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Aliskiren and hydrochlorothiazide (United States and Canada: Not available): Drug information

Aliskiren and hydrochlorothiazide (United States and Canada: Not available): Drug information
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For additional information see "Aliskiren and hydrochlorothiazide (United States and Canada: Not available): Patient drug information"

For abbreviations, symbols, and age group definitions show table
ALERT: US Boxed Warning
Fetal toxicity:

When pregnancy is detected, discontinue therapy as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

Brand Names: US
  • Tekturna HCT [DSC]
Pharmacologic Category
  • Antihypertensive;
  • Diuretic, Thiazide;
  • Renin Inhibitor
Dosing: Adult

Note: Tekturna HCT has been discontinued in the United States for >1 year.

Note: Dosage must be individualized. Prior to initiation, correct hypovolemia and/or closely monitor volume status during treatment initiation. Not recommended for use as initial therapy in patients with intravascular volume depletion.

Hypertension

Hypertension: Oral:

Initial therapy or add-on therapy: Aliskiren 150 mg/hydrochlorothiazide 12.5 mg once daily; may titrate after 2- to 4-weeks of therapy. Maximum: Aliskiren 300 mg/hydrochlorothiazide 25 mg per day.

Replacement therapy: Substitute for the individually titrated components. Maximum: Aliskiren 300 mg/hydrochlorothiazide 25 mg per day.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

CrCl ≥30 mL/minute: No dosage adjustment necessary.

CrCl <30 mL/minute: There are no dosage adjustments provided in the manufacturer’s labeling; however, limited data suggests no adjustment necessary for aliskiren (Ref). Risk of hyperkalemia is increased and progressive renal impairment may occur with aliskiren (use with caution). Hydrochlorothiazide is usually ineffective when CrCl <30 mL/minute and is contraindicated in patients who are anuric.

ESRD (requiring hemodialysis): There are no dosage adjustments provided in the manufacturer’s labeling; however, no dosage adjustment necessary for aliskiren (Ref). Risk of hyperkalemia is increased with chronic aliskiren therapy; use with extreme caution. Hydrochlorothiazide is usually ineffective when CrCl <30 mL/minute and is contraindicated in patients who are anuric.

Dosing: Liver Impairment: Adult

No dosage adjustment necessary. Use with caution.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Also see individual agents.

>10%: Renal: Increased blood urea nitrogen (12%)

1% to 10%:

Endocrine & metabolic: Hypokalemia (2%)

Gastrointestinal: Diarrhea (2%)

Hepatic: Increased serum alanine aminotransferase (1%)

Nervous system: Dizziness (2%), vertigo (1%)

Neuromuscular & skeletal: Arthralgia (1%), asthenia (1%)

Respiratory: Cough (1%)

<1%:

Endocrine & metabolic: Hyperkalemia

Hematologic & oncologic: Decreased hematocrit, decreased hemoglobin

Contraindications

Hypersensitivity to aliskiren, hydrochlorothiazide, sulfonamide-derived drugs, or any component of the formulation; anuria; concomitant use with an angiotensin-converting enzyme (ACE) inhibitor or angiotensin-receptor blocker (ARB) in patients with diabetes

Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Note: Although the FDA-approved product labeling states this medication is contraindicated in patients with hypersensitivity to sulfonamide-containing drugs, the scientific basis of this cross-sensitivity has been challenged.

Canadian labeling: Additional contraindications (not in US labeling): History of angioedema with aliskiren, ACE inhibitors, or ARBs; hereditary or idiopathic angioedema; severe progressive renal disease (GFR <30 mL/minute/1.73 m2) and if increasing azotemia and oliguria occur during therapy; use in pregnant or breastfeeding women; hyponatremia, hypercalcemia, symptomatic hyperuricemia, and conditions involving enhanced potassium loss (refractory hypokalemia); concomitant use with ACE inhibitors or ARBs in patients with GFR <60 mL/minute/1.73 m2; hereditary galactose intolerance, congenital lactase deficiency, or glucose-galactose malabsorption; pediatric patients <2 years of age.

