Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1949
Predicate | Object |
---|---|
rdf:type | |
rdfs:label |
Meperidine Hydrochloride (Injection, Solution)
|
dailymed-instance:dosage |
For use as a single-dose unit to provide analgesia via the
intravenous route using a compatible Hospira infusion device. Each vial is
intended for SINGLE DOSE ONLY. When the dosing requirement is complete, the
unused portion should be discarded in an appropriate manner. DO NOT AUTOCLAVE. PHYSICIANS
SHOULD COMPLETELY FAMILIARIZE THEMSELVES WITH A COMPATIBLE HOSPIRA INFUSION
DEVICE BEFORE DECIDING TO ADMINISTER MEPERIDINE HYDROCHLORIDE INJECTION VIA
THE INFUSER. Dosage should be adjusted according to
the severity of the pain and the response of the patient. There can be considerable
variability in both the dosage requirement and patient response. When
administered intravenously, meperidine hydrochloride should be given very slowly. Rapid intravenous injection increases
the incidence of adverse reactions; severe respiratory depression, apnea,
hypotension, peripheral circulatory collapse and cardiac arrest have occurred.
This drug should be administered intravenously only if a narcotic antagonist
(i.e., naloxone) and the facilities for assisted or controlled respiration
are immediately available. When meperidine hydrochloride is given parenterally,
especially intravenously, the patient should be lying down. Adults: The usual initial dose for adult administration
via a compatible Hospira infusion device is 10 mg, with a range of 1 to 5
mg per incremental dose. The recommended Lockout Interval is 6 to 10 minutes.
The minimum recommended Lockout Interval is 5 minutes. The
physician may adjust the dosage either upward or downward; or, increase or
decrease the Lockout Interval, depending on patient response. For continuous
infusion the usual adult dose is 15 to 35 mg per hour administered intravenously
as required. Incompatibility: Meperidine hydrochloride is incompatible with soluble barbiturates,
aminophylline, heparin, morphine sulfate, methicillin, phenytoin, sodium bicarbonate,
iodide, sulfadiazine and sulfisoxazole. Dosage of meperidine
hydrochloride should be carefully adjusted according to the severity of pain
and the response of the patient. Reduced dosage is indicated in poor-risk
patients, in the very young or very old, in patients with impaired renal or
hepatic function and in patients receiving other central nervous system depressants.
For surgical patients, dosage should be based on response of the patient,
other premedication and concomitant medications, the anesthetic being used
and the nature and duration of the operation. Occasionally,
it may be necessary to exceed the usual dosage recommended in cases of exceptionally
severe pain or in those patients who become tolerant. Parenteral
drug products should be inspected visually for particulate matter and discoloration
whenever solution and container permit prior to administration.
|
dailymed-instance:descripti... |
Meperidine Hydrochloride Injection, USP 10 mg/mL is a sterile,
nonpyrogenic, hypotonic solution of meperidine hydrochloride, USP, in an acetate
buffer. This product is to be administered by the intravenous route via a
compatible Hospira infusion device. Each mL contains
meperidine hydrochloride 10 mg. Sodium acetate, anhydrous 1.5 mg and glacial
acetic acid, 0.0012 mL are added as buffers. pH 4.5 (3.5 to 6.0). The
solution contains no bacteriostat or antimicrobial agent and is intended only
for use as a single-dose unit to provide analgesia via the intravenous route
using a compatible Hospira infusion device. Meperidine
is classified pharmacologically as a synthetic narcotic analgesic. Meperidine
Hydrochloride is ethyl-1-methyl-4-phenylisonipecotate hydrochloride, a white,
crystalline substance with a melting point of 186��to 189��C. It
is readily soluble in water and has a neutral reaction and a slightly bitter
taste. The solution is not decomposed by a short period of boiling. It
has the following structural formula:
|
dailymed-instance:clinicalP... |
Meperidine hydrochloride is a narcotic analgesic with multiple
actions qualitatively similar to those of morphine; the most prominent of
these involve the central nervous system and organs composed of smooth muscle.
The principal actions of therapeutic value are analgesia and sedation. There
is some evidence which suggests that meperidine may produce less smooth muscle
spasm, constipation, and depression of the cough reflex than equianalgesic
doses of morphine. Meperidine, in 60 mg to 80 mg parenteral doses, is approximately
equivalent in analgesic effect to 10 mg of morphine. The onset of action is
slightly more rapid than with morphine, and the duration of action is slightly
shorter. Meperidine is significantly less effective by the oral than by the
parenteral route, but the exact ratio of oral to parenteral effectiveness
is unknown. Meperidine is metabolized through biotransformation.
