Label Changes for:

Exforge HCT (amlodipine/valsartan/hydrochlorothiazide) Tablets

March 2014

Changes have been made to the PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) 

 

March 2014

ADVERSE REACTIONS

Post-Marketing Experience
  • Dermatologic: bullous dermatitis

DRUG INTERACTIONS

  • Lithium: Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium angiotensin II receptor antagonists, including valsartan. Monitor serum lithium levels is during concomitant use.

 

September 2012 

4 CONTRAINDICATIONS

  • Do not use in patients with anuria, hypersensitivity to other sulfonamide-derived drugs or hypersensitivity to any component of this product.

5 WARNINGS AND PRECAUTIONS

5.3 Risk of Myocardial Infarction or Increased Angina
  • Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine, particularly in patients with severe obstructive coronary artery disease
5.5 Potassium abnormalities
  • Some patients with heart failure have developed increases in potassium on valsartan. These effects are usually minor and transient, and they are more likely to occur in patients with pre-existing renal impairment. Dosage reduction and/or discontinuation of the diuretic and/or valsartan may be required.
5.9 Metabolic Imbalances
  • Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides.
  • Hydrochlorothiazide may raise the serum uric acid level due to reduced clearance of uric acid and may cause or exacerbate hyperuricemia and precipitate gout in susceptible patients.
  • Hydrochlorothiazide decreases urinary calcium excretion and may cause elevations of serum calcium. Monitor calcium levels in patients with hypercalcemia receiving Exforge HCT

6 ADVERSE REACTIONS

6.2 Postmarketing Experience

Valsartan

  • Hypersensitivity: There are rare reports of angioedema. Some of these patients previously experience angioedema with other drugs including ACE inhibitors. Exforge HCT should not be re-administered to patients who have had angioedema.

7 DRUG INTERACTIONS

7.1 Drug/Drug Interactions

Simvastatin: Co-administration of simvastatin with amlodipine increases the systemic exposure of simvastatin. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily.

CYP3A4 Inhibitors: Co-administration with CYP3A4 inhibitors (moderate and strong) result in increased systemic exposure to amlodipine warranting dose reduction. Monitor for symptoms of hypotension and edema when amlodipine is co-administered with CYP3A4 inhibitors to determine the need for dose adjustment.

CYP3A4 Inducers: No information is available on the quantitative effects of CYP3A4 inducers on amlodipine. Blood pressure should be monitored when amlodipine is coadministered with CYP3A4 inducers.

Valsartan Potassium: Concomitant use of valsartan with other agents that block the reninangiotensin system, potassium sparing diuretics (e.g., spironolactone, triamterene,amiloride), potassium supplements, or salt substitutes containing potassium may lead toincreases in serum potassium and in heart failure patients to increases in serum creatinine.

If co-medication is considered necessary, monitoring of serum potassium is advisable 

8 USE IN SPECIFIC POPULATIONS

8.5 Geriatric Use
  • Exposure to amlodipine is increased in elderly patients, thus consider lower initial doses of Exforge HCT [see Clinical Pharmacology (12.3)].
8.7 Hepatic Impairment

Amlodipine

Exposure to amlodipine is increased in patients with hepatic insufficiency, thus consider using lower doses of Exforge HCT [see Clinical Pharmacology (12.3)]

Valsartan

No dose adjustment is necessary for patients with mild-to-moderate disease. No dosing recommendations can be provided for patients with severe liver disease

17 PATIENT COUNSELING INFORMATION

Information for Patients/What Should I tell my doctor before taking EXFORGE HCT?

Especially tell your doctor if you take:

  • simvastatin or other cholesterol lowering medicine
  • medicines used to prevent and treat fungal infections (such as ketoconazole,intraconazole)
  • medicines used to treat bacterial infections (such as clarithromycin,telithromycin) 

 

 

February 2012

 

WARNINGS AND PRECAUTIONS

Impaired Renal Function
  • Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system and by diuretics. Patients whose renal function may depend in part on the activity of the renin-angiotensin system (e.g. patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute renal failure on Exforge HCT. Monitor renal function periodically in these patients. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on Exforge HCT.
 
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