Warnings/Precautions

Concerns related to adverse effects:

• Electrolyte disturbances: Hyperkalemia may occur with renin inhibitors; risk increased in patients with renal impairment or diabetes, or concomitant use with ACE inhibitors, ARBs, NSAIDs, potassium-sparing diuretics, potassium supplements, and/or potassium-containing salts. Use cautiously, if at all, with these agents and monitor potassium closely. Thiazide diuretics may cause hypokalemia, hypochloremic alkalosis, hypomagnesemia, and hyponatremia.

• Gout: In certain patients with a history of gout, a familial predisposition to gout, or chronic renal failure, gout can be precipitated by hydrochlorothiazide. This risk may be increased with doses ≥25 mg (Gurwitz 1997).

• Hypersensitivity: Anaphylaxis and angioedema have been reported. Since the effect of aliskiren on bradykinin levels is unknown, the risk of kinin-mediated etiologies of angioedema occurring is also unknown. Use with caution in any patient with a history of angioedema (of any etiology) as angioedema, some cases necessitating hospitalization and intubation, has been observed with aliskiren use. Discontinue immediately following the occurrence of anaphylaxis or angioedema; do not readminister. Prolonged frequent monitoring may be required especially if tongue, glottis, or larynx are involved as they are associated with airway obstruction. Patients with a history of airway surgery may have a higher risk of airway obstruction. Early, aggressive, and appropriate management is critical. Hypersensitivity reactions may also occur with hydrochlorothiazide; risk is increased in patients with a history of allergy or bronchial asthma.

• Hypotension: During the initiation of therapy, symptomatic hypotension may occur, particularly in volume- or salt-depleted patients or with concomitant use of other agents acting on the renin-angiotensin-aldosterone system. Prior to initiation, correct hypovolemia or salt depletion, or closely monitor volume status in patients during treatment initiation. If hypotension does occur, this is not a contraindication for further use; once blood pressure has been stabilized, aliskiren usually can be continued without difficulty.

• Ocular effects: Hydrochlorothiazide may cause acute transient myopia and acute angle-closure glaucoma, typically occurring within hours to weeks following initiation; discontinue therapy immediately in patients with acute decreases in visual acuity or ocular pain. Additional treatments may be needed if uncontrolled intraocular pressure persists. Risk factors may include a history of sulfonamide or penicillin allergy.

• Photosensitivity: Photosensitization may occur with hydrochlorothiazide use.

• Renal effects: Changes in renal function, including acute renal failure, may occur with aliskiren; risk is increased in patients with renal artery stenosis, severe heart failure, post-myocardial infarction, volume depletion, or patients receiving ARB, ACEI or NSAIDs. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function.

• Skin cancer, nonmelanoma: Prolonged use (≥3 years) may increase the risk for squamous cell carcinoma up to 4 times and increase the risk for basal cell carcinoma up to 1.25 times compared to patients not treated with hydrochlorothiazide (Pedersen 2018; Pottegård 2017).

• Sulfonamide (“sulfa”) allergy: The FDA-approved product labeling for many medications containing a sulfonamide chemical group includes a broad contraindication in patients with a prior allergic reaction to sulfonamides. There is a potential for cross-reactivity between members of a specific class (eg, two antibiotic sulfonamides). However, concerns for cross-reactivity have previously extended to all compounds containing the sulfonamide structure (SO2NH2). An expanded understanding of allergic mechanisms indicates cross-reactivity between antibiotic sulfonamides and nonantibiotic sulfonamides may not occur or at the very least this potential is extremely low (Brackett 2004; Johnson 2005; Slatore 2004; Tornero 2004). In particular, mechanisms of cross-reaction due to antibody production (anaphylaxis) are unlikely to occur with nonantibiotic sulfonamides. T-cell-mediated (type IV) reactions (eg, maculopapular rash) are less well understood and it is not possible to completely exclude this potential based on current insights. In cases where prior reactions were severe (Stevens-Johnson syndrome/TEN), some clinicians choose to avoid exposure to these classes.

Disease-related concerns:

• Bariatric surgery: Dehydration: Avoid diuretics in the immediate postoperative period after bariatric surgery; electrolyte disturbances and dehydration may occur. Diuretics may be resumed, if indicated, once oral fluid intake goals are met (Ziegler 2009).

