MEPERIDINE HYDROCHLORIDE- meperidine hydrochloride tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

MEPERIDINE HYDROCHLORIDE (UNII: N8E7F7Q170) (MEPERIDINE - UNII:9E338QE28F)

Dostupné s:

Teva Pharmaceuticals USA, Inc.

INN (Mezinárodní Name):

MEPERIDINE HYDROCHLORIDE

Složení:

MEPERIDINE HYDROCHLORIDE 50 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Meperidine hydrochloride tablets are indicated for the management of acute 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 meperidine hydrochloride 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. Meperidine hydrochloride tablets should not be used for treatment of chronic pain. Prolonged meperidine hydrochloride tablets use may increase the risk of toxicity (e.g. seizures) from the accumulation of the meperidine metabolite, normeperidine. Meperidine hydrochloride tablets are contraindicated in patients with: - Significant respiratory depression [see Warnings and Preca

Přehled produktů:

Meperidine Hydrochloride Tablets USP are available as: 50 mg: White, round, biconvex, scored tablet, debossed with 381 over stylized b on the scored side. Available in bottles of 100 tablets. NDC 0555-0381-02 100 mg: White, round, biconvex, unscored tablet, debossed with 382 on one side and stylized barr on the other side. Available in bottles of 100 tablets. NDC 0555-0392-02 Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

Teva Pharmaceuticals USA, Inc.
----------
Medication Guide
Meperidine
Hydrochloride (me-
PER-ih-deen HYE-
droe-KLOR-ide)
Tablets USP, CII
Meperidine
hydrochloride tablets
are:
•
A strong
prescription pain
medicine that
contain an opioid
(narcotic) that is
used to manage
the relief short-
term (acute)
pain, when other
pain treatments
such as non-
opioid pain
medicines do not
treat your pain
well enough or
you cannot
tolerate them.
•
An opioid pain
medicine 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 meperidine
hydrochloride tablets:
•
Get emergency
help right away
if you take too
many
meperidine
hydrochloride
tablets
(overdose).
When you first
start taking
meperidine
hydrochloride
tablets, 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
meperidine
hydrochloride
tablets 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
meperidine
hydrochloride
tablets. They
could die from
taking it. Store
meperidine
hydrochloride
tablets away
from children
and in a safe
place to prevent
stealing or
abuse. Selling or
giving away
meperidine
hydrochloride
tablets is against
the law.
Do not take meperidine
hydrochloride tablets if
you have:
•
severe asthma,
trouble
breathing, or
other lung
problems.
•
a bowel
blockage or have
narrowing of the
stomach or
intestines.
•
allergy to
meperidine
Before taking
meperidine
hydrochloride tablets,
tell your healthcare
provider if you have a
history of:
•
head injury,
seizures ● liver,
kidney, thyroid
problems
•
problems
urinating ●
pancreas or
gallbladder
problems
•
abuse of street or
prescription
drugs, alcohol
addicti

Charakteristika produktu

MEPERIDINE HYDROCHLORIDE- MEPERIDINE HYDROCHLORIDE TABLET
TEVA PHARMACEUTICALS USA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MEPERIDINE HYDROCHLORIDE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MEPERIDINE HYDROCHLORIDE TABLETS.
MEPERIDINE HYDROCHLORIDE, TABLETS, FOR ORAL USE, CII
INITIAL U.S. APPROVAL: 1942
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION
STRATEGY
(REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION;
NEONATAL
OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; RISKS
FROM
CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; AND
MONOAMINE
OXIDASE INHIBITORS (MAOIS) INTERACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
MEPERIDINE HYDROCHLORIDE TABLETS 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. (5.2)
TO ENSURE THAT THE BENEFITS OF OPIOID ANALGESICS OUTWEIGH THE RISKS OF
ADDICTION, ABUSE, AND MISUSE, THE
FOOD AND DRUG ADMINISTRATION (FDA) HAS REQUIRED A RISK EVALUATION AND
MITIGATION STRATEGY (REMS)
FOR THESE PRODUCTS. (5.3)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY, ESPECIALLY UPON
INITIATION OR FOLLOWING A DOSE INCREASE. (5.4)
ACCIDENTAL INGESTION OF MEPERIDINE HYDROCHLORIDE TABLETS, ESPECIALLY
BY CHILDREN, CAN RESULT IN A FATAL
OVERDOSE OF MEPERIDINE. (5.4)
PROLONGED USE OF MEPERIDINE HYDROCHLORIDE TABLETS DURING PREGNANCY CAN
RESULT IN NEONATAL OPIOID
WITHDRAWAL SYNDROME, WHICH MAY BE LIFE-THREATENING IF NOT RECOGNIZED
AND TREATED. IF PROLONGED
OPIOID USE IS REQUIRED IN A PREGNANT WOMAN, ADVISE THE PATIENT OF THE
RISK OF NEONATAL OPIOID
WITHDRAWAL SYNDROME AND ENSURE THAT APPROPRIATE TREATMENT WILL BE
AVAILABLE. (5.5)
CONCOMITANT USE WITH CYP3A4 INHIBITORS (OR DISCONTINUATION OF CYP3A4
INDUCERS) CAN RESULT IN FATAL
OVERDOSE OF