Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/576
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Hydromorphone Hydrochloride (Injection, Solution)
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Parenteral: HYDROMORPHONE
HYDROCHLORIDE INJECTION (HIGH POTENCY) SHOULD BE GIVEN ONLY TO PATIENTS
WHO ARE ALREADY RECEIVING LARGE DOSES OF OPIOIDS. Hydromorphone
Hydrochloride Injection (High Potency) is indicated for relief of
moderate-to-severe pain in opioid-tolerant patients. Thus, these patients
will already have been treated with other opioid analgesics. If the
patient is being changed from regular hydromorphone hydrochloride
to high potency formulation, similar doses should be used, depending
on the patient's clinical response to the drug. If Hydromorphone Hydrochloride
Injection (High Potency) is substituted for a different opioid analgesic,
the following equivalency table should be used as a guide to determine
the appropriate starting dose of Hydromorphone Hydrochloride Injection
(High Potency). Patients with hepatic and renal impairment should
be started on a lower starting dose. (See CLINICAL PHARMACOLOGY: PHARMACOKINETICS
AND METABOLISM.) The dosage of Hydromorphone Hydrochloride
Injection (High Potency) should be individualized for any given patient,
since adverse events can occur at doses that may not provide complete
freedom from pain. Safe and effective administration
of opioid analgesics to patients with acute or chronic pain depends
upon a comprehensive assessment of the patient. The nature of the
pain (severity, frequency, etiology, and pathophysiology) as well
as the concurrent medical status of the patient will affect selection
of the starting dosage. In open clinical trials with Hydromorphone Hydrochloride
Injection (High Potency) in patients with terminal cancer, doses ranged
from 1 to 14 mg subcutaneously or intramuscularly; one patient received
30 mg subcutaneously on two occasions. In these trials, both subcutaneous
and intramuscular injections of Hydromorphone Hydrochloride Injection
(High Potency) were well-tolerated, with minimal pain and/or burning
at the injection site. Mild erythema was rarely noted after intramuscular
injection. There was no induration after either intramuscular or subcutaneous
administration of Hydromorphone Hydrochloride Injection (High Potency).
Subcutaneous injections of Hydromorphone Hydrochloride Injection (High
Potency) were particularly well accepted when administered with a
short, 30-gauge needle. Experience with administration
of Hydromorphone Hydrochloride Injection (High Potency) by the intravenous
route is limited. Should intravenous administration be necessary,
the injection should be given slowly, over at least 2 to 3 minutes.
The intravenous route is usually painless. A
gradual increase in dose may be required if analgesia is inadequate,
tolerance occurs, or if pain severity increases. The first sign of
tolerance is usually a reduced duration of effect. NOTE: Parenteral drug products should be inspected visually for particulate
matter and discoloration prior to administration, whenever solution
and container permit. A slight yellowish discoloration may develop
in Hydromorphone Hydrochloride Injection (High Potency) ampuls. No
loss of potency has been demonstrated. Hydromorphone hydrochloride
injection is physically compatible and chemically stable for at least
24 hours at 25��C protected from light in most common large volume
parenteral solutions.
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dailymed-instance:descripti... |
Hydromorphone hydrochloride, a hydrogenated ketone
of morphine, is an opioid analgesic. HIGH POTENCY HYDROMORPHONE HYDROCHLORIDE is available
in AMBER ampuls for intravenous
(IV) subcutaneous (SC) or intramuscular (IM) administration. Each
1 mL of sterile solution contains 10 mg hydromorphone hydrochloride
with 0.2% sodium citrate, and 0.2% citric acid solution in Water for
Injection; pH 3.5 to 5.5. The chemical name
of hydromorphone hydrochloride is 4,5��-Epoxy-3-hydroxy-17-methylmorphinan-6-one
hydrochloride and it has the following structural formula:<br/>CLINICAL PHARMACOLOGY: Hydromorphone hydrochloride is a pure opioid agonist
with the principal therapeutic activity of analgesia. A significant
feature of the analgesia is that it can occur without loss of consciousness.
