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:

Bryant Ranch Prepack

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]: - 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) [see WARNINGS ] 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 use of opioid analgesic products carries the risk of addiction even under appropriate medical use. Prescription drug abuse is the intentional nontherapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal. “Drug-seeking” behavior is very common in persons with substance use disorders. Drug- seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated “loss” of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating health care provider(s). “Doctor shopping” (visiting multiple prescribers to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control. Abuse and addiction are separate and distinct from physical dependence and tolerance. Health care providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true addiction. Levorphanol Tartrate Tablets, like other opioids, can be diverted for non-medical use into illicit channels of distribution. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. Proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. Risks Specific to Abuse of Levorphanol Tartrate Tablets Levorphanol Tartrate Tablets are for oral use only. Abuse of Levorphanol Tartrate Tablets poses a risk of overdose and death. The risk is increased with concurrent abuse of Levorphanol Tartrate Tablets with alcohol and other central nervous system depressants. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV. Both tolerance and physical dependence can develop during chronic opioid therapy. Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects. Physical dependence is a physiological state in which the body adapts to the drug after a period of regular exposure, resulting in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug. Withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage. Do not abruptly discontinue Levorphanol Tartrate Tablets in a patient physically dependent on opioids. Rapid tapering of Levorphanol Tartrate Tablets in a patient physically dependent on opioids may lead to serious withdrawal symptoms, uncontrolled pain, and suicide. Rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse. When discontinuing Levorphanol Tartrate Tablets, gradually taper the dosage using a patient- specific plan that considers the following: the dose of Levorphanol Tartrate Tablets the patient has been taking, the duration of treatment, and the physical and psychological attributes of the patient. To improve the likelihood of a successful taper and minimize withdrawal symptoms, it is important that the opioid tapering schedule is agreed upon by the patient. In patients taking opioids for a long duration at high doses, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper [see DOSAGE AND ADMINISTRATION, WARNINGS ]. Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see PRECAUTIONS; Pregnancy ].

Product summary:

Levorphanol Tartrate Tablets, USP 2 mg for oral administration are supplied as – White, round tablet debossed with “N” above “236” on one side and score on other side. NDC 63629-2093-1 Bottle 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/CAREGIVERS ]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LEVORPHANOL TARTRATE- LEVORPHANOL TARTRATE TABLET
Bryant Ranch Prepack
----------
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

Summary of Product characteristics

LEVORPHANOL TARTRATE- LEVORPHANOL TARTRATE TABLET
BRYANT RANCH PREPACK
----------
LEVORPHANOL TARTRATE TABLETS USP, CII
RX ONLY
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND
MITIGATION STRATEGY (REMS); LIFE-THREATENING
RESPIRATORYDEPRESSION; 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
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 INGESTIONACCIDENTAL INGESTION OF LEVORPHANOL TARTRATE
TABLETS, ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL OVERDO