SIDE EFFECTS
The most frequent adverse reaction in 1066 patients treated in clinical
NUBAIN®
(nalbuphine hydrochloride)
INDICATIONS
NUBAIN is indicated for the relief of moderate to severe pain.
NUBAIN can also be used as a supplement to balanced anesthesia, for
preoperative and postoperative analgesia, and for obstetrical analgesia
during labor and delivery
DOSAGE AND ADMINISTRATION
The usual recommended adult dose is 10 mg for a 70 kg individual,
administered subcutaneously, intramuscularly or intravenously; this
dose may be repeated every 3 to 6 hours as necessary. Dosage should
be adjusted according to the severity of the pain, physical status of the
patient, and other medications which the patient may be receiving. In
non-tolerant individuals, the recommended single maximum dose is 20
mg, with a maximum total daily dose of 160 mg.
NUBAIN is physically incompatible with
nafcillin and keterolac.
CONTRAINDICATIONS
NUBAIN should not be administered to patients who are
hypersensitive to nalbuphine hydrochloride, or to any of the other
ingredients in NUBAIN.
studies with NUBAIN was sedation 381 (36%).
Less frequent reactions were: sweaty/clammy 99 (9%),
nausea/vomiting 68 (6%), dizziness/vertigo 58 (5%), dry mouth 44
(4%), and headache 27 (3%).
Other adverse reactions which occurred (reported incidence of 1% or
less) were:
CNS Effects: Nervousness, depression, restlessness, crying, euphoria,
floating, hostility, unusual dreams, confusion, faintness, hallucinations,
dysphoria, feeling of heaviness, numbness, tingling, unreality. The
incidence of psychotomimetic effects, such as unreality,
depersonalization, delusions, dysphoria and hallucinations has been
shown to be less than that which occurs with pentazocine.
Cardiovascular: Hypertension, hypotension, bradycardia, tachycardia.
Gastrointestinal: Cramps, dyspepsia, bitter taste.
Respiratory: Depression, dyspnea, asthma.
Dermatologic: Itching, burning, urticaria.
Miscellaneous: Speech difficulty, urinary urgency, blurred vision,
flushing and warmth.
WARNINGS
NUBAIN should be administered as a supplement to
general anesthesia only by persons specifically
trained in the use of intravenous anesthetics and
management of the respiratory effects of potent
opioids.
Naloxone, resuscitative and intubation equipment
and oxygen should be readily available.

Anectine®
(succinylcholine chloride)
Injection, USP INDICATIONS
Succinylcholine chloride is indicated as an adjunct to general
anesthesia, to facilitate tracheal intubation, and to provide skeletal
muscle relaxation during surgery or mechanical ventilation.
DOSAGE AND ADMINISTRATION
The dosage of succinylcholine should be individualized and should
always be determined by the clinician after careful assessment of the
patient
Adults
For Short Surgical Procedures
The average dose required to produce neuromuscular blockade and to
facilitate tracheal intubation is 0.6 mg/kg ANECTINE Injection given
intravenously. The optimum dose will vary among individuals and
may be from 0.3 to 1.1 mg/kg for adults. Following administration of
doses in this range, neuromuscular blockade develops in about 1
minute; maximum blockade may persist for about 2 minutes, after
which recovery takes place within 4 to 6 minutes. However, very
large doses may result in more prolonged blockade. A 5- to 10-mg
test dose may be used to determine the sensitivity of the patient and
the individual recovery time
DRUG INTERACTIONS
Drugs which may enhance the neuromuscular blocking action of
succinylcholine include: promazine, oxytocin, aprotinin, certain non-
penicillin antibiotics, quinidine, β-adrenergic blockers, procainamide,
lidocaine, trimethaphan, lithium carbonate, magnesium salts, quinine,
chloroquine, diethylether, isoflurane, desflurane, metoclopramide,
and terbutaline. The neuromuscular blocking effect of
succinylcholine may be enhanced by drugs that reduce plasma
cholinesterase activity (e.g., chronically administered oral
contraceptives, glucocorticoids, or certain monoamine oxidase
inhibitors) or by drugs that irreversibly inhibit plasma cholinesterase
CONTRAINDICATIONS
Succinylcholine is contraindicated in persons with personal or
familial history of malignant hyperthermia, skeletal muscle
myopathies, and known hypersensitivity to the drug. It is also
contraindicated in patients after the acute phase of injury following
major burns, multiple trauma, extensive denervation of skeletal
muscle, or upper motor neuron injury, because succinylcholine
administered to such individuals may result in severe hyperkalemia
which may result in cardiac arrest. The risk of hyperkalemia in these
patients increases over time and usually peaks at 7 to 10 days after
the injury. The risk is dependent on the extent and location of the
injury. The precise time of onset and the duration of the risk period
are not known.
