LEVORPHANOL TARTRATE tablet

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

LEVORPHANOL TARTRATE (UNII: 04WQU6T9QI) (LEVORPHANOL - UNII:27618J1N2X)

から入手可能:

Virtus Pharmaceuticals, LLC

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Levorphanol Tartrate Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Levorphanol Tartrate Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: Levorphanol Tartrate Tablets are contraindicated in patients with: Levorphanol Tartrate Tablets contains levorphanol, a Schedule II controlled substance. Levorphanol Tartrate Tablets contains levorphanol, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone and tapentadol. Levorphanol can be abused and is subject to misuse, addiction, and criminal diversion [see WARNINGS]. All patients treated with opioids require careful monitoring for signs of abuse and addiction, because u

製品概要:

Levorphanol Tartrate Tablets USP, 2 mg White to off white, scored tablets (Identified V2003) NDC: 69543-417-10 Bottles of 100 tablets. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in an amber airtight container as defined in the USP. Store Levorphanol Tartrate Tablets securely and dispose of properly [see PRECAUTIONS; Information for Patients]. Distributed by: Virtus Pharmaceuticals, LLC Langhorne, PA 19047 Rev. 08/2020

認証ステータス:

Abbreviated New Drug Application

情報リーフレット

Virtus Pharmaceuticals, LLC
----------
MEDICATION GUIDE
Levorphanol Tartrate
(lee vor’ fa nol tar’ trate)
Tablets CII
Levorphanol Tartrate Tablets are:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage pain,
severe enough to require an opioid pain medicine 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 Levorphanol Tartrate Tablets:
•
Get emergency help or call 911 right away if you take too much
Levorphanol Tartrate Tablets
(overdose). When you first start taking Levorphanol Tartrate 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. Talk to your healthcare provider about naloxone, a
medicine for the emergency
treatment of an opioid overdose.
•
Taking Levorphanol Tartrate 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 Levorphanol Tartrate Tablets. They could
die from taking it. Selling
or giving away Levorphanol Tartrate Tablets is against the law.
•
Store Levorphanol Tartrate Tablets securely, out of sight and reach of
children, and in a location
not accessible by others, including visitors to the home.
Do not take Levorphanol Tartrate Tablets if you have:
•
severe asthma trouble breathing, or other lung problems
•
a bowel blockage or have narrowing of the stomach or intestines
•
previously had an allergic reaction to levorphanol
Before taking Levorphanol Tartrate Tablets, tell your healthcare
provider if you have a history of:
•
head injur

製品の特徴

LEVORPHANOL TARTRATE- LEVORPHANOL TARTRATE TABLET
VIRTUS PHARMACEUTICALS, LLC
----------
LEVORPHANOL TARTRATE TABLETS USP, CII
RX ONLY
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND
MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY
DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL
SYNDROME; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR
OTHER CNS DEPRESSANTS
ADDICTION, ABUSE, AND MISUSE
LEVORPHANOL TARTRATE TABLETS EXPOSES 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 LEVORPHANOL TARTRATE TABLETS, AND MONITOR
ALL PATIENTS REGULARLY
FOR THE DEVELOPMENT OF THESE BEHAVIORS AND CONDITIONS [SEE WARNINGS].
OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY (REMS):
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 REMS FOR
THESE PRODUCTS
[SEE WARNINGS]. UNDER THE REQUIREMENTS OF THE REMS, DRUG COMPANIES
WITH APPROVED
OPIOID ANALGESIC PRODUCTS MUST MAKE REMS-COMPLIANT EDUCATION PROGRAMS
AVAILABLE TO
HEALTHCARE PROVIDERS. HEALTHCARE PROVIDERS ARE STRONGLY ENCOURAGED TO
•
•
•
•
LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH USE OF
LEVORPHANOL TARTRATE TABLETS. MONITOR FOR RESPIRATORY DEPRESSION,
ESPECIALLY DURING
INITIATION OF LEVORPHANOL TARTRATE TABLETS OR FOLLOWING A DOSE
INCREASE [SEE WARNINGS].
ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF LEVORPHANOL TARTRATE TABLETS, ESPECIALLY BY
CHILDREN, CAN RESULT IN A
FATAL OVERDOSE OF LEVORPHANOL TARTRATE TABLETS [SEE WARNINGS].
NEONATAL OPIOID WITHDRAWAL SYNDROME
PROLONGED USE OF LEVORPHANOL TARTRATE TABLETS DURING PREGNANCY CAN
RESULT IN NEONATAL
OPIOID WITHDRAWAL SYNDROME, WHICH MAY BE LIFE-THREATENING IF NOT
RECOGNIZED AND TREATED,
AND REQUIRES MANAGEMENT ACCORDING TO PROTOCOLS DEVELOPED BY
NEONATOLOGY EXPERTS. IF
OPIOID USE IS REQUIRED F