• Diabetes: Use hydrochlorothiazide with caution in patients with prediabetes or diabetes; may see a change in glucose control. Use of aliskiren in patients with diabetes has demonstrated an increased incidence of renal impairment, hypotension, and hyperkalemia; use is contraindicated in patients with diabetes who are taking an ACE inhibitor or ARB.

• Hepatic impairment: Use caution in patients with hepatic impairment. In progressive or severe liver disease, avoid electrolyte and acid/base imbalances that might lead to hepatic encephalopathy/coma.

• Hypercalcemia: Thiazide diuretics may decrease renal calcium excretion; consider avoiding use in patients with hypercalcemia.

• Hypercholesterolemia: Use with caution in patients with moderate or high cholesterol concentrations; increased cholesterol and triglyceride levels have been reported with thiazides.

• Hypovolemia: Avoid use or use a smaller dose in patients who are volume depleted; correct depletion prior to initiating therapy.

• Parathyroid disease: Thiazide diuretics reduce calcium excretion; pathologic changes in the parathyroid glands with hypercalcemia and hypophosphatemia have been observed with prolonged use; should be discontinued prior to testing for parathyroid function.

• Renal impairment: Use aliskiren with caution in patients with renal impairment; risk of developing acute renal failure and hyperkalemia is increased. Thiazide diuretics are not recommended in patients with CrCl <30 mL/minute, loop diuretics are preferred over thiazides. Cumulative effects may develop, including azotemia, in patients with impaired renal function. Avoid concomitant use with an ACE inhibitor or ARB in patients with CrCl <60 mL/minute.

• Systemic lupus erythematosus (SLE): Hydrochlorothiazide can cause SLE exacerbation or activation.

Special populations:

• Pregnancy: [US Boxed Warning]: Drugs that act on the renin-angiotensin system can cause injury and death to the developing fetus. Discontinue as soon as possible once pregnancy is detected.

Product Availability

Tekturna HCT has been discontinued in the United States for >1 year.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet, Oral:

Tekturna HCT: Aliskiren 150 mg and hydrochlorothiazide 25 mg [DSC], Aliskiren 300 mg and hydrochlorothiazide 25 mg [DSC], Aliskiren 150 mg and hydrochlorothiazide 12.5 mg [DSC], Aliskiren 300 mg and hydrochlorothiazide 12.5 mg [DSC] [contains wheat]

Generic Equivalent Available: US

No

Pricing: US

Tablets (Tekturna HCT Oral)

300-12.5 mg (per each): $13.46

300-25 mg (per each): $13.46

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Administer at the same time daily with or without a meal, but consistent administration with regards to meals is recommended.

Use: Labeled Indications

Hypertension: Management of hypertension

Medication Safety Issues
Older Adult: High-Risk Medication:

Beers Criteria: Diuretics (hydrochlorothiazide) are identified in the Beers Criteria as potentially inappropriate medications to be used with caution in patients 65 years and older due to the potential to cause or exacerbate syndrome of inappropriate antidiuretic hormone secretion (SIADH) or hyponatremia; monitor sodium concentration closely when initiating or adjusting the dose in older adults (Beers Criteria [AGS 2023]).

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Agents with Clinically Relevant Anticholinergic Effects: May increase serum concentration of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor

Ajmaline: Sulfonamides may increase adverse/toxic effects of Ajmaline. Specifically, the risk for cholestasis may be increased. Risk C: Monitor

Alcohol (Ethyl): May increase orthostatic hypotensive effects of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor

Alfuzosin: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Allopurinol: Thiazide and Thiazide-Like Diuretics may increase hypersensitivity effects of Allopurinol. Risk C: Monitor

Amifostine: Blood Pressure Lowering Agents may increase hypotensive effects of Amifostine. Management: When used at chemotherapy doses, hold blood pressure lowering medications for 24 hours before amifostine administration. If blood pressure lowering therapy cannot be held, do not administer amifostine. Use caution with radiotherapy doses of amifostine. Risk D: Consider Therapy Modification

Aminolevulinic Acid (Systemic): Photosensitizing Agents may increase photosensitizing effects of Aminolevulinic Acid (Systemic). Risk X: Avoid

