HYDROMORPHONE HYDROCHLORIDE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

STAT Rx USA LLC

INN (Nome Internazionale):

HYDROMORPHONE HYDROCHLORIDE

Composizione:

HYDROMORPHONE HYDROCHLORIDE 2 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 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 tablets can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing hydromorphone hydrochloride tablets 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 si

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

HYDROMORPHONE HYDROCHLORIDE - HYDROMORPHONE HYDROCHLORIDE TABLET
STAT RX USA LLC
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HYDROMORPHONE HYDROCHLORIDE TABLETS USP
2MG AND 4MG
RX ONLY
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, 2 mg, 4 mg, and 8 mg are
supplied in tablet form for oral
administration.
Hydromorphone hydrochloride, a hydrogenated ketone of morphine, is an
opioid analgesic.
The chemical name of hydromorphone hydrochloride tablets USP is
4,5α-epoxy-3-hydroxy-17-
methylmorphinan-6-one hydrochloride. The structural formula of
hydromorphone hydrochloride is:
Each Hydromorphone Hydrochloride Tablet USP, 2 mg contains:
Each Hydromorphone Hydrochloride Tablet USP, 4 mg contains:
Each Hydromorphone Hydrochloride Tablet USP, 8 mg contains:
In addition, each tablet contains the following inactive ingredients:
lactose monohydrate, magnesium
Hydromorphone Hydrochloride USP . . . . . . . . . . . . 2 mg
Hydromorphone Hydrochloride USP . . . . . . . . . . . . 4 mg
Hydromorphone Hydrochloride USP . . . . . . . . . . . . 8 mg
stearate, microcrystalline cellulose and stearic acid.
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 a