telmisartan and amlodipine
Regulatory sources consulted
Approved indications
- Essential hypertension in adults as combination therapy when control is insufficient or as replacement for separately administered telmisartan and amlodipine at the same doses.
Contraindications
Absolute
- Hypersensitivity to telmisartan, amlodipine, or any component.
- Second or third trimester of pregnancy.
- Concomitant aliskiren in patients with diabetes or GFR below 60 mL/min/1.73 m².
- Biliary obstructive disorder or severe hepatic impairment.
- Shock, including cardiogenic shock; severe left-ventricular outflow obstruction; or hemodynamically unstable heart failure after acute myocardial infarction.
Clinical warnings
- Boxed warning · Fetal toxicity: discontinue immediately when pregnancy is diagnosed. — DailyMed telmisartan/amlodipine set ID ca60a4d5-ace7-4889-94ee-e2265fd63811
- Major warning · Correct volume or sodium depletion and monitor for hypotension; periodically monitor renal function, creatinine, and potassium. — CIMA registro 10648023
Drug interactions
- HighLithium
Mechanism: Telmisartan may reversibly increase lithium concentration and toxicity.
Recommendation: Avoid if possible; if used, closely monitor serum lithium.
https://cima.aemps.es/cima/dochtml/ft/10648023/FT_10648023.html
- ModerateNSAIDs
Mechanism: May reduce the antihypertensive effect and increase renal impairment.
Recommendation: Ensure hydration and monitor renal function periodically.
https://cima.aemps.es/cima/dochtml/ft/10648023/FT_10648023.html
- ModerateGrapefruit or grapefruit juice
Mechanism: May increase amlodipine bioavailability and potentiate hypotension.
Recommendation: Concomitant administration is not recommended.
https://cima.aemps.es/cima/dochtml/ft/10648023/FT_10648023.html
- ModeratePotassium, potassium supplements, potassium-containing salt substitutes, or potassium-sparing diuretics
Mechanism: The combination may increase serum potassium and the risk of hyperkalemia.
Recommendation: Use cautiously and monitor serum potassium.
https://cima.aemps.es/cima/dochtml/ft/10648023/FT_10648023.html
- HighACE inhibitors, ARBs, or aliskiren
Mechanism: Dual RAAS blockade increases hypotension, hyperkalemia, and renal impairment, including acute renal failure.
Recommendation: Not recommended; if essential, use under specialist supervision and monitor blood pressure, renal function, and electrolytes. Aliskiren is contraindicated with diabetes or GFR below 60 mL/min/1.73 m².
https://cima.aemps.es/cima/dochtml/ft/10648023/FT_10648023.html
- ModerateDigoxinC01AA05
Mechanism: Telmisartan may increase peak and trough plasma digoxin concentrations.
Recommendation: Monitor digoxin concentrations when telmisartan is started, adjusted, or discontinued.
https://cima.aemps.es/cima/dochtml/ft/10648023/FT_10648023.html
- ModerateModerate or strong CYP3A4 inhibitors
Mechanism: They may significantly increase amlodipine exposure.
Recommendation: Closely monitor for hypotension and edema; amlodipine dose adjustment may be required.
https://cima.aemps.es/cima/dochtml/ft/10648023/FT_10648023.html
- ModerateSimvastatinC10AA01
Mechanism: Amlodipine increases simvastatin exposure.
Recommendation: Limit simvastatin to 20 mg daily during concomitant use.
https://cima.aemps.es/cima/dochtml/ft/10648023/FT_10648023.html
Adverse events
Common (≥1%)
Peripheral edema · Dizziness · Back pain
Rare but serious
Angioedema or anaphylaxis · Acute renal failure · Syncope or severe hypotension
Pregnancy and lactation
Use is not recommended in the first trimester and is contraindicated in the second and third; discontinue when pregnancy is diagnosed. Amlodipine passes into milk and the combination is not recommended during breastfeeding; a better-established alternative is preferred.