Aminolevulinic Acid (Topical): Photosensitizing Agents may increase photosensitizing effects of Aminolevulinic Acid (Topical). Risk C: Monitor

Amphetamines: May decrease antihypertensive effects of Antihypertensive Agents. Risk C: Monitor

Angiotensin II Receptor Blockers: Aliskiren may increase nephrotoxic effects of Angiotensin II Receptor Blockers. Aliskiren may increase hyperkalemic effects of Angiotensin II Receptor Blockers. Aliskiren may increase hypotensive effects of Angiotensin II Receptor Blockers. Management: Aliskiren use with ACEIs or ARBs in patients with diabetes is contraindicated. Combined use in other patients should be avoided, particularly when CrCl is less than 60 mL/min. If combined, monitor potassium, creatinine, and blood pressure closely. Risk D: Consider Therapy Modification

Angiotensin-Converting Enzyme Inhibitors: Aliskiren may increase hyperkalemic effects of Angiotensin-Converting Enzyme Inhibitors. Aliskiren may increase nephrotoxic effects of Angiotensin-Converting Enzyme Inhibitors. Aliskiren may increase hypotensive effects of Angiotensin-Converting Enzyme Inhibitors. Management: Aliskiren use with ACEIs or ARBs in patients with diabetes is contraindicated. Combined use in other patients should be avoided, particularly when CrCl is less than 60 mL/min. If combined, monitor potassium, creatinine, and blood pressure closely. Risk D: Consider Therapy Modification

Antidiabetic Agents: Hyperglycemia-Associated Agents may decrease therapeutic effects of Antidiabetic Agents. Risk C: Monitor

Antidiabetic Agents: Thiazide and Thiazide-Like Diuretics may decrease therapeutic effects of Antidiabetic Agents. Risk C: Monitor

Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may increase hypotensive effects of Antipsychotic Agents (Second Generation [Atypical]). Risk C: Monitor

Arginine: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Arsenic Trioxide: Thiazide and Thiazide-Like Diuretics may increase hypotensive effects of Arsenic Trioxide. Thiazide and Thiazide-Like Diuretics may increase QTc-prolonging effects of Arsenic Trioxide. Management: When possible, avoid concurrent use of arsenic trioxide with drugs that can cause electrolyte abnormalities, such as the thiazide and thiazide-like diuretics. Risk D: Consider Therapy Modification

Barbiturates: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Benperidol: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Beta2-Agonists: May increase hypokalemic effects of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor

Bile Acid Sequestrants: May decrease absorption of Thiazide and Thiazide-Like Diuretics. Management: Separate administration of bile acid sequestrants and oral thiazide diuretics by at least 4 hours. Monitor for decreased therapeutic effects of thiazide diuretics if coadministered with a bile acid sequestrant. Risk D: Consider Therapy Modification

Brigatinib: May decrease antihypertensive effects of Antihypertensive Agents. Brigatinib may increase bradycardic effects of Antihypertensive Agents. Risk C: Monitor

Brimonidine (Topical): May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Bromperidol: May decrease hypotensive effects of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may increase hypotensive effects of Bromperidol. Risk X: Avoid

Calcium Salts: Thiazide and Thiazide-Like Diuretics may increase serum concentration of Calcium Salts. Risk C: Monitor

Cardiac Glycosides: Thiazide and Thiazide-Like Diuretics may increase adverse/toxic effects of Cardiac Glycosides. Specifically, cardiac glycoside toxicity may be enhanced by the hypokalemic and hypomagnesemic effect of thiazide diuretics. Risk C: Monitor

Corticosteroids (Systemic): May increase hypokalemic effects of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor

CycloPHOSphamide: Thiazide and Thiazide-Like Diuretics may increase adverse/toxic effects of CycloPHOSphamide. Specifically, granulocytopenia may be enhanced. Risk C: Monitor

CycloSPORINE (Systemic): May increase serum concentration of Aliskiren. Risk X: Avoid

Desmopressin: Hyponatremia-Associated Agents may increase hyponatremic effects of Desmopressin. Risk C: Monitor

Dexketoprofen: May increase adverse/toxic effects of Sulfonamides. Risk C: Monitor

Dexmethylphenidate: May decrease therapeutic effects of Antihypertensive Agents. Risk C: Monitor