Opioid analgesics also suppress the cough reflex and may cause respiratory
depression, mood changes, mental clouding, euphoria, dysphoria, nausea,
vomiting and electroencephalographic changes. Many of the effects
described below are common to the class of mu-opioid analgesics which
includes morphine, oxycodone, hydrocodone, codeine, and fentanyl.
In some instances, data may not exist to demonstrate that hydromorphone
possesses similar or different effects than those observed with other
opioid analgesics. However, in the absence of data to the contrary,
it is assumed that hydromorphone would possess these effects. Central Nervous System: The precise mode of analgesic action of opioid analgesics is unknown.
However, specific CNS opiate receptors have been identified. Opioids
are believed to express their pharmacological effects by combining
with these receptors. Hydromorphone depresses
the cough reflex by direct effect on the cough center in the medulla. Hydromorphone produces respiratory depression by direct
effect on brain stem respiratory centers. The mechanism of respiratory
depression also involves a reduction in the responsiveness of the
brain stem respiratory centers to increases in carbon dioxide tension. Hydromorphone causes miosis. Pinpoint pupils are a common
sign of opioid overdose but are not pathognomonic (e.g., pontine lesions
of hemorrhagic or ischemic origin may produce similar findings). Marked
mydriasis rather than mioisis may be seen with hypoxia in the setting
of hydromorphone overdose. Gastrointestinal Tract and Other Smooth Muscle: Gastric, biliary and pancreatic secretions are decreased by opioids
such as hydromorphone. Hydromorphone causes a reduction in motility
associated with an increase in tone in the gastric antrum and duodenum.
Digestion of food in the small intestine is delayed and propulsive
contractions are decreased. Propulsive peristaltic waves in the colon
are decreased, and tone may be increased to the point of spasm. The
end result is constipation. Hydromorphone can cause a marked increase
in biliary tract pressure as a result of spasm of the sphincter of
Oddi. Cardiovascular
System: Hydromorphone may produce hypotension as a result
of either peripheral vasodilation, release of histamine, or both.
Other manifestations of histamine release and/or peripheral vasodilation
may include pruritus, flushing, and red eyes. Effects on the myocardium after intravenous administration of opioid
are not significant in normal persons, vary with different opioid
analgesic agents and vary with the hemodynamic state of the patient,
state of hydration and sympathetic drive.<br/>PHARMACOKINETICS AND METABOLISM:<br/>Distribution:: At therapeutic plasma levels, hydromorphone is approximately
8-19% bound to plasma proteins. After an intravenous bolus dose, the
steady state of volume of distribution [mean(%cv)] is 302.9 (32%)
liters.<br/>Metabolism:: Hydromorphone is extensively metabolized via glucuronidation
in the liver, with greater than 95% of the dose metabolized to hydromorphone-3-glucuronide
along with minor amounts of 6-hydroxy reduction metabolites.<br/>Elimination:: Only a small amount of the hydromorphone dose is
excreted unchanged in the urine. Most of the dose is excreted as hydromorphone-3-glucuronide
along with minor amounts of 6-hydroxy reduction metabolites. The systemic
clearance is approximately 1.96 (20%) liters/minute. The terminal
elimination half-life of hydromorphone after an intravenous dose is
about 2.3 hours.<br/>Special Populations:: Hepatic Impairment: After oral administration of hydromorphone at a single 4 mg dose,
mean exposure to hydromorphone (Cand AUC) is increased 4-fold in patients with moderate (Child-Pugh Group
B) hepatic impairment compared with subjects with normal hepatic function.
Due to increased exposure of hydromorphone, patients with moderate
hepatic impairment should be started at a lower dose and closely monitored
during dose titration. Pharmacokinetics of hydromorphone in severe
hepatic impairment patients has not been studied. Further increase
in Cand AUC of hydromorphone in this group is expected.
