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Label: EXALGO- hydromorphone hydrochloride tablet, extended release DailyMed is not really displaying pill images from RxImage. For more information, simply click here.
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING
RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; and NEONATAL OPIOID WITHDRAWAL SYNDROME
Addiction, Abuse, and Misuse
EXALGO exposes patients along with users towards the risks of opioid addiction, abuse, and misuse, be a catalyst for overdose and death. Assess each patients risk just before prescribing EXALGO, and monitor all patients regularly to add mass to these behaviors or conditions see Warnings and Precautions 5.1.
Serious, life-threatening, or fatal respiratory depression may occur with utilization of EXALGO. Monitor for respiratory depression, especially during initiation of EXALGO or carrying out a dose increase. Instruct patients to swallow EXALGO tablets whole; crushing, chewing, or dissolving EXALGO tablets could cause rapid release and absorption of an potentially fatal dose of hydromorphone see Warnings and Precautions 5.2.
Accidental ingestion of even one dose of EXALGO, especially by children, may result in a fatal overdose of hydromorphone see Warnings and Precautions 5.2.
Prolonged usage of EXALGO during pregnancy can lead to neonatal opioid withdrawal syndrome, which might be life-threatening in any other case recognized and treated, as well as management in line with protocols created by neonatology experts. If opioid use is essential for a prolonged period within a pregnant woman, advise the individual of the chance neonatal opioid withdrawal syndrome and make certain that appropriate treatment is going to be available see Warnings and Precautions 5.3.
These highlights don't include the information needed to use EXALGO safely and effectively.
See full prescribing information for EXALGO.
EXALGO hydromorphone HCl extended-release tablets,
EXALGO exposes users to perils associated with addiction, abuse, and misuse, be a catalyst for overdose and death. Assess each patients risk before prescribing, and monitor regularly for growth and development of these behaviors or conditions. 5.1
Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or after a dose increase. Instruct patients to swallow EXALGO tablets whole in order to avoid exposure to a potentially terminal dose of hydromorphone. 5.2
Accidental ingestion of EXALGO, specially in children, can lead to fatal overdose of hydromorphone. 5.2
Prolonged by using EXALGO during pregnancy could lead to neonatal opioid withdrawal syndrome, which can be life-threatening or even recognized and treated. If opioid use is necessary for a prolonged period in a very pregnant woman, advise the affected person of the probability of neonatal opioid withdrawal syndrome make certain that appropriate treatment are going to be available 5.3.
EXALGO is undoubtedly an opioid agonist indicated in opioid-tolerant patients with the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment as well as which complementary healthcare options are inadequate. 1
Patients considered opioid tolerant are the types who are taking, for starters week or longer, at the least 60 mg oral morphine on a daily basis, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day or perhaps an equianalgesic dose of some other opioid. 1
Because of the perils associated with addiction, abuse, and misuse with opioids, even at recommended doses, and because from the greater perils associated with overdose and death with extended-release opioid formulations, reserve EXALGO in order to use in patients for whom complementary medicine options, non-opioid analgesics or immediate-release opioids are ineffective, not tolerated, or could be otherwise inadequate to supply sufficient treatments for pain.
EXALGO will not be indicated for an as-needed prn analgesic.
For once daily administration 2.1
Instruct patients to swallow EXALGO tablets intact. 2.6
To become EXALGO from another opioid, use available conversion factors to have estimated dose. 2.1
Dose could possibly be increased using increments of four years old to 8 mg every three to four days as was required to achieve adequate analgesia. 2.2
Extended-release tablets: 8 mg, 12 mg, 16 mg, 32 mg 3
Known hypersensitivity to the components including hydromorphone hydrochloride and sulfites 4, 5.10
Interactions with CNS depressants: Concomitant use could potentially cause profound sedation, respiratory depression, and death. If coadministration becomes necessary, consider dose lowering of one or both drugs on account of additive pharmacological effects. 5.4
Elderly, cachectic, debilitated patients and the ones with chronic pulmonary disease: Monitor closely due to increased risk for life-threatening respiratory depression. 5.5, 5.6
Hypotensive effect: Monitor during dose initiation and titration 5.7
Patients with head injury or increased intracranial pressure: Monitor for sedation and respiratory depression. Avoid usage of EXALGO in patients with impaired consciousness or coma prone to intracranial outcomes of CO 2 retention. 5.8
Most common side effects 10% are: constipation, nausea, vomiting, somnolence, headache, and dizziness 6.1.
