A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Demerol Warnings, Precautions, Pregnancy, Nursing, Abuse - Meperidine
Demerol Warnings, Precautions, Pregnancy, Nursing, Abuse - Meperidine
WARNINGS
DEMEROL is an opioid agonist and a
Schedule II controlled substance with an abuse liability similar to
morphine.
DEMEROL can be abused in a manner similar
to other opioid agonists, legal or illicit. This should be considered when
prescribing or dispensing DEMEROL in situations where the
physician or pharmacist is concerned about an increased risk of misuse,
abuse, or diversion.
Misuse, Abuse, and Diversion of
Opioids
Meperidine is an opioid agonist of the
morphine-type. Such drugs are sought by drug abusers and people with
addiction disorders and are subject to criminal diversion.
Meperidine can be abused in a manner similar to other opioid
agonists, legal or illicit. This should be considered when prescribing or
dispensing DEMEROL in situations where the physician or
pharmacist is concerned about an increased risk of misuse, abuse, or
diversion.
DEMEROL has been reported as being abused by
crushing, chewing, snorting, or injecting the dissolved product. These
practices will result in the uncontrolled delivery of the opioid and pose
a significant risk to the abuser that could result in overdose or death
(see WARNINGS and DRUG ABUSE AND ADDICTION ).
Concerns about
abuse, addiction, and diversion should not prevent the proper management
of pain.
Healthcare professionals should contact their State
Professional Licensing Board or State Controlled Substances Authority for
information on how to prevent and detect abuse or diversion of this
product.
Interactions with Alcohol and Drugs of Abuse
Meperidine may be expected to have additive effects when
used in conjunction with alcohol, other opioids, or illicit drugs that
cause central nervous system depression.
Head Injury and Increased Intracranial
Pressure: The respiratory
depressant effects of meperidine and its capacity
to elevate cerebrospinal fluid pressure
may be markedly exaggerated in the presence of head
injury, other intracranial
lesions, or a preexisting increase in intracranial
pressure. Furthermore, narcotics produce adverse reactions which
may obscure the clinical
course of patients with head
injuries. In such
patients, meperidine must be used with extreme caution and only
if its use is deemed essential.
Intravenous Use: If necessary, meperidine may be given intravenously,
but the injection
should be given very slowly, preferably in the form
of a diluted solution. Rapid intravenous
injection of narcotic
analgesics, including meperidine, increases the incidence
of adverse reactions; severe respiratory depression,
apnea, hypotension,
peripheral circulatory
collapse, and cardiac
arrest have occurred.
Meperidine should not be administered intravenously in less a narcotic
antagonist and the
facilities for assisted or controlled respiration
are immediately available. When meperidine is given parenterally,
especially intravenously, the patient
should be lying down.
Asthma and Other Respiratory Conditions: Meperidine should
be used with extreme caution in patients having an acute
asthmatic attack, patients with chronic
obstructive pulmonary
disease or cor
pulmonale, patients having a substantially decreased respiratory
reserve, and patients with preexisting respiratory
depression, hypoxia,
or hypercapnia. In such
patients, even usual therapeutic
doses of narcotics may decrease respiratory
drive while simultaneously increasing airway
resistance to the
point of apnea.
Hypotensive Effect: The administration
of meperidine may result in severe hypotension
in the postoperative patient
or any individual whose ability to maintain blood
pressure has been compromised
by a depleted blood volume or the administration
of drugs such as the phenothiazines
or certain anesthetics.
Usage in Ambulatory Patients: Meperidine may impair the
mental and/or physical
abilities required for the performance
of potentially hazardous tasks such
as driving a car or operating machinery. The patient
should be cautioned accordingly.
Meperidine, like other narcotics, may produce orthostatic
hypotension in ambulatory patients.
Usage in Pregnancy: Meperidine should not
be used in pregnant
women prior to the labor
period, unless in the judgment
of the physician the
potential benefits
outweigh the possible hazards, because safe use in pregnancy
prior to labor has not
been established relative to possible adverse effects on fetal
development.
