{"adverse_reactions":["ADVERSE REACTIONS THE MAJOR HAZARDS OF MORPHINE, AS OF OTHER NARCOTIC ANALGESICS, ARE RESPIRATORY DEPRESSION AND, TO A LESSER DEGREE, CIRCULATORY DEPRESSION, RESPIRATORY ARREST, SHOCK, AND CARDIAC ARREST HAVE OCCURED. 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 suffering severe pain. In such individuals, lower doses are advisable. Some adverse reactions may be alieviated in the ambulatory patient if he lies down. Other adverse reactions include the following: Central Nervous System - Euphoria, dysphona, weakness, headache, insomnia, agitation, disonentation, and visual disturbances. Gastrointestinal - Dry mouth, anorexia, constipation, and biliary tract spasm. Cardiovascular - Flushing of the face, bradycardia, palpitation, faintness and syncope. Allergic -Pruritus, urticana, other skin rashes, edema, and, rarely hemorrhagic urticana. Treatment of the most frequent adverse reactions Constipation Ample intake of water or other liquids should be encouraged. Concomitant administration of a stool softener and a peristatic stimulant with the narcotic analgesic can be an effetive preventive meassure for those patients in need of therapeutics. If elimination does not occur for two days, an enema should be administered to prevent impaction. In the event diarrhea occurs, seepage around fecal impaction is a possible cause to consider before antidiarrheal measures are employed. Nausea and Vomiting Phenothiazines and antihistamines can be effective treatments of nausea of the medullary and vestibular sources respectively. However, these drugs may potentiate the side effects of the narcotic or the anti-nauseant. Drowsiness (sedation) Once pain control is achieved, undesirable sedation can be minimized by titrating the dosage to a level that just maintains a tolerable pain or pain free state."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenicity/Mutagenicity Long-term studies to determine the carcinogenic and mutagenic potential of morphine are not available."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY The major effects of morphine are on the central nervous system and the bowel. Opioids act as agonists, interacting with stereospecific and saturable binding sites or receptors in the brain and other tissues. Morphine is about two-thirds absorbed from the gastrointestinal tract with the maximum analgesic effect occurring 60 minutes post administration."],"contraindications":["CONTRAINDICATIONS Hypersensitivity to morphine; respiratory insufficiency or depression; severe CNS depression; attack of bronchial asthma; heart failure secondary to chronic lung disease; cardiac arrhythmias; increased intracranial or cerebrospinal pressure; head injuries; brain tumor; acute alcoholism; delirium tremens; convulsive disorders; after biliary tract surgery; suspected surgical abdomen; surgical anastomosis; concomitantly with MAO inhibitors or within 14 days of such treatment."],"description":["DESCRIPTION Each 1 mL of morphine sulfate immediate-release CONCENTRATED oral solution (available in bottles) contains: morphine sulfate 20 mg Inactive ingredients: citric acid, FD&C Red No. 40, flavors, purified water, saccharin sodium, sodium benzoate, sodium citrate dihydrate, and sorbitol solution. Chemically, morphine sulfate is morphinan 3,6-diol, 7,8-didehydro-4,5-epoxy-17-methyl-(5-α,6-α)-, sulfate(2:1)(salt), pentahydrate, which can be represented by the following structural formula: (C 17 H 19 NO 3 )2 •H 2 SO 4 •SH 2 O 758.83 M.W. Morphine sulfate acts as a narcotic analgesic. Chemical Structure"],"description_table":["
morphine sulfate 20 mg
"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION CAUTION! HIGHLY CONCENTRATED SOLUTION! VERIFY DOSAGE AND MEASURE CAREFULLY. Usual Adult Oral Dose 10 to 20 mg every 4 hours or as directed by physician. Dosage is a patient dependent variable, therefore increased dosage may be required to achieve adequate analgesia. For control of severe, chronic pain in patients with certain terminal diseases, this drug should be administered on a regularly scheduled basis, every 4 hours, at the lowest dosage level that will achieve adequate analgesia. Note: Medication may suppress respiration in the elderly, the very ill, and those patients with respiratory problems, therefore lower doses may be required. Morphine Dosage Reduction During the first two to three days of effective pain relief, the patient may sleep for many hours. This can be misinterpreted as the effect of excessive analgesic dosing rather than the first sign of relief in a pain exhausted patient. The dose, therefore, should be maintained for at least three days before reduction, if respiratory activity and other vital signs are adequate. Following successful relief of severe pain, periodic attempts to reduce the narcotic dose should be made. Smaller doses or complete discontinuation of narcotic analgesic may become feasible due to a physiologic change or the improved mental state of the patient."],"drug_abuse_and_dependence":["DRUG ABUSE AND DEPENDENCE Morphine sulfate, a narcotic, is a Schedule II controlled substance under the Federal Controlled Substance Act. As with other narcotics, some patients may develop a physical and psychological dependence on morphine. They may increase dosage without consulting a physician and subsequently may develop a physical dependence on the drug. In such cases, abrupt discontinuance may precipitate