As such, starting dose should be even more conservative. Use of oral
liquid is recommended to adjust the dose (see DOSAGE AND ADMINISTRATION). Renal
Impairment: After oral administration of hydromorphone at
a single 4 mg dose, mean exposure to hydromorphone (Cand AUC) is increased in patients with impaired renal
function by 2-fold, in moderate (CLcr = 40-60 mL/min) and 3-fold in
severe (CLcr<30 mL/min) renal impairment compared with normal subjects
(CLcr>80 mL/min). In addition, in patients with severe renal impairment
hydromorphone appeared to be more slowly eliminated with longer terminal
elimination half-life (40 hr) compared to patients with normal renal
function (15 hr). Patients with moderate renal impairment should be
started on a lower dose. Starting doses for patients with severe renal
impairment should be even lower. Patients with renal impairment should
be closely monitored during dose titration. Use of oral liquid is
recommended to adjust the dose (see DOSAGE AND ADMINISTRATION). Pediatrics: Pharmacokinetics
of hydromorphone have not been evaluated in children. Geriatric: Age has no effect
on the pharmacokinetics of hydromorphone. Gender: Gender has little effect on the
pharmacokinetics of hydromorphone. Females appear to have higher C(25%) than males with comparable AUCvalues.
The difference observed in Cmay not be clinically relevant. Pregnancy and nursing mothers: Hydromorphone crosses the placenta. Hydromorphone is also found
in low levels in breast milk, and may cause respiratory compromise
in newborns when administered during labor or delivery.
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Hydromorphone hydrochloride is a pure opioid agonist
with the principal therapeutic activity of analgesia. A significant
feature of the analgesia is that it can occur without loss of consciousness.
Opioid analgesics also suppress the cough reflex and may cause respiratory
depression, mood changes, mental clouding, euphoria, dysphoria, nausea,
vomiting and electroencephalographic changes. Many of the effects
described below are common to the class of mu-opioid analgesics which
includes morphine, oxycodone, hydrocodone, codeine, and fentanyl.
In some instances, data may not exist to demonstrate that hydromorphone
possesses similar or different effects than those observed with other
opioid analgesics. However, in the absence of data to the contrary,
it is assumed that hydromorphone would possess these effects. Central Nervous System: The precise mode of analgesic action of opioid analgesics is unknown.
However, specific CNS opiate receptors have been identified. Opioids
are believed to express their pharmacological effects by combining
with these receptors. Hydromorphone depresses
the cough reflex by direct effect on the cough center in the medulla. Hydromorphone produces respiratory depression by direct
effect on brain stem respiratory centers. The mechanism of respiratory
depression also involves a reduction in the responsiveness of the
brain stem respiratory centers to increases in carbon dioxide tension. Hydromorphone causes miosis. Pinpoint pupils are a common
sign of opioid overdose but are not pathognomonic (e.g., pontine lesions
of hemorrhagic or ischemic origin may produce similar findings). Marked
mydriasis rather than mioisis may be seen with hypoxia in the setting
of hydromorphone overdose. Gastrointestinal Tract and Other Smooth Muscle: Gastric, biliary and pancreatic secretions are decreased by opioids
such as hydromorphone. Hydromorphone causes a reduction in motility
associated with an increase in tone in the gastric antrum and duodenum.
Digestion of food in the small intestine is delayed and propulsive
contractions are decreased. Propulsive peristaltic waves in the colon
are decreased, and tone may be increased to the point of spasm. The
end result is constipation. Hydromorphone can cause a marked increase
in biliary tract pressure as a result of spasm of the sphincter of
Oddi. Cardiovascular
System: Hydromorphone may produce hypotension as a result
of either peripheral vasodilation, release of histamine, or both.
Other manifestations of histamine release and/or peripheral vasodilation
may include pruritus, flushing, and red eyes. Effects on the myocardium after intravenous administration of opioid
are not significant in normal persons, vary with different opioid
analgesic agents and vary with the hemodynamic state of the patient,
state of hydration and sympathetic drive.
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Hydromorphone Hydrochloride Injection (High Potency)
is contraindicated in: patients who are not already receiving large
amounts of parenteral opioids, patients with known hypersensitivity
to hydromorphone, patients with respiratory depression in the absence
of resuscitative equipment, and in patients with status asthmaticus.
