Adult Dosing

Hypertension

• Recommended dose: 600 mg/12.5 mg PO qd in patients who are not volume-depleted; if the antihypertensive effect is inadequate with this dosage, titrate the dose to 600/25 mg PO qd

Note:

• Maximum response occurs in 2-3 wks
• Monotherapy with eprosartan 600 mg PO qd is recommended first

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of hypertension; may be used alone or in combination with other antihypertensives such as calcium channel blockers

• Hypersensitivity to any of the ingredients of the product
• Hypersensitivity to sulfonamides
• Anuria
• Pregnancy
• Co-administration of aliskiren in patients with diabetes

• Drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus when used in pregnancy during the second and third trimesters
• Suspend therapy as soon as possible when pregnancy is detected

Renal Dose Adjustment

• Moderate-severe impairment: No initial dose adjustment is required with maximum dose of eprosartan not exceeding 600 mg PO qd

Hepatic Dose Adjustment

• Hepatic impairment: No dose adjustments

See Supplemental Patient Information

• As drugs that act directly on the renin-angiotensin system can cause fatal/neonatal morbidity/mortality when administered to pregnant women, therapy should be suspended as soon as possible once the pregnancy is detected [US Black Box Warning]
• Hydrochlorothiazide may precipitate azotemia in patients with renal disease. Therefore, use with caution in severe renal disease. Cumulative effects of the drug may develop in patients with impaired renal function
• Use with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma
• Use with caution in patients with or without a history of allergy or bronchial asthma in order to avoid hypersensitivity reactions to hydrochlorothiazide
• Hydrochlorothiazide can cause an idiosyncratic reaction resulting in acute transient myopia and acute angle-closure glaucoma; discontinue hydrochlorothiazide as soon as possible if such reaction occurs
• Avoid concomitant lithium use with thiazides
• Thiazide diuretics may cause exacerbation or activation of systemic lupus erythematosus
• Carefully monitor patients receiving thiazide therapy for clinical signs of fluid or electrolyte imbalance such as hyponatremia, hypochloremic alkalosis, and hypokalemia
• Patients receiving eprosartan/hydrochlorothiazide should be told not to use potassium supplements or salt substitutes containing potassium without consulting their physician
• Carefully adjust dosage of insulin or oral hypoglycemic agents when administering hydrochlorothiazide in diabetic patients
• Thiazides may increase the urinary excretion of magnesium; this may result in hypomagnesemia
• Thiazides may also decrease urinary calcium excretion. Suspend hydrochlorothiazide before carrying out tests for parathyroid function because marked hypercalcemia may be evidence of hidden hyperparathyroidism
• Hydrochlorothiazide may cause increases in cholesterol and triglyceride levels
• Symptomatic hypotension may occur after initiation of eprosartan/hydrochlorothiazide therapy in volume- and/or salt-depleted patients (e.g., those treated with diuretics). Correct these conditions prior to starting therapy with eprosartan/hydrochlorothiazide or start treatment under medical supervision
• Patients with renal artery stenosis may experience acute renal failure. In patients with severe heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment may be associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. Use with caution in severe CHF

Cautions: Use cautiously in

• Severe renal impairment
• Hepatic impairment
• Progressive hepatic disease
• Electrolyte abnormalities
• Post-sympathectomy
• Seizure disorder
• Gestational HTN
• Hx of gout
• Hx of pancreatitis
• Elderly patients

Supplemental Patient Information

• Inform female patients of childbearing age about the consequences of second- and third-trimester exposure to drugs that act on the renin-angiotensin system; instruct them to promptly report pregnancies to their physicians as soon as possible so that treatment may be discontinued under medical supervision
• Caution patients regarding lightheadedness that can occur, particularly during the first days of therapy; advise patients to discontinue therapy until the physician has been consulted if syncope occurs

Pregnancy Category:C (first trimester); D (second and third trimesters)

Breastfeeding: Safety unknown. Hydrochlorothiazide doses of 50 mg daily or less are acceptable during lactation. Intense diuresis with large doses may decrease breastmilk production. No data available regarding the use of eprosartan during breastfeeding; hence, an alternate drug may be preferred, especially while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 31 May 2011). Maternal medication is usually compatible with breastfeeding; no observable change was seen in the nursing infant while the mother was ingesting the compound. This information is based upon data from AAP Policy Guidelines (available at http://aappolicy.aappublications.org/cgi/content/full/pediatrics;108/3/776/T6 last accessed 31 May 2011). Due to the potential for serious adverse reactions in nursing infants, manufacturer recommends discontinuation of nursing or discontinuation of the drug, analyzing the importance of the drug to the mother.

