Aliskiren
Contraindicated
Textbook
Increased risk of hypotension, hyperkalemia, and renal impairment.
Avoid concomitant use.
Source: G&G 14e · p603
Drug reference
Telmisartan + Amlodipine + Hydrochlorothiazide
ARB · Antihypertensive
Also known as Telma AMH, Telsar AMH, Telmikind AMH, Clopivas AMH, Temsan AMH
ARBAntihypertensiveATC C09DX03
CDSCO approvedSchedule HATC C09DX03
- ONSET
- 45min · Telmisartan: 0.5-1 hour; Amlodipine: 2-3 hours (initial effect), 6-12 hours (peak effect); Hydrochlorothiazide: 2 hours
- PEAK
- 45min · Telmisartan: 0.5-1 hour; Amlodipine: 6-12 hours; Hydrochlorothiazide: 4-6 hours
- t½
- 22h · Telmisartan: ~20-24 hours; Amlodipine: ~30-50 hours; Hydrochlorothiazide: ~5.6-14.8 hours
- DURATION
- 9h · Telmisartan: >24 hours; Amlodipine: >24 hours; Hydrochlorothiazide: 6-12 hours
EXCRETION
—
not curated
INTERACTIONS
12 major
incl. contraindicated
PREGNANCY
Contraindicated. Telmisartan is Pregnancy Category D (second and third trimesters) due to fetal toxicity (renal dysfunction, oligohydramnios, fetal death). Amlodipine is Pregnancy Category C. Hydrochlorothiazide is Pregnancy Category B, but generally not recommended due to potential fetal/neonatal jaundice, thrombocytopenia, and other possible adverse reactions. The overall combination is contraindicated during pregnancy.
FDA category + note
Top interactionssee all 12 →
- AliskirenContraindicatedTextbookG&G 14e · p603
- Sacubitril ValsartanContraindicatedTextbookG&G 14e · p602
- Angiotensin Converting Enzyme InhibitorsSevereTextbookHarrison 22e · p2396
- BenazeprilSevereTextbookG&G 14e
Mechanism
Telmisartan is an Angiotensin Receptor Blocker (ARB) that selectively blocks the AT1 receptor, inhibiting the vasoconstrictor and aldosterone-secreting effects of angiotensin II. Amlodipine is a dihydropyridine calcium channel blocker (DHP-CCB) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle, leading to peripheral vasodilation. Hydrochlorothiazide is a thiazide diuretic that inhibits sodium reabsorption in the distal convoluted tubule, increasing the excretion of sodium, chloride, and water. The combination provides synergistic blood pressure reduction by addressing multiple pathways involved in hypertension. Combination rationale: This triple fixed-dose combination provides comprehensive blood pressure control by targeting three distinct physiological mechanisms. It is particularly useful for patients who do not achieve their target blood pressure with dual therapy. The combination improves patient adherence by simplifying the medication regimen, leading to better long-term outcomes in managing hypertension.
Indications
Treatment of essential hypertension in patients whose blood pressure is not adequately controlled on dual therapy (e.g., Telmisartan and Amlodipine, or Telmisartan and Hydrochlorothiazide, or Amlodipine and Hydrochlorothiazide).
Dosing
- Adult
- Standard oral dosing typically ranges from Telmisartan 40mg/Amlodipine 5mg/Hydrochlorothiazide 12.5mg once daily to Telmisartan 80mg/Amlodipine 10mg/Hydrochlorothiazide 25mg once daily. Strengths commonly available in India include 40mg/5mg/12.5mg, 80mg/5mg/12.5mg, 40mg/10mg/12.5mg, 80mg/10mg/12.5mg, 40mg/5mg/25mg, and 80mg/5mg/25mg.…
- Pediatric
- Safety and efficacy have not been established in children and adolescents below 18 years of age. Not recommended for pediatric use.
- Renal adjustment
- Contraindicated in severe renal impairment (creatinine clearance <30 mL/min) or anuria, primarily due to the hydrochlorothiazide component. For patients with moderate renal impairment (CrCl 30-60 mL/min), use with caution and monitor renal function and electrolytes closely. Thiazide diuretics are ineffective in severe renal failure.
- Hepatic adjustment
- Use with extreme caution in mild to moderate hepatic impairment. Contraindicated in severe hepatic impairment, especially due to telmisartan (biliary excretion) and amlodipine (extensive hepatic metabolism).
- Geriatric
- No dose adjustment is generally required, but caution should be exercised due to potentially reduced renal and hepatic function, and increased susceptibility to adverse effects. Start with the lowest effective dose and monitor closely.
- Max dose
- The maximum recommended daily dose is typically Telmisartan 80mg/Amlodipine 10mg/Hydrochlorothiazide 25mg.
