DILAUDID- hydromorphone hydrochloride liquid DILAUDID- 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:

Purdue Pharma LP

INN (Nome Internazionale):

hydromorphone hydrochloride

Composizione:

hydromorphone hydrochloride 5 mg in 5 mL

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

DILAUDID Oral Solution and DILAUDID 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 DILAUDID Oral Solution and DILAUDID Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: - Have not been tolerated, or are not expectedto be tolerated, - Have not provided adequate analgesia, or are not expected to provide adequate analgesia DILAUDID Oral Solution and DILAUDID Tablets are contraindicated in patients with: - Significant respiratory depression [see Warnings and Precautions (5.6)] - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.6)] - Known or suspected gastrointestinal obstruction, including

Dettagli prodotto:

Protect from light. DILAUDID Oral Solution is a a clear, colorless to pale yellow, slightly viscous liquid. It is available in: Bottles of 1 pint (473 mL) – NDC# 59011-451-01. DILAUDID 2 mg Tablets are light orange, round, flat-faced tablets, with beveled edges, debossed with a “P” on one side and the number “2” on the opposite side. They are available in: Bottles of 100 - NDC # 59011-452-10 Unit Dose Packages of 100 (4x25) - NDC # 59011-452-01 DILAUDID 4 mg Tablets are light yellow, round, flat-faced tablets, with beveled edges, debossed with a “P” on one side and the number “4” on the opposite side. They are available in: Bottles of 100 - NDC # 59011-454-10 Unit Dose Packages of 100 (4x25) - NDC # 59011-454-01 Bottles of 500 - NDC # 59011-454-05 DILAUDID 8 mg Tablets are white, triangular shaped tablets debossed with a “P” and an inverted “P” separated with a bisect on one side of the tablet and debossed with the number “8” on the other side of the tablet. They are available in: Bottles of 100 - NDC# 59011-458-10 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].

Stato dell'autorizzazione:

New Drug Application

Foglio illustrativo

DILAUDID- HYDROMORPHONE HYDROCHLORIDE TABLET
Purdue Pharma LP
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Medication Guide
DILAUDID® (dī-law-did)
([hydromorphone hydrochloride) Tablets and Oral Solution , CII
DILAUDID Tablets and DILAUDID 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 DILAUDID:
•
Get emergency help right away if you take too much DILAUDID Tablets or
DILAUDID Oral
Solution (overdose). When you first start taking DILAUDID Tablets or
DILAUDID 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 DILAUDID Tablets or DILAUDID 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 DILAUDID Tablets or DILAUDID Oral
Solution. They could die
from taking it. Store DILAUDID Tablets or DILAUDID Oral Solution away
from children and in
a safe place to prevent stealing or abuse. Selling or giving away
DILAUDID Tablets or
DILAUDID Oral Solution is against the law.
Do not take DILAUDID Tablets or DILAUDID Oral Solution if you have:
•
severe asthma, trouble breathing, or other lung problems.
•
a bowel blockage or have narrowing of the stomach or intestines.
Before taking DILAUDID Tablets or DILAUDID Oral Solution, tell your
healthcare provider if you
have a history of:
•
head injury, seizures
•
problems urinating
•
abuse of street or prescription dru

Scheda tecnica

DILAUDID- HYDROMORPHONE HYDROCHLORIDE LIQUID
DILAUDID- HYDROMORPHONE HYDROCHLORIDE TABLET
PURDUE PHARMA LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DILAUDID ORAL SOLUTION AND
DILAUDID TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR DILAUDID ORAL
SOLUTION AND DILAUDID TABLETS.
DILAUDID (HYDROMORPHONE HYDROCHLORIDE) ORAL SOLUTION
DILAUDID (HYDROMORPHONE HYDROCHLORIDE) TABLETS, FOR ORAL USE, C-II
INITIAL U.S. APPROVAL: JANUARY 1984
WARNING: RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE;
LIFE-THREATENING
RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID
WITHDRAWAL
SYNDROME; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
RECENT MAJOR CHANGES
Boxed Warning
12/2016
Indications and Usage (1)
12/2016
Dosage and Administration (2)
12/2016
Warnings and Precautions (5)
12/2016
INDICATIONS AND USAGE
DILAUDID Oral Solution and DILAUDID Tablets contain hydromorphone, an
opioid agonist, and are indicated for the
management of pain severe enough to require an opioid analgesic and
for which alternative treatments are inadequate. (1)
Limitations of Use (1)
Because of the risks of addiction, abuse, and misuse with opioids,
even at recommended doses, reserve DILAUDID Oral
Solution or DILAUDID Tablets for use in patients for whom alternative
treatment options [e.g., non-opioid analgesics or
opioid combination products]:
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide
adequate analgesia
DOSAGE AND ADMINISTRATION
Use the lowest effective dosage for the shortest duration consistent
with individual patient treatment goals.
Individualize dosing based on the severity of pain, patient response,
prior analgesic experience, and risk factors for
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ENSURE ACCURACY WHEN PRESCRIBING, DISPENSING, AND ADMINISTERING
DILAUDID ORAL SOLUTION. DOSING
ERRO