NDC 54868-3559 Meperidine Hydrochloride

NDC Product Code 54868-3559

NDC 54868-3559-1

Package Description: 25 VIAL in 1 PACKAGE > 1 mL in 1 VIAL

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Meperidine Hydrochloride with NDC 54868-3559 is a product labeled by Physicians Total Care, Inc.. The generic name of Meperidine Hydrochloride is . The product's dosage form is and is administered via form.

Labeler Name: Physicians Total Care, Inc.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ACETIC ACID (UNII: Q40Q9N063P)
  • SODIUM ACETATE (UNII: 4550K0SC9B)
  • WATER (UNII: 059QF0KO0R)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Physicians Total Care, Inc.
Labeler Code: 54868
Start Marketing Date: 03-04-2010 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2017 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I - INACTIVATED, the listing data was inactivated by the FDA. What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Information for Patients

Meperidine Injection

Meperidine Injection is pronounced as (me per' i deen)

Why is meperidine injection medication prescribed?
Meperidine injection is used to relieve moderate to severe pain. It may also be used before and during surgery or other medical procedures. Meperidine injection is in a c...
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Meperidine Hydrochloride Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

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Description

Meperidine Hydrochloride Injection, USP is a sterile solution for
intramuscular, subcutaneous or slow intravenous use as a narcotic analgesic.Each mL of the DOSETTE vial contains meperidine hydrochloride, either 25 mg,
50 mg, 75 mg or 100 mg in Water for Injection. Buffered with acetic acid-sodium
acetate. pH 3.5-6.0.Meperidine hydrochloride is ethyl 1-methyl-4-phenylisonipecotate
hydrochloride, a white crystalline substance with a melting point of 186°-189°C.
It is readily soluble in water and has a slightly bitter taste. Its structural
formula is as follows:C15H21NO2•HCl      MW 283.79

Clinical Pharmacology

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 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.In clinical studies, changes in several pharmacokinetic parameters with
increasing age have been observed. The initial volume of distribution and
steady-state volume of distribution may be higher in elderly patients than in
younger patients.1 The free fraction of meperidine in
plasma may be higher in patients over 45 years of age than in younger
patients.2

Indications And Usage

For the relief of moderate to severe pain.For preoperative medication.For support of anesthesia.For obstetrical analgesia.

Contraindications

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
preexisting 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 free of 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.

Warnings

Drug DependenceMeperidine 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.
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
DepressantsMEPERIDINE 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), SEDATIVEHYPNOTICS (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 PressureThe 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 UseIf 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 unless
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 ConditionsMeperidine 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 EffectThe administration of meperidine may result in severe hypotension
in the postoperative patient or any individual whose ability to maintain blood
pressure has already been compromised by a depleted blood volume or
administration of drugs, such as the phenothiazines or certain
anesthetics.Usage in Ambulatory PatientsMeperidine 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 LactationMeperidine 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.

Precautions

As with all intramuscular preparations, meperidine intramuscular
injection should be injected well within the body of a large muscle.Supraventricular TachycardiasMeperidine 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.ConvulsionsMeperidine 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 ConditionsThe administration of meperidine or other narcotics may obscure
the diagnosis or clinical course in patients with acute abdominal
conditions.Special Risk PatientsMeperidine 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.Geriatric UseClinical studies of meperidine did not include sufficient numbers
of subjects aged 65 and over to determine whether they respond differently from
younger subjects. Other reported clinical experience has not identified
differences in response between the elderly and younger patients. In general,
dose selection for an elderly patient should be low, usually starting at the low
end of the dosing range, reflecting the greater frequency of decreased hepatic,
renal, or cardiac function, and of concomitant disease or other drug therapy.
Doses of meperidine should be reduced in elderly patients. (See DOSAGE AND ADMINISTRATION.)Sedating drugs may cause confusion and oversedation in the elderly; elderly
patients generally should be started on low doses of meperidine and observed
closely.This drug is known to be substantially excreted by the kidney, and the risk
of toxic reactions to this drug may be greater in patients with impaired renal
function. Because elderly patients are more likely to have decreased renal
function, care should be taken in dose selection, and it may be useful to
monitor renal function.Clinical studies indicate that differences in various pharmacokinetic
parameters may exist between elderly and younger patients. (See CLINICAL PHARMACOLOGY.)