Labor and Delvery: Meperidine crosses the placental barrier and can produce depression
of respiration and
psychophysiologic functions in the newborn. Resuscitation may be
required (see OVERDOSAGE.)
Nursing Mothers: Meperidine
appears in the milk of nursing mothers receiving the drug. Due to the
potential for serious adverse reactions in nursing infants, a decision
should be made whether to discontinue nursing or to discontinue the drug,
taking into account the potential benefits of the drug to the nursing
woman.
PRECAUTIONS
General
Opioid analgesics
can have a narrow therapeutic index in certain patient populations,
particularly when combined with CNS depressant drugs. The use of these
products should be reserved for cases where the benefits of opioid
analgesia outweigh the known risks of respiratory depression, altered
mental state, and postural hypotension.
Use of DEMEROL
may be associated with increased potential risks and should be used with
caution in the following conditions: sickle cell anemia, pheochromocytoma,
acute alcoholism; adrenocortical insufficiency (e.g., Addison's disease);
CNS depression or coma; delirium tremens; debilitated patients;
kyphoscoliosis associated with respiratory depression; myxedema or
hypothyroidism; prostatic hypertrophy or urethral stricture; severe
impairment of hepatic, pulmonary, or renal function; and toxic psychosis.
The administration of meperidine may obscure the diagnosis or
clinical course in patients with acute abdominal conditions. All opioids
may induce or aggravate seizures in some clinical settings.
Interactions with other CNS Depressants
DEMEROL should be used with caution and consideration should
be given to starting with a reduced dosage in patients who are
concurrently receiving other central nervous system depressants including
sedatives or hypnotics, general anesthetics, phenothiazines, other
tranquilizers, and alcohol. Drug-drug interactions may result in
respiratory depression, hypotension, profound sedation, or coma if these
drugs are taken in combination with the usual doses of DEMEROL .
Interactions with Mixed Agonist/Antagonist Opioid
Analgesics
Agonist/antagonist analgesics (i.e.,
pentazocine, nalbuphine, butorphanol, and buprenorphine) should be
administered with caution to a patient who has received or is receiving a
course of therapy with a pure opioid agonist analgesic such as meperidine.
In this situation, mixed agonist/antagonist analgesics may reduce the
analgesic effect of medperidine and/or may precipitate withdrawal symptoms
in these patients.
As with all intramuscular preparations meperidine intramuscular
injection should be injected well within the body of a large muscle.
Supraventricular Tachycardias: Meperidine should be used
with caution in patients with atrial
flutter and other supraventricular
tachycardias because of a possible vagolytic
action which may produce
a significant increase in the ventricular
response rate.
Convulsions: Meperidine may aggravate preexisting convulsions
in patients with convulsive
disorders. If dosage
is escalated substantially above recommended levels because of tolerance
development, convulsions may occur in individuals without a history
of convulsive disorders.
Acute Abdominal Conditions: The administration
of meperidine or other narcotics may obscure
the diagnosis of clinical
course in patients with acute
abdominal conditions.
Tolerance and Physical Dependence:
Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia
(in the absence of disease progression or other external factors). Physical dependence is manifested
by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of
an antagonist. Physical dependence and tolerance are not unusual during chronic opioid therapy.
The opioid abstinence or withdrawal syndrome is characterized by some or all of the following:
restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, mydriasis. Other
symptoms also may develop, including: irritability, anxiety, backache, joint pain, weakness,
abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure,
respiratory rate, or heart rate.
In general, opioids used regularly should not be abruptly discontinued.
Use in Drug and Alcohol Addiction:
Meperidine is an opioid with no approved use in the management of addictive disorders. Its
proper usage in individuals with drug or alcohol dependence, either active or in remission, is for the
management of pain requiring opioid analgesia. Meperidine should be used with caution in patients
with alcoholism and other drug dependencies due to the increased frequency of narcotic tolerance,
dependence, and the risk of addiction observed in these patient populations. Abuse of meperidine in
combination with other CNS depressant drugs can result in serious risk to the patient.
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