Pronunciation:

bue-PIV-a-kane hye-droe-KLOR-ide

Brand Names:

• Xaracoll

Dosage Forms:

• Implant

Classifications:

Therapeutic—

Anesthetic, Local

Chemical—

Bupivacaine

Uses of This Medicine:

Bupivacaine implant is used to prevent pain for up to 24 hours after surgery in the groin area (open inguinal hernia repair). It is a local anesthetic.

Bupivacaine causes a loss of feeling and prevents pain by blocking signals at the nerve endings. It 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 bupivacaine implant 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 bupivacaine implant in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults and are more likely to have age-related kidney problems, which may require caution for patients receiving bupivacaine implant.

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.

• Amifampridine
• Articaine
• Benoxinate
• Benzocaine
• Benzyl Alcohol
• Bupropion
• Chloroprocaine
• Cocaine
• Dibucaine
• Donepezil
• Dyclonine
• Ethyl Chloride
• Etidocaine
• Fospropofol
• Hyaluronidase
• Levobupivacaine
• Lidocaine
• Mepivacaine
• Pramoxine
• Prilocaine
• Procaine
• Proparacaine
• Propofol
• Propranolol
• Ropivacaine
• St John's Wort
• Tetracaine
• Verapamil

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.

• Alacepril
• Benazepril
• Captopril
• Cilazapril
• Delapril
• Enalaprilat
• Enalapril Maleate
• Fosinopril
• Imidapril
• Lisinopril
• Moexipril
• Pentopril
• Perindopril
• Quinapril
• Ramipril
• Spirapril
• Temocapril
• Trandolapril
• Zofenopril

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or 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 (G6PD) deficiency or
• Lung or breathing problems or
• Methemoglobinemia (blood disorder), hereditary or idiopathic (unknown cause)—Use with caution. May increase risk of having methemoglobinemia.

• Heart or blood vessel disease (eg, heart block) or
• Hypotension (low blood pressure)—Use with caution. The chance of side effects may be increased.

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

• Surgery, other (eg, bone surgery)—Safety and efficacy have not been established in other surgical procedures.

Proper Use of This Medicine:

Your doctor will place this medicine in your groin area after a surgical procedure (open inguinal hernia repair).

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely while receiving this medicine to see if it is working properly. Blood tests may be needed to check for any 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 have pale, gray, or blue-colored skin, lips, or nails, confusion, headache, lightheadedness, fast heartbeat, or unusual tiredness or weakness.

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

Fever

headache

shakiness in the legs, arms, hands, or feet

swelling or discharge where the implant is placed

Incidence not known

Anxiety

blurred vision

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

chest pain or discomfort

chills

confusion

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

fast, slow, pounding, or irregular heartbeat or pulse

flushing, redness of the skin

lightheadedness, dizziness, or fainting

nausea

no blood pressure or pulse

palpitations

restlessness

skin rash, itching, hives, or welts

sweating

unconsciousness

unusual tiredness or weakness

unusually warm skin

vomiting

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

Change in taste

loss of taste

numbness in the mouth

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.