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Telmisartan and amlodipine: Drug information

Telmisartan and amlodipine: Drug information
(For additional information see "Telmisartan and amlodipine: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Fetal toxicity:

Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. When pregnancy is detected, discontinue therapy as soon as possible.

Brand Names: US
  • Twynsta [DSC]
Brand Names: Canada
  • Twynsta
Pharmacologic Category
  • Angiotensin II Receptor Blocker;
  • Antianginal Agent;
  • Antihypertensive;
  • Calcium Channel Blocker;
  • Calcium Channel Blocker, Dihydropyridine
Dosing: Adult

Dose is individualized; combination product may be substituted for individual components in patients currently maintained on both agents separately or in patients not adequately controlled with monotherapy (using one of the agents or an agent within the same antihypertensive class). May also be used as initial therapy in patients who are likely to need >1 antihypertensive to control BP.

Hypertension

Hypertension: Oral:

Initial therapy (antihypertensive naive): Telmisartan 40 mg/amlodipine 5 mg once daily; dose may be increased after 2 weeks of therapy. Patients requiring larger blood pressure reductions may be started on telmisartan 80 mg/amlodipine 5 mg once daily. Maximum dose: Telmisartan 80 mg/amlodipine 10 mg per day

Add-on therapy for patients not adequately controlled on antihypertensive monotherapy: Telmisartan 40 mg/amlodipine 5 mg, telmisartan 40 mg/amlodipine 10 mg, telmisartan 80 mg/amlodipine 5 mg, or telmisartan 80 mg/amlodipine 10 mg once daily; dose may be increased after 2 weeks of therapy. Maximum dose: Telmisartan 80 mg/amlodipine 10 mg per day

Replacement therapy: Substitute for the individually titrated components. Maximum dose: Telmisartan 80 mg/amlodipine 10 mg per day.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

Mild to moderate impairment: No dosage adjustment necessary.

Severe impairment: Titrate slowly.

Hemodialysis: Telmisartan and amlodipine: Nondialyzable

Dosing: Hepatic Impairment: Adult

Hepatic impairment or biliary obstructive disorders: Not recommended for initial therapy. For add-on/replacement therapy initiate amlodipine 2.5 mg once daily (use of individual agents is necessary as appropriate combination dose is not available). Titrate slowly.

Ascites: Should be used with caution in patients with ascites due to cirrhosis (AASLD [Biggins 2021]; AASLD [Runyon 2013]).

Dosing: Older Adult

Initial therapy (antihypertensive naive): Not recommended for initial therapy in patients ≥75 years of age.

Add-on/replacement therapy: Initiate amlodipine therapy at 2.5 mg once daily and titrate slowly. Note: Use of individual agents is necessary (appropriate combination dose is not available).

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reactions/percentages reported with combination product; also see individual agents.

>10%: Cardiovascular: Peripheral edema (dose related: 1% to 11%)

1% to 10%:

Cardiovascular: Orthostatic hypotension (6%), edema (<2%), hypotension (<2%), syncope (<2%)

Central nervous system: Dizziness (3%)

Neuromuscular & skeletal: Back pain (2%)

Contraindications

Hypersensitivity (eg, anaphylaxis or angioedema) to amlodipine, telmisartan, or any component of the formulation; concomitant use with aliskiren in patients with diabetes mellitus

Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to dihydropyridine derivatives; known hypersensitivity (anaphylaxis) or angioedema to angiotensin II receptor blockers (ARBs); concomitant use with aliskiren in patients with moderate to severe renal impairment (GFR <60 mL/minute/1.73 m2); biliary obstructive disorders; severe hepatic impairment; shock (including cardiogenic shock); severe hypotension; obstruction of the outflow tract of the left ventricle (eg, high-grade aortic stenosis); hemodynamically unstable heart failure after acute myocardial infarction; pregnancy; breastfeeding; fructose intolerance; hereditary conditions incompatible with an excipient of the product.

