Tekturna HCT 150/12.5 - For hypertension: A thiazide plus aliskiren

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Product:

Tekturna HCT 150/12.5

Company:

Novartis

Pharmacologic class:

Antihypertensive (direct renin inhibitor + thiazide)

Active ingredients:

Aliskiren 150 mg, hydrochlorothiazide (HCTZ) 12.5 mg; tabs.

Also:

Tekturna HCT 150/25

Active ingredients:

Aliskiren 150 mg, hydrochlorothiazide 25 mg; tabs.

Also:

Tekturna HCT 300/12.5

Active ingredients:

Aliskiren 300 mg, hydrochlorothiazide 12.5 mg; tabs.

Also:

Tekturna HCT 300/25

Active ingredients:

Aliskiren 300 mg, hydrochlorothiazide 25 mg; tabs.

Indication:

Hypertension.

Pharmacology:

Tekturna HCT combines the antihypertensive drugs aliskiren, a direct renin inhibitor, and the thiazide diuretic, hydrochlorothiazide (HCTZ). Aliskiren decreases plasma renin activity and inhibits the conversion of angiotensinogen to angiotensin I. Thiazide diuretics reduce electrolyte resorption in the renal tubules, resulting in increased diuresis along with electrolyte loss, notably potassium. Drugs that inhibit the renin-angiotensin system tend to blunt the potassium-losing effects of the thiazides.

Clinical trials:

An eight-week, placebo-controlled study involving >2,700 patients with mild to moderate hypertension was conducted to evaluate the safety and efficacy of Tekturna HCT. Various combinations of aliskiren and HCTZ were given once daily to patients in this parallel-group study. The combination of aliskiren and HCTZ resulted in additive decreases in BP at trough compared with placebo. These reductions were greater than those attained with monotherapy.

One trial investigated the addition of 300 mg aliskiren in obese hypertensive patients who did not respond adequately to HCTZ 25 mg and showed decreases of systolic and diastolic BP of approximately 7/4 mmHg.

Additive effects of Tekturna HCT with maximal doses of ACE inhibitors and beta blockers have not been demonstrated.

Adults:

Not for initial therapy. May substitute for previously titrated components, or switch to Tekturna HCT if inadequate response to either therapy alone, or if hypokalemia occurs with HCTZ monotherapy, or if dose- limiting effects occur with either component as monotherapy. Take consistently with regard to meals (absorption reduced by high-fat meals). ³18 years: One tablet once daily. May titrate up if BP uncontrolled after 2-4 weeks; max dose aliskiren 300 mg/HCTZ 25 mg.

Children:

<18 years: not recommended.

Contraindications:

Anuria. Sulfonamide allergy.

Precautions:

Severe renal impairment: not recommended. Severe renal disease. Correct salt/volume depletion before starting, or monitor closely. Hepatic dysfunction. Asthma. SLE. Monitor electrolytes. Pregnancy (Cat. D). Nursing mothers: not recommended.

Interactions:

Lithium toxicity (avoid). Potentiates antihypertensives, possibly nondepolarizing muscle relaxants. Potentiated by ketoconazole, atorvastatin. Antagonized by irbesartan, NSAIDs. May antagonize furosemide. ACTH, corticosteroids increase hypokalemia risk. Adjust antidiabetic drugs. Orthostatic hypotension potentiated by alcohol, CNS depressants.

Adverse reactions:

Dizziness, diarrhea, cough, asthenia, arthralgia, elevated BUN/creatinine, ALT, uric acid; rare: angioedema (discontinue if occurs).

How supplied:

Tabs—30, 90

For more information, call 800.693.9993.

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