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:

Sun Pharmaceutical Industries, Inc.

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. Limitations of Use 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

Product summary:

Levorphanol Tartrate Tablets, USP Dosage Strength Tablet Color Tablet Shape Tablet Debossing Tablet Scored NDC Number 2 mg White to mottled off-white Flat face beveled edge Bisect scored on one side and embossed with “762” on other side Yes 57664-762-88 Bottles of 100 tablets. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure. Store levorphanol tartrate tablets securely and dispose of properly [see PRECAUTIONS/ Information for Patients/Caregivers ]. Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512 Iss. 06/2021 5220337

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Sun Pharmaceutical Industries, Inc.
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Medication Guide
Levorphanol Tartrate (lee vor' fa nol tar' trate) Tablets USP, 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:
•

Summary of Product characteristics

LEVORPHANOL TARTRATE- LEVORPHANOL TARTRATE TABLET
SUN PHARMACEUTICAL INDUSTRIES, INC.
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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 RE