typical withdrawal symptoms, including convulsions. Therefore the drug should be withdrawn gradually from any patient known to be taking excessive dosages over a long period of time. In treating the terminally ill patient, the benefit of pain relief may outweigh the possibility of drug dependence. The chance of drug dependence is substantially reduced when the patient is placed on scheduled narcotic programs instead of a \"pain to relief-of-pain\" cycle typical of a PRN regimen."],"drug_interactions":["Drug Interactions Generally, effects of morphine may be potentiated by alkalizing agents and antagonized by acidifying agents. Analgesic effect of morphine is potentiated by chlorpromazine and methocarbamol. CNS depressants such as anesthetics, hypnotics, barbiturates, phenothiazines, chloral hydrate, glutethimide, sedatives, MAO inhibitors (including procarbazine hydrochloride), antihistamines, β-blockers (propranolol), alcohol, furazolidone and other narcotics may enhance the depressant effects of morphine. Morphine may increase anticoagulant activity of coumarin and other anticoagulants."],"effective_time":"20110519","general_precautions":["General Head Injury and Increased Intracranial Pressure The respiratory depressant effects of morphine and its capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of increased intracranial pressure. Furthermore, narcotics produce side effects that may obscure the clinical course of patients with head injuries. In such patients, morphine must be used with caution and only if it is deemed essential. Asthma and Other Respiratory Conditions Morphine should be used with caution in patients having an acute asthmatic attack, in those with chronic obstructive pulmonary disease or cor pulmonate, and in individuals with a substantially decreased respiratory reserve, 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 morphine may result in severe hypotension in an individual whose ability to maintain blood pressure has already been compromised by a depleted blood volume or concurrent administration of such drugs as the phenothiazines or certain anesthetics. Special-Risk Patients Morphine 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, hypothyroidism. Addison's disease, prostatic hypertrophy, or urethral stricture. Acute Abdominal Conditions The administration of morphine or other narcotics may obscure the diagnosis or clinical course in patients with acute abdominal conditions."],"geriatric_use":["Geriatric Use Clinical studies on this product did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of morphine sulfate immediate-release CONCENTRATED oral solution and observed closely."],"how_supplied":["HOW SUPPLIED Morphine Sulfate Oral Concentrate Solution, 20 mg/1 mL is a red, berry flavored liquid packaged as follows: Bottles of 30 mL NDC# 64950-352-03 supplied with a calibrated dropper Bottles of 120 mL NDC# 64950-352-12 supplied with a calibrated dropper Bottles of 240 mL NDC# 64950-352-24 supplied with a calibrated spoon Keep this and all medication out of the reach of children. In case of accidental overdose, seek professional assistance or call a poison control center immediately. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F)[See USP Controlled Room Temperature]. Protect from light. For the 30 mL and 120 mL bottles dispense solution in original bottle with the provided calibrated dropper. For the 240 mL bottles dispense solution in original bottle with the provided calibrated spoon. Discard opened bottle after 90 days. DEA Order Form Required"],"how_supplied_table":["
Bottles of 30 mL NDC# 64950-352-03 supplied with a calibrated dropper
Bottles of 120 mL NDC# 64950-352-12 supplied with a calibrated dropper
Bottles of 240 mL NDC# 64950-352-24 supplied with a calibrated spoon
"],"id":"86c24058-b1bc-4cd2-b382-bcb93d6b9f5e","indications_and_usage":["INDICATIONS AND USAGE Morphine is indicated for the relief of severe acute and severe chronic pain."],"information_for_patients":["Information for Patients Use in Ambulatory Patients Morphine 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. Morphine, like other narcotics, may produce orthostatic hypotension in ambulatory patients. Patients should be cautioned about the combined effects of alcohol or other central nervous system depressants with morphine."],"labor_and_delivery":["Labor and Delivery Morphine readily crosses the placental barrier and if administered during labor, may lead to respiratory depression in the neonate."],"nursing_mothers":["Nursing Mothers Morphine has been detected in human milk. For this reason, caution should be exercised when morphine is administered to a nursing woman."],"openfda":{},"overdosage":["OVERDOSAGE Signs and Symptoms Serious overdose with morphine is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold or 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 the institution of assisted or controlled ventilation. The narcotic antagonist naloxone is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to narcotics, including morphine. Therefore, an appropriate dose of nalovone (usual initial adult dose: 0.4 mg) should be administered, preferably by the intravenous route and simultaneously with efforts at respiratory resuscitation. Since the duration of action of morphine may exceed that of the antagonist, the patient should be kept under continued surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. 