{"adverse_reactions":["ADVERSE REACTIONS The major hazards of meperidine, as with other narcotic analgesics, are respiratory depression and, to a lesser degree, circulatory depression; respiratory arrest, shock, and cardiac arrest have occurred. The most frequently observed adverse reactions include light-headedness, dizziness, sedation, nausea, vomiting, and sweating. These effects seem to be more prominent in ambulatory patients and in those who are not experiencing severe pain. In such individuals, lower doses are advisable. Some adverse reactions in ambulatory patients may be alleviated if the patient lies down. Other adverse reactions include: Central Nervous System: Euphoria, dysphoria, weakness, headache, agitation, tremor, uncoordinated muscle movements, transient halluciations and disorientation, visual disturbances and, rarely, extrapyramidal reactions. Gastrointestinal: Dry mouth, constipation, biliary-tract spasm. Cardiovascular: Flushing of the face, tachycardia, bradycardia, palpitation, faintness, syncope. Cardiovascular effects from promethazine have been rare. Minor increases in blood pressure and occasional mild hypotension have been detected."],"clinical_pharmacology":["ACTIONS Meperidine hydrochloride is a narcotic analgesic with multiple actions qualitatively similar to those of morphine. Promethazine hydrochloride is a phenothiazine derivative that has several different pharmacologic properties, including antihistaminic, sedative, and antiemetic actions."],"contraindications":["CONTRAINDICATIONS Hypersensitivity to mperidine or promethazine. Meperidine is contraindicated in patients who are receiving monoamine oxidase inhibitors (MAOI) or those who have received such agents within 14 days. Therapeutic doses of meperidine have inconsistently precipitated unpredictable, severe, and occasionally fatal reactions in patients who have received such agents within 14 days. The mechanism of these reactions is unclear. Some have been characterized by coma, severe respiratory depression, cyanosis, and hypotension and have resembled the syndrome of acute narcotic overdose. In other reactions the predominant manifestations have been hyperexcitabilty, convulsions, tachycardia, hyperppyrexia, and phypertension. Although it is not known that other narcotics are free of the risk of such reaction, virtually all of the reported reactions have occurred with meperidine. If a narcotic is needed in such patients, a sensitivity test should be performed in which repeated, small, incremental doses of morphine are administered over the course of several hours while the patient's condition and vital signs are under careful observation. (Intravenous hydrocortisone or prednisolone have been used to treat severe reactions, with the addition of intravenous chlorpromazine in those cases exhibiting hypertension and hyperpyrexia. The usefulness and safety of narcotic antagonists in the treatment of these reactions is unknown.)"],"description":["DESCRIPTION Meperidine HCl and Promethazine HCl capsules each contain 50 mg meperidine hydrochloride and 25 mg promethazine hydrochloride."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION The usual dosage is one capsule every four to six hours as needed for the relief of paint."],"effective_time":"20130122","how_supplied":["HOW SUPPLIED Meperidine HCl and Promethazine HCl capsules are red capsuels imprinted \"4206/V\", available in Bottles of 10 NDC 54868-5151-1 Bottles of 20 NDC 54868-5151-2 Bottles of 90 NDC 54868-5151-5 Bottles of 100 NDC 54868-5151-4 DISPENSE in a tight, light-resistant container as defined in the USP. Protect from light. Rx only Manufactured by: VINTAGE PHARMACEUTICALS, LLC Huntsville, AL 35811 80052 Rev 8/01 R0 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146"],"how_supplied_table":["
Bottles of 10 NDC 54868-5151-1
Bottles of 20 NDC 54868-5151-2
Bottles of 90 NDC 54868-5151-5
Bottles of 100 NDC 54868-5151-4
"],"id":"c5fcce83-58d9-4e5f-9baa-51540e77d5d7","inactive_ingredient":["INACTIVE INGREDIENTS Black iron oxide, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, gelatin, lactose, and magnesium stearate."],"indications_and_usage":["INDICATIONS Affords sedation as well as analgesia for moderate paint as seen in post-operative patients, post-partum patients, and in patients with pain associated with malignancies."],"openfda":{},"overdosage":["OVERDOSAGE Symptoms: Serous overdose with meperidine is characterized by respiratory depression (a crease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest, and death may occur. Treatment: Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patient airway and institution of assisted or controlled ventilation. The narcotic antagonist, naloxone hydrochloride, is a specific antidote against respiratory depression that may result from overdosage or unusual sensitivity to narcotics, including meperidine. Therefore, an appropriate dose of naloxone hydrochloride should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. An antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression. Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. NOTE: In an individual physically dependent on narcotics, the administration of the usual dose of a narcotic antagonist will precipitate an acute withdrawal syndrome. The severity of this syndrome will depend on the degree of physical dependence and the dose of antagonist administered. The use of narcotic antagonists in such individuals should be avoided is possible. If a narcotic antagonist must be used to treat serious respiratory depression in the physically dependent patient, the antagonist should be administered with extreme care and only one-tenth to one-fifth the usual initial dose administered. Attempted suicides with promethazine have resulted in deep sedation, coma, rarely convulsions and cardiorespiratory symptoms compatible with the depth of sedation present. Extrapyramidal reactions may be treated with anticholinergic antiparkinson agents, diphenhydramine, or barbiturates. If severe hypotension occurs, levarterenol or phenylephrine may be indicated. Epinephrine is probably best avoided, since it has been suggested that promethazine overdosage could produce a partial alpha-adrenergic blockade. A paradoxical reaction, characterized by hyperexcitability and nightmares, has been reported in children receiving large single doses of promethazine."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL image of package label"],"precautions":["PRECAUTIONS Supraventricular Tachycardias: Meperidine should be used with caution in patients with atrial flutter and other supraventricular tachycardias because of a possible vagolytic action which may produce a significant increase in the ventricular response rate. Convulsions: Meperidine may aggravate preexisting convulsions in patients with convulsive disorders. If dosage is escalated substantially above recommended levels because of tolerance development, convulsions may occur in individuals without a history of convulsive disorders. Acute Abdominal Conditions: The administration of meperidine or other narcotics may obscure the diagnosis or clinical course in patients with acute abdominal conditions. Special-Risk Patients: Meperidine should be given with caution, and the initial dose should be reduced in certain patients, such as the elderly or debilitated, and those with severe impairment of hepatic or renal function, hypothyrodism, Addison's disease, and prostatic hypertrophy or urethral stricture. Ambulatory patients should be cautioned against driving automobiles or operating dangerous machinery until it is known that they do not become drowsy or dizzy from promethazine hydrochloride therapy. Antiemetics such as promethazine may mask the symptoms of an unrecognized disease and thereby interfere with diagnosis."],"set_id":"cf93a1e2-aaf0-4b15-9435-19cf299ea459","spl_product_data_elements":["Meperidine Hcl and Promethazine Hcl Meperidine Hcl and Promethazine Hcl MEPERIDINE HYDROCHLORIDE MEPERIDINE PROMETHAZINE HYDROCHLORIDE PROMETHAZINE FERROSOFERRIC OXIDE D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN LACTOSE MAGNESIUM STEARATE 4206;V"],"version":"2","warnings":["WARNINGS Tolerance and Addiction Liability Drug Dependence: Meperidine can produce drug dependence of the morphine type and therefore has the potential for being abused. Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of meperidine, and it should be prescribed and administered with the same degree of caution appropriate to the use of morphine. Like other narcotics, meperidine is subject to the provisions of the Federal narcotic laws. Interaction with Other Central Nervous System Depressants: Meperidine should be used with great caution and in reduced dosage in patients who are concurrently receiving other narcotic analgesics, general anesthetics, phenothiazines, other tranquilizers, sedative-hypnotics, tricyclic antidepressants, and other CNS depressants (including alcohol). Respiratory depression, hypotension, and profound sedation or coma may result. The sedative action of promethazine hydrochloride is additive to the sedative effects of central nervous system depressants; therefore, agents such as alcohol, barbiturates, and narcotic analgesics should either be eliminated or given in reduced dosage in the presence of promethazine hydrochloride. When given concomitantly with promethazine hydrochloride, the dose of barbiturates should be reduced by at least one-half and the dose of analgesic depressants, such as morphine or meperidine, should be reduced by one-quarter to one-half. 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 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. Asthma and Other 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 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 an individual whose ability to maintain his blood pressure has already been compromised by a depleted blood volume or concurrent administration of drugs such as the phenothiazines or certain anesthetics. 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 and Lactation: 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 hazards, because safe use in pregnancy prior to labor has not been established relative to possible adverse effects on fetal development. When used as an obstertrical analgesic, meperidine crosses the placental barrier and can produce respiratory depression in the newborn; resuscitation may be required (see OVERDOSAGE). Meperidine appears in the milk of nursing mothers receiving the drug."]}