Methods: Consecutive strong opioid-naive patients with cancer pain were enrolled in a multicenter uncontrolled phase 4 clinical trial. Oral NRM was administered at 2 different dosages: 5 and 10 mg every 4 hours, respectively, for opioids-naive group A and nonopioids-naive group B patients as starting therapy.
Average daily dosages of NRM and opioid escalation index OEI were calculated and the reduction in pain score was tested through Student t test both in group A and in group B patients. Avoid use of partial agonists e. The severity of the withdrawal syndrome produced will depend on the degree of physical dependence and on the administered dose of the opioid antagonist.
Morphine tablets, capsules, oral solution, and solution for injection are contraindicated in patients with known or suspected GI obstruction, including paralytic ileus. Morphine suspension for injection is contraindicated in patients with paralytic ileus.
Due to the effects of opioid agonists on the gastrointestinal tract, all forms of morphine should be used cautiously in patients with GI disease including GI obstruction, ulcerative colitis, GI bleeding, or pre-existing constipation. Instruct patients not to pre-soak, lick, or otherwise wet Arymo extended-release tablets prior to placing in the mouth; tablets may become sticky leading to difficulty in swallowing, choking, gagging, regurgitation, and tablets stuck in the throat.
Patients should take 1 tablet at a time with enough water to ensure complete swallowing. Tablet stickiness and swelling may predispose patients to intestinal obstruction and diverticulitis exacerbation. Patients with underlying GI disorders such as esophageal cancer or colon cancer with a small gastrointestinal lumen are at a greater risk of developing these complications.
Consider use of an alternative analgesic in patients who have difficulty swallowing and patients at risk for underlying GI disorders resulting in small gastrointestinal lumen. Patients with ulcerative colitis UC or other inflammatory bowel disease may be more sensitive to the constipating effects of morphine.
Opioid agonists may obscure the diagnosis or clinical course in patients with an acute abdomen; morphine rectal suppositories are contraindicated for use in patients with known or suspected acute abdomen or surgical anastomosis.
Although opioid agonists are not desirable for use in patients with diarrhea secondary to poisoning or infectious diarrhea, antimotility agents have been used successfully in these patients. If possible, opioid agonists should not be given until the toxic substance has been eliminated. Morphine and other opioid agonists increase the tone and pressure in the biliary tract causing spasms especially in the sphincter of Oddi. Morphine should be used cautiously in patients with biliary tract disease or in patients undergoing biliary tract surgery; morphine suppositories are contraindicated for use after biliary tract surgery.
The biliary effects of morphine may result in increased plasma amylase and lipase concentrations of 2 to 15 times the normal values. Morphine should be used with extreme caution in patients with head trauma, a brain tumor, increased intracranial pressure ICP , convulsive disorders such as seizure disorders , or severe CNS depression; the use of morphine suppositories is specifically contraindicated in each of these conditions.
Additionally, morphine suspension for injection DepoDur is contraindicated in patients with head trauma or increased intracranial pressure ICP. Opioid agonists can compromise the evaluation of neurologic parameters. Rapid administration of high-dose opioid agonists may transiently elevate ICP and reduce cerebral perfusion pressures. These events are associated with opioid-induced lowering of mean arterial pressure, which stimulates a regulatory response to increase cerebral blood flow leading to increased ICP.
Opioid agonist-induced respiratory depression can produce cerebral hypoxia and raise cerebrospinal fluid CSF pressure. Monitor patients for signs of sedation and depressed respirations. Use caution in patients with a pre-existing seizure disorder or cerebral arteriosclerosis. Morphine can precipitate seizures, especially at high doses; monitor patients with a history of seizure disorders for worsened seizure control during therapy. Morphine and other opioid agonists produce cholinergic side effects by stimulating medullary vagal nuclei.
Bradycardia and induction of histamine release causing peripheral vasodilation may result. As such, the use of morphine injectable solution Astramorph is contraindicated in patients whose ability to maintain blood pressure has already been compromised by hypovolemia.
Extreme caution should be exercised when using other dosage forms in patients with hypovolemia or in those taking phenothiazines or general anesthetics, which may alter the capacity to sustain adequate pressures. Morphine suspension injection DepoDur is contraindicated in patients with circulatory shock; use of other morphine formulations should also be avoided.
Morphine suppositories are contraindicated in patients with cardiac arrhythmias or heart failure secondary to chronic lung disease, as bradycardia and vasodilation may aggravate these conditions. Use morphine with caution in patients with atrial flutter, atrial fibrillation, or other supraventricular tachycardias, as vagolytic action may produce significant increases in ventricular response rate.
Morphine should also be used cautiously in patients with cardiac disease, angina, or hypotension. Opioid agonists can induce vasovagal syncope or orthostatic hypotension; use caution in patients with pre-existing orthostatic hypotension. Morphine and other opioid agonists can cause urinary retention and oliguria, due to increasing the tension of the detrusor muscle. Patients more prone to these effects include those with bladder obstruction, prostatic hypertrophy, urethral stricture, pelvic malignancy, or renal disease.
