Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1405
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Morphine Sulfate (Injection, Solution)
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PHYSICIANS SHOULD COMPLETELY FAMILIARIZE THEMSELVES WITH
THE HOSPIRA INFUSION DEVICE BEFORE PRESCRIBING PRESERVATIVE-FREE MORPHINE
SULFATE INJECTION, USP. Preservative-free
Morphine Sulfate Injection was developed for intravenous administration
with a compatible Hospira infusion device. Parenteral drug products should be inspected for particulate
matter and discoloration prior to administration, whenever solution and container
permit. Do not use if color is darker than pale yellow, if it is discolored
in any other way, or if it contains a precipitate. Intravenous Administration For
use in a compatible Hospira infusion device, dosage should be adjusted according
to the severity of the pain and the response of the patient. Patients must
be closely monitored because of the considerable variability in both the dosage
requirements and patient response. Following are recommendations that have
to be individualized for each patient. Intravenous
Adult Dosage: The usual dose for administration to adults, via a
compatible Hospira infusion device, is a 1 mg bolus, with a range of 0.2 to
3 mg per incremental dose for the 0.5 mg/mL and 1 mg/mL concentrations and
a range of 0.5 to 3 mg per incremental dose for the 5 mg/mL concentration.
The recommended Lockout Interval is 6 minutes. The physician may adjust the
dosage either upward or downward (see INDIVIDUALIZATION OF DOSAGE); depending
on patient response. Occasionally, it may be necessary to exceed the usual
dosage in cases of exceptionally severe pain or in those patients who become
tolerant. SAFETY AND HANDLING
INSTRUCTIONS Preservative-free
Morphine Sulfate Injection is supplied in sealed PCA vials. Accidental
dermal exposure should be treated by the removal of any contaminated clothing
and rinsing the affected area with water. Each vial of Preservative-free
Morphine Sulfate Injection contains a potent narcotic which has
been associated with abuse and dependence among health care providers. Due
to the limited indications for this product, the risk of overdosage and the
risk of its diversion and abuse, it is recommended that special measures be
taken to control this product within the hospital or clinic. Preservative-free
Morphine Sulfate Injection should be subject to rigid accounting,
rigorous control of wastage and restricted access.
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Morphine, the most important alkaloid of opium, is classified
pharmacologically as a narcotic analgesic. Morphine Sulfate, USP (pentahydrate),
is chemically designated 7, 8-didehydro-4, 5��-epoxy-17-methylmorphinan-3,
6��-diol sulfate (2:1) (salt), pentahydrate, a white crystalline powder,
soluble in water. It has the following structural formula: Preservative-free Morphine Sulfate Injection,
USP, is a sterile, nonpyrogenic solution of morphine sulfate in water for
injection. This product was designed to be administered by the intravenous
route with a compatible Hospira infusion device. For
0.5 mg or 1 mg presentation, each mL contains morphine sulfate, USP (pentahydrate)
0.5 mg or 1 mg, respectively, and sodium chloride, USP, 9 mg in water for
injection, USP. May contain sodium hydroxide and/or hydrochloric acid for
pH adjustments. For 5 mg presentation, each mL contains morphine sulfate,
USP (pentahydrate), 5 mg, sodium chloride, USP, 7.6 mg, with citric acid,
USP, anhydrous 0.4 mg and sodium citrate, USP, dihydrate 0.2 mg added as buffers
in water for injection, USP. May contain additional citric acid and/or sodium
citrate for pHadjustment. The pH range for all preservative-free Morphine
Sulfate Injection, USP presentations is 2.5 to 6.5. Morphine Sulfate Injection,
USP, contains no antioxidant, bacteriostatic or antimicrobial agent, and is
intended only as a single-dose unit, to provide analgesia via the intravenous
route, using a compatible Hospira infusion device. Each vial is intended for
SINGLE USE ONLY. When the dosing requirement is completed, the unused portion
should be discarded in an appropriate manner. DO NOT HEAT STERILIZE. Do not use the injection if its color
is darker than pale yellow, if it is discolored in any other way, or if it
contains a precipitate.
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Morphine produces a wide spectrum of pharmacologic effects
including analgesia, dysphoria, euphoria, somnolence, respiratory depression,
diminished gastrointestinal motility, and physical dependence. Opiate analgesia
involves at least three anatomical areas of the central nervous system: the
periaqueductal-periventricular gray matter, the ventromedial medulla, and
the spinal cord. A systemically administered opiate may produce analgesia
by acting at any, all, or some combination of these distinct regions. Morphine
interacts predominantly with the��-receptor. The��-binding sites
of opioids are very discretely distributed in the human brain, with high densities
of sites found in the posterior amygdala, hypothalamus, thalamus, nucleus
caudatus, putamen, and certain cortical areas. They are also found on the
terminal axons of primary afferents within laminae I and II (substantia gelatinosa)
of the spinal cord and in the spinal nucleus of the trigeminal nerve. Pharmacokinetics Morphine
has an apparent volume of distribution ranging from 1 to 4.7 L/kg after intravenous
dosage. Protein binding is low, about 36%, and muscle tissue binding is reported
as 54%. When morphine is introduced outside of the CNS, plasma concentrations
of morphine remain higher than the corresponding CSF morphine levels. Morphine
has a total plasma clearance which ranges from 0.9 to 1.2 L/kg/h (liters/kilogram/hour)
in postoperative patients, but shows considerable interindividual variation.
