HYDROMORPHONE HYDROCHLORIDE suppository

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Padagis US LLC

INN (국제 이름):

HYDROMORPHONE HYDROCHLORIDE

구성:

HYDROMORPHONE HYDROCHLORIDE 3 mg

관리 경로:

RECTAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Hydromorphone hydrochloride suppositories 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 (5.1)] , reserve hydromorphone hydrochloride suppositories for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: Hydromorphone hydrochloride suppositories are contraindicated in patients with: Risk Summary Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.3)] . 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 reproduction studies, reduced postnatal survival of pups, and decreased were noted following oral treatment of pregnant rats wit

제품 요약:

Hydromorphone Hydrochloride Suppositories are off-white suppositories. It is available in: Cartons of 6 suppositories – NDC 0574-7224-06 Store refrigerated between 2°- 8°C (36°- 46°F). Protect from light. Store hydromorphone hydrochloride suppositories securely and dispose of properly [see Patient Counseling Information (17)] .

승인 상태:

unapproved drug other

환자 정보 전단

Padagis US LLC
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.
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Medication Guide
Hydromorphone Hydrochloride (hy-dro-MOR-fone hy-dro-KLOR-id)
Suppositories, CII
Hydromorphone hydrochloride suppositories 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 suppositories:
•
Get emergency help right away if you take too much hydromorphone
hydrochloride suppositories
(overdose). When you first start taking hydromorphone hydrochloride
suppositories, 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 suppositories 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 suppositories.
They could die from taking
it. Store hydromorphone hydrochloride suppositories away from children
and in a safe place to prevent
stealing or abuse. Selling or giving away hydromorphone hydrochloride
suppositories is against the
law.
•
Store hydromorphone hydrochloride suppositories securely, out of sight
and reach of children, and in a
location not accessible by others, including visitors to the home.
Do not take hydromorphone hydrochloride suppositories if you have:
•
sever

제품 특성 요약

HYDROMORPHONE HYDROCHLORIDE- HYDROMORPHONE
HYDROCHLORIDE SUPPOSITORY
PADAGIS US LLC
_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._
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HYDROMORPHONE
HYDROCHLORIDE SUPPOSITORIES SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
HYDROMORPHONE HYDROCHLORIDE SUPPOSITORIES.
HYDROMORPHONE HYDROCHLORIDE SUPPOSITORIES, FOR RECTAL USE, CII
INITIAL U.S. APPROVAL: 1984
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY
DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME;
AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
•
•
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Hydromorphone hydrochloride suppositories 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) (1)
Limitations of Use (1) (1)
Because of the risks of addiction, abuse, and misuse with opioids,
even at recommended doses, reserve
hydromorphone hydrochloride suppositories for use in patients for whom
alternative treatment options
[e.g., non-opioid analgesics or opioid combination products]: (1)
•
HYDROMORPHONE HYDROCHLORIDE SUPPOSITORIES EXPOSE USERS TO RISKS OF
ADDICTION,
ABUSE, AND MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS
PATIENT’S RISK
BEFORE PRESCRIBING AND MONITOR REGULARLY FOR THESE BEHAVIORS AND
CONDITIONS. (5.1)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR
CLOSELY, ESPECIALLY UPON INITIATION OR FOLLOWING A DOSE INCREASE.
(5.2)
ACCIDENTAL EXPOSURE OF HYDROMORPHONE HYDROCHLORIDE SUPPOSITORIES,
ESPECIALLY BY
CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF HYDROMORPHONE. (5.2)
PROLONGED U