FDA label 903d37a4-8c2f-4f98-91fb-925107ef114a

WARNINGS Duocaine™, like any local anesthetics, should only be employed by clinicians who are well versed in diagnosis and management of dose-related toxicity and other acute emergencies which might arise from the block to be employed, and then only after ensuring the immediate availability of oxygen, other resuscitative drugs, cardiopulmonary resuscitative equipment, and the personnel resources needed for proper management of toxic reaction and related emergencies (see: ADVERSE REACTIONS , PRECAUTIONS , and OVERDOSAGE ). Delay in proper management of dose-related toxicity, underventilation from any cause and/or altered sensitivity may lead to the development of acidosis, cardiac arrest and, possibly, death. Systemic toxicity of local anesthetics usually results from either accidental intravascular injection or administration of an excessive dose. It is essential that aspiration for blood be done prior to injecting Duocaine™, both the original dose and all subsequent doses, to avoid intravascular injection. The needle must be repositioned until no blood can be elicited by aspiration. Note, however, that the absence of blood in the syringe does not guarantee that intravascular injection has been avoided. If a vasoconstrictor, such as epinephrine, has been added for reducing the rate of systemic absorption of anesthetics, Duocaine™ solution should not be used concomitantly with ergot-type oxytocic drugs, because a severe persistent hypertension may occur. Likewise, Duocaine™ containing a vasoconstrictor should be used with extreme caution in patients receiving monoamine oxidase (MAO) inhibitors or antidepressants of the triptyline or imipramine types, because severe prolonged hypertension may be the result.

ADVERSE REACTIONS Reactions to Duocaine™ are characteristic of those associated with other amide-type local anesthetics. A major cause of adverse reactions to this group of drugs may be associated with its excessive plasma levels, which may be due to overdosage, unintentional intravascular injection or slow metabolic degradation. Systemic The most commonly encountered acute adverse experiences that demand immediate countermeasures are related to the central nervous system and the cardiovascular system. These adverse experiences are generally dose related and due to high plasma levels which may result from overdosage, rapid absorption from the injection site, diminished tolerance or from unintentional intravascular injection of the Duocaine™. Hypotension due to loss of sympathetic tone and respiratory paralysis or underventilation due to cephalad extension of the motor level of anesthesia may occur. This may lead to the secondary cardiac arrest if untreated. Factors influencing plasma protein binding, such as acidosis, systemic diseases which alter protein production, or competition with other drugs for protein binding sites, may diminish individual tolerance. Central Nervous System Reactions These are characterized by excitation and/or depression. Restlessness, anxiety, dizziness, tinnitus, blurred vision or tremors may occur, possibly proceeding to convulsions. However, excitement may be transient or absent, with depression being the first manifestation of an adverse reaction. This may quickly be followed by drowsiness merging into unconsciousness and respiratory arrest. Drowsiness following the administration of Duocaine™ is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption. Other central nervous system effects may be nausea, vomiting, chills, and constriction of the pupils. Cardiovascular System Reactions High doses or unintentional intravascular injection may lead to high plasma levels and related depression of the myocardium, decreased cardiac output, heart block, hypotension, bradycardia, ventricular arrhythmia, including ventricular tachycardia and ventricular fibrillation, and cardiac arrest (see: WARNINGS , PRECAUTIONS , and OVERDOSAGE sections). Allergic Duocaine™, as a mixture of amide-type local anesthetic, allergic type reactions are rare and may occur as a result of sensitivity to the local anesthetic or to other formulation ingredients, such as sulfites in epinephrine containing solutions (see WARNINGS ). These reactions are characterized by signs such as cutaneous lesions, urticaria, pruritus, erythema, angioneurotic edema (including laryngeal edema), tachycardia, sneezing, nausea, vomiting, dizziness, syncope, excessive sweating, elevated temperature, and possibly, anaphylactoid symptomatology (including severe hypotension). Cross sensitivity among members of the amide-type local anesthetic group has been reported. If allergic reactions occur, they should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value. Neurologic In the practice of retrobulbar or peribulbar block, occasional unintentional penetration of ophthalmic artery or nerve may occur. Subsequent adverse effects may depend partially on the amount of drug administered intrathecally and the physiological and physical effects of a dural sheath puncture. Inadvertent needle penetration of the optic nerve sheath may result in depositing the local anesthetic directly in the subarachnoid space. Neurologic effects following unintentional subarachnoid administration during ocular block anesthesia may include spinal block by varying magnitude (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; or cranial nerve palsies due to traction on nerves from loss of cerebrospinal fluid. There have been reported cases of permanent injury to extraocular muscles requiring surgical repair following retrobulbar administration of bupivacaine.