Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/453
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Morphine Sulfate (Injection, Solution)
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Preservative-free morphine
sulfate injection is intended for intravenous, epidural or intrathecal administration. Intravenous Administration Dosage: The initial dose of morphine sulfate should
be 2 mg to 10 mg/70 kg of body weight. Patients under the age of 18; no information
available. Epidural Administration PRESERVATIVE-FREE MORPHINE SULFATE INJECTION SHOULD BE ADMINISTERED EPIDURALLY ONLY
BY PHYSICIANS EXPERIENCED IN THE TECHNIQUES OF EPIDURAL ADMINISTRATION AND
WHO ARE THOROUGHLY FAMILIAR WITH THE LABELING. IT SHOULD BE ADMINISTERED ONLY
IN SETTINGS WHERE ADEQUATE PATIENT MONITORING IS POSSIBLE. RESUSCITATIVE EQUIPMENT
AND A SPECIFIC ANTAGONIST (NALOXONE HYDROCHLORIDE INJECTION) SHOULD BE IMMEDIATELY
AVAILABLE FOR THE MANAGEMENT OF RESPIRATORY DEPRESSION AS WELL AS COMPLICATIONS
WHICH MIGHT RESULT FROM INADVERTENT INTRATHECAL OR INTRAVASCULAR INJECTION.
(NOTE: INTRATHECAL DOSAGE IS USUALLY 1/10 THAT OF EPIDURAL DOSAGE) PATIENT MONITORING SHOULD BE CONTINUED FOR AT LEAST 24 HOURS
AFTER EACH DOSE, SINCE DELAYED RESPIRATORY DEPRESSION MAY OCCUR. Proper
placement of a needle or catheter in the epidural space should be verified
before preservative-free morphine sulfate
injection is injected. Acceptable techniques for verifying proper placement
include: a) aspiration to check for absence of blood or cerebrospinal fluid,
or b) administration of 5 mL (3 mL in obstetric patients) of UNPRESERVED
1.5% Lidocaine and Epinephrine (1:200,000) Injection and then observe the
patient for lack of tachycardia (this indicates that vascular injection has not been made) and lack of sudden onset of segmental
anesthesia (this indicates that intrathecal injection has not been made). Epidural
Adult Dosage: Initial injection of 5 mg in the lumbar region may
provide satisfactory pain relief for up to 24 hours. If adequate pain relief
is not achieved within one hour, careful administration of incremental doses
of 1 to 2 mg at intervals sufficient to assess effectiveness may be given.
No more than 10 mg/24 hr should be administered. Thoracic
administration has been shown to dramatically increase the incidence of early
and late respiratory depression even at doses of 1 to 2 mg. For
continuous infusion an initial dose of 2 to 4 mg/24 hours is recommended.
Further doses of 1 to 2 mg may be given if pain relief is not achieved initially. Aged
or debilitated patients���Administer with extreme caution (see PRECAUTIONS).
Doses of less than 5 mg may provide satisfactory pain relief for up to 24
hours. Epidural Pediatric
Use: No information on use in pediatric patients is available. Intrathecal Administration NOTE: INTRATHECAL DOSAGE IS USUALLY 1/10 THAT OF EPIDURAL
