hydrochlorothiazide/aliskiren (Rx)

Brand and Other Names:Tekturna HCT
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

hydrochlorothiazide/aliskiren

tablet

  • 12.5mg/150mg
  • 12.5mg/300mg
  • 25mg/150mg
  • 25mg/300mg
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Hypertension

Add-on or initial therapy: Initiate with 12.5 mg/150 mg PO qDay; after 2-4 weeks, may increase dose if needed; not to exceed 25 mg/300 mg

Add-on therapy: Initiate by adding lowest available dose of alternative component (hydrochlorothiazide 12.5 mg or aliskiren 150 mg)

Replacement therapy: May be substituted for individually titrated components

Renal Impairment

CrCl <30 mL/min: Use caution; hydrochlorothiazide usually ineffective when CrCl <30 mL/min and contraindicated in anuric patients; hyperkalemia and progressive renal dysfunction may occur with aliskiren

CrCl ≥30 mL/min: Dose adjustment not necessary

Hepatic Impairment

Dose adjustment not necessary

Safety and efficacy not established

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Interactions

Interaction Checker

and hydrochlorothiazide/aliskiren

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Adverse reactions reported with combination product and individual agents

            >10%

            Increased BUN

            1-10%

            Dizziness (2%)

            Vertigo (1%)

            Hypokalemia (2%)

            Increased uric acid level (2%)

            Hyperkalemia (1%)

            Diarrhea (2%)

            Increased ALT (1%)

            Flu-like syndrome (2%)

            Cough (1%)

            Weakness (1%)

            Arthralgia (1%)

            Aliskiren

            • Diarrhea (2.3%)
            • Cough (1.1%)
            • Rash (1%)
            • Increased creatinine kinase (1%)
            • Increased BUN (≤ 7%)
            • Hyperkalemia (≤1%)

            <1%

            Decreased hematocrit

            Decreased hemoglobin

            Aliskiren

            • Gastroesophageal reflux
            • Periorbital edema
            • Toxic epiderma necrolysis
            • Increased uric acid
            • Severe hypotension
            • Stevens Johnson syndrome

            Frequency Not Defined

            Hydrochlorothiazide

            • AnorexiaEpigastric distress
            • Hypotension
            • Orthostatic hypotension
            • Photosensitivity
            • Anaphylaxis
            • Anemia
            • Confusion
            • Erythema multiforme
            • Stevens-Johnson syndrome
            • Exfoliative dermatitis including toxic epidermal necrolysis
            • Dizziness
            • Hypokalemia and/or hypomagnesemia
            • Hyperuricemia
            • Headache

            Postmarketing Reports

            Aliskiren

            • Nausea/vomiting
            • Hyponatremia
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            Warnings

            Black Box Warnings

            Discontinue as soon as possible when pregnancy is detected; affects renin-angiotensin system causing oligohydramnios, which may result in fetal injury and/or death

            Contraindications

            Hypersensitivity to aliskiren, hydrochlorothiazide, or sulfonamides

            Anuria

            Concomitant use with ACEIs or ARBs in patients with diabetes

            Cautions

            Caution in volume- or salt-depleted patients

            Not for initial treatment

            Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported with aliskiren, necessitating hospitalization and intubation; may occur at any time during treatment and has occurred with and without a history of angioedema with ACE inhibitors or angiotensin receptor antagonist; patients who experience these effects, even without respiratory distress, require prolonged observation and appropriate monitoring measures; treatment with antihistamines and corticosteroids may not be sufficient to prevent respiratory involvement; prompt administration of subcutaneous epinephrine solution 1:1000 (0.3 mL to 0.5 mL) and measures to ensure a patent airway may be necessary; discontinue therapy immediately in patients who develop anaphylactic reactions or angioedema, and do not readminister

            Acute transient myopia and acute angle-closure glaucoma has been reported, particularly with history of sulfonamide or penicillin allergy (hydrochlorothiazide is a sulfonamide)

