Pronunciation:

roe-PIV-a-kane

Brand Names:

• Naropin

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Anesthetic, Local

Chemical—

Amino Amide

Uses of This Medicine:

Ropivacaine injection is used to cause numbness or loss of feeling in patients before and during surgery or labor and delivery. It is also used to relieve acute pain. Ropivacaine is a local anesthetic and does not cause loss of consciousness.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of ropivacaine injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ropivacaine injection in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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 doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Bupivacaine
• Capmatinib
• Hyaluronidase
• Peginterferon Alfa-2b
• Pixantrone
• St John's Wort

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ciprofloxacin
• Fluvoxamine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Tobacco

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Glucose-6-phosphate dehydrogenase deficiency (G6PD) or
• Heart problems or
• Lung or breathing problems or
• Methemoglobinemia (blood disorder), hereditary or idiopathic (unknown cause)—Use with caution. May increase risk of having methemoglobinemia.

• Heart block or
• Hypotension (low blood pressure) or
• Hypovolemia (low blood volume)—Use with caution.

• Heart or blood vessel disease—Use with caution. The chance of side effects may be increased.

• Kidney disease, severe or
• Liver disease, severe—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins, into your upper arm, into the head and neck area, or into the space around the spinal nerves in your lower back.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely while you are receiving this medicine to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause a rare, but serious blood problem called methemoglobinemia. The risk may be increased in children younger than 6 months of age, elderly patients, or patients with certain inborn defects. It is more likely to occur in patients receiving too much of the medicine, but can also occur with small amounts. Check with your doctor right away if you or your child has the following symptoms after receiving this medicine: pale, gray, or blue-colored skin, lips, or nails, confusion, headache, lightheadedness, fast heartbeat, or unusual tiredness or weakness.

If you receive this medicine into your lower back (epidural), you may experience temporary loss of sensation and movement, usually in the lower half of your body. Talk with your doctor if you have concerns.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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.

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

More common

Blurred vision

chest pain or discomfort

confusion

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

lightheadedness, dizziness, or fainting

slow or irregular heartbeat

sweating

unusual tiredness or weakness

Less common

Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chills

decrease in frequency or amount of urine

difficulty in passing urine (dribbling)

fever

painful urination

Rare

Absence of or decrease in body movement

agitation

anxiety

bluish color of the skin or changes in skin color

changes in vision

clumsiness

continuing ringing or buzzing or other unexplained noise in the ears

cough

decreased awareness or responsiveness

difficulty breathing

drooping upper eyelids

drowsiness

fast or irregular heartbeat

general feeling of discomfort or illness

hearing loss

loss of appetite

loss of consciousness

low body temperature

mood or mental changes

muscle aches

muscle spasms (tetany) or twitching seizures

muscle weakness

nausea

nervousness

noisy breathing

pain or discomfort in the arms, jaw, back, or neck

pain, redness, or swelling in the arm or leg

problems with memory

seeing or hearing things that are not there

seizures

severe sleepiness

severe, unusual tiredness or weakness

shivering

slow heartbeat

swelling of the foot or leg tenderness

tightness in the chest

trembling

trouble sleeping

vomiting

weak or feeble pulse

weight gain

yellow skin or eyes

Incidence not known

Anxiety

depression

difficulty swallowing

excitation

fast, irregular, pounding, or racing heartbeat or pulse

hives, itching, skin rash

inability to breathe without assistance

paralysis of the arms

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

restlessness

slow heartbeat

tremors

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

Headache

Less common

Anxiety

runny or stuffy nose

sneezing

Rare

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

difficulty in moving

frequent urge to defecate

joint pain or swelling

lack or loss of strength

loss of bowel control

muscle pain, cramps, or stiffness

straining while passing stool

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.