Pronunciation:

(tel mi SAR tan & hye droe klor oh THYE a zide)

U.S. Brand Names:

Synonyms:

Generic Available:

Canadian Brand Names:

Use:

Pregnancy Risk Factor:

Pregnancy Implications:

Telmisartan: C (1st trimester); D (2nd and 3rd trimesters): Discontinue as soon as possible when pregnancy is detected. Drugs that act directly on renin-angiotensin can cause fetal and neonatal morbidity and death. Adverse effects to the fetus appear to be limited to the 2nd and 3rd trimesters.

Hydrochlorothiazide: B (per manufacturer); D (based on expert analysis): Although there are no adequate and well-controlled studies using hydrochlorothiazide in pregnancy, thiazide diuretics may cause an increased risk of congenital defects. Hypoglycemia, hypokalemia, hyponatremia, jaundice, and thrombocytopenia are also reported as possible complications to the fetus or newborn.

Lactation:

Contraindications:

Warnings/Precautions:

Telmisartan: Deterioration in renal function can occur with initiation. Use with caution in unilateral renal artery stenosis and pre-existing renal insufficiency; significant aortic/mitral stenosis

Hydrochlorothiazide: Hepatic coma can be caused by electrolyte disturbances in patients with severe hepatic dysfunction. Can cause SLE exacerbation or activation. Hypersensitivity reactions can occur and may be more likely in patients with bronchial asthma. Gout can be precipitated in certain patients with a history of gout, a familial predisposition to gout, or chronic renal failure. Electrolyte disturbances (hypokalemia, hypochloremic alkalosis, hypomagnesemia, hypercalcemia, hyponatremia) can occur. Cautious use in diabetics; may see a change in glucose control. Avoid in severe renal disease (ineffective), may precipitate azotemia; discontinue or consider withholding if renal impairment occurs. Use with caution in patients with moderate or high cholesterol concentrations; increased cholesterol and triglyceride concentrations have been reported with thiazides. Photosensitization may occur. Chemical similarities are present among sulfonamides, sulfonylureas, carbonic anhydrase inhibitors, thiazides, and loop diuretics (except ethacrynic acid). Use in patients with sulfonamide allergy is specifically contraindicated in product labeling, however, a risk of cross-reaction exists in patients with allergy to any of these compounds; avoid use when previous reaction has been severe.

Adverse Reactions:

2% to 10%:

Central nervous system: Dizziness (5%)

Gastrointestinal: Diarrhea (3%), nausea (2%)

Renal: BUN increased (3%)

Respiratory: Upper respiratory tract infection (8%), sinusitis (4%)

Miscellaneous: Flu-like syndrome (2%)

<2%: Abdominal pain, back pain, bilirubin increased, bronchitis, dyspepsia, hematocrit decreased, hemoglobin decreased, hypokalemia, liver enzymes increased, pharyngitis, postural hypotension, rash, serum creatinine increased, tachycardia, vomiting; rhabdomyolysis has been reported (rarely) with angiotensin-receptor antagonists

Overdosage/Toxicology:

Telmisartan: Information is limited; expected symptoms would be dizziness, hypotension, and tachycardia; bradycardia may also occur. Treatment is supportive. Not removed by hemodialysis.

Hydrochlorothiazide: Hypochloremia, hypokalemia, hyponatremia, and dehydration may occur. Treatment is supportive.

Drug Interactions:

Also see individual agents.

Ethanol/Nutrition/Herb Interactions:

Stability:

Mechanism of Action:

Telmisartan: Telmisartan is an angiotensin 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 as well as water are reabsorbed. The end result is an elevation in blood pressure. Telmisartan binds to the AT1 angiotensin II receptor. This binding prevents angiotensin II from binding to the receptor thereby blocking the vasoconstriction and the aldosterone secreting effects of angiotensin II.

Hydrochlorothiazide: Inhibits sodium reabsorption in the distal tubules causing increased excretion of sodium and water as well as potassium and hydrogen ions

Pharmacodynamics/Kinetics:

Dosage:

Patients currently on telmisartan: Initial dose if blood pressure is not currently controlled on monotherapy of 80 mg telmisartan: Telmisartan 80 mg/hydrochlorothiazide 12.5 mg once daily; may titrate up to telmisartan 160 mg/hydrochlorothiazide 25 mg if needed

Patients currently on HCTZ: Initial dose if blood pressure is not currently controlled on monotherapy of 25 mg once daily: Telmisartan 80 mg/hydrochlorothiazide 12.5 mg once daily or telmisartan 80 mg/hydrochlorothiazide 25 mg once daily; may titrate up to telmisartan 160 mg/hydrochlorothiazide 25 mg if blood pressure remains uncontrolled after 2-4 weeks of therapy. Patients who develop hypokalemia may be switched to telmisartan 80 mg/hydrochlorothiazide 12.5 mg.

Dosage adjustment in renal impairment:

Clcr >30 mL/minute: Usual recommended dose

Clcr 30 mL/minute: Not recommended

Dosage adjustment in hepatic impairment: Dosing should be started at telmisartan 40 mg/hydrochlorothiazide 12.5 mg; do not use in patients with severe hepatic impairment

Elderly: No dosing adjustment needed based on age; monitor renal and hepatic function

Monitoring Parameters:

Dietary Considerations:

Patient Education:

Nursing Implications:

Cardiovascular Considerations:

Dental Health: Effects on Dental Treatment:

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

Mental Health: Effects on Mental Status:

Mental Health: Effects on Psychiatric Treatment:

Dosage Forms:

40/12.5: Telmisartan 40 mg and hydrochlorothiazide 12.5 mg

80/12.5: Telmisartan 80 mg and hydrochlorothiazide 12.5 mg

80/25: Telmisartan 80 mg and hydrochlorothiazide 25 mg

International Brand Names: