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:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

LEVORPHANOL TARTRATE

Composition:

LEVORPHANOL TARTRATE 2 mg

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, which can occur at any dosage or duration [see WARNINGS] , reserve levorphanol tartrate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: Levorphanol tartrate tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. 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 misuse and abuse, which can lead to the development of substance use disorder, including addiction [see WARNINGS]. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Misuse and abuse of levorphanol tartrate tablets increases risk of overdose, which may lead to central nervous system and respiratory depression, hypotension, seizures, and death. The risk is increased with concurrent abuse of levorphanol tartrate tablets with alcohol and other CNS depressants. Abuse of and addiction to opioids in some individuals may not be accompanied by concurrent tolerance and symptoms of physical dependence. In addition, abuse of opioids can occur in the absence of addiction. All patients treated with opioids require careful and frequent reevaluation for signs of misuse, abuse, and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. Patients at high risk of levorphanol tartrate tablets abuse include those with a history of prolonged use of any opioid, including products containing levorphanol, those with a history of drug or alcohol abuse, or those who use levorphanol tartrate tablets in combination with other abused drugs. “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 healthcare provider(s). “Doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among people who abuse drugs and people with substance use disorder. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with inadequate pain control. Levorphanol tartrate tablets, like other opioids, can be diverted for nonmedical 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 Abuse of levorphanol tartrate tablets poses a risk of overdose and death. The risk is increased with concurrent use of levorphanol tartrate tablets with alcohol and/or other CNS 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 use of opioid therapy. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). Physical dependence is a state that develops as a result of a physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Withdrawal may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone), 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 use. 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 an extended period of time 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 ; AND WARNINGS]. Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see Pregnancy].

Product summary:

Levorphanol Tartrate Tablets, USP Dosage Strength Tablet Color Tablet Shape Tablet Debossing Tablet Scored NDC Number 2 mg White Round “54 410” on one side and scored on the other Yes 0054-0438-25 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. Store Levorphanol Tartrate Tablets securely and dispose of properly [see PRECAUTIONS, Information for Patients/Caregivers]. Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 C50001259/02 Revised January 2024

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVORPHANOL TARTRATE- LEVORPHANOL TARTRATE TABLET
HIKMA PHARMACEUTICALS USA INC.
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LEVORPHANOL TARTRATE TABLETS USP, CII
R ONLY
X
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF
LEVORPHANOL TARTRATE TABLETS
ADDICTION, ABUSE, AND MISUSE
BECAUSE THE USE OF 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 AND REASSESS ALL PATIENTS REGULARLY FOR THE DEVELOPMENT OF
THESE BEHAVIORS AND CONDITIONS _[SEE WARNINGS]._
LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH
USE OF LEVORPHANOL TARTRATE TABLETS, ESPECIALLY DURING INITIATION OR
FOLLOWING A DOSAGE INCREASE. TO REDUCE THE RISK OF RESPIRATORY
DEPRESSION, PROPER DOSING AND TITRATION OF LEVORPHANOL TARTRATE
TABLETS
ARE ESSENTIAL _[SEE WARNINGS]._
ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF EVEN ONE DOSE OF LEVORPHANOL TARTRATE TABLETS,
ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF LEVORPHANOL
_[SEE_
_WARNINGS]._
RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS
CONCOMITANT USE OF OPIOIDS WITH BENZODIAZEPINES OR OTHER CENTRAL
NERVOUS SYSTEM (CNS) DEPRESSANTS, INCLUDING ALCOHOL, MAY RESULT IN
PROFOUND SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH. RESERVE
CONCOMITANT PRESCRIBING OF LEVORPHANOL TARTRATE TABLETS AND
BENZODIAZEPINES OR OTHER CNS DEPRESSANTS FOR USE IN PATIENTS FOR WHOM
ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE_ [SEE WARNINGS]._
NEONATAL OPIOID WITHDRAWAL SYNDROME (NOWS)
IF OPIOID USE IS REQUIRED FOR AN EXTENDED PERIOD OF TIME IN A PREGNANT
WOMAN, ADVISE THE PATIENT OF THE RISK OF NOWS, WHICH MAY BE LIFE-
THREATENING IF NOT RECOGNIZED AND TREATED. ENSURE THAT MANAGEMENT BY
NEONATOLOGY EXPERTS WILL BE AVAILABLE AT DELIVERY _[SEE WARNINGS]._
OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY (REMS):
HEALTHCARE PROVIDERS ARE STRONGLY ENCOURAGED TO COMPLETE A REMS-
COMPLIANT EDUCATION PR