FDA label c708d43e-9606-46af-a541-7701a192d060

WARNING TALWIN ® Nx is intended for oral use only. Severe, potentially lethal, reactions may result from misuse of TALWIN ® Nx by injection either alone or in combination with other substances. (See DRUG ABUSE AND DEPENDENCE section.)

WARNINGS Drug Dependence Pentazocine can cause a physical and psychological dependence. (See DRUG ABUSE AND DEPENDENCE .) Use In Head Injury and Increased Intracranial Pressure In the presence of head injury, intracranial lesions or a preexisting increase in intracranial pressure, the possible respiratory depressant effects of pentazocine and its potential to elevate cerebrospinal fluid pressure (resulting from vasodilation following CO2 retention) may be markedly increased . Furthermore, pentazocine can produce effects on pupillary response and consciousness, which may obscure neurologic signs of further increases in intracranial pressure in patients with head injuries. In such patients, pentazocine must be used with extreme caution and only if its use is deemed essential. Interactions with Alcohol and Drugs of Abuse Pentazocine may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression because respiratory depression, hypotension, profound sedation, coma or death may result. Patients Receiving Narcotics Pentazocine is a mild narcotic antagonist. Some patients previously given narcotics, including methadone for the daily treatment of narcotic dependence, have experienced withdrawal symptoms after receiving pentazocine. Respiratory Depression Respiratory depression occurs more frequently in elderly or debilitated patients and in those suffering from conditions accompanied by hypoxia, hypercapnia, or upper airway obstruction, in whom even moderate therapeutic doses may significantly decrease pulmonary ventilation. Use TALWIN Nx with extreme caution in patients with chronic obstructive pulmonary disease or cor pulmonale and in patients having a substantially decreased respiratory reserve (e.g., severe kyphoscoliosis), hypoxia, hypercapnia, or pre-existing respiratory depression. Alternative non-opioid analgesics should be considered, and TALWIN Nx should be employed only under careful medical supervision at the lowest effective dose in such patients. Acute CNS Manifestations Patients receiving therapeutic doses of TALWIN Nx have experienced hallucinations (usually visual), disorientation, and confusion which have cleared spontaneously within a period of hours. The mechanism of this reaction is not known. Such patients should be very closely observed and vital signs checked. If the drug is reinstituted, it should be done with caution since these acute CNS manifestations may recur.

ADVERSE REACTIONS Cardiovascular. Hypertension, hypotension, circulatory depression, tachycardia, syncope. Respiratory. Rarely, respiratory depression. Acute CNS Manifestations. Hallucinations (usually visual), disorientation, and confusion. Other CNS Effects. Grand mal convulsions, increase in intracranial pressure, dizziness, lightheadedness, hallucinations, sedation, euphoria, headache, confusion, disorientation; infrequently weakness, disturbed dreams, insomnia, syncope, and depression; and rarely tremor, irritability, excitement, tinnitus. Autonomic. Sweating; infrequently flushing; and rarely chills. Gastrointestinal. Nausea, vomiting, constipation, diarrhea, anorexia, dry mouth, biliary tract spasm, and rarely abdominal distress. Allergic. Edema of the face; anaphylactic shock; dermatitis, including pruritus; flushed skin, including plethora; infrequently rash, and rarely urticaria. Ophthalmic. Visual blurring and focusing difficulty, miosis. Hematologic. Depression of white blood cells (especially granulocytes), with rare cases of agranulocytosis, which is usually reversible, moderate transient eosinophilia. Dependence and Withdrawal Symptoms. (See WARNINGS , PRECAUTIONS , and DRUG ABUSE AND DEPENDENCE Sections). Other. Urinary retention, paresthesia, serious skin reactions, including erythema multiforme, Stevens-Johnson syndrome toxic epidermal necrolysis, and alterations in rate or strength of uterine contractions during labor.