Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1663
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Demerol (Tablet)
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For Relief of Pain: Dosage should be adjusted according to the severity of the pain and the response of the patient. Meperidine is less effective orally than on parenteral administration. The dose of DEMEROL should be proportionately reduced (usually by 25 to 50 percent) when administered concomitantly with phenothiazines and many other tranquilizers since they potentiate the action of DEMEROL.<br/>Adults: The usual dosage is 50 mg to 150 mg orally, every 3 or 4 hours as necessary.<br/>Pediatric Patients: The usual dosage is 1.1 mg/kg to 1.8 mg/kg orally, up to the adult dose, every 3 or 4 hours as necessary. Each dose of the oral solution should be taken in one-half glass of water, since if taken undiluted, it may exert a slight topical anesthetic effect on mucous membranes.
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Meperidine hydrochloride, a white crystalline substance with a melting point of 186��C to 189��C. It is readily soluble in water and has a neutral reaction and a slightly bitter taste. The solution is not decomposed by a short period of boiling. The oral solution is a pleasant-tasting, nonalcoholic, banana-flavored solution containing 50 mg of DEMEROL, brand of meperidine hydrochloride, per 5 mL teaspoon (25 drops contain 13 mg of DEMEROL). The tablets contain 50 mg or 100 mg of the analgesic. Inactive Ingredients - TABLETS: Calcium Sulfate, Dibasic Calcium Phosphate, Starch, Stearic Acid, Talc. ORAL SOLUTION: Benzoic Acid, Flavor, Liquid Glucose, Purified Water, Saccharin Sodium. Chemically, DEMEROL is 4-Piperidinecarboxylic acid, 1-methyl-4-phenyl-, ethyl ester, hydrochloride and has the following structure:
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Meperidine hydrochloride is a narcotic analgesic with multiple actions qualitatively similar to those of morphine; the most prominent of these involve the central nervous system and organs composed of smooth muscle. The principal actions of therapeutic value are analgesia and sedation. There is some evidence which suggests that meperidine may produce less smooth muscle spasm, constipation, and depression of the cough reflex than equianalgesic doses of morphine. Meperidine, in 60 mg to 80 mg parenteral doses, is approximately equivalent in analgesic effect to 10 mg of morphine. The onset of action is slightly more rapid than with morphine, and the duration of action is slightly shorter. Meperidine is significantly less effective by the oral than by the parenteral route, but the exact ratio of oral to parenteral effectiveness is unknown.
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DEMEROL is contraindicated in patients with hypersensitivity to meperidine. Meperidine is contraindicated in patients who are receiving monoamine oxidase (MAO) inhibitors or those who have recently received such agents. Therapeutic doses of meperidine have occasionally precipitated unpredictable, severe, and occasionally fatal reactions in patients who have received such agents within 14 days. The mechanism of these reactions is unclear, but may be related to a preexisting hyperphenylalaninemia. Some have been characterized by coma, severe respiratorydepression, cyanosis, and hypotension, and have resembled the syndrome of acute narcotic overdose. In other reactions the predominant manifestations have been hyper-excitability, convulsions, tachycardia, hyperpyrexia, and hypertension. Although it is not known that other narcotics are free of the risk of such reactions, 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.)
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For Oral Use: Tablets are white, round and convex. The 50 mg tablet has a stylized���W���on one side and���M���score���35���on the other side. The 100 mg tablet has a stylized���W���on one side and���M���score���37���on the other side. Tablets of 50 mg, bottles of 100 (NDC 0024-0335-04) and 100 mg, bottles of 100 (NDC 0024-0337-04). Oral Solution, nonalcoholic, banana-flavored 50 mg per 5 mL teaspoon, bottles of 16 fl oz (NDC 0024-0332-06). Store at 25��C (77��F); excursions permitted to 15�����30��C (59�����86��F) [See USP Controlled Room Temperature].