Hydromorphone Hydrochloride Injection (High Potency) is also contraindicated
for use in obstetrical analgesia.
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Hydromorphone Hydrochloride Injection, USP (High
Potency) is available as: No added preservative. STORAGE:
Parenteral forms of hydromorphone hydrochloride injection should be
stored at 20 to 25��C (68 to 77��F). [See USP Controlled Room
Temperature.] Protect
from light. Revised: July, 2007
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General:: Because of its high concentration, the delivery of
precise doses of Hydromorphone Hydrochloride Injection (High Potency)
may be difficult if low doses of hydromorphone are required. Therefore,
Hydromorphone Hydrochloride Injection (High Potency) should be used
only if the amount of hydromorphone required can be delivered accurately
with this formulation. Special Risk Patients: Hydromorphone Hydrochloride Injection
(High Potency) should be given with caution and the initial dose should
be reduced in the elderly or debilitated and those with severe impairment
of hepatic, pulmonary or renal function; myxedema or hypothyroidism;
adrenocortical insufficiency (e.g., Addison's Disease); CNS
depression or coma; toxic psychoses; prostatic hypertrophy or urethral
stricture; gall bladder disease; acute alcoholism; delirium tremens;or kyphoscoliosis, or following gastrointestinal surgery. In the case of Hydromorphone Hydrochloride Injection (High
Potency), however, the patient is presumed to be receiving an opioid
to which he or she exhibits tolerance and the initial dose of Hydromorphone
Hydrochloride Injection (High Potency) selected should be estimated
based on the relative potency of hydromorphone and the opioid previously
used by the patient (see DOSAGE AND ADMINISTRATION). The administration of opioid analgesics including Hydromorphone
Hydrochloride Injection (High Potency) may obscure the diagnosis or
clinical course in patients with acute abdominal conditions and may
aggravate preexisting convulsions in patients with convulsive disorders. Reports of mild to severe seizures and myoclonus have
been reported in severely compromised patients, administered high
doses of parenteral hydromorphone, for cancer and severe pain. Opioid
administration at very high doses is associated with seizures and
myoclonus in a variety of diseases where pain control is the primary
focus. Use in Drug
and Alcohol Dependent Patients: Hydromorphone Hydrochloride
Injection (High Potency) should be used with caution in patients with
alcoholism and other drug dependencies due to the increased frequency
of opioid tolerance, dependence, and the risk of addiction observed
in these patient populations. Abuse of Hydromorphone Hydrochloride
Injection (High Potency) in combinationwith other CNS depressant
drugs can result in serious risk to the patient. Hydromorphone is an opioid with no approved use in the management
of addictive disorders. Use in Ambulatory Patients: Hydromorphone Hydrochloride
Injection (High Potency) may impair mental and/or physical ability
required for the performance of potentially hazardous tasks (e.g.,
driving, operating machinery). Patients should be cautioned accordingly.
