Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/4030
| Predicate | Object |
|---|---|
| rdf:type | |
| rdfs:label |
DILAUDID-HP (Solution)
|
| dailymed-instance:dosage |
Parenteral: DILAUDID-HP
SHOULD BE GIVEN ONLY TO PATIENTS WHO ARE ALREADY RECEIVING LARGE DOSES OF
OPIOIDS. DILAUDID-HP 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 DILAUDID to DILAUDID-HP, similar doses should be used, depending
on the patient's clinical response to the drug. If DILAUDID-HP is substituted
for a different opioid analgesic, the following equivalency table should be
used as a guide to determine the appropriate dose of DILAUDID-HP (hydromorphone
hydrochloride). Patients with hepatic and renal impairment should be started
on a lower starting dose (See CLINICAL PHARMACOLOGY
- Pharmacokinetics and Metabolism). The dosage of DILAUDID-HP 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 DILAUDID-HP in patients
with terminal cancer, doses ranged from 1-14 mg subcutaneously or intramuscularly;
one patient received 30 mg subcutaneously on two occasions. In these trials,
both subcutaneous and intramuscular injections of DILAUDID-HP 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 DILAUDID-HP. Subcutaneous
injections of DILAUDID-HP were particularly well accepted when administered
with a short, 30 gauge needle. Experience with
administration of DILAUDID-HP 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 DILAUDID-HP ampules. No loss of potency
has been demonstrated. DILAUDID 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.<br/>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. CAUTION: The packaging (vial stopper)
of this product contains rubber latex which may cause allergic reactions.<br/>Reconstitution of Sterile Lyophilized DILAUDID-HP 250 mg: Reconstitute immediately prior to use with 25 mL
of Sterile Water for Injection USP to provide a sterile solution containing
10 mg/mL.
|
| dailymed-instance:descripti... |
DILAUDID (hydromorphone hydrochloride), a hydrogenated
ketone of morphine, is an opioid analgesic. HIGH
POTENCY DILAUDID is available in AMBER ampules or 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%
citric acid solution. It is also available as
lyophilized DILAUDID for intravenous (IV), subcutaneous (SC), or intramuscular
(IM) administration. Each single dose vial contains 250 mg sterile, lyophilized
hydromorphone HCl to be reconstituted with 25 mL of Sterile Water for Injection
USP to provide a solution containing 10 mg/mL. The
chemical name of DILAUDID (hydromorphone hydrochloride) is 4,5��-epoxy-3-hydroxy-17-methylmorphinan-6-one
hydrochloride. The structural formula is: M.W. 321.8
|
| dailymed-instance:clinicalP... |
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 DILAUDID-HP
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 DILAUDID-HP would possess these effects.<br/>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 miosis may be
seen with hypoxia in the setting of DILAUDID overdose.<br/>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.<br/>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.<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:
|
| dailymed-instance:activeIng... | |
| dailymed-instance:contraind... |
DILAUDID-HP 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.
DILAUDID-HP is also contraindicated for use in obstetrical analgesia.
|
| dailymed-instance:supply |
DILAUDID-HP amber ampules and single dose vials
contain 10 mg hydromorphone hydrochloride per mL with 0.2% sodium citrate
and 0.2% citric acid solution. No added preservative. NOTE: DILAUDID-HP ampules are amber in color. The lyophilized DILAUDID-HP Single Dose Vial contains 250
mg of sterile, lyophilized hydromorphone HCl.<br/>Storage: Store at 25��C (77��F); excursions permitted
to 15��-30��C (59��-86��F). [See USP Controlled Room Temperature].
Protect from light. A Schedule CS-II Narcotic. DEA Order Form Required. AbbottAll rights reserved. Manufactured
by Hospira, Inc., Lake Forest, IL 60045, U.S.A. for
|
| dailymed-instance:activeMoi... | |
| dailymed-instance:inactiveI... | |
| dailymed-instance:overdosag... |
Serious overdosage with DILAUDID-HP is characterizedby 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 asindicated. 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 DILAUDID-HP. 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 DILAUDID-HP. In such cases,
an abrupt or complete reversal of opioid effects may precipitate an acute
withdrawal syndrome. Since the duration of action of
DILAUDID-HP 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.
|
| dailymed-instance:genericMe... |
hydromorphone hydrochloride
|
| dailymed-instance:fullName |
DILAUDID-HP (Solution)
|
| dailymed-instance:adverseRe... |
The major hazards of DILAUDID-HP 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.<br/>Less Frequently Observed Adverse Reactions:<br/>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, increased intracranial pressure<br/>Cardiovascular: Flushing of the face, chills, tachycardia, bradycardia,
palpitation, faintness, syncope, hypotension, hypertension<br/>Respiratory: Bronchospasm and laryngospasm<br/>Gastrointestinal: Constipation, biliary tract spasm, ileus, anorexia,
diarrhea, cramps, taste alterations<br/>Genitourinary: Urinary retention or hesitancy, antidiuretic effects<br/>Dermatologic: Urticaria, other skin rashes, wheal and flare
over the vein with intravenous injection, diaphoresis<br/>Other: In clinical trials, neither local tissue irritation
nor induration was observed at the site of subcutaneous injection of DILAUDID-HP;
pain at the injection site was rarely observed. However, local irritation
and induration have been seen following parenteral injection of other opioid
drug products.
|
| dailymed-instance:warning |
Respiratory Depression: Respiratory depression is the chief hazard of DILAUDID-HP.
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. DILAUDID-HP 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. DILAUDID-HP 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.<br/>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. DILAUDID-HP can
be abused in a manner similar to other opioid agonists, legal or illicit.
This should be considered when prescribing or dispensing DILAUDID 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.<br/>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.<br/>Neonatal Withdrawal Syndrome: Infants born to mothers physically dependent on
DILAUDID-HP will also be physically dependent and may exhibit respiratory
difficulties and withdrawal symptoms. (see DRUG
ABUSE AND DEPENDENCE).<br/>Head Injury and Increased Intracranial Pressure: The respiratory depressant effects of DILAUDID-HP 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 DILAUDID-HP 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.<br/>Hypotensive Effect: Opioid analgesics, including DILAUDID-HP, 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 PRECAUTIONS
- Drug Interactions). DILAUDID-HP may produce orthostatic hypotension
in ambulatory patients. DILAUDID-HP should
be administered with caution to patients in circulatory shock, since vasodilation
produced by the drug may further reduce cardiac output and blood pressure.<br/>Sulfites: Contains sodium metabisulfite, a sulfite that may
cause allergic-type reactions including anaphylactic symptoms and life-threatening
or less severe asthmatic episodes in certain susceptible people. The overall
prevalence of sulfite sensitivity in the general population is unknown and
probably low. Sulfite sensitivity is seen more frequently in asthmatic than
in nonasthmatic people.
|
| dailymed-instance:indicatio... |
DILAUDID-HP 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 DILAUDID-HP 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.
|
| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
DILAUDID-HP
|