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. Gastric emptying may be useful in removing unabsorbed drug."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label L V T Lehigh Valley Technologies, Inc. NDC 64950-352-03 Morphine Sulfate Oral Solution (CONCENTRATE) 20 mg / mL Rx Only CII 30 mL Principal Display Panel - 30 mL Bottle Label"],"pediatric_use":["Pediatric Use Safety and effectiveness in pediatric patients have not been established."],"precautions":["PRECAUTIONS General Head Injury and Increased Intracranial Pressure The respiratory depressant effects of morphine and its capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of increased intracranial pressure. Furthermore, narcotics produce side effects that may obscure the clinical course of patients with head injuries. In such patients, morphine must be used with caution and only if it is deemed essential. Asthma and Other Respiratory Conditions Morphine should be used with caution in patients having an acute asthmatic attack, in those with chronic obstructive pulmonary disease or cor pulmonate, and in individuals with a substantially decreased respiratory reserve, 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 morphine may result in severe hypotension in an individual whose ability to maintain blood pressure has already been compromised by a depleted blood volume or concurrent administration of such drugs as the phenothiazines or certain anesthetics. Special-Risk Patients Morphine 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, hypothyroidism. Addison's disease, prostatic hypertrophy, or urethral stricture. Acute Abdominal Conditions The administration of morphine or other narcotics may obscure the diagnosis or clinical course in patients with acute abdominal conditions. Information for Patients Use in Ambulatory Patients Morphine 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. Morphine, like other narcotics, may produce orthostatic hypotension in ambulatory patients. Patients should be cautioned about the combined effects of alcohol or other central nervous system depressants with morphine. Drug Interactions Generally, effects of morphine may be potentiated by alkalizing agents and antagonized by acidifying agents. Analgesic effect of morphine is potentiated by chlorpromazine and methocarbamol. CNS depressants such as anesthetics, hypnotics, barbiturates, phenothiazines, chloral hydrate, glutethimide, sedatives, MAO inhibitors (including procarbazine hydrochloride), antihistamines, β-blockers (propranolol), alcohol, furazolidone and other narcotics may enhance the depressant effects of morphine. Morphine may increase anticoagulant activity of coumarin and other anticoagulants. Carcinogenicity/Mutagenicity Long-term studies to determine the carcinogenic and mutagenic potential of morphine are not available. Pregnancy Teratogenic Effects Category C Animal reproduction studies have not been conducted with morphine. It is also not known whether morphine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Morphine should be given to a pregnant woman only if clearly needed. Labor and Delivery Morphine readily crosses the placental barrier and if administered during labor, may lead to respiratory depression in the neonate. Nursing Mothers Morphine has been detected in human milk. For this reason, caution should be exercised when morphine is administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Clinical studies on this product did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of morphine sulfate immediate-release CONCENTRATED oral solution and observed closely."],"pregnancy":["Pregnancy Teratogenic Effects Category C Animal reproduction studies have not been conducted with morphine. It is also not known whether morphine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Morphine should be given to a pregnant woman only if clearly needed."],"set_id":"32b1da94-1317-4b4f-ba02-f8c5d0efc167","spl_product_data_elements":["Morphine Sulfate Morphine Sulfate Morphine Sulfate Morphine Citric Acid Monohydrate FD&C Red NO. 40 Saccharin Sodium Sodium Benzoate Sodium Citrate Sorbitol Water"],"spl_unclassified_section":["Rx Only","Mfg. by: Lehigh Valley Technologies Inc. Allentown, PA 18102 Rev. 3/10"],"storage_and_handling":["Keep this and all medication out of the reach of children. In case of accidental overdose, seek professional assistance or call a poison control center immediately. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F)[See USP Controlled Room Temperature]. Protect from light. For the 30 mL and 120 mL bottles dispense solution in original bottle with the provided calibrated dropper. For the 240 mL bottles dispense solution in original bottle with the provided calibrated spoon. Discard opened bottle after 90 days. DEA Order Form Required"],"teratogenic_effects":["Teratogenic Effects Category C Animal reproduction studies have not been conducted with morphine. It is also not known whether morphine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Morphine should be given to a pregnant woman only if clearly needed."],"version":"2","warnings":["WARNINGS Morphine can cause tolerance, psychological and physical dependence. Withdrawal will occur on abrupt discontinuation or administration of a narcotic antagonist. Interaction with Other Central-Nervous-System Depressants Morphine should be used with 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."]}