Pharmacokinetics
Onset
Telmisartan: 0.5-1 hour; Amlodipine: 2-3 hours (initial effect), 6-12 hours (peak effect); Hydrochlorothiazide: 2 hours
Peak effect
Telmisartan: 0.5-1 hour; Amlodipine: 6-12 hours; Hydrochlorothiazide: 4-6 hours
Duration
Telmisartan: >24 hours; Amlodipine: >24 hours; Hydrochlorothiazide: 6-12 hours
Half-life
Telmisartan: ~20-24 hours; Amlodipine: ~30-50 hours; Hydrochlorothiazide: ~5.6-14.8 hours
Bioavailability
Telmisartan: ~42-58%; Amlodipine: ~64-90%; Hydrochlorothiazide: ~65-75%
Protein binding
Telmisartan: >99.5%; Amlodipine: >97%; Hydrochlorothiazide: 40-68%
Metabolism
Telmisartan: Hepatic, conjugated to an acylglucuronide; Amlodipine: Extensive hepatic metabolism (CYP3A4) to inactive metabolites; Hydrochlorothiazide: Not significantly metabolized
Excretion
Telmisartan: Primarily fecal/biliary (97%); Amlodipine: Primarily renal (60% as metabolites); Hydrochlorothiazide: Primarily renal (95% unchanged)
Contraindications
- Hypersensitivity to telmisartan, amlodipine, hydrochlorothiazide, or other sulfonamide-derived drugs
- Pregnancy and lactation
- Severe hepatic impairment, biliary obstructive disorders
- Severe renal impairment (creatinine clearance <30 ml/min) or anuria
- Refractory hypokalemia, hyponatremia, hypercalcemia
- Symptomatic hypotension
- Obstructive hypertrophic cardiomyopathy and severe aortic stenosis
- Concomitant use with aliskiren in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m2)
Side effects
Common
DizzinessHeadacheFatiguePeripheral edema (less than amlodipine monotherapy)NauseaOrthostatic hypotensionHypokalemiaHyperglycemiaHyperuricemia
Serious
- Angioedema
- Severe hypotension
- Renal impairment/failure
- Electrolyte disturbances (severe hypokalemia, hyponatremia, hypercalcemia)
- Pancreatitis
- Hepatotoxicity
- Blood dyscrasias (e.g., thrombocytopenia, aplastic anemia)
- Stevens-Johnson Syndrome (SJS)
- Acute angle-closure glaucoma (HCTZ)
Pregnancy & lactation
Pregnancy
Contraindicated. Telmisartan is Pregnancy Category D (second and third trimesters) due to fetal toxicity (renal dysfunction, oligohydramnios, fetal death). Amlodipine is Pregnancy Category C. Hydrochlorothiazide is Pregnancy Category B, but generally not recommended due to potential fetal/neonatal jaundice, thrombocytopenia, and other possible adverse reactions. The overall combination is contraindicated during pregnancy.
Lactation
This combination is contraindicated during lactation. Telmisartan and hydrochlorothiazide are known to be excreted in breast milk. Amlodipine excretion into breast milk is unknown, but a risk to the infant cannot be excluded.
Drug interactions
Sacubitril Valsartan
Contraindicated
Textbook
Potentially excessive hypotension, increased risk of adverse effects.
Do not use in conjunction with other ARBs.
Source: G&G 14e · p602
Angiotensin Converting Enzyme Inhibitors
Severe
Textbook
Greater incidence of acute kidney injury (AKI) and adverse cardiac events.
The combination of these two classes should be avoided.
Source: Harrison 22e · p2396
Benazepril
Severe
Textbook
Increased worsening of renal function, hypotension, syncope, and hyperkalemia without increased efficacy.
Not recommended for the treatment of hypertension. Previous studies indicate more harm than benefit.
Source: G&G 14e
Captopril
Severe
Textbook
Increased worsening of renal function, hypotension, syncope, and hyperkalemia without increased efficacy.
Not recommended for the treatment of hypertension. Previous studies indicate more harm than benefit.
Source: G&G 14e
Enalapril
Severe
Textbook
Increased worsening of renal function, hypotension, syncope, and hyperkalemia without increased efficacy.
Not recommended for the treatment of hypertension. Previous studies indicate more harm than benefit.
Source: G&G 14e
Enalaprilat
Severe
Textbook
Increased worsening of renal function, hypotension, syncope, and hyperkalemia without increased efficacy.
Not recommended for the treatment of hypertension. Previous studies indicate more harm than benefit.
Source: G&G 14e
Fosinopril
Severe
Textbook
Increased worsening of renal function, hypotension, syncope, and hyperkalemia without increased efficacy.
Not recommended for the treatment of hypertension. Previous studies indicate more harm than benefit.
Source: G&G 14e
Imidapril
Severe
Textbook
Greater incidence of acute kidney injury (AKI) and adverse cardiac events.
The combination of these two classes should be avoided.
Source: Harrison 22e · p2396
Lisinopril
Severe
Textbook
Increased worsening of renal function, hypotension, syncope, and hyperkalemia without increased efficacy.
Not recommended for the treatment of hypertension. Previous studies indicate more harm than benefit.
Source: G&G 14e
Moexipril
Severe
Textbook
Increased worsening of renal function, hypotension, syncope, and hyperkalemia without increased efficacy.
Not recommended for the treatment of hypertension. Previous studies indicate more harm than benefit.
Source: G&G 14e
Perindopril
Severe
Textbook
Increased worsening of renal function, hypotension, syncope, and hyperkalemia without increased efficacy.
Not recommended for the treatment of hypertension. Previous studies indicate more harm than benefit.
Source: G&G 14e
Related guidelines
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