Adverse Reactions

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 lightheadedness,
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:Central 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, palpitations, hypotension (see WARNINGS),
syncope, phlebitis following intravenous injection.Genitourinary-Urinary retention.Allergic-Pruritus, urticaria, other skin rashes,
wheal and flare over the vein with IV injection.Other-Pain at injection site; local tissue irritation
and induration following subcutaneous injection, particularly when repeated;
antidiuretic effect.

Overdosage

SymptomsSerious overdose 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.TreatmentPrimary attention should be given to the reestablishment 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 naloxone hydrochloride 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.

Dosage And Administration

For Relief of PainDosage should be adjusted according to the severity of the pain
and the response of the patient. While subcutaneous administration is suitable
for occasional use, intramuscular administration is preferred when repeated
doses are required. If intravenous administration is required, dosage should be
decreased and the injection made very slowly, preferably utilizing a diluted
solution. Meperidine is less effective orally than by parenteral administration.
The dose of meperidine should be proportionately reduced (usually by 25 to 50
percent) when administered concomitantly with phenothiazines and many other
tranquilizers since they potentiate the action of meperidine.AdultsThe usual dosage is 50 to 150 mg intramuscularly or
subcutaneously every 3 to 4 hours as necessary. Elderly patients should usually
be given meperidine at the lower end of the dose range and observed
closely.ChildrenThe usual dosage is 0.5 to 0.8 mg/lb intramuscularly or
subcutaneously up to the adult dose, every 3 to 4 hours as necessary.For Preoperative MedicationAdultsThe usual dosage is 50 to 150 mg intramuscularly or
subcutaneously every 3 to 4 hours as necessary. Elderly patients should usually
be given meperidine at the lower end of the dose range and observed
closely.ChildrenThe usual dosage is 0.5 to 1 mg/lb intramuscularly or
subcutaneously up to the adult dose, 30 to 90 minutes before the beginning of
anesthesia.For Support of AnesthesiaRepeated slow intravenous injections of fractional doses (e.g.,
10 mg/mL) or by a continuous intravenous infusion of a more dilute solution
(e.g., 1 mg/mL) should be used. The dose should be titrated to the needs of the
patient and will depend on the premedication and type of anesthesia being
employed, the characteristics of the particular patient and the nature and
duration of the operative procedure. Elderly patients should usually be given
meperidine at the lower end of the dose range and observed closely.For Obstetrical AnalgesiaThe usual dosage is 50 to 100 mg intramuscularly or
subcutaneously when pain becomes regular and may be repeated at 1 to 3 hour
intervals.Parenteral drug products should be inspected visually for
particulate matter and discoloration prior to administration, whenever solution
and container permit.

How Supplied

Meperidine Hydrochloride Injection, USP is available in the
following packages:50 mg/mL1 mL DOSETTE vials packaged in 25s ( NDC 54868-3559-1)StorageStore at 20°-25°C (68°-77°F), excursions
permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

References

1. Mather, LE et al: Meperidine kinetics in man. Intravenous
injection in surgical patients and volunteers. Clin
Pharmacol Ther 17:21-30, 1975.2. Herman, RJ et al: Effects of age on meperidine disposition. Clin Pharmacol Ther 37:19-24, 1985.Baxter and Dosette are trademarks of Baxter International Inc., or its
subsidiaries.Manufactured byBaxter Healthcare CorporationDeerfield, IL 60015 USAFor Product Inquiry 1 800 ANA DRUG (1-800-262-3784)MLT-01168/3.0Relabeling of "Additional Barcode" by:Physicians Total Care, Inc.Tulsa, OK     74146

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