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General: Opioid analgesics can have a narrow therapeutic index in certain patient populations, particularly when combined with CNS depressant drugs. The use of these products should be reserved for cases where the benefits of opioid analgesia outweigh the known risks of respiratory depression, altered mental state, and postural hypotension. Use of DEMEROL may be associated with increased potential risks and should be used with caution in the following conditions: sickle cell anemia, pheochromocytoma, acute alcoholism; adrenocortical insufficiency (e.g., Addison's disease); CNS depression or coma; delirium tremens; debilitated patients; kyphoscoliosis associated with respiratory depression; myxedema or hypothyroidism; prostatic hypertrophy or urethral stricture; severe impairment of hepatic, pulmonary, or renal function; and toxic psychosis. The administration of meperidine may obscure the diagnosis or clinical course in patients with acute abdominal conditions. All opioids may induce or aggravate seizures in some clinical settings.<br/>Interactions with other CNS Depressants: DEMEROL should be used with caution and consideration should be given to starting with a reduced dosage in patients who are concurrently receiving other central nervous system depressants including sedatives or hypnotics, general anesthetics, phenothiazines, other tranquilizers, and alcohol. Drug-drug interactions may result in respiratory depression, hypotension, profound sedation, or coma if these drugs are taken in combination with the usual doses of DEMEROL.<br/>Interactions with Mixed Agonist/Antagonist Opioid Analgesics: Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, butorphanol, and buprenorphine) should be administered with caution to a patient who has received or is receiving a course of therapy with a pure opioid agonist analgesic such as meperidine. In this situation, mixed agonist/antagonist analgesics may reduce the analgesic effect of meperidine and/or may precipitate withdrawal symptoms in these patients.<br/>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.<br/>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.<br/>Acute Abdominal Conditions: The administration of meperidine or other narcotics may obscure the diagnosis or clinical course in patients with acute abdominal conditions.<br/>Tolerance and Physical Dependence: Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Physical dependence is manifested by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist. Physical dependence and tolerance are not unusual during chronic opioid therapy. The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, mydriasis. Other symptoms also may develop, including: irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. In general, opioids used regularly should not be abruptly discontinued.<br/>Use in Drug and Alcohol Addiction: DEMEROL is an opioid with no approved use in the management of addictive disorders. Its proper usage in individuals with drug or alcohol dependence, either active or in remission, is for the management of pain requiring opioid analgesia. DEMEROL should be used with caution in patients with alcoholism and other drug dependencies due to the increased frequency of narcotic tolerance, dependence, and the risk of addiction observed in these patient populations. Abuse of DEMEROL in combination with other CNS depressant drugs can result in serious risk to the patient.<br/>Information for Patients/Caregivers: If clinically advisable, patients receiving DEMEROL (meperidine hydrochloride) tablets or their caregivers should be given the following information by the physician, nurse, pharmacist, or caregiver:<br/>Drug Interactions: Also see WARNINGS.<br/>Acyclovir: Plasma concentrations of meperidine and its metabolite, normeperidine, may be increased by acyclovir, thus caution should be used with concomitant administration.<br/>Cimetidine: Cimetidine reduced the clearance and volume of distribution of meperidine and also the formation of the metabolite, normeperidine, in healthy subjects and thus, caution should be used with concomitant administration.<br/>Phenytoin: The hepatic metabolism of meperidine may be enhanced by Phenytoin. Concomitant administration resulted in reduced half-life and bioavailability with increased clearance of meperidine in healthy subjects, however, blood concentrations of normeperidine were increased.<br/>Ritonavir: Plasma concentrations of the active metabolite normeperidine may be increased by ritonavir, thus concomitant administration should be avoided. Opioid analgesics, including DEMEROL, may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.<br/>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, Sickle Cell Anemia, hypothyroidism, Addison's disease, Pheochromocytoma and prostatic hypertrophy or urethral stricture. In patients with pheochromocytoma, meperidine has been reported to provoke hypertension.<br/>Usage in Hepatically Impaired Patients: Accumulation of meperidine and/or its active metabolite, normeperidine, can occur in patients with hepatic impairment. Meperidine should therefore be used with caution in patients with hepatic impairment.<br/>Usage in Renally Impaired Patients: Accumulation of meperidine and/or its active metabolite, normeperidine, can also occur in patients with renal impairment. Meperidine should therefore be used with caution in patients with renal impairment.<br/>Carcinogensis, mutagenesis, impairment of fertility: Studies to assess the carcinogenic or mutagenic potential of meperidine have not been conducted. Studies to determine the effect of meperidine on fertility have not been conducted.<br/>Pregnancy:<br/>Teratogenic effects: Pregnancy Category C: Animal reproduction studies have not been conducted with meperidine. It is also not known whether DEMEROL can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. DEMEROL should be given to a pregnant woman only if clearly needed.<br/>Labor and Delivery: See WARNINGS.<br/>Nursing Mothers: See WARNINGS.<br/>Pediatric Use: Literature reports indicate that meperidine has a slower elimination rate in neonates and young infants compared to older children and adults. Neonates and young infants may also be more susceptible to the effects, especially the respiratory depressant effects. Meperidine should therefore be used with caution in neonates and young infants, and any potential benefits of the drug weighed against the relative risk to a pediatric patient.<br/>Geriatric Use: Clinical studies of DEMEROL during product development did not include sufficient numbers of subjects aged 65 and over to evaluate age-related differences in safety or efficacy. Literature reports indicate that geriatric patients have a slower elimination rate compared to young patients and they may be more susceptible to the effects of meperidine. A reduction in the total daily dose of meperidine may be required in elderly patients, and the potential benefits of the drug weighed against the relative risk to a geriatric patient.
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Meperidine Hydrochloride
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Demerol (Tablet)
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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 lightheadedness, 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 alleviatedif the patient lies down. Other adverse reactions include: Nervous System: Euphoria, dysphoria, weakness, headache, agitation, tremor, uncoordinated muscle movements (e.g. muscle twitches, myoclonus), severe convulsions, transient hallucinations and disorientation, visual disturbances. Gastrointestinal: Dry mouth, constipation, biliary tract spasm. Cardiovascular: Flushing of the face, tachycardia, bradycardia, palpitation, hypotension , syncope. Genitourinary: Urinary retention. Allergic: Pruritus, urticaria, other skin rashes, wheal and flare over the vein with intravenous injection. Hypersensitivity reactions including anaphylaxis.
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DEMEROL is indicated for the relief of moderate to severe pain.
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Demerol
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