Advanced Consumer Information

ROPIVACAINE (Parenteral-Local)

Some commonly used brand names are:

In the U.S.—

Naropin

In Canada—

Naropin

Description

Ropivacaine (roe-PIV-a-kane) is a local anesthetic ((an-ess-THET-ik)) given by injection to cause loss of feeling before and during surgery or labor and delivery. It does not cause loss of consciousness.

Ropivacaine is given only by or under the immediate supervision of a medical doctor, or by a specially trained nurse, in the doctor's office or in a hospital. It is available in the following dosage form:

Parenteral
Injection (U.S. and Canada)

Before Receiving This Medicine

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your health care professional will make. For ropivacaine, the following should be considered:

Allergies—Tell your health care professional if you have ever had an unusual or allergic reaction to ropivacaine or any other local anesthetic.

Pregnancy—Ropivacaine has not been shown to cause birth defects in humans.

Use of ropivacaine during labor and delivery may rarely cause unwanted effects. This medicine may increase the length of labor by making it more difficult for the mother to bear down (push). It may also cause unwanted effects in the fetus or newborn baby. Before receiving ropivacaine for labor and delivery, you should discuss with your doctor the good the medicine will do as well as the risks of receiving it.

Breast-feeding—It is not known whether ropivacaine passes into breast milk. However, this medicine has not been reported to cause problems in nursing babies.

Children—Studies on this medicine have been done only in adolescents and adults, and there is no specific information comparing use of ropivacaine in children with use in other age groups.

Older adults—Many medicines have not been specifically studied in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of ropivacaine in the elderly with use in other age groups. Based on information about similar medicines, it is expected that elderly people will be more sensitive than younger adults to the effects of ropivacaine. This may increase the chance of side effects.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your medical doctor or nurse may want to change the dose, or other precautions may be necessary. When you are taking ropivacaine it is especially important that your health care professional knows if you are taking any of the following:

Amiodarone (e.g., Cordarone)—may increase your chance of serious heart side effects

Other medical problems—The presence of other medical problems may affect the use of ropivacaine. Make sure you tell your health care professional if you have any other medical problems, especially:

Heart disease—This medicine may make your condition worse

Kidney disease or
Liver disease—Side effects may be more likely in patients with kidney disease or liver disease

Proper Use of This Medicine

Dosing—The dose of ropivacaine will be different for different patients. Your health care professional will decide on the right amount for you, depending on:

Your age;
Your general physical condition;
The reason the medicine is being given; and
Other medicines you are taking or will receive before or after ropivacaine is given.

Precautions After Receiving This Medicine

For patients going home before the numbness or loss of feeling caused by ropivacaine wears off:

During the time that the injected area feels numb, serious injury can occur without your knowing it. Be especially careful to avoid injury until the medicine wears off or feeling returns to the area.

Side Effects of This Medicine

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. While you are in the hospital or in your doctor's office, your medical doctor or nurse will carefully follow the effects of any medicine you have received. However, some effects may not be noticed until later.

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

Less common or rare

Burning or prickling sensation; fever; itching

Check with your doctor as soon as possible if any of the following side effects occur:

Less common or rare

Back pain; difficulty urinating; headache; pain

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

Revised: 10/25/2004

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