Drug accumulation or prolonged duration of action can occur in patients with renal impairment or hepatic disease. In acute situations, patients require close monitoring to avoid excessive toxicity.
Patients with chronic liver or renal disease may require less frequent dosing intervals. Urinary retention may occur with single epidural or intrathecal morphine administration, or during the first several days of hospitalization for the initiation of continuous intrathecal or epidural morphine therapy.
Urinary retention may persist for 10 to 20 hours and occurs more frequently in male patients than females. Opioid agonists may be used in children with moderate to severe pain.
However, certain morphine dosage formulations or administration methods may not be appropriate for children; children also require close monitoring during opioid use. Neonates and infants younger than 6 months of age have highly variable clearance of opioid agonists.
Therefore, infants younger than 6 months of age may be given morphine but must be closely monitored for apnea until 24 hours after their last dose. Clinical practice guidelines suggest close monitoring of children up to 1 year of age. The safety and efficacy of epidural or intrathecal use of morphine in children, including the DepoDur product, have not been established.
The safety and efficacy of extended-release morphine formulations have not been established in pediatric patients younger than 18 years. Use morphine with caution in geriatric or debilitated patients. Geriatric or debilitated patients are more susceptible to adverse reactions, especially sedation and respiratory depression, probably as a result of the altered distribution of the drug or decreased elimination. Initial doses may need to be reduced, and doses should be carefully titrated, taking into account analgesic effects, adverse reactions, and concomitant conditions and drugs that may increase CNS depression and depress respiration.
If an opiate must be used, consider reducing the use of other CNS-active medications that increase the risk of falls and fractures and implement strategies to reduce fall risk. In patients receiving palliative care or hospice, the balance of benefits and harms of medication management may differ from those of the general population of older adults. OBRA cautions that opioids may cause constipation, nausea, vomiting, sedation, lethargy, weakness, confusion, dysphoria, physical and psychological dependency, hallucinations, and unintended respiratory depression, especially in individuals with compromised pulmonary function.
These adverse effects can lead to other consequences such as falls. The initiation of longer-acting opioids is not recommended unless shorter-acting opioids have been unsuccessful, or titration of shorter-acting doses has established a clear daily dose of opioid analgesic that can be provided by using a long-acting form.
Any patient receiving an opioid agonist should be warned about the possibility of sedation and to use caution when driving or operating machinery. Use of morphine oral dosage forms, suppositories, and solution for injection is contraindicated in patients who are receiving or have received MAOI therapy within the past 14 days. Manufacturers of other morphine dosage forms do not recommend the concurrent use of MAOIs or morphine use within 14 days of stopping such treatment.
Additive CNS depression, drowsiness, dizziness, or hypotension may occur. Use morphine with caution in patients with adrenal insufficiency i. Such patients may be at increased risk of adverse events. Opioids inhibit the secretion of adrenocorticotropic hormone ACTH , cortisol, and luteinizing hormone LH ; however, the thyroid stimulating hormone may be either stimulated or inhibited by opioids.
Rarely, adrenal insufficiency has been reported in association with opioid use. Patients should seek immediate medical attention if they experience symptoms such as nausea, vomiting, loss of appetite, fatigue, weakness, dizziness, or hypotension. If adrenocortical insufficiency is suspected, confirm with diagnostic testing as soon as possible. If diagnosed, the patient should be treated with physiologic replacement doses of corticosteroids, and if appropriate, weaned off of opioid therapy.
If the opioid can be discontinued, a follow-up assessment of adrenal function should be performed to determine if corticosteroid treatment can be discontinued. Other opioids may be tried; some cases reported use of a different opioid with no recurrence of adrenocortical insufficiency. It is unclear which, if any, opioids are more likely to cause adrenocortical insufficiency.
In addition, chronic opioid use may lead to symptoms of hypogonadism, resulting from changes in the hypothalamic-pituitary-gonadal axis. Monitor patients for symptoms of opioid-induced endocrinopathy, particularly those receiving a daily dose equivalent to mg or more of morphine. Patients presenting with signs or symptoms of androgen deficiency should undergo laboratory evaluation. Use morphine with caution in breast-feeding mothers because it can pass into breast milk.
The milk to plasma AUC ratio of morphine is approximately 2. In studies of epidural morphine given postcesarean section, morphine passage into colostrum and breast milk is minimal, while higher concentrations are found with intravenous or oral administration. Morphine passage into breast milk was assessed in a study of 5 women who were given a 7. Average IV morphine consumption in the first 48 hours was approximately mg. Average morphine consumption across the entire study period 96 hours was approximately mg IV and oral.
Previous American Academy of Pediatrics recommendations considered morphine usually compatible with breast-feeding, particularly in short-term post-partum use, due to a lack of data regarding symptoms in exposed infants. However, opioids may cause serious adverse effects in the infant, including drowsiness, CNS depression, and death. If morphine is used during breast-feeding, short durations and low doses are recommended with close infant monitoring.
