Telmisartan

Telmisartan is an angiotensin II receptor blocker (ARB). The label we reviewed is for telmisartan tablets taken by mouth.

The label lists two uses: treating high blood pressure, and lowering the risk of cardiovascular events in people who cannot take ACE inhibitors.

The label says lowering blood pressure reduces the risk of strokes and heart attacks, and that many people need more than one medicine to reach their blood pressure goal.

• Treatment of hypertension
• Cardiovascular risk reduction in patients unable to take ACE inhibitors

In India, 'salt' usually means the active ingredient listed on a medicine pack, such as telmisartan. It does not mean table salt. Brands that carry the same salt contain the same active medicine.

The label we reviewed describes telmisartan as a non-peptide angiotensin II (AT1) receptor antagonist. Each tablet contains 20, 40 or 80 mg of telmisartan.

The label says telmisartan tablets also have inactive ingredients, which are not the medicine itself.

Telmisartan is also sold in fixed combinations with other medicines. The Jan Aushadhi list shows telmisartan with hydrochlorothiazide, amlodipine, chlorthalidone, metoprolol and cilnidipine. A combination pack is a different product, so read its label.

• Salt on a pack = the active medicine, not table salt
• Same salt, different brand = same active ingredient
• Combination packs contain additional medicines

The label says angiotensin II is the main substance that narrows blood vessels in the renin-angiotensin system.

Telmisartan blocks angiotensin II from binding to the AT1 receptor in tissues such as blood vessel muscle and the adrenal gland. This stops the narrowing effect and the release of aldosterone.

It does not block the ACE enzyme, so it does not affect the bradykinin response that ACE inhibitors do.

This section covers the telmisartan tablet label for adults (oral route). Indian tablets and combination packs can differ, and your prescriber decides.

For hypertension, the US label for adults gives a usual starting dose of 40 mg once daily, with a range of 40 to 80 mg once daily. Most of the effect appears within 2 weeks, and the largest reduction is generally reached after 4 weeks.

For cardiovascular risk reduction, the label gives 80 mg once daily. It says it is not known whether lower doses are effective for this use.

The label says tablets may be taken with or without food. It says no starting dose change is needed for elderly people or those with kidney impairment, including dialysis. Patients on dialysis may develop low blood pressure on standing.

In liver disease or bile blockage, the label says to start at a low dose and raise it slowly.

• Hypertension: 40 mg once daily to start, 40 to 80 mg range
• Cardiovascular risk reduction: 80 mg once daily
• With or without food
• Liver disease: start low, raise slowly

The label has a boxed warning on fetal toxicity. Drugs acting on the renin-angiotensin system can injure and kill the developing baby. When pregnancy is detected, the label says to stop telmisartan as soon as possible.

The label says telmisartan must not be used with a known allergy to it, or with aliskiren in people with diabetes.

Low blood pressure can occur in people who are salt- or volume-depleted, for example those on high-dose diuretics. Potassium can rise, especially with advanced kidney disease, heart failure or potassium supplements.

Kidney function can change, especially in those whose kidneys depend on this system. Liver disease and bile blockage reduce clearance.

Breastfeeding: the label says not to breastfeed during treatment. Children: safety and effectiveness have not been established. Older adults: no overall difference, though greater sensitivity cannot be ruled out.

• Pregnancy: stop when pregnancy is detected (boxed warning)
• Aliskiren with diabetes: contraindicated
• Kidney and liver disease: caution
• Breastfeeding: label says not to breastfeed

• Aliskiren: contraindicated in diabetes
• Digoxin and lithium: monitor levels
• NSAIDs: kidney risk and weaker effect
• ACE inhibitors: avoid together
• Potassium products: raise potassium
• Aliskiren must not be used with telmisartan in people with diabetes.
• The label advises avoiding it in kidney impairment as well.
• Digoxin levels rose when given with telmisartan, so levels should be monitored.
• Lithium levels can rise with toxicity, so levels should be monitored.
• NSAIDs, including COX-2 inhibitors, may worsen kidney function in elderly, volume-depleted or kidney-impaired people, and may weaken the blood pressure effect.
• The label also advises against using an ACE inhibitor together with an ARB, and notes renal dysfunction with ramipril.
• Potassium supplements, potassium-sparing diuretics and potassium-containing salt substitutes can raise potassium.

No match in this label text. Ask your pharmacist about any medicine you take.

The label says limited data are available. The most likely effects are low blood pressure, dizziness and a fast heartbeat, and a slow heartbeat could occur.

Treatment is supportive. Telmisartan is not removed by hemofiltration and is not dialyzable. Treat any overdose as an emergency.

The US label says to store tablets at 20 to 25 degrees C, with excursions allowed from 15 to 30 degrees C.

It says to keep the bottle tightly closed and not to remove tablets until immediately before use, because they are hygroscopic and need protection from moisture. Indian packs may differ, so follow your pack.

Telmisartan is in Schedule H (serial 483), so it is sold only on a prescription.

The National List of Essential Medicines 2022 includes telmisartan as 40 mg and 80 mg tablets (page 89).

NPPA has ceiling prices for telmisartan tablets, shown below.

Banned combinations: the list we checked has 3 mentions of telmisartan. Use the checker for your exact combination.

NPPA ceiling prices set the most a seller can charge per unit before local taxes. Check the pack and the seller.

Jan Aushadhi lists telmisartan tablets of 20, 40 and 80 mg, plus several combinations. Combination products also contain other medicines, so read the label. We have not shown a brand price here.

• Telmisartan Tablets IP 20mg (pack 10's)
• Telmisartan Tablets IP 40mg (pack 10's)
• Telmisartan Tablets IP 80mg (pack 10's)