Warnings/Precautions

Concerns related to adverse effects:

• Angioedema: Angioedema has been reported rarely with some angiotensin II receptor antagonists (ARBs) and may occur at any time during treatment (especially following first dose). It may involve the head and neck (potentially compromising airway) or the intestine (presenting with abdominal pain). Patients with idiopathic or hereditary angioedema or previous angioedema associated with ACE-inhibitor therapy may be at an increased risk. Prolonged frequent monitoring may be required, especially if tongue, glottis, or larynx are involved, as they are associated with airway obstruction. Patients with a history of airway surgery may have a higher risk of airway obstruction. Discontinue therapy immediately if angioedema occurs. Aggressive early management is critical. Intramuscular (IM) administration of epinephrine may be necessary. Do not readminister to patients who have had angioedema with ARBs.

• Angina/MI: Increased angina and/or MI have occurred with initiation or dosage titration of amlodipine. Reflex tachycardia may occur resulting in angina and/or MI in patients with obstructive coronary disease, especially in the absence of concurrent beta-blockade.

• Hyperkalemia: May occur with telmisartan use; risk factors include renal dysfunction, diabetes mellitus, concomitant use of potassium-sparing diuretics, potassium supplements and/or potassium containing salts. Use cautiously, if at all, with these agents and monitor potassium closely.

• Hypotension: Symptomatic hypotension may occur upon initiation in patients who are salt- or volume-depleted (eg, those treated with high-dose diuretics); correct volume depletion prior to administration. Use caution during initiation of therapy, particularly in patients with heart failure, volume or salt depletion, severe aortic stenosis, or in post-MI patients or those undergoing surgery or dialysis. This transient hypotensive response is not a contraindication to further treatment with telmisartan/amlodipine.

• Peripheral edema: The most common side effect of amlodipine is peripheral edema; occurs within 2 to 3 weeks of starting therapy.

• Renal function deterioration: Telmisartan may be associated with deterioration of renal function and/or increases in serum creatinine, particularly in patients with low renal blood flow (eg, renal artery stenosis, heart failure) whose glomerular filtration rate (GFR) is dependent on efferent arteriolar vasoconstriction by angiotensin II; deterioration may result in oliguria, acute renal failure, and progressive azotemia. Small increases in serum creatinine may occur following initiation; consider discontinuation only in patients with progressive and/or significant deterioration in renal function.

Disease-related concerns:

• Aortic/mitral stenosis: Use with caution in patients with severe aortic stenosis or significant aortic/mitral stenosis; may reduce coronary perfusion resulting in ischemia.

• Ascites: Generally, avoid use in patients with ascites due to cirrhosis or refractory ascites; if use cannot be avoided in patients with ascites due to cirrhosis, monitor BP and renal function carefully to avoid rapid development of renal failure (AASLD [Runyon 2013]).

• Heart failure (HF): Use caution when initiating in HF; may need to adjust dose, and/or concurrent diuretic therapy.

• Hepatic impairment: Use with caution in patients who have biliary obstructive disorders or hepatic impairment; amlodipine and telmisartan clearance is decreased so initiation at the lowest dose is recommended; the appropriate dose for hepatic impairment is not available in combination dosage form, therefore, initiation of treatment with this product is not recommended in patients with hepatic impairment.

• Hypertrophic cardiomyopathy (HCM) with outflow tract obstruction: Use amlodipine with caution in patients with HCM and outflow tract obstruction since reduction in afterload may worsen symptoms associated with this condition (ACCF/AHA [Gersh 2011]).

• Renal artery stenosis: Use telmisartan with caution in patients with unstented unilateral/bilateral renal artery stenosis. When unstented bilateral renal artery stenosis is present, use is generally avoided due to the elevated risk of deterioration in renal function unless possible benefits outweigh risks.

• Renal impairment: Use with caution in patients with renal impairment.

Special populations:

• Older adult: Not recommended for initial therapy in patients ≥75 years of age. The appropriate combination dose is not available.

