Aliskiren/hydrochlorothiazide

What Is Aliskiren/hydrochlorothiazide?

Aliskiren/hydrochlorothiazide (Tekturna HCT) s a combination of aliskiren, a renin inhibitor, and hydrochlorothiazide (HCTZ), a thiazide diuretic.

What are the uses of this medicine?

This medicine is indicated for the treatment of hypertension, to lower blood pressure:

• In patients not adequately controlled with monotherapy.
• As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.

How does this medicine work?

Aliskiren

• Aliskiren is a direct renin inhibitor, decreasing plasma renin activity (PRA) and inhibiting the conversion of angiotensinogen to Ang I.

Hydrochlorothiazide (HCTZ)

• HCTZ is a thiazide diuretic.
• Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts.

• The renin-aldosterone link is mediated by angiotensin II, so coadministration of agents that block the production or function of angiotensin II tends to reverse the potassium loss associated with these diuretics.

Who Should Not Use this medicine?

This medicine cannot be used in:

• In patients with diabetes
• In patients with known anuria or hypersensitivity to sulfonamide-derived drugs like HCTZ or to any of the components

Is this medicine FDA approved?

• It was approved for use in the United States in 2008.

How should this medicine be used?

• The recommended once-daily doses of Tekturna HCT in order of increasing mean effect are 150/12.5 mg, 150/25 mg or 300/12.5 mg, and 300/25 mg.
• Initiate with 150/12.5mg daily.
• Take Tekturna HCT once each day, about the same time each day.
• Take Tekturna HCT the same way every day, either with or without a meal.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• 150 mg/12.5 mg tablets
• 150 mg/25 mg tablets
• 300 mg/12.5 mg tablets
• 300 mg/25 mg tablets

What side effects can this medication cause?

Common possible side effects of this medicine include:

• dizziness
• flu-like symptoms
• diarrhea
• cough
• tiredness
• high levels of potassium in the blood (hyperkalemia)
• vertigo
• arthralgia

Tekturna HCT may cause serious side effects:

• Harm to an unborn baby, causing injury or death
• Severe Allergic Reactions and Angioedema (hypersensitivity)
• Low blood pressure (hypotension)
• Renal Impairment or Failure
• Tekturna HCT may affect your potassium levels
• Allergic reactions
• Active or Worsened Systemic Lupus Erythematosus (SLE)
• Eye problems

What special precautions should I follow?

• Monitor serum creatinine periodically
• Monitor potassium levels periodically
• 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
• Discontinue Tekturna HCT immediately in patients who develop anaphylactic reactions or angioedema, and do not readminister
• Symptomatic hypotension may occur
• Monitor renal function periodically in patients treated with Tekturna HCT

What to do in case of emergency/overdose?

Aliskiren

• The most likely manifestation of overdosage would be hypotension.
• If symptomatic hypotension should occur, supportive treatment should be initiated.
• Aliskiren is poorly dialyzed.
• Therefore, hemodialysis is not adequate for overdosage.

Hydrochlorothiazide (HCTZ)

• The most common signs and symptoms of overdose observed in humans are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis.
• If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias.
• The degree to which HCTZ is removed by hemodialysis has not been established.

Can this medicine be used in pregnancy?

• Tekturna HCT can cause fetal harm when administered to a pregnant woman.
• When pregnancy is detected, discontinue Tekturna HCT as soon as possible.

Can this medicine be used in children?

• Safety and effectiveness of Tekturna HCT in pediatric patients have not been established.

What should I know about storage and disposal of this medication?

• Store Tekturna HCT tablets at room temperature between 59°F to 86°F (15°C to 30°C).
• Keep Tekturna HCT in the original prescription bottle in a dry place. Do not remove the desiccant (drying agent) from the bottle.

• Dailymed label info on Aliskiren/hydrochlorothiazide
• FDA Aliskiren/hydrochlorothiazide