Recent literature (PubMed)
Systemic arterial hypertension is a health condition causing target organ damage (TOD) in dogs. Early and effective treatment is essential to prevent hypertensive emergencies and to reduce the risk of TOD. This study investigated the diseases underlying hypertension and compared the short-term efficacy of antihypertensive drugs in dogs. We evaluated the medical records of client-owned dogs treated with antihypertensive drugs between 2017 and 2018. The study included 75 dogs diagnosed with systemic arterial hypertension (systolic blood pressure ≥150 mmHg). The dogs were classified based on treatment with the following antihypertensive drugs: calcium channel blocker amlodipine, angiotensin-converting enzyme inhibitor ramipril, and angiotensin receptor blocker telmisartan, either as monotherapy or combination therapy (telmisartan + amlodipine or ramipril + amlodipine). Systolic blood pressure was measured using an indirect Doppler method over 4 weeks. Naturally acquired hyperadrenocorticism was the most common disorder to be diagnosed in conjunction with systemic hypertension. In the telmisartan group, the systolic blood pressure decreased more rapidly for 3 weeks compared to ramipril. The combination of telmisartan and amlodipine showed the greatest decrease in systolic blood pressure throughout the 4-week treatment period. This study is meaningful as it suggests guidelines for the use of various antihypertensive drugs in dogs.
Hypertension is a major cause of cardiovascular disease and death worldwide. Low-dose combination therapy is a promising approach for managing hypertension due to its safety and efficacy. This systematic review evaluates the safety and efficacy of a single-pill, low-dose combination of amlodipine, telmisartan, and chlorthalidone for essential hypertension based on evidence from randomized controlled trials (RCTs). We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and searched the Cochrane, Scopus, PubMed, and Web of Science databases until July 01, 2024, using the following search string: (telmisartan) AND (amlodipine) AND (chlorthalidone) AND (randomized OR randomly). The quality of the RCTs was assessed using the revised Cochrane risk of bias tool. The primary endpoint was the mean change in sitting systolic blood pressure (BP), with secondary endpoints including BP target achievement rates, BP response rates, and serious treatment-related adverse events. Overall, three RCTs met the inclusion criteria and exhibited a low risk of bias. The doses in the combination pill ranged from 2.5 to 5 mg of amlodipine, 20 to 80 mg of telmisartan, and 4.167 to 25 mg of chlorthalidone. Control groups varied, including usual care, amlodipine 10 mg, and dual therapy of telmisartan and amlodipine. Results showed significant reductions in mean sitting systolic and diastolic BP, improved BP control and response rates, and a generally safe profile with no significant differences in serious adverse events. Despite encouraging data, results should be interpreted with caution due to heterogeneity in doses and control groups. Further research should address the long-term effects and explore predictors of response to this therapy.
There is lacking evidence that telmisartan can improve insulin resistance in patients on high-intensity statins. This study compared the effects of telmisartan and amlodipine on glucose metabolism in hypertensive atherosclerotic cardiovascular disease (ASCVD) patients with impaired fasting glucose (IFG) requiring high-intensity rosuvastatin therapy. Ninety-nine patients were randomly assigned to 2 groups [telmisartan-statin group (n=48) and amlodipine-statin group (n=51)] as add-on therapy to high-intensity rosuvastatin therapy (20 mg). The primary endpoint was to assess insulin resistance using the homeostatic model assessment (HOMA-IR) value at week 24. The secondary endpoint was the change in glucose metabolism indices from baseline to week 24. The HOMA-IR at week 24 (2.4 [interquartile range, 1.8-3.8] versus 2.7 [1.7-3.7]; P = .809) and changes in the HOMA-IR from baseline to week 24 (-7.0 [-29.0 to 21.0] versus -5.5 [-53.3 to 27.3]; P = .539) were not significantly different between 2 groups. However, the fasting glucose level at week 24 was significantly lower in the telmisartan-statin group than in the amlodipine-statin group (107.7 ± 13.4 mg/dL versus 113.3 ± 12.4 mg/dL; P = .039) and significantly decreased in the telmisartan-statin group (-3.2 ± 8.6% versus 3.8 ± 13.2%; P = .003). The proportion of patients with fasting glucose ≥100 mg/dL (71.1% versus 89.6%; P = .047) or new-onset diabetes mellitus (12.5% versus 31.4%, P = .044) at week 24 was also significantly lower in the telmisartan-statin group than in the amlodipine-statin group. In comparison to amlodipine, telmisartan did not decrease the HOMA-IR. However, telmisartan preserved insulin secretion, led to a regression from IFG to euglycemia and prevented new-onset diabetes mellitus in ASCVD patients with IFG requiring high-intensity statins.