Diacerein: May increase therapeutic effects of Diuretics. Specifically, the risk for dehydration or hypokalemia may be increased. Risk C: Monitor

Diazoxide Choline: May increase adverse/toxic effects of Thiazide and Thiazide-Like Diuretics. Specifically, the hyperglycemic and hyperuricemic effects may be increased. Risk C: Monitor

Diazoxide: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Diazoxide: Thiazide and Thiazide-Like Diuretics may increase adverse/toxic effects of Diazoxide. Risk C: Monitor

Dichlorphenamide: Thiazide and Thiazide-Like Diuretics may increase hypokalemic effects of Dichlorphenamide. Risk C: Monitor

Dofetilide: HydroCHLOROthiazide may increase QTc-prolonging effects of Dofetilide. HydroCHLOROthiazide may increase serum concentration of Dofetilide. Risk X: Avoid

Drospirenone-Containing Products: May increase hyperkalemic effects of Aliskiren. Risk C: Monitor

DULoxetine: Blood Pressure Lowering Agents may increase hypotensive effects of DULoxetine. Risk C: Monitor

EPINEPHrine (Systemic): Diuretics may increase arrhythmogenic effects of EPINEPHrine (Systemic). Diuretics may decrease vasopressor effects of EPINEPHrine (Systemic). Risk C: Monitor

Flunarizine: May increase therapeutic effects of Antihypertensive Agents. Risk C: Monitor

Furosemide: Aliskiren may decrease serum concentration of Furosemide. Risk C: Monitor

Grapefruit Juice: May decrease serum concentration of Aliskiren. Risk C: Monitor

Heparins (Low Molecular Weight): May increase hyperkalemic effects of Aliskiren. Risk C: Monitor

Herbal Products with Blood Pressure Increasing Effects: May decrease antihypertensive effects of Antihypertensive Agents. Risk C: Monitor

Herbal Products with Blood Pressure Lowering Effects: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Hypotension-Associated Agents: Blood Pressure Lowering Agents may increase hypotensive effects of Hypotension-Associated Agents. Risk C: Monitor

Iloperidone: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Indoramin: May increase hypotensive effects of Antihypertensive Agents. Risk C: Monitor

Ipragliflozin: May increase adverse/toxic effects of Thiazide and Thiazide-Like Diuretics. Specifically, the risk for intravascular volume depletion may be increased. Risk C: Monitor

Isocarboxazid: May increase antihypertensive effects of Antihypertensive Agents. Risk X: Avoid

Isocarboxazid: May increase hypotensive effects of Diuretics. Risk X: Avoid

Itraconazole: May increase serum concentration of Aliskiren. Risk X: Avoid

Ivabradine: Thiazide and Thiazide-Like Diuretics may increase arrhythmogenic effects of Ivabradine. Risk C: Monitor

Levodopa-Foslevodopa: Blood Pressure Lowering Agents may increase hypotensive effects of Levodopa-Foslevodopa. Risk C: Monitor

Levosulpiride: Thiazide and Thiazide-Like Diuretics may increase adverse/toxic effects of Levosulpiride. Risk X: Avoid

Licorice: May increase hypokalemic effects of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor

Lithium: Thiazide and Thiazide-Like Diuretics may decrease excretion of Lithium. Management: Reduce the lithium dose if coadministered with thiazide or thiazide-like diuretics. Monitor serum lithium levels during coadministration with thiazide and thiazide-like diuretics. Risk D: Consider Therapy Modification

Lonafarnib: May increase serum concentration of P-glycoprotein/ABCB1 Substrates (High risk with Inhibitors). Risk C: Monitor

Loop Diuretics: May increase hypotensive effects of Antihypertensive Agents. Risk C: Monitor

Lormetazepam: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Lumacaftor and Ivacaftor: May increase serum concentration of P-glycoprotein/ABCB1 Substrates (High risk with Inhibitors or Inducers). Lumacaftor and Ivacaftor may decrease serum concentration of P-glycoprotein/ABCB1 Substrates (High risk with Inhibitors or Inducers). Risk C: Monitor