DOSAGE. PRESERVATIVE-FREE MORPHINE
SULFATE INJECTION SHOULD BE ADMINISTERED INTRATHECALLY ONLY BY PHYSICIANS
EXPERIENCED IN THE TECHNIQUES OF INTRATHECAL ADMINISTRATION AND WHO ARE THOROUGHLY
FAMILIAR WITH THE LABELING. IT SHOULD BE ADMINISTERED ONLY IN SETTINGS WHERE
ADEQUATE PATIENT MONITORING IS POSSIBLE. RESUSCITATIVE EQUIPMENT AND A SPECIFIC
ANTAGONIST (NALOXONE HYDROCHLORIDE INJECTION) SHOULD BE IMMEDIATELY AVAILABLE
FOR THE MANAGEMENT OF RESPIRATORY DEPRESSION AS WELL AS COMPLICATIONS WHICH
MIGHT RESULT FROM INADVERTENT INTRAVASCULAR INJECTION. PATIENT
MONITORING SHOULD BE CONTINUED FOR AT LEAST 24 HOURS AFTER EACH DOSE, SINCE
DELAYED RESPIRATORY DEPRESSION MAY OCCUR. RESPIRATORY DEPRESSION
(BOTH EARLY AND LATE ONSET) HAS OCCURRED MORE FREQUENTLY FOLLOWING INTRATHECAL
ADMINISTRATION. Intrathecal
Adult Dosage: A single injection of 0.2 to 1 mg may provide satisfactory
pain relief for up to 24 hours. (CAUTION: THIS IS ONLY 0.4 TO 2 ML OF THE
5 MG/10 ML CONTAINER OR 0.2 TO 1 ML OF THE 10 MG/10 ML CONTAINER OF PRESERVATIVE-FREE MORPHINE SULFATE INJECTION.)
DO NOT INJECT INTRATHECALLY MORE THAN 2 ML OF THE 5 MG/10 ML CONTAINER OR
1 ML OF THE 10 MG/10 ML CONTAINER. USE IN THE LUMBAR AREA ONLY IS RECOMMENDED.
Repeated intrathecal injections of preservative-free morphine sulfate injection are not recommended. A constant intravenous
infusion of naloxone hydrochloride, 0.6 mg/hr, for 24 hours after intrathecal
injection may be used to reduce the incidence of potential side effects. Aged
or debilitated patients���Administer with extreme caution (see PRECAUTIONS).
A lower dosage is usually satisfactory. Repeat
Dosage: If pain recurs, alternative routes of administration should
be considered, since experience with repeated doses of morphine by the intrathecal
route is limited. Intrathecal
Pediatric Use: No information on the use in pediatric patients is
available. Parenteral drug products should be inspected
for particulate matter and discoloration prior to administration, whenever
solution and container permit. Do not administer unless solution is clear
and container is undamaged. Discard unused portion.
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Preservative-free Morphine
Sulfate Injection, USP is a sterile, nonpyrogenic, isobaric solution of morphine
sulfate in water for injection. Each mL contains morphine
sulfate, pentahydrate 0.5 mg or 1 mg (Warning: May be habit forming) and sodium
chloride 9 mg. May contain sodium hydroxide and/or hydrochloric acid for pH
adjustment. The pH is 5.0 (2.5 to 6.5). The osmolarity of the 0.5 mg/mL and
1 mg/mL solutions is 310 and 312 mOsmol/liter (calc.), respectively. Preservative-Free
Morphine Sulfate Injection, USP is oxygen sensitive. The
solution contains no antioxidant, bacteriostat or antimicrobial agent and
is intended as a single-dose injection to provide analgesia via the intravenous,
epidural or intrathecal routes. Each ampul and vial is intended for SINGLE
USE ONLY. Discard unused portion. 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. 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: Sodium
Chloride, USP is chemically designated NaCl, a white crystalline compound
freely soluble in water.
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Morphine exerts its primary effects on the central nervous
system and organs containing smooth muscle. Pharmacologic effects include
analgesia, drowsiness, alteration in mood (euphoria), reduction in body temperature
(at low doses), dose-related depression of respiration, interference with
adrenocortical response to stress (at high doses), reduction in peripheral
resistance with little or no effect on cardiac index and miosis. Morphine,
as other opioids, acts as an agonist interacting with stereospecific and saturable
binding sites/receptors in the brain, spinal cord and other tissues. These
sites have been classified as��receptors and are widely distributed
throughout the central nervous system being present in highest concentration
in the limbic system (frontal and temporal cortex, amygdala and hippocampus),
thalamus, striatum, hypothalamus, midbrain and laminae I, II, IV and V of
the dorsal horn in the spinal cord. It has been postulated that exogenously
administered morphine exerts its analgesic effect, in part, by altering the
central release of neurotransmitter from afferent nerves sensitive to noxious
stimuli. Peripheral threshold or responsiveness to noxious stimuli is unaffected
leaving monosynaptic reflexes such as the patellar or the Achilles tendon
reflex intact. Autonomic reflexes are not affected by
epidural or intrathecal morphine, however morphine exerts spasmogenic effects
on the gastrointestinal tract that result in decreased peristaltic activity. Central
nervous system effects of intravenously administered morphine sulfate are
influenced by ability to cross the blood-brain barrier. The
delay in the onset of analgesia following epidural or intrathecal injection
may be attributed to its relatively poor lipid solubility (i.e., an oil/water
partition coefficient of 1.42), and its slow access to the receptor sites.