SIDE EFFECTS
Adverse reactions to succinylcholine consist primarily of an extension
of its pharmacological actions. Succinylcholine causes profound muscle
relaxation resulting in respiratory depression to the point of apnea; this
effect may be prolonged. Hypersensitivity reactions, including
anaphylaxis, may occur in rare instances. The following additional
adverse reactions have been reported: cardiac arrest, malignant
hyperthermia, arrhythmias, bradycardia, tachycardia, hypertension,
hypotension, hyperkalemia, prolonged respiratory depression or apnea,
increased intraocular pressure, muscle fasciculation, jaw rigidity,
postoperative muscle pain, rhabdomyolysis with possible myoglobinuric
acute renal failure, excessive salivation, and rash.
There have been post-marketing reports of severe allergic reactions
(anaphylactic and anaphylactoid reactions) associated with use of
neuromuscular blocking agents, including ANECTINE. These reactions,
in some cases, have been life-threatening and fatal. Because these
reactions were reported voluntarily from a population of uncertain size,
it is not possible to reliably estimate their frequency
WARNINGS
SUCCINYLCHOLINE SHOULD BE USED ONLY BY THOSE
SKILLED IN THE MANAGEMENT OF ARTIFICIAL
RESPIRATION AND ONLY WHEN FACILITIES ARE INSTANTLY
AVAILABLE FOR TRACHEAL INTUBATION AND FOR
PROVIDING ADEQUATE VENTILATION OF THE PATIENT,
INCLUDING THE ADMINISTRATION OF OXYGEN UNDER
POSITIVE PRESSURE AND THE ELIMINATION OF CARBON
DIOXIDE. THE CLINICIAN MUST BE PREPARED TO ASSIST OR
CONTROL RESPIRATION.
TO AVOID DISTRESS TO THE PATIENT, SUCCINYLCHOLINE
SHOULD NOT BE ADMINISTERED BEFORE
UNCONSCIOUSNESS HAS BEEN INDUCED. IN EMERGENCY
SITUATIONS, HOWEVER, IT MAY BE NECESSARY TO
ADMINISTER SUCCINYLCHOLINE BEFORE
UNCONSCIOUSNESS IS INDUCED. SUCCINYLCHOLINE IS
METABOLIZED BY PLASMA CHOLINESTERASE AND SHOULD
BE USED WITH CAUTION, IF AT ALL, IN PATIENTS KNOWN TO
BE OR SUSPECTED OF BEING HOMOZYGOUS FOR THE
ATYPICAL PLASMA CHOLINESTERASE GENE.
 DIPRIVAN®
(propofol) Injectable Emulsion SIDE EFFECTS
General
INDICATIONS Adverse event information is derived from controlled clinical trials and
worldwide marketing experience. In the description below, rates of the
more common events represent US/Canadian clinical study results. Less
DIPRIVAN Injectable Emulsion is an IV sedative-hypnotic agent that frequent events are also derived from publications and marketing
can be used as described in the table below. experience in over 8 million patients; there are insufficient data to
support an accurate estimate of their incidence rates. These studies were
conducted using a variety of premedicants, varying lengths of
Indications for DIPRIVAN Injectable Emulsion
surgical/diagnostic procedures, and various other anesthetic/sedative
agents. Most adverse events were mild and transien
Approved Patient Population
Initiation and maintenance of Monitored
Anesthesia Care (MAC) sedation
Adults only DRUG INTERACTIONS
Combined sedation and regional anesthesia Adults only
Induction of General Anesthesia Patients ≥ 3 years of age The induction dose requirements of DIPRIVAN Injectable Emulsion
may be reduced in patients with intramuscular or intravenous
Mainenance of General Anesthesia Patients ≥ 2 months of age premedication, particularly with narcotics (e.g., morphine, meperidine,
Intensive Care Unit (ICU) sedation of intubated, and fentanyl, etc.) and combinations of opioids and sedatives (e.g.,
Adults only
mechanically ventilated patients benzodiazepines, barbiturates, chloral hydrate, droperidol, etc.). These
agents may increase the anesthetic or sedative effects of DIPRIVAN
Injectable Emulsion and may also result in more pronounced decreases
CONTRAINDICATIONS in systolic, diastolic, and mean arterial pressures and cardiac output.
DIPRIVAN Injectable Emulsion is contraindicated in patients with a
known hypersensitivity to DIPRIVAN Injectable Emulsion or any of
During maintenance of anesthesia or sedation, the rate of DIPRIVAN
its components.
Injectable Emulsion administration should be adjusted according to the
desired level of anesthesia or sedation and may be reduced in the
presence of supplemental analgesic agents (e.g., nitrous oxide or
opioids). The concurrent administration of potent inhalational agents
(e.g., isoflurane, enflurane, and halothane) during maintenance with
DIPRIVAN Injectable Emulsion has not been extensively evaluated.
These inhalational agents can also be expected to increase the anesthetic
or sedative and cardiorespiratory effects of DIPRIVAN Injectable
Emulsion.
Xylocaine®
(lidocaine HCl) Injection, USP
INDICATIONS
Xylocaine (lidocaine HCl) Injections are indicated for production of
local or regional anesthesia by infiltration techniques such as
percutaneous injection and intravenous regional anesthesia by
peripheral nerve block techniques such as brachial plexus and
intercostal and by central neural techniques such as lumbar and caudal
epidural blocks, when the accepted procedures for these techniques as
described in standard textbooks are observed.