Mecamylamine: Thiazide and Thiazide-Like Diuretics may increase adverse/toxic effects of Mecamylamine. Management: Consider avoiding the use of mecamylamine and thiazide diuretics. If combined, mecamylamine prescribing information suggests reducing the mecamylamine dose by 50% in order to avoid excessive hypotension. Risk D: Consider Therapy Modification

Metergoline: May decrease antihypertensive effects of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may increase orthostatic hypotensive effects of Metergoline. Risk C: Monitor

Methenamine: Thiazide and Thiazide-Like Diuretics may decrease therapeutic effects of Methenamine. Risk C: Monitor

Methotrexate: HydroCHLOROthiazide may increase nephrotoxic effects of Methotrexate. Risk C: Monitor

Methoxsalen (Systemic): Photosensitizing Agents may increase photosensitizing effects of Methoxsalen (Systemic). Risk C: Monitor

Methylphenidate: May decrease antihypertensive effects of Antihypertensive Agents. Risk C: Monitor

Molsidomine: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Multivitamins/Fluoride (with ADE): May increase hypercalcemic effects of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor

Multivitamins/Minerals (with ADEK, Folate, Iron): Thiazide and Thiazide-Like Diuretics may increase hypercalcemic effects of Multivitamins/Minerals (with ADEK, Folate, Iron). Risk C: Monitor

Multivitamins/Minerals (with AE, No Iron): Thiazide and Thiazide-Like Diuretics may increase serum concentration of Multivitamins/Minerals (with AE, No Iron). Specifically, thiazide diuretics may decrease the excretion of calcium, and continued concomitant use can also result in metabolic alkalosis. Risk C: Monitor

Naftopidil: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Neuromuscular-Blocking Agents (Nondepolarizing): Thiazide and Thiazide-Like Diuretics may increase neuromuscular-blocking effects of Neuromuscular-Blocking Agents (Nondepolarizing). Risk C: Monitor

Nicergoline: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Nicorandil: May increase hyperkalemic effects of Aliskiren. Risk C: Monitor

Nirmatrelvir and Ritonavir: May increase serum concentration of Aliskiren. Risk X: Avoid

Nitroprusside: Blood Pressure Lowering Agents may increase hypotensive effects of Nitroprusside. Risk C: Monitor

Nonsteroidal Anti-Inflammatory Agents (Topical): May decrease therapeutic effects of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor

Nonsteroidal Anti-Inflammatory Agents: May increase nephrotoxic effects of Aliskiren. Nonsteroidal Anti-Inflammatory Agents may decrease antihypertensive effects of Aliskiren. Risk C: Monitor

Obinutuzumab: May increase hypotensive effects of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Risk D: Consider Therapy Modification

Opioid Agonists: May increase adverse/toxic effects of Diuretics. Opioid Agonists may decrease therapeutic effects of Diuretics. Risk C: Monitor

P-glycoprotein/ABCB1 Inducers: May decrease serum concentration of Aliskiren. Risk C: Monitor

P-glycoprotein/ABCB1 Inhibitors: May increase serum concentration of Aliskiren. Risk C: Monitor

Palopegteriparatide: Thiazide and Thiazide-Like Diuretics may increase therapeutic effects of Palopegteriparatide. Thiazide and Thiazide-Like Diuretics may decrease therapeutic effects of Palopegteriparatide. Risk C: Monitor

Pentoxifylline: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Perazine: May increase hypotensive effects of Antihypertensive Agents. Risk C: Monitor

Pholcodine: Blood Pressure Lowering Agents may increase hypotensive effects of Pholcodine. Risk C: Monitor

Phosphodiesterase 5 Inhibitors: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Piperacillin: May increase hypokalemic effects of Diuretics. Risk C: Monitor

Polyethylene Glycol-Electrolyte Solution: Diuretics may increase nephrotoxic effects of Polyethylene Glycol-Electrolyte Solution. Risk C: Monitor

Porfimer: Photosensitizing Agents may increase photosensitizing effects of Porfimer. Risk X: Avoid

Potassium Salts: May increase hyperkalemic effects of Aliskiren. Risk C: Monitor

Potassium-Sparing Diuretics: May increase hyperkalemic effects of Aliskiren. Risk C: Monitor

Prazosin: Antihypertensive Agents may increase hypotensive effects of Prazosin. Risk C: Monitor

