Label Changes for:

Accuretic (quinapril HCl/ hydrochlorothiazide) 10/12.5 mg, 20/12.5 mg, 20/25 mg Tablets

January 2012

Changes have been made to the BOXED WARNING, WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – January 2012

 

  • Accupril (quinapril hydrochloride) 5 mg, 10 mg 20 mg, 40 mg Tablets
  • Accuretic (quinapril HCl/ hydrochlorothiazide) 10/12.5 mg, 20/12.5 mg, 20/25 mg Tablets
  • Altace (ramipril) 1.25, 2.5, 5, and 10 mg Tablets
  • Avalide (irbesartan/hydrochlorothiazide) Tablets, 150/12.5 mg and 300/12.5 mg
  • Avapro (irbesartan) 75 mg, 150 mg, and 300 mg Tablets
  • Azor (amlodipine/olmesartan) 5/20 mg, 10/20 mg, 5/40 mg, and 10/40 mg Tablets
  • Benicar HCT (olmesartan medoxomil/hydrochlorothiazide) 20/12.5 mg, 40/12.5 mg, and 40/25 mg Tablets
  • Diovan (valsartan) 40 mg, 80 mg, 160 mg, and 320 mg Tablets
  • Diovan HCT (valsartan/hydrochlorothiazide) 80/12.5 mg, 160/12.5 mg,160/25 mg, 320/12.5 mg, and 320/25 mg Tablets
  • Exforge (amlodipine/valsartan) 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg Tablets
  • Exforge HCT (amlodipine/valsartan/hydrochlorothiazide) 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg, 10/160/25 mg, and 10/320/25 mg Tablets
  • Lotensin (benazepril) 5 mg, 10 mg, 20 mg, and 40 mg Tablets
  • Lotensin HCT (benazepril/hydrochlorothiazide) 5/6.25 mg, 10/12.5 mg, 20/12.5 mg, and 25/25/mg Tablets
  • Lotrel (amlodipine besylate and benazepril hydrochloride) 2.5/10 mg, 5/10 mg, 5/20 mg, 10/20 mg, 5/40 mg, and 10/40 mg Tablets
  • Mavik (trandolapril) 1 mg, 2 mg and 4 mg Tablets
  • Micardis (telmisartan) 20 mg, 40 mg, and 80 mg Tablets
  • Micardis HCT (telmisartan/hydrochlorothiazide) 40/12.5 mg, 80/12.5 mg, and 80/25 mg Tablets
  • Tarka (trandolapril/verapamil hydrochloride) 2/180 mg, 1/240 mg 2/240 mg and 4/240 mg Tablets
  • Teveten (eprosartan mesylate) 400 mg and 600 mg Tablets
  • Teveten HCT (eprosartan mesylate/hydrochlorothiazide) 600/12.5 mg and 600/25 mg Tablets
  • Tribenzor (olmesartan medoxomil/amlodipine/hydrochlorothiazide) 20/5/12.5 mg, 40/5/12.5 mg, 40/5/25 mg, 40/10/12.5 and 40/10/25 mg Tablets 
  • Univasc (moexipril hydrochloride) 7.5 mg and 15 mg Tablets
  • Uniretic (moexipril hydrochloride/hydrochlorothiazide) 7.5/12.5 mg, 15/12.5 mg and 15/25 mg Tablets

 

Old Label Format:

 

BOXED WARNING

WARNING: FETAL TOXICITY
  • When pregnancy is detected, discontinue [xxx] as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS: Fetal Toxicity

WARNINGS

Fetal Toxicity
Pregnancy Category D
  • Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death......

PRECAUTIONS

Information for Patients
  • Female patients of childbearing age should be told about the consequences of exposure.....
Pediatric Use 
  • Neonates with a history of in utero exposure to [xxx]:
    • If oliguria or hypotension occurs, direct attention toward support..... 

 

New Label Format (PLR):

 

BOXED WARNING

WARNING: FETAL TOXICITY

See full prescribing information for complete boxed warning

  • When pregnancy is detected, discontinue [xxx] as soon as possible (5.x)
  • Drugs that act directly on the renin-angiotensin system can cause injury and  death to the developing fetus (5.x)

5 WARNINGS AND PRECAUTIONS

5.x Fetal Toxicity

Pregnancy Category D

  • Use of drugs that act on the renin-angiotensin system during the second and trimesters of pregnancy reduces.....

8 USE IN SPECIAL POPULATIONS

8.1 Pregnancy

Pregnancy Category D

  • Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.....
8.4 Pediatric Use [new section]

Neonates with a history of in utero exposure to [xxx]:

  • If oliguria or hypotension occurs, direct attention toward support....

17 PATIENT COUNSELING INFORMATION

Information for Patients
  • Female patients of childbearing age should be told about the consequences of exposure to [xxx] during pregnancy. Discuss treatment options....

PATIENT PACKAGE INSERT

What is the most important information I should know about [xxx]?
  • [xxx] can cause harm or death to an unborn baby.
  • Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant.
  • If you get pregnant while taking [xxx], tell your doctor right away.
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