Hydromorphone Hydrochloride Injection (High Potency) may produce orthostatic
hypotension in ambulatory patients. Use in Biliary Tract Disease: Opioid analgesics,
including Hydromorphone Hydrochloride Injection (High Potency), shouldbe used with caution in patients about to undergo surgery of the biliary
tract since it may cause spasm of the sphincter of Oddi. Tolerance and Physical Dependence: Tolerance is the need for increasing doses of opioids to maintain
a defined effect such as analgesia (in the absence of disease progression
or other external factors). Physical dependence is manifested by withdrawal
symptoms after abrupt discontinuation of a drug or upon administration
of an antagonist. Physical dependence and tolerance are not unusual
during chronic opioid therapy. The opioid abstinence
or withdrawal syndrome is characterized by some or all of the following:
restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills,
myalgia, mydriasis. Other symptoms also may develop, including: irritability,
anxiety, backache, joint pain, weakness, abdominal cramps, insomnia,
nausea, anorexia, vomiting, diarrhea, or increased blood pressure,
respiratory rate, or heart rate. In general,
opioids used regularly should not be abruptly discontinued.<br/>Drug Interactions:: Drug Interactions with
other CNS Depressants: The concomitant use of other central
nervous system depressants including sedatives or hypnotics, general
anesthetics, phenothiazines, tranquilizers and alcohol may produce
additive depressant effects. Respiratory depression, hypotension and
profound sedation or coma may occur. When such combined therapy is
contemplated, the dose of one or both agents should be reduced. Opioid
analgesics, including Hydromorphone Hydrochloride Injection (High
Potency), may enhance the action of neuromuscular blocking agents
and produce an increased degree of respiratory depression. Interactions with Mixed Agonist/Antagonist Opioid Analgesics: Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine,
butorphanol, and buprenorphine) should be administered with caution
to a patient who has received or is receiving a course of therapy
with a pure opioid agonist analgesic such as hydromorphone. In this
situation, mixed agonist/antagonist analgesics may reduce the analgesic
effect of hydromorphone and/or may precipitate withdrawal symptoms
in these patients.<br/>Carcinogenesis, Mutagenesis, Impairment
of Fertility:: No carcinogenicity studies have been conducted in
animals. Hydromorphone was not mutagenic in
the in vitro Ames reverse mutation
assay, or the human lymphocytes chromosome aberration assay. Hydromorphone
was not clastogenic in the in vivo mouse micronucleus assay. No effects on fertility,
reproductive performance, or reproductive organ morphology were observed
in male or female rats given oral doses up to 7 mg/kg/day which is
equivalent to and 3-fold higher than the human dose of hydromorphone
hydrochloride injection (high potency) when substituted for ORAL LIQUID
or 8 mg TABLET, respectively, on a body surface area basis.<br/>PREGNANCY���PREGNANCY CATEGORY C:: No effects on teratogenicity or embryotoxicity were
observed in female rats given oral doses up to 7 mg/kg/day which is
equivalent to and 3-fold higher than the human dose of hydromorphone
hydrochloride injection (high potency), on a body surface area basis.
Hydromorphone produced skull malformations (exencephaly and cranioschisis)
in Syrian hamsters given oral doses up to 20 mg/kg during the peak
of organogenesis (gestation days 8-9). The skull malformations were
observed at doses approximately 2-fold and 7-fold higher than the
human dose of hydromorphone hydrochloride injection (high potency)
when substituted for ORAL LIQUID or 8 mgTABLET, respectively, on
a body surface area basis. There are no adequate and well-controlled
studies of hydromorphone in pregnant women. Hydromorphone crosses the placenta, resulting in fetal exposures.
Hydromorphone hydrochloride injection (high potency) should be used
in pregnant women only if the potential benefit justifies the potential
risk to the fetus (see Labor and Delivery and DRUG
ABUSE AND DEPENDENCE).<br/>Nonteratogenic effects:: Babies born to mothers who have been taking opioids
regularly prior to delivery will be physically dependent. The withdrawal
signs include irritability and excessive crying, tremors, hyperactive
reflexes, increased respiratory rate, increased stools, sneezing,
yawning, vomiting, and fever. The intensity of the syndrome does not
always correlate with the duration of maternal opioid use or dose.
There is no consensus on the best method of managing withdrawal. Approaches
to the treatment of this syndrome have included supportive care and,
when indicated, drugs such as paregoric or phenobarbital.<br/>Labor and Delivery:: Hydromorphone Hydrochloride Injection (High Potency)
is contraindicated in Labor and Delivery (see CONTRAINDICATIONS).<br/>Nursing Mothers:: Low levels of opioid analgesics have been detected
in human milk. As a general rule, nursing should not be undertaken
while a patient is receiving Hydromorphone Hydrochloride Injection
(High Potency) since it, and other drugs in this class, may be excreted
in the milk.<br/>Pediatric Use:: Safety and effectiveness have not been established.<br/>Geriatric Use:: Clinical studies of hydromorphone hydrochloride did
not include sufficient numbers of subjects aged 65 and over to determine
whether they respond differently from younger subjects. In general,
dose selection for an elderly patient should be cautious, 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 (see PRECAUTIONS).
