Adult Dosing
Treatment of hypertension
- 1 tab PO qd
- Increase dose after 2 wks of therapy
- Max dose: 10/25/320 mg (amlodipine/hydrochlorothiazide/valsartan)
Notes:- Use the drug as add-on/switch therapy for patients not adequately controlled on any two of the following antihypertensive classes: calcium channel blockers, angiotensin receptor blockers, and diuretics
- May be substituted for its individually titrated components for patients on amlodipine, valsartan and hydrochlorothiazide
- The full blood pressure lowering effect has been achieved 2 wks after being on the maximal dose
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
Renal Dose Adjustment (Based on CrCl)
Hepatic Dose Adjustment
- Mild-moderate impairment: Use with caution
- Severe impairment: Avoid use
See Supplemental Patient Information
- Therapy can harm fetus on administration to a pregnant woman. Use of ACE inhibitor during the second and third trimesters of pregnancy is associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death
- Excessive hypotension, including orthostatic hypotension has occurred in patients with moderate to severe uncomplicated hypertension. On occurrence of excessive hypotension place the patient in a supine position and, if necessary, give an IV infusion of normal saline
- Correct symptomatic hypotension occurring in patients receiving angiotensin receptor blockers before initiation of therapy
- Use of this drug is not evaluated in patients with heart failure, recent myocardial infarction, or in patients undergoing surgery or dialysis
- Avoid initiating treatment in patients with aortic, mitral stenosis or obstructive hypertrophic cardiomyopathy
- Exacerbation of angina or acute myocardial infarction may develop on initiation or increasing dose of amlodipine, especially in patients with severe obstructive coronary artery disease
- Avoid usage in patients with severe hepatic impairment. Monitor patients with mild-to-moderate hepatic impairment, including patients with biliary obstructive disorders for worsening of hepatic or renal function, including fluid status, electrolytes, and adverse reactions when administering this drug
- Anticipate changes in renal function in susceptible individuals. Oliguria, progressive azotemia and rare occasions of acute renal failure and/or death have occurred in patients with severe heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system being treated with angiotensin-converting enzyme inhibitors and angiotensin receptor antagonists
- Avoid usage in patients with severe renal disease. Use of this drug in patients with a recent kidney transplant or heart failure is not evaluated
- Hypersensitivity reactions to hydrochlorothiazide are more likely in patients with a history of allergy or bronchial asthma
- Exacerbation or activation of systemic lupus erythematosus have occurred
- Increased risk of lithium toxicity reported, hence monitor serum lithium concentrations during concurrent use
- Elevations of serum creatinine, BUN have occurred. Monitor serum creatinine, BUN, potassium periodically. Monitor patients for worsening of renal and liver functions
- Closely monitor patients, and conduct follow up for fluid status, electrolytes, renal function, and blood pressure in patients with heart failure
- Periodically monitor serum electrolytes based on the use of this drug and other factors such as renal function, other medications, or history of prior electrolyte imbalances
- Hydrochlorothiazide may cause idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma; discontinue treatment as rapidly as possible
Cautions: Use cautiously in
- Renal impairment
- Renal artery stenosis
- Hyponatremia
- Hepatic impairment
- Diabetes mellitus
- Volume depletion
- CHF
- Post-MI
- Severe CAD
- Aortic stenosis
- Mitral stenosis
- Hypertrophic cardiomyopathy
- Post-sympathectomy
- History of asthma
- Systemic lupus erythematosus
- Surgery
- Gout
- Geriatrics
Supplemental Patient Information
- Apprise patients about the potential hazard to the fetus if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug
- Inform patients that therapy can cause serious problems in the fetus and infant including low blood pressure, poor development of skull bones, kidney failure and death. Instruct women undergoing therapy with the drug to consult physician on becoming pregnant
- Inform patients to report prescribing physician on occurrence of lightheadedness. Warn patients to discontinue therapy until physician has been consulted on occurrence of syncope
- Caution patients that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure
- Advise patients to avoid using potassium supplements or salt substitutes containing potassium without consulting the prescribing physician
Pregnancy Category:D
Breastfeeding: Prefer an alternative drug during breastfeeding as appropriate literature on the use of amlodipine/valsartan is unavailable. 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 27 December 2010). Unknown whether amlodipine and valsartan are excreted in human milk, but thiazides are excreted in human milk. 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
amlodipine/hydrochlorothiazide/valsartan (generic)
- TABS:
- 5 mg/12.5 mg/160 mg
- 5 mg/25 mg/160 mg
- 10 mg/12.5 mg/160 mg
- 10 mg/25 mg/160 mg
- 10 mg/25 mg/320 mg
Exforge HCT (amlodipine/hydrochlorothiazide/valsartan)
- TABS:
- 5 mg/12.5 mg/160 mg
- 5 mg/25 mg/160 mg
- 10 mg/12.5 mg/160 mg
- 10 mg/25 mg/160 mg
- 10 mg/25 mg/320 mg
Canadian Trade Name(s)
Canadian Availability
UK Trade Name(s)
UK Availability
Australian Trade Name(s)
Australian Availability
Exforge HCT (amlodipine/hydrochlorothiazide/valsartan)
- TABS:
- 5 mg/12.5 mg/160 mg
- 5 mg/25 mg/160 mg
- 10 mg/12.5 mg/160 mg
- 10 mg/25 mg/160 mg
- 10 mg/25 mg/320 mg
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Exforge HCT 5-160-12.5 MG TABS [Bottle] (NOVARTIS)
30 mg = $117.99
90 mg = $341.97 - Exforge HCT 5-160-25 MG TABS [Bottle] (NOVARTIS)
30 mg = $119.99
90 mg = $339.99 - Exforge HCT 10-160-12.5 MG TABS [Bottle] (NOVARTIS)
30 mg = $128.99
90 mg = $372.95
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.