Finished product reference
Telmisartan / Hydrochlorothiazide
Tablet · Oral · 40 mg/12.5 mg
- List code
- 53173
- Pharmacologic class
- Thiazide Diuretic · Angiotensin 2 Receptor Blocker
BOXED WARNING WARNING: FETAL TOXICITY When pregnancy is detected, discontinue telmisartan and hydrochlorothiazide 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 class: Angiotensin 2 Receptor Antagonists
Indications
Telmisartan and hydrochlorothiazide 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 classes to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with telmisartan and hydrochlorothiazide tablets. 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)
Usual starting dose is 80 mg/12.5 mg once daily Titrate up to 160 mg/25 mg as needed Initiate patients with biliary obstructive disorders or hepatic insufficiency at 40 mg/12.5 mg Dosing Information Initiate a patient whose blood pressure is not adequately controlled with telmisartan monotherapy 80 mg on telmisartan and hydrochlorothiazide tablets, 80 mg/12.5 mg orally once daily. Dose can be titrated up to 160 mg/25 mg after 2 to 4 weeks, if necessary.
Contraindications
Telmisartan and hydrochlorothiazide tablets are contraindicated: In patients who are hypersensitive to any component of this product . In patients with anuria. For co-administration with aliskiren in patients with diabetes . Hypersensitivity to telmisartan or any component Anuria Co-Administration with aliskiren in patients with diabetes
Warnings and precautions
Avoid fetal or neonatal exposure Correct volume or salt depletion before initiating therapy. Observe for signs and symptoms of hypotension Monitor renal function and potassium in susceptible patients Observe for clinical signs of fluid or electrolyte imbalance Hypersensitivity Reaction Acute Myopia and Secondary Angle-Closure Glaucoma Fetal Toxicity Telmisartan 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.
Storage and supply
Telmisartan and hydrochlorothiazide tablets, USP are available in three strengths as: 40 mg/12.5 mg tablet : white to off white and light yellow to yellow colored, bilayered, oblong shaped, biconvex tablets, debossed with "LS" on one side and "315" on other side. The white to off white layer may contain yellow specks.
Source: Telmisartan And Hydrochlorothiazide (Telmisartan And Hydrochlorothiazide) — US FDA prescribing information, 2025-08-20, 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.
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