Sensorcaine with Epinephrine

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Your doctor will give Sensorcaine with Epinephrine.
• It is given as a shot into the skin or the spine.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• A heartbeat that does not feel normal.
• Fast or slow heartbeat.
• Change in balance.
• Dizziness or passing out.
• Restlessness.
• Anxiety.
• Change in speech.
• Numbness or tingling in the mouth.
• Metallic taste.
• Blurred eyesight.
• Ringing in ears.
• Shakiness.
• Twitching.
• Low mood (depression).
• Feeling sleepy.
• Feeling confused.
• Seizures.
• Trouble breathing, slow breathing, or shallow breathing.

Spinal:

• Trouble passing urine.
• Loss of bladder or bowel control.
• Change in sex ability.
• Long-lasting burning, numbness, tingling, or paralysis in the lower half of the body.
• Headache.
• Backache.
• Fever or chills.
• Very upset stomach or throwing up.
• Stiff neck.
• If bright lights bother your eyes.

Applies to bupivacaine / epinephrine: injectable solution

General

In general, reactions to bupivacaine are typical of those associated with other amide-type local anesthetics. A major cause of adverse reactions to these drugs is high plasma levels, which may be due to overdosage, rapid absorption from injection site, diminished tolerance, accidental intravascular injection, or slow metabolic degradation.

The most common side effects that require immediate countermeasures are related to the central nervous system and the cardiovascular system. These reactions are generally dose related and due to excessive plasma levels. Accidental subarachnoid injection may result in underventilation or apnea. Hypotension caused by loss of sympathetic tone and respiratory paralysis or underventilation caused by cephalad extension of the motor level of anesthesia may occur and may lead to cardiac arrest if untreated. Elderly patients over 65 years of age, especially those with hypertension, may be at higher risk of hypotensive effects. Factors influencing plasma protein binding, such as acidosis, altered protein production due to systemic diseases, or competition with other drugs for protein binding sites, may decrease tolerance.[Ref]

Nervous system

Nervous system side effects following epidural or caudal anesthesia have included spinal block (including high or total spinal block); hypotension secondary to spinal block; urinary retention; fecal and urinary incontinence; loss of perineal sensation and sexual function; persistent anesthesia, paresthesia, weakness, paralysis of the lower extremities and loss of sphincter control all of which may have slow, incomplete, or no recovery; headache; backache; septic meningitis; meningismus; slowing of labor; increased incidence of forceps delivery; and cranial nerve palsies due to traction on nerves from loss of cerebrospinal fluid. Neurologic effects following other procedures or routes of administration may include persistent anesthesia, paresthesia, weakness, paralysis, all of which may have slow, incomplete, or no recovery. Central nervous system side effects have included excitation and/or depression, restlessness, anxiety, dizziness, tinnitus, blurred vision, tremors, convulsions, drowsiness, unconsciousness, respiratory arrest, nausea, vomiting, chills, and pupil constriction.[Ref]

Cardiovascular

Cardiovascular side effects have included myocardial depression, decreased cardiac output, heart block, hypotension, bradycardia, ventricular arrhythmias (including ventricular tachycardia and ventricular fibrillation), and cardiac arrest.[Ref]

Other

Other side effects have included a high spinal (characterized by paralysis of the legs, loss of consciousness, respiratory paralysis, and bradycardia) following accidental subarachnoid injection.[Ref]

Hypersensitivity

Hypersensitivity side effects have included allergic-type reactions including signs such as urticaria, pruritus, erythema, angioneurotic edema (including laryngeal edema), tachycardia, sneezing, nausea, vomiting, dizziness, syncope, excessive sweating, elevated temperature, and possibly, anaphylactoid-like symptomatology (including severe hypotension).[Ref]

Some side effects of Sensorcaine with Epinephrine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.