Monopril

Yes

See also How to Use and Precautions section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: aliskiren, lithium, drugs that may increase the level of potassium in the blood (such as ARBs including losartan/valsartan, birth control pills containing drospirenone).Check the labels on all your medicines (such as cough-and-cold products, diet aids, or NSAIDs such as ibuprofen, naproxen) because they may contain ingredients that could increase your blood pressure or worsen your heart failure. Ask your pharmacist for more details.Low-dose aspirin, as prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually at dosages of 81-325 milligrams per day) should be continued. Consult your doctor or pharmacist for more details.A very serious reaction may occur if you are getting injections for bee/wasp sting allergy (desensitization) and are also taking fosinopril. Make sure all your doctors know which medicines you are using.This medication may interfere with certain laboratory tests (including digoxin levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

MONOPRIL® (fosinopril sodium tablets)

10 mg tablets: White to off-white, biconvex flat-end diamond-shaped, compressed partially scored tablets with “BMS” on one side and “MONOPRIL (fosinopril sodium) 10” on the other. They are supplied in bottles of 90 (NDC 0087-0158-46) and 1000 (NDC 0087-0158-85). Bottles contain a desiccant canister.

20 mg tablets: White to off-white, oval-shaped, compressed tablets with “BMS” on one side and “MONOPRIL (fosinopril sodium) 20” on the other. They are supplied in bottles of 90 (NDC 0087-0609-42) and 1000 (NDC 0087-0609-85). Bottles contain a desiccant canister.

40 mg tablets: White to off-white, biconvex hexagonal-shaped, compressed tablets with “BMS” on one side and “MONOPRIL (fosinopril sodium) 40” on the other. They are supplied in bottles of 90 (NDC 0087-1202-13). Bottles contain a desiccant canister.

Storage

Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59°F - 86°F) [see USP Controlled Room Temperature]. Protect from moisture by keeping bottle tightly closed.

Bristol-Myers Squibb Company Princeton, NJ 08543 USA. Rev July 2008.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Monopril has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Monopril, a choice should be made whether to stop nursing or to stop use of this medication. Determining the importance of the drug to the mother should be considered.

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Fosinopril can be taken with or without food.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking fosinopril. This can lead to very low blood pressure, electrolyte disorders, or kidney failure.

While using fosinopril, you may need frequent blood tests at your doctor's office. Your blood pressure will need to be checked often.

If you need surgery or medical tests, tell the doctor ahead of time that you are using fosinopril. You may need to stop using the medicine for a short time.

If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store at room temperature away from moisture and heat.

In the U.S.

• Monopril

Available Dosage Forms:

• Tablet

Therapeutic Class: Antihypertensive

Pharmacologic Class: ACE Inhibitor

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Blurred vision
• chest pain or discomfort
• chills
• cold sweats
• confusion
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• fast, slow, or irregular heartbeat
• pounding or rapid pulse
• sweating
• unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Cough

Less common

• Body aches or pain
• diarrhea
• difficult breathing
• ear congestion
• fever
• headache
• loss of voice
• muscle or bone pain
• nasal congestion
• nausea and vomiting
• runny nose
• sneezing
• sore throat
• weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Do not use Monopril if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away.

If you have diabetes, do not use Monopril together with any medication that contains aliskiren (Amturnide, Tekturna, Tekamlo).

You may also need to avoid taking Monopril with aliskiren if you have kidney disease.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Applies to fosinopril: oral tablet

Along with its needed effects, fosinopril (the active ingredient contained in Monopril) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking fosinopril:

Less common

• Blurred vision
• chest pain or discomfort
• chills
• cold sweats
• confusion
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• fast, slow, or irregular heartbeat
• pounding or rapid pulse
• sweating
• unusual tiredness or weakness

Some side effects of fosinopril may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Cough

Less common

• Body aches or pain
• diarrhea
• difficult breathing
• ear congestion
• fever
• headache
• loss of voice
• muscle or bone pain
• nasal congestion
• nausea and vomiting
• runny nose
• sneezing
• sore throat
• weakness