            Patients whose renal function may depend in part on activity of renin-angiotensin‐ aldosterone system (RAAS; e.g., patients with renal artery stenosis, severe heart failure, postmyocardial infarction or volume depletion) or patients receiving ARB, ACE inhibitors or nonsteroidal anti-inflammatory drug (NSAID), including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors), therapy may be at particular risk of developing acute renal failure; monitor renal function periodically; consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function

            Hydrochlorothiazide can cause hypokalemia and hyponatremia; hypomagnesemia can also result in hypokalemia

            Preclinical studies indicate a potential for substantial increase in exposure to aliskiren in pediatric patients

            If patient becomes pregnant, discontinue therapy; patient should inform doctor right away; therapy is not for patients who plan to become pregnant

            Symptomatic hypotension may occur after initiation of treatment 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); volume or salt depletion should be corrected prior to administration of therapy, or treatment should start under close medical supervision; a transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once blood pressure has stabilized

            Coadministration with ACE inhibitors or ARBs

            • When aliskiren was prescribed with ACE inhibitors or angiotensin receptor blockers (ARBs) in the ALTITUDE study, an increased incidence of nonfatal stroke, renal complications, hyperkalemia, and hypotension was observed after 18-24 months
            • The ALTITUDE trial included patients with hypertension plus type 2 diabetes and renal impairment who were at high risk of cardiovascular and renal events
            • Coadministration of aliskiren with angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) in patients with diabetes or kidney (renal) impairment; their use is contraindicated in patients with diabetes
            • Avoid use of aliskiren with ARBs or ACEIs in moderate to severe renal impairment (ie, GFR <60 mL/min)
            • Hyperkalemia: Increases in serum potassium >5.5 mEq/L were infrequent with aliskiren (0.9% compared to 0.6% with placebo); however, when used in combination with an ACE inhibitor in a diabetic population, increases in serum potassium were more frequent (5.5%)
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            Pregnancy & Lactation

            Pregnancy

            Hypertension in pregnancy increases maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage); hypertension increases fetal risk for intrauterine growth restriction and intrauterine death; pregnant women with hypertension should be carefully monitored and managed accordingly

            Aliskiren

            • Use of drugs that act on renin-angiotensin system in second and third trimesters of pregnancy can result in reduced fetal renal function leading to anuria and renal failure, oligohydramnios, fetal lung hypoplasia and skeletal deformations, including skull hypoplasia, hypotension, and death
            • In patients taking this combination drug during pregnancy, perform serial ultrasound examinations to assess intra-amniotic environment; fetal testing may be appropriate, based on the week of gestation; patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury; closely observe infants with histories of in utero exposure to the drug combination for hypotension, oliguria, and hyperkalemia; if oliguria or hypotension occur in neonates with a history of in utero exposure to the drug combination, support blood pressure and renal perfusion; exchange transfusions or dialysis may be required as a means of reversing hypotension and substituting for disordered renal function

            Lactation

            Limited published studies report that hydrochlorothiazide is present in human milk; however, there is insufficient information to determine the effects hydrochlorothiazide on the breastfed infant or effects of hydrochlorothiazide on milk production; because of 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 therapy

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Hydrochlorothiazide: Thiazide diuretic; affects renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride

            Aliskiren: Direct renin inhibitor; decreases plasma renin activity and inhibits conversion of angiotensinogen to angiotensin I

            Pharmacokinetics

            Hydrochlorothiazide

            • Half-Life: 6-15 hr
            • Bioavailability: 70%
            • Onset: 2 hr (diuresis); 4-6 hr (peak effect)
            • Duration: 6-12 hr (diuresis); 1 wk (HTN)
            • Vd: 3.6-7.8 L/kg
            • Peak Plasma:1.5-2.5 hr
            • Protein Bound: 68%
            • Metabolism: Minimally metabolized
            • Clearance: 335 mL/min
            • Excretion: Urine 50-70%
            • Dialyzable: No
            • Aliskiren: 1 hr

            Aliskiren

            • Onset: Within 2 weeks
            • Bioavailability: 3%
            • Peak Plasma Time: 1-3 hr
            • Metabolism: Metabolized by CYP3A4
            • Half-Life: 24 hr
            • Excretion: Urine (25% as parent compound in urine)
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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
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