP 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, USP is available as tablets for oral administration, containing 20 mg, 40 mg or 80 mg of telmisartan, USP. The tablets contain the following inactive ingredients: magnesium stearate, mannitol, meglumine, povidone, sodium hydroxide and talc. Telmisartan tablets, USP are hygroscopic and require protection from moisture.
What does Telmisartan look like?
What are the available doses of Telmisartan?
What should I talk to my health care provider before I take Telmisartan?
How should I use Telmisartan?
Telmisartan tablets are an angiotensin II receptor blocker (ARB) indicated for:
May be administered with or without food
What interacts with Telmisartan?
Sorry No Records found
What are the warnings of Telmisartan?
Sorry No Records found
What are the precautions of Telmisartan?
Sorry No Records found
What are the side effects of Telmisartan?
Sorry No records found
What should I look out for while using Telmisartan?
Telmisartan tablets are contraindicated in patients with known hypersensitivity (e.g., anaphylaxis or angioedema) to telmisartan or any other component of this product
Do not co-administer aliskiren with telmisartan in patients with diabetes .
What might happen if I take too much Telmisartan?
Limited data are available with regard to overdosage in humans. The most likely manifestation of overdosage with telmisartan tablets would be hypotension, dizziness and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Telmisartan is not removed by hemodialysis.
How should I store and handle Telmisartan?
Store at 25ºC (77ºF); excursions permitted to 15° to 30ºC (59° to 86ºF) [see USP Controlled Room Temperature].Telmisartan tablets, USP, are supplied as white to off-white, round shaped uncoated tablets, debossed with ‘AN’ on one side and ‘291’ on the other side.They are available as follows:Bottles of 30: NDC 53746-291-30Telmisartan tablets, USP, are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN’ on one side and ‘292’ on the other side.They are available as follows:Bottles of 30: NDC 53746-292-30Telmisartan tablets, USP, are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN293’ on one side and plain on the other side.They are available as follows:Bottles of 30: NDC 53746-293-30Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F)Telmisartan tablets, USP, are supplied as white to off-white, round shaped uncoated tablets, debossed with ‘AN’ on one side and ‘291’ on the other side.They are available as follows:Bottles of 30: NDC 53746-291-30Telmisartan tablets, USP, are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN’ on one side and ‘292’ on the other side.They are available as follows:Bottles of 30: NDC 53746-292-30Telmisartan tablets, USP, are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN293’ on one side and plain on the other side.They are available as follows:Bottles of 30: NDC 53746-293-30Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F)Telmisartan tablets, USP, are supplied as white to off-white, round shaped uncoated tablets, debossed with ‘AN’ on one side and ‘291’ on the other side.They are available as follows:Bottles of 30: NDC 53746-291-30Telmisartan tablets, USP, are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN’ on one side and ‘292’ on the other side.They are available as follows:Bottles of 30: NDC 53746-292-30Telmisartan tablets, USP, are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN293’ on one side and plain on the other side.They are available as follows:Bottles of 30: NDC 53746-293-30Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F)Telmisartan tablets, USP, are supplied as white to off-white, round shaped uncoated tablets, debossed with ‘AN’ on one side and ‘291’ on the other side.They are available as follows:Bottles of 30: NDC 53746-291-30Telmisartan tablets, USP, are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN’ on one side and ‘292’ on the other side.They are available as follows:Bottles of 30: NDC 53746-292-30Telmisartan tablets, USP, are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN293’ on one side and plain on the other side.They are available as follows:Bottles of 30: NDC 53746-293-30Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F)Telmisartan tablets, USP, are supplied as white to off-white, round shaped uncoated tablets, debossed with ‘AN’ on one side and ‘291’ on the other side.They are available as follows:Bottles of 30: NDC 53746-291-30Telmisartan tablets, USP, are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN’ on one side and ‘292’ on the other side.They are available as follows:Bottles of 30: NDC 53746-292-30Telmisartan tablets, USP, are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN293’ on one side and plain on the other side.They are available as follows:Bottles of 30: NDC 53746-293-30Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F)Telmisartan tablets, USP, are supplied as white to off-white, round shaped uncoated tablets, debossed with ‘AN’ on one side and ‘291’ on the other side.They are available as follows:Bottles of 30: NDC 53746-291-30Telmisartan tablets, USP, are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN’ on one side and ‘292’ on the other side.They are available as follows:Bottles of 30: NDC 53746-292-30Telmisartan tablets, USP, are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN293’ on one side and plain on the other side.They are available as follows:Bottles of 30: NDC 53746-293-30Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F)Telmisartan tablets, USP, are supplied as white to off-white, round shaped uncoated tablets, debossed with ‘AN’ on one side and ‘291’ on the other side.They are available as follows:Bottles of 30: NDC 53746-291-30Telmisartan tablets, USP, are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN’ on one side and ‘292’ on the other side.They are available as follows:Bottles of 30: NDC 53746-292-30Telmisartan tablets, USP, are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN293’ on one side and plain on the other side.They are available as follows:Bottles of 30: NDC 53746-293-30Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F)Telmisartan