The major pathway of clearance is hepatic glucuronidation to morphine-3-glucuronide,
which is pharmacologically inactive. The major excretion path of the conjugate
is through the kidneys, with about 10% in the feces. Morphine is also eliminated
by the kidneys, 2 to 12% being excreted unchanged in the urine. Terminal half-life
is commonly reported to vary from 1.5 to 4.5 hours, although the longer half-lives
were obtained when morphine levels were monitored over protracted periods
with very sensitive radioimmunoassay methods. The accepted elimination half-life
in normal subjects is 1.5 to 2 hours. The minimum analgesic
morphine plasma concentration during Patient-Controlled Analgesia (PCA) has
been reported as 20-40 ng/mL, corresponding to a self-administration rate
of 1.5 to 3 mg/h.<br/>Clinical Trials: Morphine is the most frequently-used opioid administered
by PCA, and has been studied in controlled clinical trials in both acute postoperative
settings and the chronic pain of malignancy. PCA morphine was administered
to opioid-naive postoperative patients using a 1-2 mg bolus size and a six
minute lockout interval. This resulted in an average self-administration rateof 2-3 mg/h, and average blood level of 30-70 ng/mL, and an analgesic efficacy
similar to that observed with conventional dosing. In
opioid-tolerant patients with pain from malignancy, most patients were studied
with a bolus size of 1-3 mg, a lockout of six minutes, and self-administered
at a rate of 3-10 mg/h. In a minority of cases, patients were studied using
subcutaneous route of administration, and in such cases a bolus size of 10
mg was used with a lockout of 30 minutes. PCA analgesia was rated as effective
as conventional therapy by both patients and physicians. Individualization of Dosage The
mean morphine self-administration rate observed in controlled clinical trials
ranged from 1-10 mg/h, depending on the nature of the pain, the degree
of opioid tolerance developed by the patient, and the individual patient factors.
Most patients will achieve adequate analgesia with a 1 mg bolus and a
six minute lockout, although patients with a high degree of opioid tolerance
may require a larger bolus size to be comfortable without excessively frequent
triggering of the device. In such patients, a bolus size of 2-3 mg is usually
adequate, although up to a 5 mg bolus has been used in opioid-tolerant patients
in some studies. Although the lockout interval may be varied, most investigators
have left it at 6 minutes to facilitate easy calculation of the maximal dosing
rate. For opioid-naive patients, the combination of
dosing rate and lockout should not permit a maximal dosing rate greater than
10 mg/h (1 mg possible every 6 minutes), while for opioid-tolerant patients
maximal dosing rates up to 30 mg/h are common (3 mg every 6 minutes) and greater
rates may be needed in selected patients.
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The only absolute contraindication for Preservative-free
Morphine Sulfate Injection is allergy to morphine or other opiates.
Relative contraindications to its use are acute bronchial asthma and upper
airway obstruction (see PRECAUTIONS).
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Preservative-free Morphine Sulfate Injection, USP, is supplied in single-dose 30
mL PCA vials as follows: 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). NOTE: Vial
injector and PCA set are sold separately. CONTAINS
NO PRESERVATIVES. DISCARD UNUSED PORTION. DO NOT HEAT-STERILIZE. Store
at 20 to 25��C (68 to 77��F). [See USP Controlled Room Temperature.]
