HYDROMORPHONE HYDROCHLORIDE tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

STAT RX USA LLC

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Hydromorphone Hydrochloride Tablets, USP are indicated for the management of pain in patients where an opioid analgesic is appropriate. Hydromorphone Hydrochloride Tablets are contraindicated in: Patients with known hypersensitivity to hydromorphone, patients with respiratory depression in the absence of resuscitative equipment, and in patients with status asthmaticus. Hydromorphone Hydrochloride Tablets are also contraindicated for use in obstetrical analgesia. Hydromorphone Hydrochloride Tablets contain hydromorphone, a Schedule II controlled opioid agonist. Schedule II opioid substances which include morphine, oxycodone, oxymorphone, fentanyl, and methadone have the highest potential for abuse and risk of fatal overdose. Hydromorphone can be abused and is subject to criminal diversion. Opioid analgesics may cause psychological and physical dependence. Physical dependence results in withdrawal symptoms in patients who abruptly discontinue the drug. Physical dependence usually does not occur to a

Přehled produktů:

Hydromorphone Hydrochloride 2 mg Tablets, USP are orange, debossed with a “P” on one side and the number “2” on the opposite side. They are available in: Bottles of 100 - NDC # 42858-301-01 Unit Dose Packages of 100 (4x25) - NDC # 42858-301-25 Hydromorphone Hydrochloride 4 mg Tablets, USP are yellow, debossed with a “P” on one side and the number “4” on the opposite side. They are available in: Bottles of 100 - NDC # 42858-302-01 Unit Dose Packages of 100 (4x25) - NDC # 42858-302-25 Bottles of 500 - NDC # 42858-302-50 Hydromorphone Hydrochloride 8 mg Tablets, USP are white, triangular shaped tablets bisected and debossed with a “P” and an inverted “P” on one side and deposed with the number “8” on the other side. They are available in: Bottles of 100 - NDC# 42858-303-01 Healthcare professionals can telephone Rhodes Pharmaceuticals at 1-888-827-0616 for information on this product. 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 is required. Marketed by: Rhodes Pharmaceuticals L.P., Coventry, RI 02816 Manufactured by: Halo Pharmaceuticals, Inc., Whippany, NJ 07981 Revised: 03/2010 302270-0B

Stav Autorizace:

New Drug Application Authorized Generic

Charakteristika produktu

HYDROMORPHONE HYDROCHLORIDE - HYDROMORPHONE HYDROCHLORIDE TABLET
STAT RX USA LLC
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WARNING: HYDROMORPHONE HYDROCHLORIDE TABLETS CONTAIN
HYDROMORPHONE, WHICH IS A POTENT SCHEDULE II CONTROLLED OPIOID
AGONIST. SCHEDULE II OPIOID AGONISTS, INCLUDING MORPHINE,
OXYMORPHONE, OXYCODONE, FENTANYL, AND METHADONE, HAVE THE
HIGHEST POTENTIAL FOR ABUSE AND RISK OF PRODUCING 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.
DESCRIPTION
Hydromorphone Hydrochloride Tablets, USP, a hydrogenated ketone of
morphine, are an opioid
analgesic.
The chemical name of hydromorphone hydrochloride is
4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-
one hydrochloride. The structural formula is:
M.W. 321.8
Color Coded Tablets (for oral administration) contain:
2 mg hydromorphone hydrochloride (orange tablet) and D and C red #30
Lake dye, D and C yellow #10
Lake dye, lactose, and magnesium stearate. Hydromorphone Hydrochloride
2 mg Tablets may contain
traces of sodium metabisulfite.
4 mg hydromorphone hydrochloride (yellow tablet) and D and C yellow
#10 Lake dye, lactose, and
magnesium stearate. Hydromorphone Hydrochloride 4 mg Tablets may
contain traces of sodium
metabisulfite.
8 mg hydromorphone hydrochloride (white tablet) and lactose anhydrous,
and magnesium stearate.
Hydromorphone Hydrochloride 8 mg Tablets may contain traces of sodium
metabisulfite.
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 this class of mu-opioid
agonist analge