warnings
WARNINGS Meperidine should not be used for treatment of chronic pain. Meperidine should only be used in the treatment of acute episodes of moderate to severe pain. Prolonged meperidine use may increase the risk of toxicity (e.g. seizures) from the accumulation of the meperidine metabolite, normeperidine. DEMEROL is an opioid agonist and a Schedule II controlled substance with an abuse liability similar to morphine. DEMEROL can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing DEMEROL in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. Misuse, Abuse, and Diversion of Opioids Meperidine is an opioid agonist of the morphine-type. Such drugs are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Meperidine can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing DEMEROL in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. DEMEROL has been reported as being abused by crushing, chewing, snorting, or injecting the dissolved product. These practices will result in the uncontrolled delivery of the opioid and pose a significant risk to the abuser that could result in overdose or death (see WARNINGS and DRUG ABUSE AND ADDICTION ). Concerns about abuse, addiction, and diversion should not prevent the proper management of pain. Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product. Interactions with Alcohol and Drugs of Abuse Meperidine may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression. Head Injury and Increased Intracranial Pressure The respiratory depressant effects of meperidine and its capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions, or a preexisting increase in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries. In such patients, meperidine must be used with extreme caution and only if its use is deemed essential. Respiratory Conditions Meperidine should be used with extreme caution in patients having an acute asthmatic attack, patients with chronic obstructive pulmonary disease or cor pulmonale, patients having a substantially decreased respiratory reserve, and patients with preexisting respiratory depression, hypoxia, or hypercapnia. In such patients, even usual therapeutic doses of narcotics may decrease respiratory drive while simultaneously increasing airway resistance to the point of apnea. Hypotensive Effect The administration of meperidine may result in severe hypotension in the postoperative patient or any individual whose ability to maintain blood pressure has been compromised by a depleted blood volume or the administration of drugs such as the phenothiazines or certain anesthetics. Serotonin Syndrome Due to the risk of serotonin syndrome, meperidine should not be used in combination with serotoninergic products (see PRECAUTIONS, Drug Interactions ). Usage in Ambulatory Patients Meperidine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. The patient should be cautioned accordingly. Meperidine, like other narcotics, may produce orthostatic hypotension in ambulatory patients. Usage in Pregnancy Meperidine should not be used in pregnant women prior to the labor period, unless in the judgment of the physician the potential benefits outweigh the possible risks, because safe use in pregnancy prior to labor has not been established relative to possible adverse effects on fetal development. Labor and Delivery Meperidine crosses the placental barrier and can produce depression of respiration and psychophysiologic functions in the newborn. Resuscitation may be required (see OVERDOSAGE ). Therefore meperidine is not recommended during labor. Nursing Mothers Meperidine appears in the milk of nursing mothers receiving the drug. Due to the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the potential benefits of the drug to the nursing woman.