To report SUSPECTED ADVERSE REACTIONS, contact Mallinckrodt at 1-800-778-7898 or FDA at 1-800-FDA-1088 or /medwatch.
Mixed agonist/antagonist and partial agonist opioid analgesics: Avoid use with EXALGO given that they may reduce analgesic effect of EXALGO or precipitate withdrawal symptoms. 5.12, 7.2
Monoamine oxidase inhibitors MAOIs: Avoid by using EXALGO in patients taking MAOIs or within a fortnight of stopping such treatment. 7.3
Pregnancy: EXALGO is just not recommended. Based on animal data, could potentially cause fetal harm. 8.1
Nursing mothers: EXALGO will not be recommended. Hydromorphone may be detected in human milk. Closely monitor infants of nursing women receiving EXALGO. 8.3
Hepatic or renal impairment: Administer the lowest dose of EXALGO in patients with moderate hepatic 8.6 and moderate renal impairment 8.7. Consider using an alternate analgesic in patients with severe hepatic 8.6 and renal impairment. 8.7
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Sections or subsections omitted from your full prescribing information usually are not listed.
EXALGO is indicated for that management of pain in opioid-tolerant patients severe enough to require daily, around-the-clock, long-term opioid treatment along with which complementary medicine options are inadequate.
Patients considered opioid tolerant are the type who are getting, for example week or longer, at the very least 60 mg oral morphine every day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day or perhaps an equianalgesic dose of one other opioid.
To avoid medication errors, prescribers and pharmacists should be aware that hydromorphone is accessible as both immediate-release 8 mg tablets and extended-release 8 mg tablets.
EXALGO ought to be prescribed only by healthcare professionals that are knowledgeable in the by using potent opioids for that management of chronic pain.
Due for the risk of respiratory depression, EXALGO is simply indicated to be used in patients who're already opioid-tolerant. Discontinue or taper all the extended-release opioids when beginning EXALGO therapy. As EXALGO is only to be used in opioid-tolerant patients, don't begin any patient on EXALGO since the first opioid.
Patients considered opioid-tolerant are the type who are taking a minimum of 60 mg of morphine daily, or a minimum of 30 mg of oral oxycodone daily, or at the least 8 mg of oral hydromorphone daily or even an equianalgesic dose of some other opioid for any week or longer.
Initiate the dosing regimen for every single patient individually, looking at the patients prior analgesic treatment experience and risk factors for addiction, abuse, and misuse see Warnings and Precautions 5.1. Monitor patients closely for respiratory depression, especially in the first 24 to 72 hours of initiating therapy with EXALGO see Warnings and Precautions 5.2.
EXALGO tablets has to be taken whole. Crushing, chewing, or dissolving EXALGO extended-release tablets can lead to uncontrolled delivery of hydromorphone and will lead to overdose or death see Warnings and Precautions 5.2.
Patients receiving oral immediate-release hydromorphone could possibly be converted to EXALGO by administering a starting dose equivalent on the patients total daily oral hydromorphone dose, taken once daily.
Discontinue other around-the-clock opioid drugs when EXALGO remedies are initiated.
While you'll find useful tables of opioid equivalents easily available, there's substantial inter-patient variability inside relative potency of various opioid drugs and products. As such, it can be safer to underestimate a patients 24-hour oral hydromorphone requirements and offer rescue medication, immediate-release opioid rather than to overestimate the 24-hour oral hydromorphone requirements, that may result in complications.
In an EXALGO medical study with an open-label titration period, patients were converted off their prior opioid to EXALGO while using Table 1 as being a guide with the initial EXALGO dose. The recommended starting dose of EXALGO is 50% in the calculated estimate of daily hydromorphone requirement. Calculate the estimated daily hydromorphone requirement using Table 1.
