LEVORPHANOL TARTRATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

SpecGx LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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): - Have not been tolerated, or are not expected to be tolerated, - Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Levorphanol Tartrate Tablets are contraindicated in patients with: - Significant respiratory depression (see WARNINGS ) - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment (see WARNINGS ) - Known or suspected gastrointestinal obstruction, including paralytic ileus (see WARNINGS ) - Hypersensitivity to levorphanol or any of the formulation excipients (e.g., anaphylaxis) (s

Product summary:

Levorphanol Tartrate Tablets USP Bottles of 100 tablets. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Store Levorphanol Tartrate Tablets securely and dispose of properly (see PRECAUTIONS, Information for Patients ). Dispense in a tight, light-resistant container as defined in the USP. Manufactured by: SpecGx LLC Webster Groves, MO 63119 USA Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. © 2021 Mallinckrodt. Rev 04/2021 Mallinckrodt™ Pharmaceuticals An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/MG20L04.pdf or by calling 1-800-778-7898 for alternate delivery options.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LEVORPHANOL TARTRATE- LEVORPHANOL TARTRATE TABLET
SpecGx 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

Summary of Product characteristics

LEVORPHANOL TARTRATE- LEVORPHANOL TARTRATE TABLET
SPECGX LLC
----------
LEVORPHANOL TARTRATE TABLETS USP, CII
Revised: April 2021
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 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 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
COMPLETE A REMS-COMPLIANT EDUCATION PROGRAM,
COUNSEL PATIENTS AND/OR THEIR CAREGIVERS, WITH EVERY PRESCRIPTION, ON
SAFE USE, SERIOUS RISKS,
STORAGE, AND DISPOSAL OF THESE PRODUCTS,
EMPHASIZE TO PATIENTS AND THEIR CAREGIVERS THE IMPORTANCE OF READING
THE MEDICATION GUIDE EVERY
TIME IT IS PROVIDED BY THEIR PHARMACIST, AND
CONSIDER OTHER TOOLS TO IMPROVE PATIENT, HOUSEHOLD, AND COMMUNITY
SAFETY.
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