Uses of This Medicine:

Parenteral-local anesthetics are given by injection to cause loss of feeling before and during surgery, dental procedures (including dental surgery), or labor and delivery. These medicines do not cause loss of consciousness.

These medicines are given only by or under the immediate supervision of a medical doctor or dentist, or by a specially trained nurse, in the doctor's office or in a hospital.

Before Using This Medicine:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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—

Children may be especially sensitive to the effects of parenteral-local anesthetics. This may increase the chance of side effects.

Older adults—

Elderly people are especially sensitive to the effects of parenteral-local anesthetics. This may increase the chance of side effects.

Pregnancy—

Local anesthetics have not been reported to cause birth defects in humans.

Use of a local anesthetic during labor and delivery may rarely cause unwanted effects. These medicines may increase the length of labor by making it more difficult for the mother to bear down (push). They may also cause unwanted effects in the fetus or newborn baby, especially if certain medical problems are present at the time of delivery. Before receiving a local anesthetic for labor and delivery, you should discuss with your doctor the good that this medicine will do as well as the risks of receiving it.

Breast-feeding—

It is not known whether local anesthetics pass into breast milk. However, these medicines have not been reported to cause problems in nursing babies.

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 any of the medicines in this class, 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 medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

• Dihydroergotamine
• Dronedarone
• Saquinavir
• Vernakalant

Using medicines in this class 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.

• Acecainide
• Alcuronium
• Amifampridine
• Amiodarone
• Amprenavir
• Arbutamine
• Articaine
• Atracurium
• Benoxinate
• Benzocaine
• Benzyl Alcohol
• Bretylium
• Bupivacaine Liposome
• Bupropion
• Chloroprocaine
• Cisatracurium
• Cobicistat
• Cocaine
• Darunavir
• Dasabuvir
• Delavirdine
• Dibucaine
• Disopyramide
• Dofetilide
• Donepezil
• Doxacurium
• Dronedarone
• Dyclonine
• Encainide
• Ethyl Chloride
• Etidocaine
• Etravirine
• Fazadinium
• Flecainide
• Fosamprenavir
• Fosphenytoin
• Gallamine
• Hexafluorenium
• Hyaluronidase
• Ibutilide
• Levobupivacaine
• Lidocaine
• Lopinavir
• Mepivacaine
• Metocurine
• Metoprolol
• Mexiletine
• Mivacurium
• Moricizine
• Nadolol
• Opicapone
• Pancuronium
• Phenytoin
• Pipecuronium
• Pramoxine
• Prilocaine
• Procainamide
• Procaine
• Propafenone
• Proparacaine
• Quinidine
• Rapacuronium
• Rocuronium
• Ropivacaine
• Sotalol
• St John's Wort
• Succinylcholine
• Telaprevir
• Tetracaine
• Tocainide
• Tubocurarine
• Vecuronium

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 medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma—Increased chance of allergic-like reactions with use of some local anesthetics

• Brain infection or tumor or
• Blood clotting disorders—Increased chance of bleeding with injection of local anesthetics

• Type 2 diabetes mellitus—Use of local anesthetics can cause stress on your heart if you have diabetes mellitus.
• Heart disease—Use of local anesthetics can worsen some kinds of heart disease.

• History of migraine headaches—Use of local anesthetics can worsen headaches.

• Hypertension (high blood pressure) or
• Hypotension (low blood pressure)—Use of local anesthetics can cause hypotension or hypertension.

• Hyperthyroidism—Use of some local anesthetics can cause stress on your heart if you have hyperthyroidism.

• Kidney disease or
• Liver disease—Increased chance of side effects

• Methemoglobinemia—Prilocaine may make this condition worse.

• Peripheral vascular disease—Use of some local anesthetics can make this condition worse or can cause your blood pressure to increase.

• Skin infection or inflammation—Your physician may not want to inject the local anesthetic into infected or inflamed skin because the local anesthetic may not work as well.

Proper Use of This Medicine:

Dosing—

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

The dose of a local anesthetic 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 local anesthetic is being given; and
• Other medicines you are taking or will receive before or after the local anesthetic is given.

Precautions While Using This Medicine:

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

• During the time that the injected area feels numb, serious injury can occur without your knowing about it. Be especially careful to avoid injury until the anesthetic wears off or feeling returns to the area.
• If you have received a local anesthetic injection in your mouth, do not chew gum or food while your mouth feels numb. You may injure yourself by biting your tongue or the inside of your cheeks

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 your medical doctor's or dentist's office, your medical doctor, dentist, 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

Bluish lips and fingernails

breathing problems

chest pain

convulsions (seizures)

dizziness

drowsiness

fatigue

fever

headache

irregular heartbeat

itching

nausea and/or vomiting

pale skin, troubled breathing, exertional, unusual bleeding or bruising, unusual tiredness or weakness

raised red swellings on the skin, lips, tongue, or in the throat

rapid heart rate

restlessness

unusual tiredness or weakness

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

Less common or rare

Back pain

constipation

difficulty in opening the mouth

inability to hold bowel movement and/or urine

loss of sexual function

paralysis of legs

persistent numbness

prolonged numbness or tingling of lips and mouth

shivering

skin rash

tingling or “pins and needles sensation

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.