• Pregnancy: [US Boxed Warning]: Drugs that act on the renin-angiotensin system can cause injury and death to the developing fetus. Discontinue as soon as possible once pregnancy is detected.

• Surgical patients: In patients on chronic angiotensin receptor blocker (ARB) therapy, intraoperative hypotension may occur with induction and maintenance of general anesthesia; however, discontinuation of therapy prior to surgery is controversial. If continued preoperatively, avoidance of hypotensive agents during surgery is prudent (Hillis, 2011).

Dosage forms specific issues:

• Sorbitol: Some products may contain sorbitol.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, oral:

Twynsta 40/5: Telmisartan 40 mg and amlodipine 5 mg [DSC]

Twynsta 40/10: Telmisartan 40 mg and amlodipine 10 mg [DSC]

Twynsta 80/5: Telmisartan 80 mg and amlodipine 5 mg [DSC]

Twynsta 80/10: Telmisartan 80 mg and amlodipine 10 mg [DSC]

Generic: Telmisartan 40 mg and amlodipine 5 mg; telmisartan 40 mg and amlodipine 10 mg; telmisartan 80 mg and amlodipine 5 mg; telmisartan 80 mg and amlodipine 10 mg

Generic Equivalent Available: US

Yes

Pricing: US

Tablets (Telmisartan-amLODIPine Oral)

40-5 mg (per each): $5.71

40-10 mg (per each): $5.71

80-5 mg (per each): $5.71

80-10 mg (per each): $5.71

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, oral:

Twynsta 40/5: Telmisartan 40 mg and amlodipine 5 mg

Twynsta 40/10: Telmisartan 40 mg and amlodipine 10 mg

Twynsta 80/5: Telmisartan 80 mg and amlodipine 5 mg

Twynsta 80/10: Telmisartan 80 mg and amlodipine 10 mg

Generic: Telmisartan 40 mg and amlodipine 5 mg; telmisartan 40 mg and amlodipine 10 mg; telmisartan 80 mg and amlodipine 5 mg; telmisartan 80 mg and amlodipine 10 mg

Administration: Adult

Oral: Administer without regard to meals.

Use: Labeled Indications

Hypertension: Management of hypertension (monotherapy or in combination with other antihypertensives).

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Alfuzosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Aliskiren: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. Aliskiren may enhance the hypotensive effect of Angiotensin II Receptor Blockers. Aliskiren may enhance the nephrotoxic effect of Angiotensin II Receptor Blockers. Management: Aliskiren use with ACEIs or ARBs in patients with diabetes is contraindicated. Combined use in other patients should be avoided, particularly when CrCl is less than 60 mL/min. If combined, monitor potassium, creatinine, and blood pressure closely. Risk D: Consider therapy modification

ALPRAZolam: CYP3A4 Inhibitors (Weak) may increase the serum concentration of ALPRAZolam. Risk C: Monitor therapy

Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When used at chemotherapy doses, hold blood pressure lowering medications for 24 hours before amifostine administration. If blood pressure lowering therapy cannot be held, do not administer amifostine. Use caution with radiotherapy doses of amifostine. Risk D: Consider therapy modification

Amphetamines: May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Angiotensin II: Receptor Blockers may diminish the therapeutic effect of Angiotensin II. Risk C: Monitor therapy

Angiotensin-Converting Enzyme Inhibitors: Angiotensin II Receptor Blockers may enhance the adverse/toxic effect of Angiotensin-Converting Enzyme Inhibitors. Angiotensin II Receptor Blockers may increase the serum concentration of Angiotensin-Converting Enzyme Inhibitors. Management: Use of telmisartan and ramipril is not recommended. It is not clear if any other combination of an ACE inhibitor and an ARB would be any safer. Consider alternatives when possible. Monitor blood pressure, renal function, and potassium if combined. Risk D: Consider therapy modification

Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may enhance the hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]). Risk C: Monitor therapy