• CV: Tachycardia, palpitation, extrasystoles, bradycardia, abnormal ECG, severe hypotension, peripheral edema
• CNS: Dizziness, vertigo, paresthesia, hypesthesia, depression, insomnia, anxiety, somnolence, restlessness, headache, asthenia
• DERM: Eczema, increased sweating, pruritus, dermatitis, rash, urticaria, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, alopecia, photosensitivity
• EENT: Sinusitis, pharyngitis, rhinitis, conjunctivitis, tinnitus, transient blurred vision, xanthopsia, secondary angle-closure glaucoma
• GI: Nausea, abdominal pain, diarrhea, dyspepsia, gastritis, gastroenteritis, vomiting, pancreatitis, sialadenitis, cramping, constipation, gastric irritation, anorexia
• GU: UTI, hematuria, cystitis, albuminuria, renal failure, renal impairment, interstitial nephritis, impotence, oligohydramnios (in utero exposure)
• REPRODUCTIVE: Fetal/neonatal harm or death (in utero exposure)
• HEMA: Epistaxis, blood dyscrasias, neutropenia, leukopenia, agranulocytosis, aplastic anemia, hemolytic anemia, thrombocytopenia, purpura
• HEPA: Hepatic function impairment, increased transaminase levels
• METABOLIC: Hyperuricemia, hyperglycemia, hypokalemia, increased BUN, increased creatine phosphokinase, hypertriglyceridemia, electrolyte imbalance, glycosuria
• RESP: Upper respiratory tract infection, influenza-like symptoms, bronchitis, cough, dyspnea, respiratory distress including pneumonitis and pulmonary edema
• MUSC: Back pain, fatigue, pain, chest pain, muscle spasm, arthralgia, myalgia, arthrosis, arthritis, leg cramps, rhabdomyolysis
• MISC: Angioedema, sciatica, infection, viral infection, fever, weakness, anaphylactic reactions, necrotizing angiitis

Eprosartan

• Angiotensin II receptor antagonist; blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues
• Bioavailability: 13%
• Metabolized in the liver; CYP450: None
• Excreted in feces (90%) and urine (7%)
• Half-life: 20 hrs

Hydrochlorothiazide

• Thiazide diuretic; increases excretion of sodium and water by inhibiting reabsorption of water and electrolytes from the distal convoluted tubule
• Rapidly absorbed after oral administration
• Metabolism: None
• Excreted mainly unchanged by the kidneys
• Half-life: 5.6-14.8 hrs

US Trade Name(s)

• Teveten HCT

US Availability

Teveten HCT (eprosartan/hydrochlorothiazide)

• TABS:
• 600 mg/12.5 mg
• 600 mg/25 mg

Canadian Trade Name(s)

• Teveten Plus

Canadian Availability

Teveten Plus (eprosartan/hydrochlorothiazide)

• TABS: 600 mg/12.5 mg

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• Teveten Plus

Australian Availability

Teveten Plus (eprosartan/hydrochlorothiazide)

• TABS: 600 mg/12.5 mg

[Outline]

Cardiovascular

Antihypertensive Combinations

Pricing data from www.DrugStore.com in U.S.A.

• Teveten HCT 600-12.5 MG TABS [Bottle] (ABBOTT)
  30 mg = $120.99
  90 mg = $335.97
• Teveten HCT 600-25 MG TABS [Bottle] (ABBOTT)
  30 mg = $109.98
  90 mg = $309.98

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Teveten HCT (eprosartan 600 MG / HCTZ 12.5 MG) Oral Tablet

Ingredient(s): Eprosartan mixture with Hydrochlorothiazide

Imprint: SOLVAY;5147

Color(s): Yellow

Shape: Oval

Size (mm): 20.00

Score: 1

Inactive Ingredient(s): cellulose, microcrystalline / lactose monohydrate / starch, corn / crospovidone / magnesium stearate / water / polyethylene glycol 3350 / talc / polyvinyl alcohol / titanium dioxide / ferric oxide yellow / ferrosoferric oxide

Drug Label Author:
Abbott Laboratories

DEA Schedule:
Non-Scheduled

Drug Name: Teveten HCT (eprosartan 600 MG / HCTZ 25 MG) Oral Tablet

Ingredient(s): Eprosartan mixture with Hydrochlorothiazide

Imprint: SOLVAY;5150

Color(s): Red

Shape: Oval

Size (mm): 20.00

Score: 1

Inactive Ingredient(s): cellulose, microcrystalline / lactose monohydrate / starch, corn / crospovidone / magnesium stearate / water / polyethylene glycol 3350 / titanium dioxide / talc / polyvinyl alcohol / ferric oxide red / ferric oxide yellow

Drug Label Author:
Abbott Laboratories

DEA Schedule:
Non-Scheduled