The elimination half-life is 3 to 8 hours in healthy volunteers and is 1.3
to 2 times greater in post-operative or cirrhotic patients. The only bioactive
metabolite is normeperidine which has an average elimination half-life of
20.6 hours. Elevated serum levels have been reported to cause central nervous
system excitatory effects.
|
dailymed-instance:activeIng... | |
dailymed-instance:contraind... |
Hypersensitivity to meperidine. Meperidine
is contraindicated in patients who are receiving monoamine oxidase (MAO) inhibitors
or those who have recently received such agents. Therapeutic doses of meperidine
have occasionally precipitated unpredictable, severe, and occasionally fatal
reactions in patients who have received such agents within 14 days. The mechanism
of these reactions is unclear, but may be related to a pre-existing hyperphenylalaninemia.
Some have been characterized by coma, severe respiratory depression, cyanosis,
and hypotension, and have resembled the syndrome of acute narcotic overdose.
In other reactions the predominant manifestations have been hyperexcitability,
convulsions, tachycardia, hyperpyrexia, and hypertension. Although it is not
known that other narcotics are freeof the risk of such reactions, virtually
all of the reported reactions have occurred with meperidine. If a narcotic
is needed in such patients, a sensitivity test should be performed in which
repeated, small, incremental doses of morphine are administered over the course
of several hours while the patient's condition and vital signs are
under careful observation. (Intravenous hydrocortisone or prednisolone have
been used to treat severe reactions, with the addition of intravenous chlorpromazine
in those cases exhibiting hypertension and hyperpyrexia. The usefulness and
safety of narcotic antagonists in the treatment of these reactions is unknown). Solutions
of meperidine hydrochloride and barbiturates are chemically incompatible.
|
dailymed-instance:supply |
Meperidine Hydrochloride Injection, USP 10 mg/mL is supplied
in a 30 mL single-dose container (List No. 6030). This
vial is only for use with a compatible Hospira PCA pump set with injector
and a compatible Hospira infusion device (see directions for use supplied
with the set or infuser). Store at 20 to 25��C (68 to 77��F). [See
USP Controlled Room Temperature.] March, 2005 ��Hospira
2005 EN-0860 Printed in USA HOSPIRA,
INC., LAKE FOREST, IL 60045 USA
|
dailymed-instance:activeMoi... | |
dailymed-instance:inactiveI... | |
dailymed-instance:precautio... |
Do not use unless solution is clear and package is undamaged.
(See DOSAGE AND ADMINISTRATION.)<br/>General:: 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 pre-existing 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. The convulsive potential of meperidine may be further increased
if prolonged infusions or repeated doses are administered due to high serum
levels of normeperidine. Acute
Abdominal Conditions. The administration of meperidine or other
narcotics may obscure the diagnosis or clinical course in patients with acute
abdominal conditions. Special
Risk Patients. Meperidine should be given with caution and the initial
dose should be reduced in certain patients such as the elderly or debilitated,
and those with severe impairment of hepatic or renal function, hypothyroidism,
Addison's disease, and prostatic hypertrophy or urethral stricture.<br/>Information for Patients:: Physicians should assure the patient, or their caregiver,
has received adequate instructions for use prior to commencing therapy via
PCA.<br/>Pediatric Use.: Meperidine Hydrochloride administered by the intravenous
route via a compatible infusion device is not recommended for use in individuals
younger than 19 years of age.
|
dailymed-instance:overdosag... |
Symptoms. Serious
overdosage with meperidine is characterized by respiratory depression (a decrease
in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis),
extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity,
cold and clammy skin, and sometimes bradycardia and hypotension. In severe
overdosage, particularly by the intravenous route, apnea, circulatory collapse,
cardiac arrest, and death may occur. Treatment. Primary attention should be given to the re-establishment of adequate
respiratory exchange through provision of a patent airway and institution
of assisted or controlled ventilation. The narcotic antagonist, naloxone hydrochloride,
is a specific antidote against respiratory depression which may result from
overdosage or unusual sensitivity to narcotics, including meperidine. Therefore,
an appropriate dose of this antagonist should be administered, preferably
by the intravenous route, simultaneously with efforts at respiratory resuscitation. An
antagonist should not be administered in the absence of clinically significant
respiratory or cardiovascular depression. Oxygen, intravenous
fluids, vasopressors, and other supportive measures should be employed as
indicated. NOTE: In
an individual physically dependent on narcotics, the administration of the
usual dose of a narcotic antagonist will precipitate an acute withdrawal syndrome.