Arginine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Atosiban: Calcium Channel Blockers may enhance the adverse/toxic effect of Atosiban. Specifically, there may be an increased risk for pulmonary edema and/or dyspnea. Risk C: Monitor therapy

Barbiturates: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Benperidol: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Brigatinib: May diminish the antihypertensive effect of Antihypertensive Agents. Brigatinib may enhance the bradycardic effect of Antihypertensive Agents. Risk C: Monitor therapy

Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Bromperidol: May diminish the hypotensive effect of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may enhance the hypotensive effect of Bromperidol. Risk X: Avoid combination

Calcium Salts: May diminish the therapeutic effect of Calcium Channel Blockers. Risk C: Monitor therapy

CarBAMazepine: CYP3A4 Inhibitors (Weak) may increase the serum concentration of CarBAMazepine. Risk C: Monitor therapy

Cardiac Glycosides: Telmisartan may increase the serum concentration of Cardiac Glycosides. Risk C: Monitor therapy

Charcoal, Activated: May decrease the serum concentration of AmLODIPine. Risk C: Monitor therapy

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Clopidogrel: Calcium Channel Blockers may diminish the therapeutic effect of Clopidogrel. Risk C: Monitor therapy

CycloSPORINE (Systemic): Calcium Channel Blockers (Dihydropyridine) may increase the serum concentration of CycloSPORINE (Systemic). CycloSPORINE (Systemic) may increase the serum concentration of Calcium Channel Blockers (Dihydropyridine). Risk C: Monitor therapy

CYP3A4 Inducers (Moderate): May decrease the serum concentration of AmLODIPine. Risk C: Monitor therapy

CYP3A4 Inducers (Strong): May decrease the serum concentration of AmLODIPine. Risk C: Monitor therapy

CYP3A4 Inhibitors (Moderate): May increase the serum concentration of AmLODIPine. Risk C: Monitor therapy

CYP3A4 Inhibitors (Strong): May increase the serum concentration of AmLODIPine. Risk C: Monitor therapy

Dabigatran Etexilate: AmLODIPine may diminish the therapeutic effect of Dabigatran Etexilate. Risk C: Monitor therapy

Dantrolene: May enhance the hyperkalemic effect of Calcium Channel Blockers. Dantrolene may enhance the negative inotropic effect of Calcium Channel Blockers. Risk X: Avoid combination

Dapoxetine: May enhance the orthostatic hypotensive effect of Angiotensin II Receptor Blockers. Risk C: Monitor therapy

Dapoxetine: May enhance the orthostatic hypotensive effect of Calcium Channel Blockers. Risk C: Monitor therapy

Dexmethylphenidate: May diminish the therapeutic effect of Antihypertensive Agents. Risk C: Monitor therapy

Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Drospirenone-Containing Products: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. Risk C: Monitor therapy

DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Risk C: Monitor therapy

Eplerenone: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. Risk C: Monitor therapy

Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Finerenone: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Finerenone. Risk C: Monitor therapy

Finerenone: Angiotensin II Receptor Blockers may enhance the hyperkalemic effect of Finerenone. Risk C: Monitor therapy

Flibanserin: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Flibanserin. Risk C: Monitor therapy

Flunarizine: May enhance the therapeutic effect of Antihypertensive Agents. Risk C: Monitor therapy

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Heparin: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. Risk C: Monitor therapy

Heparins (Low Molecular Weight): May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. Risk C: Monitor therapy

Herbal Products with Blood Pressure Increasing Effects: May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Herbal Products with Blood Pressure Lowering Effects: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect of Hypotension-Associated Agents. Risk C: Monitor therapy

Indoramin: May enhance the hypotensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Inhalational Anesthetics: May enhance the hypotensive effect of Calcium Channel Blockers. Risk C: Monitor therapy

Ixabepilone: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Ixabepilone. Risk C: Monitor therapy

