Finished product reference
Telmisartan
Tablet · Oral · 80 mg
- List code
- 53008
- Pharmacologic class
- Angiotensin 2 Receptor Blocker
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue telmisartan tablets as soon as possible . Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus . WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning.
What it is and how it works
Mechanism of Action 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 1 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.
Mechanism class: Angiotensin 2 Receptor Antagonists
Indications
Telmisartan tablets, is an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Cardiovascular (CV) risk reduction in patients unable to take ACE inhibitors Hypertension Telmisartan tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals.
Dosage and administration (summary)
May be administered with or without food When used for cardiovascular risk reduction, monitoring of blood pressure is recommended, and if appropriate, adjustment of medications that lower blood pressure may be necessary Indication Starting Dose Dose Range Hypertension 40 mg once daily 40 to 80 mg once daily Cardiovascular Risk Reduction 80 mg once daily 80 mg once daily Hypertension Dosage must be individualized. The usual starting dose of telmisartan tablets is 40 mg orally once a day. Blood pressure response is dose-related over the range of 20 to 80 mg . Most of the antihypertensive effect is apparent within 2 weeks and maximal reduction is generally attained after 4 weeks.
Contraindications
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 . 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
Warnings and precautions
Avoid fetal or neonatal exposure Hypotension: Correct any volume or salt depletion before initiating therapy. Observe for signs and symptoms of hypotension Monitor carefully in patients with impaired hepatic or renal function Avoid concomitant use of an ACE inhibitor and angiotensin receptor blocker Fetal Toxicity 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.
Pregnancy
Pregnancy Risk Summary Telmisartan tablets can cause fetal harm when administered to a pregnant woman. 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 (see Clinical Considerations) .
Storage and supply
Telmisartan tablets, USP are available as white or off-white, uncoated tablets containing telmisartan, USP 20 mg, 40 mg, or 80 mg. Tablets are debossed with either CL 45, CL 46 or CL 47 for the 20 mg, 40 mg, and 80 mg strengths, respectively on one side and plain on other side.
Source: Telmisartan (Telmisartan) — US FDA prescribing information, 2026-01-28, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
Tell us the quantity, the market and the timing.
Send the molecule or ingredient, the specification and the destination. We reply from Tehran with the questions, the documents and the next step.