Protect from freezing. Protect from light. Store in carton until time of use. Revised:
April, 2006 HOSPIRA, INC., LAKE FOREST,
IL 60045 USA
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PCA Analgesia: Although
self-administration of opioids by PCA may allow each patient to individually
titrate to an acceptable level of analgesia, PCA administration has resulted
in adverse outcomes and episodes of respiratory depression. Health care providers
and family members monitoring patients receiving PCA analgesia should be instructed
in the need for appropriate monitoring for excessive sedation, respiratory
depression, or other adverse effects of opioid medications. Use in Patients with Increased Intracranial Pressure or with
Head Injury: Preservative-free Morphine
Sulfate Injection, USP, should be used with extreme caution in patients with
increased intracranial pressure or with head injury. Pupillary changes (miosis)
from morphine may obscure the existence, extent, and course of intracranial
pathology. Clinicians should maintain a high index of suspicion for adverse
drug reactions when evaluating altered mental status in patients receiving
this treatment. Use in Chronic
Pulmonary Disease: Care is urged in using
this drug in patients who have a decreased respiratory reserve (e.g., emphysema,
severe obesity, kyphoscoliosis, or paralysis of the phrenic nerve). Preservative-free Morphine Sulfate Injection,
USP, should not be given in cases of chronic asthma, upper airway obstruction,
or in any other chronic pulmonary disorder without due consideration of the
known risk of acute respiratory failure following morphine administration
in such patients. Use in Hepatic
or Renal Disease: The elimination half-life
of morphine may be prolonged in patients with reduced metabolic rates and
with hepatic and/or renal dysfunction. Hence, care should be exercised in
administering morphine to patients with these conditions, since high blood
morphine levels, due to reduced clearance, may take several days to develop. Use in Patients with Disorders of the Biliary Tract: Care
should be exercised in patients with disorders of the biliary tract because
circulating morphine may induce smooth muscle hypertonicity resulting in biliary
colic. Use with Other Central
Nervous System Depressants: The depressant
effects of morphine sulfate are potentiated by the presence of other CNS depressants
such as alcohol, sedatives or antihistaminics. The minimum effective dose
of such agents should be chosen for patients who are receiving PCA morphine
to minimize the risk of respiratory depression.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility:: Studies of morphine sulfate in animals to evaluate the carcinogenic
and mutagenic potential or the effect on fertility have not been conducted.<br/>Pregnancy Category C:: Morphine sulfate is not teratogenic in rats at 35 mg/kg/day
(thirty-five times the usual human dose), but does result in increased pup
mortality and growth retardation at doses that narcotize the animal (>10
mg/kg/day, ten times the usual human dose). Preservative-free
Morphine Sulfate Injection should only be given to pregnant women
when clearly needed and means are at hand to manage the delivery and perinatal
care of the opiate-dependent infant.<br/>Labor and Delivery:: Intravenous morphine
readily passes into the fetal circulation and may result in respiratory depression
in the neonate. Naloxone and resuscitative equipment should be available for
reversal of narcotic-induced respiratory depression in the neonate. In addition,
intravenous morphine may reduce the strength, duration and frequency of uterine
contraction resulting in prolonged labor.<br/>Nursing Mothers:: Morphine is excreted in maternal milk in amounts that may
cause sedation of a nursing infant. Use in nursing mothers should be individualized
based on the clinical situation.<br/>Pediatric Use:: Adequate studies, to establish the safety and effectiveness
of PCA-administered morphine in children, have not been performed, and usagein this population is not recommended.<br/>Geriatric Use:: The pharmacodynamic effects of morphine in the aged are more
variable than in the younger population. Patients will vary widely in the
effective initial dose, rate of development of tolerance, and the frequency
and magnitude of associated adverse effects as the dose is increased.
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Overdosage of morphine is characterized by respiratory depression,
with or without concomitant CNS depression. Since respiratory arrest may result
either through direct depression of the respiratory center, or as the result
of hypoxia, primary attention should be given to the establishment of adequate
respiratory exchange through provision of a patent airway and institution
of assisted, or controlled, ventilation. The narcotic antagonist, naloxone,
is a specific antidote. An initial dose of 0.4 mg of naloxone should be administered
intravenously, simultaneously with respiratory resuscitation. If the desired
degree of counteraction and improvement in respiratory function is not obtained,
naloxone may be repeated at 2 to 3 minute intervals. If no response is observed
after 10 mg of naloxone has been administered, the diagnosis of narcotic-induced,
or partial narcotic-induced, toxicity should be questioned. Intramuscular
or subcutaneous administration may be used if the intravenous route is not
available.
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Morphine Sulfate
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Morphine Sulfate (Injection, Solution)
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The most serious side effect is respiratory depression (see
WARNINGS). Because of delay in maximum CNS effect with intravenously administered
drug (30 min), rapid administration may result in overdosing. The depression
may be severe and could require intervention (see WARNINGS and OVERDOSAGE). While
low doses of intravenously administered morphine have little effect on cardiovascular
stability, high doses are excitatory, resulting from sympathetic hyperactivity
and increase in circulating catecholamines. Excitation of the central nervous
system, resulting in convulsions, may accompany high doses of morphine given
intravenously. Dysphoric reactions may occur after any size dose and toxic
psychoses have been reported. Constipation: Constipation
is frequently encountered during PCA-administration of morphine; this can
usually be managed by conventional therapy. Other side
effects include: dizziness, euphoria, anxiety, depression of cough reflex,
interference with thermal regulation, and oliguria. Evidence of histamine
release such as urticaria, wheals, and/or local tissue irritation may occur.
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NALOXONE INJECTION AND RESUSCITATIVE
EQUIPMENT SHOULD BE IMMEDIATELY AVAILABLE FOR USE IN CASE OF LIFE-THREATENING
OR INTOLERABLE SIDE EFFECTS AND WHENEVER MORPHINE THERAPY IS BEING INITIATED. Intravenous Preservative-free
Morphine Sulfate Injection should be used only by those familiar
with managing respiratory depression. Rapid intravenous administration may
result in chest wall rigidity. Morphine sulfate may be habit forming. (See
DRUG ABUSE AND DEPENDENCE.)
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Preservative-free Morphine
Sulfate Injection is indicated for the management of pain where use of an
opioid analgesic by PCA is appropriate. It was developed for administration
via a compatible Hospira infusion device.
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Morphine Sulfate
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