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.