Promazine: Thiazide and Thiazide-Like Diuretics may increase QTc-prolonging effects of Promazine. Risk X: Avoid

Prostacyclin Analogues: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Quinagolide: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Reboxetine: May increase hypokalemic effects of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor

Selective Serotonin Reuptake Inhibitor: May increase hyponatremic effects of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor

Silodosin: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Sodium Phosphates: Diuretics may increase nephrotoxic effects of Sodium Phosphates. Specifically, the risk of acute phosphate nephropathy may be enhanced. Risk C: Monitor

Sotagliflozin: HydroCHLOROthiazide may decrease therapeutic effects of Sotagliflozin. Sotagliflozin may decrease serum concentration of HydroCHLOROthiazide. Risk C: Monitor

Sparsentan: May increase adverse/toxic effects of Aliskiren. Risk X: Avoid

Terazosin: Antihypertensive Agents may increase hypotensive effects of Terazosin. Risk C: Monitor

Topiramate: Thiazide and Thiazide-Like Diuretics may increase hypokalemic effects of Topiramate. Thiazide and Thiazide-Like Diuretics may increase serum concentration of Topiramate. Risk C: Monitor

Toremifene: Thiazide and Thiazide-Like Diuretics may increase hypercalcemic effects of Toremifene. Risk C: Monitor

Urapidil: Antihypertensive Agents may increase hypotensive effects of Urapidil. Risk C: Monitor

Verteporfin: Photosensitizing Agents may increase photosensitizing effects of Verteporfin. Risk C: Monitor

Vimseltinib: May increase serum concentration of P-glycoprotein/ABCB1 Substrates (High risk with Inhibitors). Management: Avoid concomitant use of vimseltinib and P-gp substrates when possible. If combined, administer vimseltinib at least 4 hours before the P-gp substrate. Risk D: Consider Therapy Modification

Vitamin D Analogs: Thiazide and Thiazide-Like Diuretics may increase hypercalcemic effects of Vitamin D Analogs. Risk C: Monitor

Food Interactions

See individual agents.

Pregnancy Considerations

[US Boxed Warning]: Drugs that act on the renin-angiotensin system can cause injury and death to the developing fetus. Discontinue as soon as possible once pregnancy is detected. See individual agents for additional information.

Breastfeeding Considerations

Hydrochlorothiazide is excreted in breast milk. It is not known if aliskiren is excreted in breast milk. Due to the potential for serious adverse reactions in the nursing infant, breast-feeding is not recommended by the manufacturer. See individual agents.

Dietary Considerations

May be taken with or without food; however, a high-fat meal reduces absorption. Consistent administration with regards to meals is recommended.

Monitoring Parameters

Blood pressure; serum electrolytes, BUN, serum creatinine; fluid status

Mechanism of Action

Aliskiren: Decreases plasma renin activity and inhibits conversion of angiotensinogen to angiotensin I.

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

Pharmacokinetics (Adult Data Unless Noted)

