Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/845
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Hydromorphone Hydrochloride (Injection, Solution)
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Parenteral: HYDROMORPHONE
HYDROCHLORIDE INJECTION (HIGH POTENCY FORMULATION) SHOULD BE GIVEN
ONLY TO PATIENTS WHO ARE ALREADY RECEIVING LARGE DOSES OF OPIOIDS.
Hydromorphone hydrochloride injection (high potency formulation) 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 formulation)
is substituted for a different opioid analgesic, the following equivalency
table should be used as a guide to determine the appropriate dose
of hydromorphone hydrochloride injection (high potency formulation).
Patients with hepatic and renal impairment should be started on alower starting dose. (See CLINICAL PHARMACOLOGY: PHARMACOKINETICS
AND METABOLISM). The dosage of hydromorphone hydrochloride injection
(high potency formulation) should be individualized for anygiven
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 formulation) 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 formulation) 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 formulation). Subcutaneous injections
of hydromorphone hydrochloride injection (high potency formulation)
were particularly well accepted when administered with a short, 30-gauge
needle. Experience with administration of
hydromorphone hydrochloride injection (high potency formulation) 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 formulation) vials. 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. 500
mg/50 mL Vial: To use this single dose presentation, do
not penetrate the stopper with a syringe. Instead, remove both the
aluminum flipseal and rubber stopper in a suitable work area such
as under a laminar flow hood (or equivalent clean air compounding
area). The contents may then be withdrawn for preparation of a single,
large volume parenteral solution. Any unused portion should be discarded
in an appropriate manner.
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Hydromorphone hydrochloride, a hydrogenated ketone
of morphine, is an opioid analgesic. HYDROMORPHONE HYDROCHLORIDE INJECTION (HIGH POTENCY FORMULATION) is available in single dose vials 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% citricacid solution. The chemical
name of hydromorphone hydrochloride is 4,5��-Epoxy-3- hydroxy-17-methylmorphinan-6-one
hydrochloride and it has the following structural formula:
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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
opioids 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. PHARMACOKINETICS AND METABOLISM 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. 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. 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. 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 injection (high potency
formulation) 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 formulation) is
also contraindicated for use in obstetrical analgesia.
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Hydromorphone hydrochloride injection, USP (high
potency formulation) contains 10 mg hydromorphone hydrochloride per
mL with 0.2% sodium citrate and 0.2% citric acid solution. No added
preservative. It is supplied as: 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. Created: October, 2007
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General:: Because of its high concentration, the delivery of
precise doses of hydromorphone hydrochloride injection (high potency
formulation) may be difficult if low doses of hydromorphone are required.
Therefore, hydromorphone hydrochloride injection (high potency formulation)
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 formulation) 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 formulation),
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 formulation) 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 formulation) 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 formulation)
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 formulation)
in combination with 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 formulation)
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 formulation) may produce orthostatic hypotension
in ambulatory patients. Use in Biliary Tract Disease: Opioid analgesics, including
hydromorphone hydrochloride injection (high potency formulation),
should also be 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/>Information for Patients: n/a<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 formulation) 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
formulation) when substituted for ORAL LIQUID or 8mg TABLET, respectively,
on a body surface area basis.<br/>Pregnancy: Teratogenic Effects: 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 formulation), 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 and7-fold higher than
the human dose of hydromorphone hydrochloride injection (high potency
formulation) when substituted for ORAL LIQUID or 8mg TABLET, 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 formulation) 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). 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 opioiduse 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
formulation) 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 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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Serious overdosage with hydromorphone hydrochloride
injection (high potency formulation) 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 formulation). 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 formulation).
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 formulation) 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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The major hazards of hydromorphone hydrochloride
injection (high potency formulation) 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, and 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 antidiureticeffects. 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 formulation); 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 formulation). Respiratory depression occurs
most frequently in the 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 formulation) 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
formulation) 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 formulation) 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 formulation)
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 formulation) 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 formulation)
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 formulation),
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 formulation) may produce orthostatic hypotension
in ambulatory patients. Hydromorphone hydrochloride
injection (high potency formulation) 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
formulation) 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 formulation) 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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