The hydrophilic character of morphine may also explain its retention in the
CNS and its slow release into the systemic circulation, resulting in a prolonged
effect. Nausea and vomiting may be prominent and are
thought to be the result of central stimulation of the chemoreceptor trigger
zone. Histamine release is common; allergic manifestations of urticaria and,
rarely, anaphylaxis may occur. Bronchoconstriction may occur either as an
idiosyncratic reaction or from large dosages. Approximately
one-third of intravenous morphine is bound to plasma proteins. Free morphine
is rapidly redistributed in parenchymatous tissues. The major metabolic pathway
is through conjugation with glucuronic acid in the liver. Elimination half-life
is approximately 1.5 to 2 hours in healthy volunteers. For intravenously administered
morphine, 90% is excreted in the urine within 24 hours and traces are detectable
in urine up to 48 hours. About 7-10% of administered morphine eventually appears
in the feces as conjugated morphine. Peak serum levelsfollowing epidural or intrathecal administration of preservative-free morphine sulfate injection are reached within 30 minutes in most
subjects and decline to very low levels during the next 2 to 4 hours. The
onset of action occurs in 15 to 60 minutes following epidural administration
or intrathecal administration; analgesia may last up to 24 hours. Due to this
extended duration of action, sustained pain relief can be provided with lower
daily doses (by these two routes) than are usually required with intravenous
or intramuscular morphine administration.
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Morphine sulfate injection is contraindicated in those medical
conditions which would preclude the administration of opioids by the intravenous
route���allergy to morphine or other opiates, acute bronchial asthma,
upper airway obstruction. Administration of morphine
by the epidural or intrathecal route is contraindicated in the presence of
infection at the injection site, anticoagulant therapy, bleeding diathesis,
parenterally administered corticosteroids within a two week period or other
concomitant drug therapy or medical condition which would contraindicate the
technique of epidural or intrathecal analgesia.
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Preservative-free Morphine
Sulfate Injection, USP is supplied in cartons of five 10 mL amber ampuls or
vials as follows: 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. November, 2004 HOSPIRA, INC., LAKE FOREST, IL 60045 USA
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NOTE: INTRATHECAL DOSAGE IS USUALLY 1/10 THAT OF EPIDURAL
DOSAGE.
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General: Morphine sulfate injection should be administered with extreme
caution in aged or debilitated patients, in the presence of increased intracranial/intraocular
pressure and in patients with head injury. Pupillary changes (miosis) may
obscure the course of intracranial pathology. Care is urged in patients who
have a decreased respiratory reserve (e.g., emphysema, severe obesity, kyphoscoliosis). Seizures
may result from high doses. Patients with known seizure disorders should be
carefully observed for evidence of morphine-induced seizure activity. It
is recommended that administration of preservative-free morphine sulfate injection by the epidural or intrathecal routes
be limited to the lumbar area. Intrathecal use has been associated with a
higher incidence of respiratory depression than epidural use. Smooth
muscle hypertonicity may result in biliary colic, difficulty in urination
and possible urinary retention requiring catheterization, consideration should
be given to risks inherent in urethral catheterization, (e.g., sepsis), when
epidural or intrathecal administration is considered, especially in the perioperative
period. Elimination half-life may be prolonged in patients
with reduced metabolic rates and with hepatic or renal dysfunction. Hence,care should be exercised in administering morphine in these conditions, particularly
with repeated dosing. Patients with reduced circulating
blood volume, impaired myocardial function or on sympatholytic drugs should
be observed carefully for orthostatic hypotension, particularly in transport. Patients
with chronic obstructive pulmonary disease and patients with acute asthmatic
attack may develop acute respiratory failure with administration of morphine.
Use in these patients should be reserved for those whose conditions require
endotracheal intubation and respiratory support or control of ventilation.<br/>Drug Interactions: Depressant effects of morphine are potentiated by either
concomitant administration or in the presence of other CNS depressants such
as alcohol, sedatives, antihistaminics or psychotropic drugs (e.g., MAO inhibitors,
phenothiazines, butyrophenones and tricyclic antidepressants). Premedication
or intra-anesthetic use of neuroleptics with morphine may increase 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: Teratogenic effects���Pregnancy Category C. Animal reproduction studies
have not been conducted with morphine sulfate. It is also not known whether
morphine sulfate can cause fetal harm when administered to a pregnant woman
or can affect reproduction capacity. Morphine sulfate should be given to a
pregnant woman only if clearly needed. Nonteratogenic
effects. Infants born from mothers who have been taking morphine
chronically may exhibit withdrawal symptoms.<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. Epidurally
and intrathecally administered morphine readily passes into the
fetal circulation and may result in respiratory depression of the neonate.
Controlled clinical studies have shown that epidural administration has little or no effect on the relief of labor
pain. However, studies have suggested that in most cases
0.2 to 1 mg of morphine intrathecally provides
adequate pain relief with little effect on the duration of first stage labor.
The second stage labor, though, may be prolonged if the parturient is not
encouraged to bear down. A continuous intravenous infusion of naloxone, 0.6
mg/hr, for 24 hours after intrathecal injection may be employed to reduce
the incidence of potential side effects.<br/>Nursing Mothers: Morphine is excreted in maternal milk. Effect on the nursing
infant is not known.<br/>Pediatric Use: Safety and effectiveness in children have not been established.