DRUG INTERACTIONS
Clinically Significant Drug Interactions
The administration of local anesthetic solutions containing epinephrine
or norepinephrine to patients receiving monoamine oxidase inhibitors
or tricyclic antidepressants may produce severe, prolonged
hypertension.
CONTRAINDICATIONS
Lidocaine HCl is contraindicated in patients with a known history of
hypersensitivity to local anesthetics of the amide type.
Mechanism of Action
Lidocaine HCl stabilizes the neuronal membrane by inhibiting the
ionic fluxes required for the initiation and conduction of impulses
thereby effecting local anesthetic action
SIDE EFFECTS
Systemic
Adverse experiences following the administration of lidocaine HCl are
similar in nature to those observed with other amide local anesthetic
agents. These adverse experiences are, in general, dose-related and
may result from high plasma levels caused by excessive dosage, rapid
absorption or inadvertent intravascular injection, or may result from a
hypersensitivity, idiosyncrasy or diminished tolerance on the part of
the patient. Serious adverse experiences are generally systemic in
nature. The following types are those most commonly reported:
Central Nervous System
CNS manifestations are excitatory and/or depressant and may be
characterized by lightheadedness, nervousness, apprehension,
euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double
vision, vomiting, sensations of heat, cold or numbness, twitching,
tremors, convulsions, unconsciousness, respiratory depression and
arrest. The excitatory manifestations may be very brief or may not
occur at all, in which case the first manifestation of toxicity may be
drowsiness merging into unconsciousness and respiratory arrest.
Drowsiness following the administration of lidocaine HCl is usually an
early sign of a high blood level of the drug and may occur as a
consequence of rapid absorption.
Carbocaine™
(mepivacaine hydrochloride) Injection, USP
INDICATIONS
CARBOCAINE is indicated for production of local or regional
analgesia and anesthesia by local infiltration, peripheral nerve block
techniques, and central neural techniques including epidural and
caudal blocks.
CONTRAINDICATIONS
CARBOCAINE is contraindicated in patients with a known
hypersensitivity to it or to any local anesthetic agent of the amide-
type or to other components of solutions of CARBOCAINE
CLINICAL PHARMACOLOGY
Local anesthetics block the generation and the conduction of nerve
impulses, presumably by increasing the threshold for electrical
excitation in the nerve, by slowing the propagation of the nerve
impulse and by reducing the rate of rise of the action potential. In
general, the progression of anesthesia is related to the diameter,
myelination, and conduction velocity of affected nerve fibers.
Clinically, the order of loss of nerve function is as follows: pain,
temperature, touch, proprioception, and skeletal muscle tone.
Systemic absorption of local anesthetics produces effects on the
cardiovascular and central nervous systems. At blood concentrations
achieved with normal therapeutic doses, changes in cardiac
conduction, excitability, refractoriness, contractility, and peripheral
vascular resistance are minimal. However, toxic blood concentrations
depress cardiac conduction and excitability, which may lead to
atrioventricular block and ultimately to cardiac arrest. In addition,
myocardial contractility is depressed and peripheral vasodilation
occurs, leading to decreased cardiac output and arterial blood pressure.
Following systemic absorption, local anesthetics can produce central
nervous system stimulation, depression, or both. Apparent central
stimulation is manifested as restlessness, tremors, and shivering,
progressing to convulsions, followed by depression and coma
progressing ultimately to respiratory arrest. However, the local
anesthetics have a primary depressant effect on the medulla and on
higher centers. The depressed stage may occur without a prior excited
stage.
Carbocaine Side Effects
Carbocaine is the brand name for the generic drug mepivacaine. It is a
local anesthetic used for minor and major nerve blocks, epidurals and
arthroscopy. As with all prescription medications, side effects may
occur while using carbocaine.
Systemic
1. Carbocaine side effects can affect the entire body
(systemic) when an overdose occurs. Apnea (stop
breathing) and secondary cardiac arrest are possible if
dosage is not administered correctly.
Central Nervous System
2. Carbocaine side effects that affect the central nervous
system (CNS) include anxiety, dizziness, blurred vision,
nausea, vomiting, chills, tremors and convulsions. Serious
CNS side effects reported were unconsciousness and
respiratory arrest.
Cardiovascular
3. When administered in excessively high dosages, Cabocaine
can affect the cardiovascular system to include
hypotension, heart block, bradycadia (slow heart beat),
arrhythmia (abnormal heart beat) and cardiac arrest.
Allergic Reaction
4. Allergic reactions to Carbocaine are rare. Injection and/or
intravenous site administration which causes redness,
swelling and itching is the most common reaction.
Precautions
Carbocaine has the potential to interact with other medications and
medical conditions. Inform your physician if you have been diagnosed
with heart problems, low blood pressure, decreased blood volume
(anemia), kidney disease or liver disease.