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dailymed-instance:overdosag... |
Serious overdosage with Hydromorphone Hydrochloride
Injection (High Potency) is characterized by respiratory depression,
somnolence progressing to stupor or coma, skeletal muscle flaccidity,
cold and clammy skin, constricted pupils, and sometimes bradycardia
and hypotension. In serious overdosage, particularly following intravenous
injection, apnea, circulatory collapse, cardiac arrest and death may
occur. In the treatment of overdosage, primary
attention should be given to the reestablishment of adequate respiratory
exchange through provision of a patent airway and institution of assisted
or controlled ventilation. Supportive measures (including oxygen,
vasopressors) should be employed in the management of circulatory
shock and pulmonary edema accompanying overdose as indicated. Cardiac
arrest or arrhythmias may require cardiac massage or defibrillation. The opioid antagonist, naloxone, is a specific antidote
against respiratory depression which may result from overdosage, or
unusual sensitivity to Hydromorphone Hydrochloride Injection (High
Potency). Naloxone should not be administered in the absence of clinically
significant respiratory or circulatory depression. Naloxone should
be administered cautiously to persons who are known, or suspected
to be physically dependent on Hydromorphone Hydrochloride Injection
(High Potency). In such cases, an abrupt or complete reversal of opioid
effects may precipitate an acute withdrawal syndrome. Since the duration of action of Hydromorphone Hydrochloride Injection
(High Potency) may exceed that of the antagonist, the patient should
be kept under continued surveillance; repeated doses of the antagonist
may be required to maintain adequate respiration. Apply other supportive
measures when indicated.
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Hydromorphone Hydrochloride
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Hydromorphone Hydrochloride (Injection, Solution)
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dailymed-instance:adverseRe... |
The major hazards of Hydromorphone Hydrochloride
Injection (High Potency) include respiratory depression and apnea.
To a lesser degree, circulatory depression, respiratory arrest, shock
and cardiac arrest have occurred. The most frequently
observed adverse effects are lightheadedness, dizziness, sedation,
nausea, vomiting, sweating, flushing, dysphoria, euphoria, dry mouth,
and pruritus. These effects seem to be more prominent in ambulatory
patients and in those not experiencing severe pain. Less Frequently Observed Adverse Reactions: General and CNS: Weakness, headache, agitation, tremor, uncoordinated muscle movements,
alterations of mood (nervousness, apprehension, depression, floating
feelings, dreams), muscle rigidity, paresthesia, muscle tremor, blurred
vision, nystagmus, diplopia and miosis, transient hallucinations and
disorientation, visual disturbances, insomnia and increased intracranial
pressure. Cardiovascular: Flushing of the face, chills, tachycardia, bradycardia, palpitation,
faintness, syncope, hypotension and hypertension. Respiratory: Bronchospasm and
laryngospasm. Gastrointestinal: Constipation, biliary tract spasm, ileus, anorexia, diarrhea, cramps
and taste alterations. Genitourinary: Urinary retention or hesitancy, and antidiuretic
effects. Dermatologic: Urticaria, other skin rashes, wheal and flare over the vein with
intravenous injection, and diaphoresis. Other: In clinical trials, neither local
tissue irritation nor induration was observed at the site of subcutaneous
injection of Hydromorphone Hydrochloride Injection (High Potency);
pain at the injection site was rarely observed. However, local irritation
and induration have been seen following parenteral injection of other
opioid drug products.