Lemborexant: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Lemborexant. Management: The maximum recommended dosage of lemborexant is 5 mg, no more than once per night, when coadministered with weak CYP3A4 inhibitors. Risk D: Consider therapy modification

Levodopa-Foslevodopa: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa-Foslevodopa. Risk C: Monitor therapy

Lithium: Angiotensin II Receptor Blockers may increase the serum concentration of Lithium. Management: Initiate lithium at lower doses in patients receiving an angiotensin II receptor blocker (ARB). Consider lithium dose reductions in patients stable on lithium therapy who are initiating an ARB. Monitor lithium concentrations closely when combined. Risk D: Consider therapy modification

Lomitapide: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Lomitapide. Management: Patients on lomitapide 5 mg/day may continue that dose. Patients taking lomitapide 10 mg/day or more should decrease the lomitapide dose by half. The lomitapide dose may then be titrated up to a max adult dose of 30 mg/day. Risk D: Consider therapy modification

Lonafarnib: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Lonafarnib. Management: Avoid concurrent use of lonafarnib with weak CYP3A4 inhibitors. If concurrent use is unavoidable, reduce the lonafarnib dose to or continue at a dose of 115 mg/square meter. Monitor for evidence of arrhythmia, syncope, palpitations, or similar effects. Risk D: Consider therapy modification

Loop Diuretics: May enhance the hypotensive effect of Angiotensin II Receptor Blockers. Loop Diuretics may enhance the nephrotoxic effect of Angiotensin II Receptor Blockers. Risk C: Monitor therapy

Loop Diuretics: May enhance the hypotensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Lormetazepam: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Lovastatin: AmLODIPine may increase the serum concentration of Lovastatin. Risk C: Monitor therapy

Magnesium Sulfate: May enhance the adverse/toxic effect of Calcium Channel Blockers (Dihydropyridine). Specifically, the risk of hypotension or muscle weakness may be increased. Risk C: Monitor therapy

Melatonin: May diminish the antihypertensive effect of Calcium Channel Blockers (Dihydropyridine). Risk C: Monitor therapy

Methylphenidate: May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Midazolam: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Midazolam. Risk C: Monitor therapy

Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Naftopidil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Neuromuscular-Blocking Agents (Nondepolarizing): Calcium Channel Blockers may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents (Nondepolarizing). Risk C: Monitor therapy

Nicergoline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Nicorandil: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. Risk C: Monitor therapy

Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

NiMODipine: CYP3A4 Inhibitors (Weak) may increase the serum concentration of NiMODipine. Risk C: Monitor therapy

Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents: Angiotensin II Receptor Blockers may enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Specifically, the combination may result in a significant decrease in renal function. Nonsteroidal Anti-Inflammatory Agents may diminish the therapeutic effect of Angiotensin II Receptor Blockers. The combination of these two agents may also significantly decrease glomerular filtration and renal function. Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents (Topical): May diminish the therapeutic effect of Angiotensin II Receptor Blockers. Risk C: Monitor therapy

Obinutuzumab: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Risk D: Consider therapy modification

Patiromer: May decrease the serum concentration of Telmisartan. Management: Administer telmisartan at least 3 hours before or 3 hours after patiromer. Risk D: Consider therapy modification

Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Pholcodine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Pholcodine. Risk C: Monitor therapy

Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Pimozide: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Pimozide. Risk X: Avoid combination

Polyethylene Glycol-Electrolyte Solution: Angiotensin II Receptor Blockers may enhance the nephrotoxic effect of Polyethylene Glycol-Electrolyte Solution. Risk C: Monitor therapy

Potassium Salts: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. Risk C: Monitor therapy

Potassium-Sparing Diuretics: Angiotensin II Receptor Blockers may enhance the hyperkalemic effect of Potassium-Sparing Diuretics. Risk C: Monitor therapy

Prazosin: Antihypertensive Agents may enhance the hypotensive effect of Prazosin. Risk C: Monitor therapy

Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Ramipril: Telmisartan may enhance the adverse/toxic effect of Ramipril. Telmisartan may increase the serum concentration of Ramipril. Concentrations of the active metabolite, ramiprilat, may also be increased. Risk X: Avoid combination

Ranolazine: May enhance the adverse/toxic effect of Angiotensin II Receptor Blockers. Risk C: Monitor therapy

Red Yeast Rice: AmLODIPine may increase the serum concentration of Red Yeast Rice. Risk C: Monitor therapy

Silodosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Simvastatin: AmLODIPine may increase the serum concentration of Simvastatin. Management: Dose of simvastatin should not exceed 20 mg daily if coadministering with amlodipine. If coadministering with simvastatin and amlodipine, close laboratory and clinical monitoring for signs and symptoms of rhabdomyolysis is warranted. Risk D: Consider therapy modification

Sincalide: Drugs that Affect Gallbladder Function may diminish the therapeutic effect of Sincalide. Management: Consider discontinuing drugs that may affect gallbladder motility prior to the use of sincalide to stimulate gallbladder contraction. Risk D: Consider therapy modification

Sirolimus (Conventional): CYP3A4 Inhibitors (Weak) may increase the serum concentration of Sirolimus (Conventional). Risk C: Monitor therapy

Sirolimus (Protein Bound): CYP3A4 Inhibitors (Weak) may increase the serum concentration of Sirolimus (Protein Bound). Management: Reduce the dose of protein bound sirolimus to 56 mg/m2 when used concomitantly with a weak CYP3A4 inhibitor. Risk D: Consider therapy modification

Sodium Phosphates: Angiotensin II Receptor Blockers may enhance the nephrotoxic effect of Sodium Phosphates. Specifically, the risk of acute phosphate nephropathy may be enhanced. Risk C: Monitor therapy

Sparsentan: May enhance the adverse/toxic effect of Angiotensin II Receptor Blockers. Risk X: Avoid combination

Tacrolimus (Systemic): Calcium Channel Blockers (Dihydropyridine) may increase the serum concentration of Tacrolimus (Systemic). Risk C: Monitor therapy

Tacrolimus (Systemic): Angiotensin II Receptor Blockers may enhance the hyperkalemic effect of Tacrolimus (Systemic). Risk C: Monitor therapy

Tacrolimus (Systemic): CYP3A4 Inhibitors (Weak) may increase the serum concentration of Tacrolimus (Systemic). Risk C: Monitor therapy

Terazosin: Antihypertensive Agents may enhance the hypotensive effect of Terazosin. Risk C: Monitor therapy

Tolvaptan: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. Risk C: Monitor therapy

Triazolam: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Triazolam. Risk C: Monitor therapy

Trimethoprim: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. Risk C: Monitor therapy

Ubrogepant: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Ubrogepant. Management: In patients taking weak CYP3A4 inhibitors, the initial and second dose (given at least 2 hours later if needed) of ubrogepant should be limited to 50 mg. Risk D: Consider therapy modification

Urapidil: Antihypertensive Agents may enhance the hypotensive effect of Urapidil. Risk C: Monitor therapy

Food Interactions

Rate and extent of telmisartan absorption (in combination with amlodipine) is decreased by 60% and 24%, respectively, when administered with a high-fat meal. Management: May administer without regard to meals.

Pregnancy Considerations

[US Boxed Warning]: Drugs that act on the renin-angiotensin system can cause injury and death to the developing fetus. Discontinue as soon as possible once pregnancy is detected. Also see individual agents.

Breastfeeding Considerations

Amlodipine is present in breast milk (Naito 2015); excretion of telmisartan is unknown. Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer. See individual agents.

Dietary Considerations

Avoid salt substitutes which may contain potassium.

