Amlodipine / Valsartan

generic for Exforge

Amlodipine / Valsartan Warnings

Valsartan can cause serious (possibly fatal) harm to an unborn baby if used during pregnancy. It is important to prevent pregnancy while taking this medication. Consult your doctor for more details and to discuss the use of reliable forms of birth control while taking this medication. If you are planning pregnancy, become pregnant, or think you may be pregnant, tell your doctor right away.
  • Do not use this drug if you become pregnant.
  • May cause dizziness
  • This drug may impair the ability to operate a vehicle, vessel (e.g., boat), or machinery. Use care until you become familiar with its effects.
  • Obtain medical advice before taking non-prescription drugs as some may affect the action of this medication.
  • Read the boxed warning information for this medication.

Lactation Warnings

  • INSUFFICIENT DATA AVAIL; CONSIDER MATERNAL TREATMENT BENEFIT VS INFANT RISK
  • INSUFFICIENT HUMAN DATA; MANUFACTURER DOES NOT REC

Pregnancy Warnings

  • Manufacturer does not recommend during 2nd and 3rd trimesters. Exposure to drugs affecting the renin-angiotensin system can result in oligohydramnios and fetal death. Perform serial ultrasounds to asses the intra-amniotic environment. Discontinue treatment when pregnancy is discovered.
  • Insufficient human data available. Uncontrolled hypertension increased the maternal risk of pre-eclampsia, gestational diabetes, premature delivery and delivery complications. Hypertension increased fetal risk of intrauterine growth restriction and intrauterine death. Monitor and manage maternal blood pressure for adequate control. Consider maternal treatment benefits versus potential fetal/neonatal adverse outcomes. Animal data suggest no developmental toxicity at doses less than 10 times the maximum recommended human dose.