The severity of this syndrome will depend on the degree of physical dependence
and the dose of antagonist administered. The use of narcotic antagonists in
such individuals should be avoided if possible. If a narcotic antagonist must
be used to treat serious respiratory depression in the physically dependent
patient, the antagonist should be administered with extreme care and only
one-fifth to one-tenth the usual initial dose administered. The
use of naloxone in the presence of convulsive or other excitatory states and
other manifestations of elevated normeperidine serum levels is not recommended.
Most animal studies have shown that seizures due to normeperidine are not
naloxone reversible.
|
dailymed-instance:genericMe... |
Meperidine Hydrochloride
|
dailymed-instance:fullName |
Meperidine Hydrochloride (Injection, Solution)
|
dailymed-instance:adverseRe... |
The major hazards of meperidine, as with other narcotic analgesics,
are respiratory depression and, to a lesser degree, circulatory depression;
respiratory arrest, shock, and cardiac arrest have occurred. The
most frequently observed adverse reactions include light-headedness, dizziness,
sedation, nausea, vomiting, and sweating. These effects seem to be more prominent
in ambulatory patients and in those who are not experiencing severe pain.
In such individuals, lower doses are advisable. Some adverse reactions in
ambulatory patients may be alleviated if the patient lies down. Other adverse
reactions include: Nervous
System. Euphoria, dysphoria, weakness, headache, agitation, tremor,
uncoordinated muscle movements, severe convulsions, transient hallucinations
and disorientation, visual disturbances. Inadvertent injection about a nerve
trunk may result in sensory-motor paralysis which is usually, though not always,
transitory. Gastrointestinal. Dry mouth, constipation, biliary tract spasm. Cardiovascular. Flushing of the face, tachycardia,
bradycardia, palpitation, hypotension (see WARNINGS), syncope, phlebitis following
intravenous injection. Genitourinary. Urinary retention. Allergic. Pruritus, urticaria, other skin rashes, wheal and flare over the
vein with intravenous injection. Other. Pain at injection site; local tissue irritation and induration
following subcutaneous injection, particularly when repeated; antidiuretic
effect.
|
dailymed-instance:warning |
Drug Dependence.: Meperidine can produce drug dependence of the morphine type
and, therefore, has the potential for being abused. Psychic dependence, physical
dependence, and tolerance may develop upon repeated administration of meperidine,
and it should be prescribed and administered with the same degree of caution
appropriate to the use of morphine. Like other narcotics, meperidine is subject
to the provisions of the Federal narcotic laws. Interaction with Other Central Nervous System Depressants. MEPERIDINE SHOULD BE USED WITH GREAT CAUTION AND IN REDUCED DOSAGE
IN PATIENTS WHO ARE CONCURRENTLY RECEIVING OTHER NARCOTIC ANALGESICS, GENERAL
ANESTHETICS, PHENOTHIAZINES, OTHER TRANQUILIZERS (SEE DOSAGE AND ADMINISTRATION),
SEDATIVE-HYPNOTICS (INCLUDING BARBITURATES), TRICYCLIC ANTIDEPRESSANTS, AND
OTHER CNS DEPRESSANTS (INCLUDING ALCOHOL). RESPIRATORY DEPRESSION, HYPOTENSION,
AND PROFOUND SEDATION OR COMA MAY RESULT. 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: See DOSAGE AND ADMINISTRATION. 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 pre-existing 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 and Lactation. 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. When
used as an obstetrical analgesic, meperidine crosses the placental barrier
and can produce depression of respiration and psychophysiologic functions
in the newborn. Resuscitation may be required (see section on OVERDOSAGE). Meperidine
appears in the milk of nursing mothers receiving the drug.
|
dailymed-instance:indicatio... |
Meperidine hydrochloride administered by slow intravenous
injection is indicated for the relief of moderate to severe pain.
|
dailymed-instance:represent... | |
dailymed-instance:routeOfAd... | |
dailymed-instance:name |
Meperidine Hydrochloride
|