Monitoring Parameters

Baseline and periodic electrolyte panels (especially serum potassium); renal function (serum creatinine, BUN, urinalysis); hepatic function; heart rate, blood pressure, symptomatic hypotension, peripheral edema

Mechanism of Action

Telmisartan is a nonpeptide AT1 (angiotensin II type 1) receptor antagonist. Angiotensin II acts as a vasoconstrictor. In addition to causing direct vasoconstriction, angiotensin II also stimulates the release of aldosterone. Once aldosterone is released, sodium and water are reabsorbed. The end result is an elevation in blood pressure. Telmisartan binding to AT1 prevents angiotensin II from binding to the receptor thereby blocking the vasoconstriction and the aldosterone secreting effects of angiotensin II.

Amlodipine inhibits calcium ion from entering the “slow channels” or select voltage-sensitive areas of vascular smooth muscle and myocardium during depolarization, producing a relaxation of coronary vascular smooth muscle and coronary vasodilation; increases myocardial oxygen delivery in patients with vasospastic angina. Amlodipine directly acts on vascular smooth muscle to produce peripheral arterial vasodilation reducing peripheral vascular resistance and blood pressure.

Pharmacokinetics (Adult Data Unless Noted)

See individual agents.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Telma am;
  • (AT) Austria: Twynsta;
  • (BD) Bangladesh: Arbitel am | Cardotel | Presart AM | Telamlo | Telmacal | Telmidip;
  • (BF) Burkina Faso: Telmikaa am;
  • (BG) Bulgaria: Actelsar duo | Raventon | Teldipin | Telfort;
  • (CH) Switzerland: Micardis amlo;
  • (CI) Côte d'Ivoire: Arbitel am | Telmikaa am | Telmis a;
  • (CL) Chile: Cordiax AM | Micardis amlo;
  • (CN) China: Telmisartan and amlodipine;
  • (CO) Colombia: Cardixil plus | Cordiax AM | Micardis amlo | Temred a | Xifen A;
  • (CZ) Czech Republic: Tezefort;
  • (DE) Germany: Twynsta;
  • (DO) Dominican Republic: Telydalt duo | Tikal;
  • (EC) Ecuador: Corazox amlo | Micardis amlo | Telmisar amlo | Telsar am;
  • (EE) Estonia: Mixor;
  • (ET) Ethiopia: Amlodipine and telmisartan;
  • (FR) France: Twynsta;
  • (HU) Hungary: Cotanydon | Tamloset;
  • (IN) India: 3ts am | Acmetel am | Aldo tl | Amlip tl | Amlodac t | Amlogard tm | Amlong tl | Amlopres TL | Amvio ts | Aquatel am | Arbitel am | Axeten-am | Cortel a | Cresar am | Ecotel A | Elzen am | Eritel-am | Extel am | Gloritel AM | Hitarget AM | Holytel am | Hytel AM | Ibtel am | Inditel am | Miotel a | Mytel am | Newtel am | Safetelmi AM | Sartel am | Stamlo t | Symtel am | T let am | T mart am | T press am | Targit AM | Telapp am | Teldawn am | Telday am | Teleact AM | Teledin am | Telefix am | Telelak am | Telexia am | Telfirst am | Teli AM | Telimed at | Telindia am | Telismart am | Tellme am | Tellzy am | Tellzy H | Telma am | Telmasurge AM | Telmed-am | Telmeron am | Telmichek a | Telmidil am | Telmigraf am | Telmijub am | Telminorm AM | Telmiprime am | Telmirest am | Telmiride am | Telmirise am | Telmisafe am | Telmisurge am | Telmivas AM | Telodil am | Telong duo | Telpax am | Telpin a | Telsaan am | Telsar-A | Telsart am | Telsartan AM | Telsat am | Telscan am | Telsite am | Telster am | Teltor am | Telzox am | Temax am | Temsan am | Tetan AM | Tigatel am | Tsart AM | Xstan am;
  • (JP) Japan: Teramuro | Teramuro ap jg;