If morphine is used long-term, the importance of continuing breast-feeding should be judged against the potential risk of adverse drug effects in the infant. Withdrawal symptoms may occur in infants whose mothers discontinue chronic opioid therapy. Advise the mother to report any excessive sleepiness, breathing difficulties, or difficulties breast-feeding to their health care provider immediately.
Other alternative analgesics considered to be usually compatible with breast-feeding include ibuprofen, acetaminophen, and fentanyl. Chronic opioid use may influence the hypothalamic-pituitary-gonadal axis, leading to hormonal changes that may manifest as hypogonadism gonadal suppression and pose a reproductive risk.
Although the exact causal role of opioids in the clinical manifestations of hypogonadism is unknown, patients could experience libido decrease, impotence, amenorrhea, or infertility. It is not known whether the effects on fertility are reversible. Monitor patients for symptoms of opioid-induced endocrinopathy. PDR Search. Required field. Your Name Your name is required. Recipient's Email Separate multiple email address with a comma Please enter valid email address Recipient's email is required.
Thank you. Your email has been sent. Jump to Section. Asthma, chronic obstructive pulmonary disease COPD , coadministration with other CNS depressants, coma, cor pulmonale, emphysema, hypoxemia, obesity, pulmonary disease, respiratory depression, respiratory insufficiency, scoliosis, sleep apnea, status asthmaticus. Anticoagulant therapy, coagulopathy, infection, intramuscular administration, intrathecal administration, intravenous administration, requires a specialized care setting, requires an experienced clinician, subcutaneous administration.
Accidental exposure, opioid-naive patients, potential for overdose or poisoning. Labor, neonatal opioid withdrawal syndrome, obstetric delivery, pregnancy. NOTE: FDA-approved labeling defines adult opioid-tolerant patients as those who take the following per day for a minimum of 1 week: oral morphine 60 mg or more; oral oxycodone 30 mg or more; oral hydromorphone 8 mg or more; oral oxymorphone 25 mg or more; 60 mg oral hydrocodone or more; transdermal fentanyl 25 mcg or more per hour; or another opioid at an equivalent dose.
For the management of chronic severe pain in patients who require daily, around-the-clock, long-term opioid treatment. NOTE: Reserve extended-release morphine for when alternative options e.
Discontinue all other around-the-clock opioids upon initiation. NOTE: Do not use the following morphine products in opioid-naive patients: 60 mg, 90 mg, or mg biphasic-release capsules Avinza ; mg, mg, mg, or mg extended-release capsules Kadian ; mg or mg controlled-release tablets MS Contin ; mg extended-release tablets Morphabond. In this population, use could result in fatal respiratory depression.
Use of a single dose of more than 60 mg, or a total daily dose more than mg, should be limited to opioid-tolerant patients. NOTE: FDA-approved labeling defines adult opioid-tolerant patients as those who take the following per day for a minimum of 1 week: oral morphine 60 mg or more; oral oxycodone 30 mg or more; oral hydromorphone 8 mg or more; oral oxymorphone 25 mg or more; oral hydrocodone 60 mg or more; transdermal fentanyl 25 mcg or more per hour; or another opioid at an equivalent dose.
Oral dosage [extended-release tablets MS Contin ] in pediatric patients. Oral dosage immediate-release tablets. Children and Adolescents weighing 50 kg or more. Children and Adolescents 2 to 17 years. Intermittent Intravenous, Intramuscular, or Subcutaneous dosage. Infants, Children, and Adolescents 6 months to 17 years. Infants, Children, and Adolescents. Children 7 years and older and Adolescents. Epidural dosage morphine sulfate injection. Intrathecal dosage morphine sulfate injection.
For the treatment of noninfectious diarrhea. Serious patient harm may occur with incorrect product selection. Adolescents and Children. Intravenous dosage. NOTE: Morphine should be administered as an inducing agent only by those trained in anesthesia. Adolescents, Children, and Infants. Oral dosage extended-release formulations. Oral dosage extended-release.
Oral Administration. Oral Solid Formulations. Oral Liquid Formulations. Extemporaneous Compounding-Oral.
Injectable Administration. Intravenous Administration. Intramuscular Administration. This medicine should also come with a Medication Guide and patient instructions.
Read and follow the instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions. Morphine extended-release capsules and extended-release tablets should only be used by patients who have already been taking narcotic pain medicines, also called opioids. These patients are called opioid-tolerant.
If you are uncertain whether or not you are opioid-tolerant, check with your doctor before using this medicine. Swallow the extended-release capsules and extended-release tablets whole.
Do not crush, break, dissolve, or chew them. Do not use extended-release tablets that are broken. If you cannot swallow the extended-release capsule, you may open it and pour the contents into a small amount of applesauce. Stir this mixture well and swallow it right away without chewing. Do not receive this medicine through a nasogastric tube.
While taking the extended-release tablet, part of the tablet may pass into your stool. This is normal and nothing to worry about. Morphine extended-release capsules or tablets work differently from the regular morphine oral solution or tablets, even at the same dose. Do not switch from one brand or form to the other unless your doctor tells you to. Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label.
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