Tekturna HCT is indicated for the treatment of hypertension, to lower blood pressure.

A patient whose blood pressure is not adequately controlled with aliskiren alone or HCTZ alone may be switched to combination therapy with Tekturna HCT.

A patient whose blood pressure is controlled with HCTZ alone but who experiences hypokalemia may be switched to combination therapy with Tekturna HCT.

A patient who experiences dose-limiting adverse reactions on either component alone may be switched to Tekturna HCT containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions.

Tekturna HCT may be substituted for the titrated components.

Tekturna HCT may be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.

Do not use aliskiren with ARBs or ACEIs in patients with diabetes.

Tekturna HCT is contraindicated in patients with diabetes who are receiving ARBs or ACEIs because of the increased risk of renal impairment, hyperkalemia, and hypotension. In general, avoid combined use of aliskiren with ACE inhibitors or ARBs, particularly in patients with creatinine clearance (CrCl) less than 60 mL/min.

Tekturna HCT is contraindicated in patients with known anuria or hypersensitivity to sulfonamide-derived drugs like HCTZ or to any of the components. Hypersensitivity reactions may range from urticaria to anaphylaxis.

Symptomatic hypotension may occur after initiation of treatment with Tekturna HCT in patients with marked volume depletion, patients with salt depletion, or with combined use of aliskiren and other agents acting on the renin-angiotensin-aldosterone system (RAAS). The volume or salt depletion should be corrected prior to administration of Tekturna HCT, or the treatment should start under close medical supervision.

Monitor renal function periodically in patients treated with Tekturna HCT. Changes in renal function, including acute renal failure, can be caused by drugs that affect the RAAS and by diuretics.

Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.

Monitor serum potassium periodically in patients receiving aliskiren. Drugs that affect the RAAS can cause hyperkalemia. Risk factors for the development of hyperkalemia include renal insufficiency, diabetes, combination use with ARBs or ACEIs NSAIDs, including selective Cyclooxygenase-2 inhibitors (COX inhibitors), or potassium supplements or potassium-sparing diuretics.

HCTZ can cause hypokalemia and hyponatremia. Hypomagnesemia can result in hypokalemia which appears difficult to treat despite potassium repletion. If hypokalemia is accompanied by clinical signs (e.g., muscular weakness, paresis, or ECG alterations), Tekturna HCT should be discontinued. Correction of hypokalemia and any coexisting hypomagnesemia is recommended prior to the initiation of thiazides.

When aliskiren was given with cyclosporine or itraconazole, the blood concentrations of aliskiren were significantly increased. Avoid concomitant use of aliskiren with cyclosporine or itraconazole.

HCTZ, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma.

HCTZ may alter glucose tolerance and raise serum levels of cholesterol and triglycerides. HCTZ may raise the serum uric acid level due to reduced clearance of uric acid and may cause or exacerbate hyperuricemia and precipitate gout in susceptible patients.

HCTZ decreases urinary calcium excretion and may cause elevations of serum calcium. Monitor calcium levels in patients with hypercalcemia receiving Tekturna HCT.

Hydrochlorothiazide is associated with an increased risk of non-melanoma skin cancer.

In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors with agents that affect the RAAS, including aliskiren, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible.

The antihypertensive effect of aliskiren may be attenuated by NSAIDs.

Avoid co-administration of cyclosporine with aliskiren.

Avoid co-administration of itraconazole with aliskiren.

Antidiabetic drugs (oral agents and insulin): Dosage adjustment of the antidiabetic drug may be required.

Lithium: Diuretic agents increase the risk of lithium toxicity. Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists. Monitoring of serum lithium levels is recommended during concomitant use.

Ion-exchange Resins: Staggering the dosage of HCTZ and ion exchange resins (e.g., cholestyramine, colestipol) such that HCTZ is administered at least 4 hours before or 4 to 6 hours after the administration of resins would potentially minimize the interaction.

Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Tekturna HCT as soon as possible.

Because of the potential for serious adverse reactions, including hypotension, electrolyte imbalances and renal impairment in nursing infants, advise a nursing woman that breastfeeding is not recommended during treatment with Tekturna HCT.

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• Use in patients under 18 years of age. GoToSource

• Bartter syndrome. GoToSource

• Slow progression of HIV-associated nephropathy. GoToSource 

• Improve parasympathetic function in diabetes. GoToSource

Nasopharyngitis (swelling of nasal passages and back of throat), hypokalaemia (low blood potassium level) and hypercholesterolemia (high blood cholesterol level). GoToSource

Fetal toxicity and death. GoToSource

Angioedema (swelling in deep layers of skin). GoToSource

Acute kidney injury. GoToSource

Kidney impairment, hypotension (low blood pressure) and hyperkalemia (high potassium blood levels) when used with angiotensin converting enzyme inhibitors and angiotensin receptor blockers in patients with diabetes. GoToSource 

Ischaemic stroke. GoToSource 

Hypertriglyceridemia (elevated triglyceride levels). GoToSource

Acute-onset bilateral myopia (nearsightedness). GoToSource

Non-melanoma skin cancer. GoToSource

Drug-induced lupus erythematosus. GoToSource

Peripheral edema (swelling) and bronchitis. GoToSource 

Lawsuits filed for strokes, kidney injury and hypotension.