TEVETEN HCT

Clinical safety rating: caution

Comprehensive clinical and safety monograph for TEVETEN HCT (TEVETEN HCT).

How it works

TEVETEN HCT combines eprosartan mesylate, an angiotensin II receptor antagonist, and hydrochlorothiazide, a thiazide diuretic. Eprosartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively antagonizing the AT1 receptor. Hydrochlorothiazide inhibits the sodium-chloride symporter in the distal convoluted tubule, increasing excretion of sodium, chloride, and water, thereby reducing plasma volume.

What the body does with it

Metabolism	Eprosartan is primarily metabolized by glucuronidation (UGTs) and is not significantly metabolized by CYP450 enzymes. Hydrochlorothiazide is not metabolized and is excreted unchanged in urine.
Excretion	Eprosartan: renal (70% unchanged, 10% as metabolite), biliary/fecal (20%); Hydrochlorothiazide: renal (≥95% unchanged).
Half-life	Eprosartan: 5-9 hours; Hydrochlorothiazide: 6-15 hours; allows once-daily dosing.
Protein binding	Eprosartan: 98% (albumin); Hydrochlorothiazide: 40-68% (albumin).
Volume of Distribution	Eprosartan: 0.15 L/kg (limited tissue distribution); Hydrochlorothiazide: 3-4 L/kg (wide distribution).
Bioavailability	Eprosartan: 13% (oral); Hydrochlorothiazide: 65-75% (oral).
Onset of Action	Eprosartan: 1-2 hours (oral); Hydrochlorothiazide: 2 hours (oral).
Duration of Action	Eprosartan: 24 hours; Hydrochlorothiazide: 6-12 hours; clinical effect persists 24 hours with combination.

Classification & Brands

Dosing & administration

One tablet orally once daily, containing eprosartan 600 mg and hydrochlorothiazide 12.5 mg or 25 mg, with or without food. Maximum dose: eprosartan 600 mg/hydrochlorothiazide 25 mg per day.

Dosage form	TABLET
Renal impairment	Contraindicated in severe renal impairment (CrCl <30 mL/min). For CrCl 30-60 mL/min, no dose adjustment required but use with caution. For CrCl <30 mL/min, not recommended.
Liver impairment	No specific dose adjustment for mild to moderate hepatic impairment (Child-Pugh A or B). Use with caution in severe hepatic impairment (Child-Pugh C); not studied.
Pediatric use	Safety and effectiveness in pediatric patients (<18 years) have not been established. Not recommended.
Geriatric use	Start with the lower dose (eprosartan 600 mg/hydrochlorothiazide 12.5 mg) due to increased risk of orthostatic hypotension, electrolyte imbalance, and renal impairment. Monitor renal function and electrolytes frequently.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for TEVETEN HCT (TEVETEN HCT).

Breastfeeding	Excretion in breast milk is unknown for eprosartan; hydrochlorothiazide appears in low amounts. M/P ratio not established. Avoid use while breastfeeding due to potential adverse effects on infant renal function and electrolyte balance.
Teratogenic Risk	First trimester: Potential risk based on drugs acting on renin-angiotensin system (RAS); fetal renal development may be affected. Second and third trimesters: Known to cause fetal renal dysfunction, oligohydramnios, skull ossification defects, and neonatal hypotension. Contraindicated after first trimester.

Warnings & precautions

■ FDA Black Box Warning

None

Side Effect Profile

Serious Effects

Absolute Contraindications

["Anuria","Hypersensitivity to eprosartan, hydrochlorothiazide, or sulfonamide-derived drugs","Pregnancy (second and third trimesters)","Severe renal impairment (CrCl <30 mL/min)"]

Clinical Precautions

Precautions

["Fetal/neonatal morbidity and mortality when used in pregnancy (second and third trimesters)","Hypotension in volume-depleted patients","Impaired renal function, including acute renal failure","Electrolyte imbalances (hyperkalemia, hyponatremia, hypomagnesemia, hypochloremic alkalosis)","Exacerbation of renal impairment in bilateral renal artery stenosis","Sulfonamide allergy (hydrochlorothiazide is a sulfonamide derivative)"]

Clinical Tips & Counseling

Drug interactions

Loading safety data…

TEVETEN HCT

Clinical safety rating: caution

Comprehensive clinical and safety monograph for TEVETEN HCT (TEVETEN HCT).

How it works

What the body does with it

Metabolism	Eprosartan is primarily metabolized by glucuronidation (UGTs) and is not significantly metabolized by CYP450 enzymes. Hydrochlorothiazide is not metabolized and is excreted unchanged in urine.
Excretion	Eprosartan: renal (70% unchanged, 10% as metabolite), biliary/fecal (20%); Hydrochlorothiazide: renal (≥95% unchanged).
Half-life	Eprosartan: 5-9 hours; Hydrochlorothiazide: 6-15 hours; allows once-daily dosing.
Protein binding	Eprosartan: 98% (albumin); Hydrochlorothiazide: 40-68% (albumin).
Volume of Distribution	Eprosartan: 0.15 L/kg (limited tissue distribution); Hydrochlorothiazide: 3-4 L/kg (wide distribution).
Bioavailability	Eprosartan: 13% (oral); Hydrochlorothiazide: 65-75% (oral).
Onset of Action	Eprosartan: 1-2 hours (oral); Hydrochlorothiazide: 2 hours (oral).
Duration of Action	Eprosartan: 24 hours; Hydrochlorothiazide: 6-12 hours; clinical effect persists 24 hours with combination.

Classification & Brands

Dosing & administration

One tablet orally once daily, containing eprosartan 600 mg and hydrochlorothiazide 12.5 mg or 25 mg, with or without food. Maximum dose: eprosartan 600 mg/hydrochlorothiazide 25 mg per day.

Dosage form	TABLET
Renal impairment	Contraindicated in severe renal impairment (CrCl <30 mL/min). For CrCl 30-60 mL/min, no dose adjustment required but use with caution. For CrCl <30 mL/min, not recommended.
Liver impairment	No specific dose adjustment for mild to moderate hepatic impairment (Child-Pugh A or B). Use with caution in severe hepatic impairment (Child-Pugh C); not studied.
Pediatric use	Safety and effectiveness in pediatric patients (<18 years) have not been established. Not recommended.
Geriatric use	Start with the lower dose (eprosartan 600 mg/hydrochlorothiazide 12.5 mg) due to increased risk of orthostatic hypotension, electrolyte imbalance, and renal impairment. Monitor renal function and electrolytes frequently.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for TEVETEN HCT (TEVETEN HCT).

Breastfeeding	Excretion in breast milk is unknown for eprosartan; hydrochlorothiazide appears in low amounts. M/P ratio not established. Avoid use while breastfeeding due to potential adverse effects on infant renal function and electrolyte balance.
Teratogenic Risk	First trimester: Potential risk based on drugs acting on renin-angiotensin system (RAS); fetal renal development may be affected. Second and third trimesters: Known to cause fetal renal dysfunction, oligohydramnios, skull ossification defects, and neonatal hypotension. Contraindicated after first trimester.

Warnings & precautions

■ FDA Black Box Warning

None

Side Effect Profile

Serious Effects

Absolute Contraindications

["Anuria","Hypersensitivity to eprosartan, hydrochlorothiazide, or sulfonamide-derived drugs","Pregnancy (second and third trimesters)","Severe renal impairment (CrCl <30 mL/min)"]