Country: United States
Language: English
Source: NLM (National Library of Medicine)
LEVORPHANOL TARTRATE (UNII: 04WQU6T9QI) (LEVORPHANOL - UNII:27618J1N2X)
Novitium Pharma LLC
ORAL
PRESCRIPTION DRUG
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
HOW SUPPLIED 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 the other side. NDC 70954-236-10 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 ]. Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 Issued: 04/2020 LB4180-00
Abbreviated New Drug Application
LEVORPHANOL TARTRATE - LEVORPHANOL TARTRATE TABLET Novitium Pharma LLC ---------- SPL MEDGUIDE Medication GuideLevorphanol 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 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. • 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 injury, seizures • liver, kidney, thyroid problems • problems urinating Read the complete document
LEVORPHANOL TARTRATE - LEVORPHANOL TARTRATE TABLET NOVITIUM PHARMA LLC ---------- LEVORPHANOL TARTRATE TABLETS USP, CII RX ONLY BOXED WARNING 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 DEPRESSANTSADDICTION, 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 mis use, 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 DEPRESSIO 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 i Read the complete document