HYDROMORPHONE HYDROCHLORIDE solution

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

ATLANTIC BIOLOGICALS CORP.

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Hydromorphone Hydrochloride Oral Solution and Hydromorphone Hydrochloride Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve Hydromorphone Hydrochloride Oral Solution and Hydromorphone Hydrochloride Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: Hydromorphone Hydrochloride Oral Solution and Hydromorphone Hydrochloride Tablets are contraindicated in patients with: Risk Summary Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.4)]. There are no available data with Hydromorphone Hydrochloride in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduc

Přehled produktů:

Product: 17856-0386 NDC: 17856-0386-1 5 mL in a CUP / 72 in a CASE

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

ATLANTIC BIOLOGICALS CORP.
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MEDICATION GUIDE
Hydromorphone Hydrochloride
(hye'' droe mor' fone hye'' droe klor' ide)
Tablets and Oral Solution USP CII
Rx only
Hydromorphone Hydrochloride Tablets and Hydromorphone Hydrochloride
Oral Solution are:
•
Strong prescription pain medicines that contains an opioid (narcotic)
that is used to manage pain
severe enough to require an opioid analgesic, when other pain
treatments such as non-opioid pain
medicines do not treat your pain well enough or you cannot tolerate
them.
•
Opioid pain medicines that can put you at risk for overdose and death.
Even if you take your dose
correctly as prescribed you are at risk for opioid addiction, abuse,
and misuse that can lead to death.
Important information about Hydromorphone Hydrochloride:
•
Get emergency help right away if you take too much Hydromorphone
Hydrochloride Tablets or
Hydromorphone Hydrochloride Oral Solution (overdose). When you first
start taking Hydromorphone
Hydrochloride Tablets or Hydromorphone Hydrochloride Oral Solution,
when your dose is changed,
or if you take too much (overdose), serious or life-threatening
breathing problems that can lead to
death may occur.
•
Taking Hydromorphone Hydrochloride Tablets or Hydromorphone
Hydrochloride Oral Solution with
other opioid medicines, benzodiazepines, alcohol, or other central
nervous system depressants
(including street drugs) can cause severe drowsiness, decreased
awareness, breathing problems, coma,
and death.
•
Never give anyone else your Hydromorphone Hydrochloride Tablets or
Hydromorphone
Hydrochloride Oral Solution. They could die from taking it. Store
Hydromorphone Hydrochloride
Tablets or Hydromorphone Hydrochloride Oral Solution away from
children and in a safe place to
prevent stealing or abuse. Selling or giving away Hydromorphone
Hydrochloride Tablets or
Hydromorphone Hydrochloride Oral Solution is against the law.
Do not take Hydromorphone Hydrochloride Tablets or Hydromorphone
Hydrochloride Oral Solution if you
have:
•
severe asthma, t

Charakteristika produktu

HYDROMORPHONE HYDROCHLORIDE- HYDROMORPHONE HYDROCHLORIDE SOLUTION
ATLANTIC BIOLOGICALS CORP.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HYDROMORPHONE
HYDROCHLORIDE TABLETS AND HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION
SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR HYDROMORPHONE
HYDROCHLORIDE
TABLETS AND HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION.
HYDROMORPHONE HYDROCHLORIDE TABLETS AND HYDROMORPHONE HYDROCHLORIDE
ORAL
SOLUTION, FOR ORAL USE CII
INITIAL U.S. APPROVAL: 1984
WARNING: RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE;
LIFE-
THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL
OPIOID
WITHDRAWAL SYNDROME; AND RISKS FROM CONCOMITANT USE WITH
BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
RISK OF MEDICATION ERRORS
ENSURE ACCURACY WHEN PRESCRIBING, DISPENSING, AND ADMINISTERING
HYDROMORPHONE
HYDROCHLORIDE ORAL SOLUTION. DOSING ERRORS DUE TO CONFUSION BETWEEN MG
AND ML CAN
RESULT IN ACCIDENTAL OVERDOSE AND DEATH [SEE DOSAGE AND ADMINISTRATION
(2.1),
WARNINGS AND PRECAUTIONS (5.1)].
Addiction, Abuse, and Misuse
Hydromorphone Hydrochloride Oral Solution and Hydromorphone
Hydrochloride Tablets expose
patients and other users to the risks of opioid addiction, abuse, and
misuse, which can lead to
overdose and death. Assess each patient’s risk prior to prescribing
Hydromorphone Hydrochloride
Oral Solution or Hydromorphone Hydrochloride Tablets, and monitor all
patients regularly for the
development of these behaviors and conditions [see Warnings and
Precautions (5.2)].
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur
with use of Hydromorphone
Hydrochloride Oral Solution and Hydromorphone Hydrochloride Tablets.
Monitor for respiratory
depression, especially during initiation of Hydromorphone
Hydrochloride Oral Solution or
Hydromorphone Hydrochloride Tablets or following a dose increase [see
Warnings and Precautions
(5.3)].
Accidental Ingestion
Accidental