tablets, USP, are supplied as white to off-white, round shaped uncoated tablets, debossed with ‘AN’ on one side and ‘291’ on the other side.They are available as follows:Bottles of 30: NDC 53746-291-30Telmisartan tablets, USP, are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN’ on one side and ‘292’ on the other side.They are available as follows:Bottles of 30: NDC 53746-292-30Telmisartan tablets, USP, are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN293’ on one side and plain on the other side.They are available as follows:Bottles of 30: NDC 53746-293-30Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F)Telmisartan tablets, USP, are supplied as white to off-white, round shaped uncoated tablets, debossed with ‘AN’ on one side and ‘291’ on the other side.They are available as follows:Bottles of 30: NDC 53746-291-30Telmisartan tablets, USP, are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN’ on one side and ‘292’ on the other side.They are available as follows:Bottles of 30: NDC 53746-292-30Telmisartan tablets, USP, are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN293’ on one side and plain on the other side.They are available as follows:Bottles of 30: NDC 53746-293-30Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F)Telmisartan tablets, USP, are supplied as white to off-white, round shaped uncoated tablets, debossed with ‘AN’ on one side and ‘291’ on the other side.They are available as follows:Bottles of 30: NDC 53746-291-30Telmisartan tablets, USP, are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN’ on one side and ‘292’ on the other side.They are available as follows:Bottles of 30: NDC 53746-292-30Telmisartan tablets, USP, are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN293’ on one side and plain on the other side.They are available as follows:Bottles of 30: NDC 53746-293-30Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F)Telmisartan tablets, USP, are supplied as white to off-white, round shaped uncoated tablets, debossed with ‘AN’ on one side and ‘291’ on the other side.They are available as follows:Bottles of 30: NDC 53746-291-30Telmisartan tablets, USP, are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN’ on one side and ‘292’ on the other side.They are available as follows:Bottles of 30: NDC 53746-292-30Telmisartan tablets, USP, are supplied as white to off-white, modified capsule shaped uncoated tablets, debossed with ‘AN293’ on one side and plain on the other side.They are available as follows:Bottles of 30: NDC 53746-293-30Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F)
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (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. Telmisartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is therefore independent of the pathways for angiotensin II synthesis.
There is also an AT receptor found in many tissues, but AT is not known to be associated with cardiovascular homeostasis. Telmisartan has much greater affinity (>3,000 fold) for the AT receptor than for the AT receptor.
Blockade of the renin-angiotensin system with ACE inhibitors, which inhibit the biosynthesis of angiotensin II from angiotensin I, is widely used in the treatment of hypertension. ACE inhibitors also inhibit the degradation of bradykinin, a reaction also catalyzed by ACE. Because telmisartan does not inhibit ACE (kininase II), it does not affect the response to bradykinin. Whether this difference has clinical relevance is not yet known. Telmisartan does not bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.
Blockade of the angiotensin II receptor inhibits the negative regulatory feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and angiotensin II circulating levels do not overcome the effect of telmisartan on blood pressure.
Non-Clinical Toxicology
Telmisartan tablets are contraindicated in patients with known hypersensitivity (e.g., anaphylaxis or angioedema) to telmisartan or any other component of this productDo not co-administer aliskiren with telmisartan in patients with diabetes .
When tamoxifen is used in combination with coumarin-type anticoagulants, a significant increase in anticoagulant effect may occur. Where such coadministration exists, careful monitoring of the patient's prothrombin time is recommended.
In the NSABP P-1 trial, women who required coumarin-type anticoagulants for any reason were ineligible for participation in the trial (See ).
There is an increased risk of thromboembolic events occurring when cytotoxic agents are used in combination with tamoxifen.
Tamoxifen reduced letrozole plasma concentrations by 37%. The effect of tamoxifen on metabolism and excretion of other antineoplastic drugs, such as cyclophosphamide and other drugs that require mixed function oxidases for activation, is not known. Tamoxifen and N- desmethyl tamoxifen plasma concentrations have been shown to be reduced when coadministered with rifampin or aminoglutethimide. Induction of CYP3A4-mediated metabolism is considered to be the mechanism by which these reductions occur; other CYP3A4 inducing agents have not been studied to confirm this effect.
One patient receiving tamoxifen with concomitant phenobarbital exhibited a steady state serum level of tamoxifen lower than that observed for other patients (i.e., 26 ng/mL vs. mean value of 122 ng/mL). However, the clinical significance of this finding is not known. Rifampin induced the metabolism of tamoxifen and significantly reduced the plasma concentrations of tamoxifen in 10 patients. Aminoglutethimide reduces tamoxifen and N-desmethyl tamoxifen plasma concentrations. Medroxyprogesterone reduces plasma concentrations of N-desmethyl, but not tamoxifen.
Concomitant bromocriptine therapy has been shown to elevate serum tamoxifen and N- desmethyl tamoxifen.
Based on clinical and pharmacokinetic results from the anastrozole adjuvant trial, tamoxifen should not be administered with anastrozole (see ).
Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue telmisartan as soon as possible
The following adverse reaction is described elsewhere in labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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