  • (KE) Kenya: Amtel | Arbitel am | Telmi am | Teltan am | Twynsta;
  • (KR) Korea, Republic of: A twyn | Ajusta | Amlosatan | Amlotel | Astel | Cellmistar | Dipins | Doublelow | Doublestar | Gcp telmiamo | I sta | Inno.n telmiamlo | Misartan twyn | Newplusta | Partone | Predipine | Tellotwin | Telmiam | Telmiamlo | Telmidin | Telmiduet | Telmilopine | Telminova | Telminsta | Telmipose | Telmiroad | Telmisapin | Telmislo | Telmisylsan | Telnisapin | Telodipine | Teloditan | Telonstar | Telosapin | Telrodid | Telsalopine | Tesalbai | Tesalpine | Tesarbi | Twin plus | Twincid | Twineco | Twinstel | Twotwo star | Twyn x | Twyncombo | Twynspin;
  • (LB) Lebanon: Twynsta;
  • (LT) Lithuania: Raventon | Telmisartan/amlodipine teva;
  • (LV) Latvia: Mixor | Raventon;
  • (MX) Mexico: Micardis duo;
  • (NG) Nigeria: Cotripin | Pilorem | Suplavat | Telam | Telsart am | Valvix;
  • (PE) Peru: Cordiax AM;
  • (PK) Pakistan: Amtas | Cresar am | Ezitab am | Misar am | Sofvasc telm | Telam | Telarb plus | Telday plus | Telmipine | Telmis a | Telpine | Telsarta a | Telsun | Velmon a;
  • (PL) Poland: Telam;
  • (PR) Puerto Rico: Telmisartan and amlodipine;
  • (PT) Portugal: Amlodipina + Telmisartan Zentiva;
  • (PY) Paraguay: Micardis amlo | Nimicor am | Prilartan amlo;
  • (QA) Qatar: Twynsta;
  • (RU) Russian Federation: Telmista am | Telsartan am | Telzap am;
  • (SK) Slovakia: Mixor | Teldipin;
  • (TR) Turkey: Telmodip;
  • (TW) Taiwan: Co midis;
  • (UA) Ukraine: Izicard a | Teldipin;
  • (UG) Uganda: Telpil a;
  • (ZA) South Africa: Alcardis | Amlotel;
  • (ZW) Zimbabwe: Amlotel
  1. Biggins SW, Angeli P, Garcia-Tsao G, et al. Diagnosis, evaluation, and management of ascites, spontaneous bacterial peritonitis and hepatorenal syndrome: 2021 practice guidance by the American Association for the Study of Liver Diseases. Hepatology. 2021;74(2):1014-1048. doi:10.1002/hep.31884 [PubMed 33942342]
  2. Gersh BJ, Maron BJ, Bonow RO, et al; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, American Association for Thoracic Surgery, American Society of Echocardiography, et al. 2011 ACCF/AHA guideline for the diagnosis and treatment of hypertrophic cardiomyopathy: a report of the american college of cardiology foundation/american heart association task force on practice guidelines. Circulation. 2011;124(24):e783-e831. [PubMed 22068434]
  3. Hillis LD, Smith PK, Anderson JL, et al. 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2011, 124(23):2610-42. [PubMed 22064600]
  4. Naito T, Kubono N, Deguchi S, et al. Amlodipine passage into breast milk in lactating women with pregnancy-induced hypertension and its estimation of infant risk for breastfeeding. J Hum Lact. 2015;31(2):301-306. doi: 10.1177/0890334414560195. [PubMed 25447596]
  5. Runyon BA; AASLD. Introduction to the revised American Association for the Study of Liver Diseases practice guideline management of adult patients with ascites due to cirrhosis 2012. Hepatology. 2013;57(4):1651-1653. doi:10.1002/hep.26359 [PubMed 23463403]
  6. Twynsta (telmisartan/amlodipine) [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals Inc; February 2018.
  7. Twynsta (telmisartan/amlodipine) [product monograph]. Burlington, Ontario, Canada: Boehringer Ingelheim (Canada) Ltd; October 2022.
Topic 9550 Version 291.0

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