Renal Dose Adjustment (Based on CrCl)
- <30 mL/min: Not recommended
Hepatic Dose Adjustment
- Hepatic impairment: Use with caution; no dose adjustments
See Supplemental Patient Information
- Drugs that act directly on the renin-angiotensin system may cause injury and death to the developing fetus. Therapy should be discontinued as soon as possible if pregnancy is detected.
- Hypersensitivity reactions such as anaphylactic reactions and angioedema of the face, extremities, lips, tongue, glottis and/or larynx requiring hospitalization and intubation may occur in patients treated with this drug. This may occur at any time during treatment and may occur in patients with and without a history of angioedema with ACE inhibitors or angiotensin receptor antagonists. Airway obstruction may occur and can be fatal if angioedema involves the throat, tongue, glottis or larynx, or if the patient has a history of upper respiratory surgery. Immediately discontinue this drug in patients who develop angioedema, and do not readminister
- Symptomatic hypotension may occur in volume and/or salt depleted patients receiving high doses of diuretics; correct these conditions prior to administration of this drug or initiate the treatment under close medical supervision. On excessive fall in blood pressure, place the patient in the supine position and if necessary administer IV infusion of normal saline
- This drug is not recommended in patients with severe renal impairment (GFR <30 mL/min). Slowly uptitrate this drug in patients with renal disease. Thiazide component is associated with precipitation of azotemia. Cumulative effects of the drug may occur in patients with impaired renal function
- Minor alterations of fluid and electrolyte balance may precipitate hepatic coma; uptitrate slowly in patients with hepatic impairment
- Hypersensitivity reactions associated with hydrochlorothiazide component may occur in patients with or without a history of allergy or bronchial asthma but are more likely in patients having such a history
- Thiazide component of this drug is associated with exacerbation or activation of systemic lupus erythematosus
- Avoid administration of lithium with this drug
- At appropriate intervals periodically determine serum electrolytes to detect possible electrolyte imbalance. The intervals must be based on the history of electrolyte abnormalities in patients with aliskiren or hydrochlorothiazide monotherapy. Concurrent use of this drug with potassium sparing diuretics, potassium supplements, salt substitutes containing potassium, or other drugs that increase potassium levels may lead to increases in serum potassium
- Information is unavailable on the use of this drug in patients with unilateral or bilateral renal artery stenosis or stenosis of the artery to a solitary kidney
- Avoid concurrent use of this drug with cyclosporine or itraconazole
Cautions: Use cautiously in
- Severe renal impairment
- Renal artery stenosis
- History of renal disease
- Hepatic impairment
- Progressive hepatic disease
- Diabetes mellitus
- Volume depleted patients
- Electrolyte abnormalities
- Post-sympathectomy
- History of asthma
- SLE
- History of gout
Supplemental Patient Information
- Advise patients to discontinue therapy and notify a doctor as soon as possible if pregnancy is detected, as this medication can cause injury and death to the fetus
- May be taken with or without food; however, a high-fat meal reduces absorption. Consistent administration with regards to meals is recommended
Pregnancy Category:D
Breastfeeding: Hydrochlorothiazide doses of 
50 mg/day are acceptable during lactation. Intense diuresis with higher doses may decrease breastmilk production. This information is (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 26 May 2011). This combination drug exhibits potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother.
US Trade Name(s)
US Availability
Tekturna HCT (aliskiren/hydrochlorothiazide)
- TABS:
- 150 mg/12.5 mg
- 150 mg/25 mg
- 300 mg/12.5 mg
- 300 mg/25 mg
Canadian Trade Name(s)
Canadian Availability
Tekturna HCT (aliskiren/hydrochlorothiazide)
- TABS:
- 150 mg/12.5 mg
- 150 mg/25 mg
- 300 mg/12.5 mg
- 300 mg/25 mg
UK Trade Name(s)
UK Availability
Australian Trade Name(s)
Australian Availability
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Tekturna HCT 300-25 MG TABS [Bottle] (NOVARTIS)
30 mg = $123.41
90 mg = $341.66
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