See individual agents.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Rasilez hct;
  • (AT) Austria: Rasilez hct;
  • (BD) Bangladesh: Rasilez hct;
  • (BE) Belgium: Rasilez hct;
  • (BG) Bulgaria: Rasilez hct;
  • (BR) Brazil: Rasilez hct;
  • (CH) Switzerland: Rasilez hct;
  • (CL) Chile: Rasilez D;
  • (CO) Colombia: Rasilez hct;
  • (CZ) Czech Republic: Rasilez hct;
  • (DE) Germany: Rasilez hct;
  • (DO) Dominican Republic: Rasilez hct;
  • (EC) Ecuador: Rasilez hct;
  • (ES) Spain: Rasilez hct;
  • (FR) France: Rasilez hct;
  • (GR) Greece: Rasilez hct;
  • (HK) Hong Kong: Rasilez hct;
  • (ID) Indonesia: Rasilez hct;
  • (IE) Ireland: Rasilez hct;
  • (IN) India: Rasilez hct;
  • (IT) Italy: Rasilez hct;
  • (KW) Kuwait: Rasilez hct;
  • (LB) Lebanon: Rasilez hct;
  • (LU) Luxembourg: Rasilez hct;
  • (MX) Mexico: Rasilles HCT;
  • (MY) Malaysia: Rasilez hct;
  • (NL) Netherlands: Rasilez hct;
  • (NO) Norway: Rasilez hct;
  • (PE) Peru: Rasilez hct;
  • (PH) Philippines: Rasilez hct;
  • (PK) Pakistan: Cardiogin hct | Cozide | Philcor hct | Rasilez hct | Renikren h | Stay h | Yahtin h;
  • (PR) Puerto Rico: Tekturna hct;
  • (PT) Portugal: Rasilez hct;
  • (RU) Russian Federation: Co rasilez;
  • (SG) Singapore: Rasilez hct;
  • (SI) Slovenia: Rasilez hct;
  • (SK) Slovakia: Rasilez hct;
  • (TH) Thailand: Rasilez hct;
  • (VE) Venezuela, Bolivarian Republic of: Rasilez hct
  1. 2023 American Geriatrics Society Beers Criteria Update Expert Panel. American Geriatrics Society 2023 updated AGS Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2023;71(7):2052-2081. doi:10.1111/jgs.18372 [PubMed 37139824]
  2. Brackett CC, Singh H, Block JH. Likelihood and mechanisms of cross-allergenicity between sulfonamide antibiotics and other drugs containing a sulfonamide functional group. Pharmacotherapy. 2004;24(7):856-870. [PubMed 15303450]
  3. Gurwitz JH, Kalish SC, Bohn RL, et al. Thiazide diuretics and the initiation of anti-gout therapy. J Clin Epidemiol. 1997;50(8):953-959. [PubMed 9291881]
  4. Johnson KK, Green DL, Rife JP, Limon L. Sulfonamide cross-reactivity: fact or fiction? [published correction appears in Ann Pharmacother. 2005;39(7-8):1373]. Ann Pharmacother. 2005;39(2):290-301. [PubMed 15644481]
  5. Khadzhynov D, Slowinski T, Lieker I, et al. Pharmacokinetics of aliskiren in patients with end-stage renal disease undergoing haemodialysis. Clin Pharmacokinet. 2012;51(10):661-669. [PubMed 23018529]
  6. Pedersen SA, Gaist D, Schmidt SAJ, Hölmich LR, Friis S, Pottegård A. Hydrochlorothiazide use and risk of nonmelanoma skin cancer: a nationwide case-control study from Denmark. J Am Acad Dermatol. 2018;78(4):673-681. doi: 10.1016/j.jaad.2017.11.042. [PubMed 29217346]
  7. Pottegård A, Hallas J, Olesen M, et al. Hydrochlorothiazide use is strongly associated with risk of lip cancer. J Intern Med. 2017;282(4):322-331. doi: 10.1111/joim.12629. [PubMed 28480532]
  8. Rasilez HCT (aliskiren/hydrochlorothiazide) [product monograph]. Dublin, Ireland: Noden Pharma DAC; August 2019.
  9. Slatore CG, Tilles SA. Sulfonamide hypersensitivity. Immunol Allergy Clin North Am. 2004;24(3):477-490. [PubMed 15242722]
  10. Tekturna HCT (aliskiren/hydrochlorothiazide) [prescribing information]. Orlando, FL: Noden Pharma USA Inc; September 2020.
  11. Tornero P, De Barrio M, Baeza ML, Herrero T. Cross-reactivity among p-amino group compounds in sulfonamide fixed drug eruption: diagnostic value of patch testing. Contact Dermatitis. 2004;51(2):57-62. [PubMed 15373844]
  12. Vaidyanathan S, Bigler H, Yeh C, et al. Pharmacokinetics of the oral direct renin inhibitor aliskiren alone and in combination with irbesartan in renal impairment. Clin Pharmacokinet. 2007;46(8):661-675. [PubMed 17655373]
  13. Ziegler O, Sirveaux MA, Brunaud L, et al. Medical follow up after bariatric surgery: nutritional and drug issues. General recommendations for the prevention and treatment of nutritional deficiencies. Diabetes Metab. 2009;35(6, pt 2):544-557. doi: 10.1016/S1262-3636(09)73464-0. [PubMed 20152742]
Topic 9238 Version 300.0