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Telmisartan + Hydrochlorothiazide

ARB · Antihypertensive

Also known as Telmikind-H, Telsartan-H, Telista-H, Telma-H, Zilpres-H

ARBAntihypertensiveATC C09DA07
CDSCO approvedSchedule HATC C09DA07
Pharmacokineticsplasma · t hours
3hONSET45minPEAK22h9hDURATION
ONSET
3h · Telmisartan: Within 3 hours; Hydrochlorothiazide: Within 2 hours.
PEAK
45min · Telmisartan: 0.5-1 hour; Hydrochlorothiazide: Approximately 4 hours.
22h · Telmisartan: Approximately 20-24 hours; Hydrochlorothiazide: 5.6-14.8 hours.
DURATION
9h · Telmisartan: >24 hours; Hydrochlorothiazide: 6-12 hours.
EXCRETION
not curated
INTERACTIONS
12 major
incl. contraindicated
PREGNANCY
Category D. Use in the second and third trimesters of pregnancy is contraindicated as it can cause fetal injury or death (renal dysfunction, oligohydramnios, skull hypoplasia, anuria) due to the telmisartan component. Hydrochlorothiazide can also cross the placenta and is associated with fetal or neonatal jaundice, thrombocytopenia, and electrolyte disturbances.
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 II receptor blocker (ARB) that selectively blocks the AT1 receptor, preventing angiotensin II from binding and exerting its vasoconstrictor and aldosterone-secreting effects. This leads to vasodilation, reduced systemic vascular resistance, and decreased blood pressure. Hydrochlorothiazide is a thiazide diuretic that inhibits the reabsorption of sodium and chloride ions in the distal convoluted tubule, leading to increased excretion of sodium, chloride, and water, thereby reducing plasma volume and blood pressure. The combination provides additive antihypertensive effects and the ARB helps to counteract the potassium-wasting effect and sympathetic activation induced by the diuretic. Combination rationale: The combination of Telmisartan and Hydrochlorothiazide offers complementary mechanisms of action, providing synergistic blood pressure reduction often superior to either agent alone. Telmisartan effectively blocks the renin-angiotensin-aldosterone system, while Hydrochlorothiazide enhances sodium and water excretion. This FDC improves patient compliance due to fewer pills and is particularly useful when monotherapy fails to achieve target blood pressure.

Indications

Treatment of essential hypertension in adults where monotherapy with telmisartan or hydrochlorothiazide does not adequately control blood pressure.

Dosing

Adult
Initial: Telmisartan 40 mg/Hydrochlorothiazide 12.5 mg orally once daily. If blood pressure remains uncontrolled after 2-4 weeks, the dose may be increased to Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg or Telmisartan 80 mg/Hydrochlorothiazide 25 mg once daily. Common strengths available in India are Telmisartan 40mg/HCTZ 12.5mg, Telmisartan 80mg/HCTZ 12.5mg, and Telmisartan 80mg/HCTZ 25mg.
Pediatric
Safety and efficacy in children and adolescents below 18 years of age have not been established. Therefore, use in pediatric patients is not recommended and is generally contraindicated.
Renal adjustment
Contraindicated in severe renal impairment (creatinine clearance <30 mL/min) due to the hydrochlorothiazide component. For patients with mild to moderate renal impairment (creatinine clearance 30-80 mL/min), no initial dose adjustment is generally needed, but close monitoring of renal function and electrolytes is recommended.
Hepatic adjustment
Contraindicated in severe hepatic impairment, biliary obstructive disorders. For mild to moderate hepatic impairment, dose adjustment may be necessary for telmisartan, with a maximum dose of 40 mg telmisartan once daily for telmisartan monotherapy. Use of the FDC is not recommended in these patients unless strictly necessary and with close monitoring.
Geriatric
No dosage adjustment is generally required based solely on age. However, caution is advised, and monitoring of renal function and electrolytes is important, especially in elderly patients with potential underlying renal impairment. Starting with a lower dose may be prudent.
Max dose
Telmisartan 80 mg/Hydrochlorothiazide 25 mg once daily.

Pharmacokinetics

Onset
Telmisartan: Within 3 hours; Hydrochlorothiazide: Within 2 hours.
Peak effect
Telmisartan: 0.5-1 hour; Hydrochlorothiazide: Approximately 4 hours.
Duration
Telmisartan: >24 hours; Hydrochlorothiazide: 6-12 hours.
Half-life
Telmisartan: Approximately 20-24 hours; Hydrochlorothiazide: 5.6-14.8 hours.
Bioavailability
Telmisartan: 42-58% (dose-dependent); Hydrochlorothiazide: 60-80%.
Protein binding
Telmisartan: >99.5%; Hydrochlorothiazide: 40-68%.
Metabolism
Telmisartan: Minimally metabolized by conjugation to a pharmacologically inactive acylglucuronide; Hydrochlorothiazide: Not significantly metabolized.
Excretion
Telmisartan: Primarily via bile into feces (>97%); Hydrochlorothiazide: Primarily unchanged via urine (approximately 50-75%).

Contraindications

  • Hypersensitivity to telmisartan, hydrochlorothiazide, or any sulfonamide-derived drugs. Severe hepatic impairment, biliary obstructive disorders, or anuria. Severe renal impairment (creatinine clearance <30 mL/min). Refractory hypokalemia, hyponatremia, hypercalcemia, and symptomatic hyperuricemia. Second and third trimesters of pregnancy. Concomitant use with aliskiren in patients with diabetes mellitus or renal impairment (GFR <60 mL/min/1.73 m2).

Side effects

Common
DizzinessFatigueHeadacheNauseaDiarrheaUpper respiratory tract infectionSinusitisCoughBack painHypokalemiaHyperuricemiaHyperglycemiaMuscle cramps
Serious
  • Angioedema
  • Hypotension
  • Syncope
  • Acute renal failure
  • Electrolyte imbalances (e.g., severe hypokalemia, hyponatremia)
  • Pancreatitis
  • Blood dyscrasias (e.g., thrombocytopenia, leukopenia)
  • Hepatotoxicity
  • Stevens-Johnson syndrome (SJS)
  • Toxic epidermal necrolysis (TEN)
  • Acute myopia and secondary angle-closure glaucoma

Pregnancy & lactation

Pregnancy

Category D. Use in the second and third trimesters of pregnancy is contraindicated as it can cause fetal injury or death (renal dysfunction, oligohydramnios, skull hypoplasia, anuria) due to the telmisartan component. Hydrochlorothiazide can also cross the placenta and is associated with fetal or neonatal jaundice, thrombocytopenia, and electrolyte disturbances.

Lactation

Contraindicated. Telmisartan is excreted in the milk of lactating rats, and it is unknown if it is excreted in human milk. Hydrochlorothiazide is excreted in human milk and may suppress lactation. Due to the potential for serious adverse effects in the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Drug interactions

Aliskiren
Contraindicated
Textbook

Increased risk of hypotension, hyperkalemia, and renal impairment.

Avoid concomitant use.

Source: G&G 14e · p603

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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