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Basic Drug Info
Drug Name:Meperidine Hydrochloride
Manufacturer:HOSPIRA, INC.
Other Info:CIIRx only300 mg (10 mg/mL)ONLY FOR USE WITH A COMPATIBLEHOSPIRA PCA PUMP SET WITH INJECTORAND A COMPATIBLE HOSPIRA INFUSIONDEVICE.



Clinical Trials:


Indications and Usage
Meperidine hydrochloride administered by slow intravenous injection is indicated for the relief of moderate to severe pain.
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 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 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.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

hyperphenylalaninemia -- any of several autosomal recessive defects in the hydroxylation of phenylalanine resulting in accumulation and excretion of dietary phenylalanine; most commonly the defect is in the enzyme phenylalanine 4-monooxygenase; the most severe manifestation of this is classic PHENYLKETONURIA, but two benign forms also occur; rarely the defect is one of tetrahydrobiopterin metabolism.

comatose -- A profound state of unconsciousness associated with depressed cerebral activity from which the individual cannot be aroused. Coma generally occurs when there is dysfunction or injury involving both cerebral hemispheres or the brain stem RETICULAR FORMATION.

LUNG FUNCTION DECREASED --

Cyanosis -- A bluish or purplish discoloration of the skin and mucous membranes due to an increase in the amount of deoxygenated hemoglobin in the blood or a structural defect in the hemoglobin molecule.

Syndrome -- A symptom complex of unknown etiology, that is characteristic of a particular abnormality.

Convulsions -- the most dramatic type of seizure, characterized by tonic and clonic contraction of most skeletal muscles.

Tachycardia -- Abnormally rapid heartbeat, usually with a HEART RATE above 100 beats per minute for adults. Tachycardia accompanied by disturbance in the cardiac depolarization (cardiac arrhythmia) is called tachyarrhythmia.

Hyperpyrexia --

Hypertensive disease -- Persistently high systemic arterial BLOOD PRESSURE. Based on multiple readings (BLOOD PRESSURE DETERMINATION), hypertension is currently defined as when SYSTOLIC PRESSURE is consistently greater than 140 mm Hg or when DIASTOLIC PRESSURE is consistently 90 mm Hg or more.

Warnings

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.
Branded Drugs
The following US Branded drugs contain Meperidine Hydrochloride


ATROPINE AND DEMEROL -- ABBOTT LABORATORIES

MEPERIDINE AND ATROPINE SULFATE -- WYETH AYERST LABORATORIES

DEMEROL -- HOSPIRA INC

DEMEROL -- SANOFI AVENTIS US LLC

MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE -- ASTRAZENECA LP

MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE -- HOSPIRA INC

MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE -- INTERNATIONAL MEDICATION SYSTEM

MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE -- MALLINCKRODT CHEMICAL INC

MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE -- WATSON LABORATORIES INC

MEPERGAN -- BAXTER HEALTHCARE CORP ANESTHESIA CRITICAL CARE


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