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Respiratory Depression: Respiratory depression is the chief hazard of Hydromorphone Hydrochloride
Injection (High Potency). Respiratory depression occurs most frequently
in overdose situations, in the elderly, in the debilitated, and in
those suffering from conditions accompanied by hypoxia or hypercapnia
when even moderate therapeutic doses may dangerously decrease pulmonary
ventilation. Hydromorphone Hydrochloride Injection
(High Potency) should be used with extreme caution in patients with
chronic obstructive pulmonary disease or cor pulmonale, patients having
a substantially decreased respiratory reserve, hypoxia, hypercapnia,
or preexisting respiratory depression. In such patients even usual
therapeutic doses of opioid analgesics may decrease respiratory drive
while simultaneously increasing airway resistance to the point of
apnea. Hydromorphone
Hydrochloride Injection (High Potency) contains hydromorphone, which
is a potent Schedule II, controlled opioid agonist. Schedule II opioid
agonists, including morphine, oxycodone, oxymorphone, fentanyl and
methadone, have the highest potential for abuse and risk of fatal
respiratory depression. Alcohol,other opioids and central nervous
system depressants (sedative-hypnotics) potentiate the respiratory
depressant effects of hydromorphone, increasing the risk of respiratory
depression that might result in death. Misuse, Abuse, and Diversion of Opioids Hydromorphone is an opioid agonist of the
morphine-type. Such drugs are sought by drug abusers and people with
addiction disorders and are subject to criminal diversion. Hydromorphone Hydrochloride Injection (High Potency) can
be abused in a manner similar to other opioid agonists, legal or illicit.
This should be considered when prescribing or dispensing Hydromorphone
in situations where the physician or pharmacist is concerned about
an increased risk of misuse, abuse, or diversion. Prescribers should
monitor all patients receiving opioids for signs of abuse, misuse,
and addiction. Furthermore, patients should be assessed for their
potential for opioid abuse prior to being prescribed opioid therapy.
Persons at increased risk for opioid abuse include those with a personal
or family history of substance abuse (including drug or alcohol abuse)
or mental illness (e.g., depression). Opioids may still be appropriate
for use in these patients, however, they will require intensive monitoring
for signs of abuse. Concerns about abuse, addiction,
and diversion should not prevent the proper management of pain. Healthcare professionals should contact their State Professional
Licensing Board or State Controlled Substances Authority for information
on how to prevent and detect abuse or diversion of this product. Interactions with Alcohol and
Drugs of Abuse Hydromorphone may be
expected to have additive effects when used in conjunction with alcohol,other opioids, or illicit drugs that cause central nervous system
depression. Neonatal
Withdrawal Syndrome: Infants born to mothers physically
dependent on Hydromorphone Hydrochloride Injection (High Potency)
will also be physically dependent and may exhibit respiratory difficulties
and withdrawal symptoms (see DRUG ABUSE AND DEPENDENCE). Head Injury and
Increased Intracranial Pressure: The respiratory depressant
effects of Hydromorphone Hydrochloride Injection (High Potency) with
carbon dioxide retention and secondary elevation of cerebrospinal
fluid pressure may be markedly exaggerated in the presence of head
injury, other intracranial lesions, or preexisting increase in intracranial
pressure. Opioid analgesics including Hydromorphone Hydrochloride
Injection (High Potency) may produce effects on pupillary response
and consciousness which can obscure the clinical course and neurologic
signs of further increase in pressure in patients with head injuries. Hypotensive Effect: Opioid analgesics, including Hydromorphone Hydrochloride Injection
(High Potency), may cause severe hypotension in an individual whose
ability to maintain his blood pressure has already been compromised
by a depleted blood volume, or a concurrent administration of drugs
such as phenothiazines or general anesthetics (see also PRECAUTIONS: Drug Interactions). Hydromorphone Hydrochloride Injection
(High Potency) may produce orthostatic hypotension in ambulatory patients. Hydromorphone Hydrochloride Injection (High Potency) should
be administered with caution to patients in circulatory shock, since
vasodilation produced by the drug may further reduce cardiac output
and blood pressure.
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Hydromorphone Hydrochloride Injection (High Potency)
is indicated for the relief of moderate-to-severe pain in opioid-tolerant
patients who require larger than usual doses of opioids to provide
adequate pain relief. Because Hydromorphone Hydrochloride Injection
(High Potency) contains 10 mg of hydromorphone hydrochloride per
mL, a smaller injection volume can be used than with other parenteral
opioid formulations. Discomfort associated with the intramuscular
or subcutaneous injection of an unusually large volume of solution
can therefore be avoided.
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Hydromorphone Hydrochloride
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