HYDROMORPHONE HYDROCHLORIDE injection

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

HYDROMORPHONE HYDROCHLORIDE (UNII: L960UP2KRW) (HYDROMORPHONE - UNII:Q812464R06)

Dostupné s:

Hikma Pharmaceuticals USA Inc.

Podání:

INTRAMUSCULAR

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Hydromorphone Hydrochloride Injection is indicated for the relief of moderate to severe pain such as that due to: surgery, cancer, trauma (soft tissue and bone), biliary colic, myocardial infarction, burns, renal colic. Hydromorphone Hydrochloride Injection is contraindicated in patients with a known hypersensitivity to hydromorphone, in the presence of an intracranial lesion associated with increased intracranial pressure and whenever ventilatory function is depressed (chronic obstructive pulmonary disease, cor pulmonale, emphysema, kyphoscoliosis, status asthmaticus). [See WARNINGS . ] Narcotic analgesics, including hydromorphone, are contraindicated in premature infants or during labor when delivery of a premature infant is anticipated. Hydromorphone Hydrochloride Injection is a Schedule II controlled narcotic substance. Hydromorphone is known to be subject to abuse. Opiates produce relaxation, indifference to pain and stress, lethargy and euphoria. Patients who receive narcotics regularly for more than a few days may exhibit mild symptoms, which may not be recognized as withdrawal, upon discontinuation of therapy. However, the overwhelming majority of patients who receive opiates for medical reasons do not develop drug-seeking behavior or compulsive drug use. Personality characteristics play a major role in determining which patients are likely to abuse drugs. Hydromorphone must be administered only under close supervision to patients with a history of drug abuse or dependence. Psychological dependence, physical dependence and tolerance are known to occur with hydromorphone. Therefore, hydromorphone should be prescribed and administered with caution. The severity of the abstinence syndrome is related to the degree of dependence, the abruptness of withdrawal and the drug used. If the abstinence syndrome is precipitated by administration of a narcotic antagonist, symptoms appear within a few minutes and are maximal within thirty minutes. Administration of a narcotic antagonist as a means of detecting dependence is not usually recommended. Withdrawal symptoms in patients dependent on hydromorphone include yawning; sweating; lacrimation; rhinorrhea; a restless, tossing sleep; dilated pupils; goose flesh; irritability; tremor; nausea; vomiting and diarrhea. Treatment of the abstinence syndrome is primarily symptomatic and supportive, including maintenance of proper fluid and electrolyte balance. Tolerance, in which increasingly large doses are required in order to produce the same degree of analgesia, is manifested initially by a shortened duration of analgesic effect and subsequently by decreases in the intensity of analgesia. The rate of development of tolerance varies among patients.

Přehled produktů:

Hydromorphone Hydrochloride Injection, USP is available in the following:       2 mg/mL                    20 mL Multiple Dose vials packaged individually (NDC 0641-2341-41) PROTECT FROM LIGHT:  Keep covered in carton. Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Do not use the injection if it is more than slightly discolored or contains a precipitate. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-877-845-0689. Manufactured by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised April 2020 462-259-02

Stav Autorizace:

unapproved drug other

Charakteristika produktu

HYDROMORPHONE HYDROCHLORIDE- HYDROMORPHONE HYDROCHLORIDE INJECTION
HIKMA PHARMACEUTICALS USA INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
----------
HYDROMORPHONE HYDROCHLORIDE INJECTION, USP
CII
RX ONLY
DESCRIPTION
Hydromorphone Hydrochloride Injection, USP is a sterile solution
intended for
subcutaneous, intramuscular or slow intravenous injection. Each mL
contains
hydromorphone hydrochloride 2 mg, edetate disodium 0.5 mg,
methylparaben 1.8 mg
and propylparaben 0.2 mg in Water for Injection. The pH range is
3.5-5.5; sodium
hydroxide and/or hydrochloric acid added, if needed, for pH
adjustment.
Hydromorphone is a semisynthetic phenanthrene alkaloid of opium; it is
classified
pharmacologically as a narcotic analgesic. Hydromorphone hydrochloride
may be named
chemically as 4,5α-Epoxy-3-hydroxy-17-methylmorphinan-6-one
hydrochloride, with the
following structural formula:
C
H
NO • HCl M.W. 321.80
Hydromorphone hydrochloride occurs as a fine, white or practically
white, crystalline
powder and is freely soluble in water and sparingly soluble in
alcohol.
CLINICAL PHARMACOLOGY
Hydromorphone resembles morphine both structurally and
pharmacologically. Like other
narcotic analgesics, hydromorphone exerts its principal
pharmacological effects on the
central nervous system and gastrointestinal tract. Its primary action
of therapeutic value
is analgesia. The analgesic effects of hydromorphone are due to its
central action;
however, the precise mechanism of action of hydromorphone and other
opiates is not
17
19
3
known, although it is believed to relate to the existence of opiate
receptors in the central
nervous system. Hydromorphone, like other narcotic analgesics, appears
to increase
the patient’s tolerance for pain and to decrease the perception of
suffering, although
the presence of the pain itself may still be recognized.
In addition to analgesia, narcotics commonly prod