ROPIVACAINE (Parenteral-Local)

Some commonly used brand names are:

In the U.S.?

• Naropin

In Canada?

• Naropin

Category

• Anesthetic, local

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 laborand delivery. It does not cause loss of consciousness.

Ropivacaine is given only by or under the immediate supervision of a medicaldoctor, 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 beweighed against the good it will do. This is a decision you and your healthcare professional will make. For ropivacaine, the following should be considered:

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

Pregnancy?Ropivacaine has not been shown to cause birth defectsin humans.

Use of ropivacaine during labor and delivery may rarely cause unwantedeffects. This medicine may increase the length of labor by making it moredifficult for the mother to bear down (push). It may also cause unwanted effectsin 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 wellas the risks of receiving it.

Breast-feeding?It is not known whether ropivacaine passes intobreast milk. However, this medicine has not been reported to cause problemsin nursing babies.

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

Older adults?Many medicines have not been specifically studiedin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults or if they cause different side effectsor problems in older people. There is no specific information comparing useof ropivacaine in the elderly with use in other age groups. Based on informationabout similar medicines, it is expected that elderly people will be more sensitivethan younger adults to the effects of ropivacaine. This may increase the chanceof side effects.

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

• Amiodarone (e.g., Cordarone)?may increase your chance of seriousheart side effects

Other medical problems?The presence of other medicalproblems may affect the use of ropivacaine. Make sure you tell your healthcare 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 withkidney 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, dependingon:

• 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 ropivacaineis given.

Precautions After Receiving This Medicine

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

• During the time that the injected area feels numb, serious injurycan occur without your knowing it. Be especially careful to avoid injury untilthe 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 sideeffects may occur, if they do occur they may need medical attention. Whileyou are in the hospital or in your doctor's office, your medical doctor ornurse will carefully follow the effects of any medicine you have received.However, some effects may not be noticed until later.

Check with your doctorimmediately 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 possibleif 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 somepatients. If you notice any other effects, check with your doctor.