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Overdosage 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. Naloxone hydrochloride (see package insert for full
prescribing information) should be administered intravenously, simultaneously
with respiratory resuscitation. As the duration
of effect of naloxone is considerably shorter than that of epidural or intrathecal
morphine, repeated administration may be necessary. Patients should
be closely observed for evidence of renarcotization. Note:
Respiratory depression may be delayed in onset up to 24 hours following
epidural or intrathecal administration. In painful conditions, reversal of
narcotic effect may resultin acute onset of pain and release of catecholamines.
Careful administration of naloxone may permit reversal of side effects without
affecting analgesia. Parenteral administration of narcotics in patients receiving
epidural or intrathecal morphine may result in overdosage.
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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. Because
of delay in maximum CNS effect with intravenously administered drug (30 min),
rapid administration may result in overdosing. Bolus administration by the
epidural or intrathecal route may result in early respiratory depression due
to direct venous redistribution of morphine to the respiratory centers in
the brain. Late (up to 24 hours) onset of acute respiratory depression
has been reported with administration by the epidural or intrathecal route
andis believed to be the result of rostral spread. Reports of respiratory
depression following intrathecal administration have been more frequent, but
the dosage used in most of these cases has been considerably higher than that
recommended. This depression may be severe and could require intervention
(see WARNINGS and OVERDOSAGE). Even without clinical evidence of ventilatory
inadequacy, a diminished COventilation response may be noted
for up to 22 hours following epidural or intrathecal administration. While
low doses of intravenously administered morphine have little effect on cardiovascular
stability, high doses are excitatory, resulting from sympathetic hyperactivity
and an 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 and toxic psychoses have been
reported. Epidural or intrathecal administration is
accompanied by a high incidence of pruritus which is dose related but not
confined to site of administration. Nausea and vomiting are frequently seen
in patients following morphine administration. Urinary retention which may
persist for 10 to 20 hours following single epidural or intrathecal administration
has been reported in approximately 90% of males. Incidence is somewhat lower
in females. Patients may require catheterization (see PRECAUTIONS). Pruritus,
nausea/vomiting and urinary retention frequently can be alleviated by the
intravenous administration of low doses of naloxone (0.2 mg). Tolerance
and dependence to chronically administered morphine, by whatever route, is
known to occur (see DRUG ABUSE AND DEPENDENCE). Miscellaneous
side effects include constipation, headache, 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. In
general, side effects are amenable to reversal by narcotic antagonists. NALOXONE
HYDROCHLORIDE INJECTION AND RESUSCITATIVE EQUIPMENT SHOULD BE IMMEDIATELY
AVAILABLE FOR ADMINISTRATION IN CASE OF LIFE-THREATENING OR INTOLERABLE SIDE
EFFECTS.
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| dailymed-instance:warning |
Morphine sulfate injection administration should be limited
to use by those familiar with the management of respiratory depression, and
in the case of epidural or intrathecal administration, familiar with the techniques
and patient management problems associated with epidural or intrathecal drug
administration. Because epidural administration has been associated with lessened
potential for immediate or late adverse effects than intrathecal administration,
the epidural route should be used wheneverpossible. Rapid intravenous administration
may result in chest wall rigidity. FACILITIES WHEREMORPHINE SULFATE INJECTION IS ADMINISTERED MUST BE EQUIPPED WITH RESUSCITATIVE
EQUIPMENT, OXYGEN, NALOXONE INJECTION, AND OTHER RESUSCITATIVE DRUGS. WHEN
THE EPIDURAL OR INTRATHECAL ROUTE OF ADMINISTRATION IS EMPLOYED, PATIENTS
MUST BE OBSERVED IN A FULLY EQUIPPED AND STAFFED ENVIRONMENT FOR AT LEAST
24 HOURS. SEVERE RESPIRATORY DEPRESSION UP TO 24 HOURS
FOLLOWING EPIDURAL OR INTRATHECAL ADMINISTRATION HAS BEEN REPORTED. Morphine
sulfate may be habit forming. (See DRUG ABUSE AND DEPENDENCE.)
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Preservative-free morphine
sulfate injection is a systemic narcotic analgesic for administration by the
intravenous, epidural or intrathecal routes. It is used for the management
of pain not responsive to non-narcotic analgesics. Morphine sulfate, administered
epidurally or intrathecally, provides pain relief for extended periods without
attendant loss of motor, sensory or sympathetic function.
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Morphine Sulfate
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