Enalaprilat Intravenous

It is very important that your doctor check your progress at regular visits to make sure enalaprilat is working properly and to check for unwanted effects .

Stop using enalaprilat and call your doctor right away if you have swelling of the face, arms, legs, eyes, lips, or tongue, or problems with swallowing or breathing. These are symptoms of a condition called angioedema .

You may experience lightheadedness during the first few days with enalaprilat. If this becomes severe and you faint, talk to your doctor right away .

Tell your doctor immediately if you have any signs of infection such as chills, sore throat, or fever. These may be symptoms of an immune system condition called neutropenia .

Using enalaprilat while you are pregnant can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away .

Check with your doctor right away if you have symptoms of jaundice (yellow skin or eyes) because these may be signs of a serious liver condition .

enalaprilat may increase the amount of potassium in your blood. Do not use salt substitutes containing potassium without first checking with your doctor .

Make sure any doctor or dentist who treats you knows that you are using enalaprilat. You may need to stop using enalaprilat several days before having surgery or medical tests .

Consult your pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Consult your pharmacist.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Animal studies have revealed evidence of fetotoxicity. In humans, use of drugs that act on RAS during the second and third trimesters can cause the following: reduced fetal renal function leading to anuria and renal failure, oligohydramnios, fetal lung hypoplasia and skeletal deformations including skull hypoplasia, hypotension, and death. There are no controlled data in human pregnancy. AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details. US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

Use during pregnancy is considered contraindicated. (AU, UK) This drug is only recommended for use during pregnancy when there are no alternatives and the benefit outweighs the risk. (US) AU TGA pregnancy category: D US FDA pregnancy category: -Oral tablets: D -Injection solution: D (for use during the second and third trimesters) and C (during the first trimester) -Oral solution: Not Assigned Risk Summary: Use of drugs that act on the renin angiotensin system (RAS) during the second and third trimesters increases fetal and neonatal morbidity and death. Comments: -Adequate methods of contraception should be encouraged. -If pregnancy is detected, discontinue this drug as soon as possible. -If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.