This isn't a table of equianalgesic doses.
The conversion factors in this particular table are only to the conversion from one on the listed oral opioid analgesics to EXALGO.
The table are not used to convert from EXALGO completely to another opioid. Doing so can result in an overestimation in the dose from the new opioid and may lead to fatal overdose.
For patients for a passing fancy opioid, sum the latest total daily dose in the opioid and after that multiply the overall daily dose through the conversion step to calculate the approximate oral hydromorphone daily dose.
For patients over a regimen of over one opioid, calculate the approximate oral hydromorphone dose for every opioid and sum the totals for getting the approximate total hydromorphone daily dose.
For patients using a regimen of fixed-ratio opioid/non-opioid analgesic products, just use the opioid portion of these products from the conversion.
Always around the dose down, if required, for the appropriate EXALGO strengths available.
60 mg total daily dose of oxycodone x Conversion Factor of 0.4 24 mg of oral hydromorphone daily
Step 3: Calculate the approximate starting dose of EXALGO obtain every twenty four hours, which can be 50% from the calculated oral hydromorphone dose. Round down, as appropriate, on the appropriate EXALGO tablet strengths available.
Close observation and frequent titration are warranted until pain management is stable about the new opioid. Monitor patients for symptoms of opioid withdrawal or signs of over-sedation/toxicity after converting patients to EXALGO.
Eighteen hours pursuing the removal from the transdermal fentanyl patch, EXALGO treatment is usually initiated. To calculate the 24-hour EXALGO dose, make use of a conversion factor of 25 mcg/hr fentanyl transdermal patch to 12 mg of EXALGO. Then slow up the EXALGO dose by 50%.
Step 1: Identify the dose of transdermal fentanyl.
Step 2: Use the conversion factor of 25 mcg/hr fentanyl transdermal patch to 12 mg of EXALGO.
Step 3: Calculate the approximate starting dose of EXALGO obtain every twenty four hours, that is 50% in the converted dose. Round down, when necessary, to your appropriate EXALGO tablet strengths available.
50% of 36 mg leads to an initial dose of 18 mg, which can be rounded into
Close monitoring is of particular importance when converting from methadone for some other opioid agonists. The ratio between methadone and also other opioid agonists are different widely as being a function of previous dose exposure. Methadone includes a long half-life which enable it to accumulate within the plasma.
Individually titrate EXALGO to some dose that gives adequate analgesia and minimizes complications. Continually reevaluate patients receiving EXALGO to evaluate the maintenance of pain control as well as the relative incidence of complications, and also monitoring to add mass to addiction, abuse, or misuse. Frequent communication is very important among the prescriber, other members from the healthcare team, the sufferer, as well as the caregiver/family in times of changing analgesic requirements, including initial titration. During chronic therapy, periodically reassess the continued desire for opioid analgesics.
Plasma degrees of EXALGO are sustained for 18 to twenty four hours. Dosage adjustments of EXALGO can be made in increments of four to 8 mg every three to four days as required to achieve adequate analgesia.
Patients who experience breakthrough pain might require a dose increase of EXALGO, or may require rescue medication having an appropriate dose of your immediate-release analgesic. If the amount of pain increases after dose stabilization, try and identify the foundation of increased pain before improving the EXALGO dose.
If unacceptable opioid-related negative effects are observed, the next doses can be reduced. Adjust the dose to have an appropriate balance between therapy for pain and opioid-related side effects.
When someone no longer requires therapy with EXALGO, taper doses gradually, by 25% to 50% every 2 or 3 days down with a dose of 8 mg before discontinuation of therapy, to prevent signs of withdrawal from the opioid-tolerant patient.
To get rid of unused EXALGO flush all remaining tablets along the toilet or remit to authorities with a certified drug take-back program.
Start patients with moderate hepatic impairment on 25% on the EXALGO dose that could be prescribed for patients with normal hepatic function. Closely monitor patients with moderate hepatic impairment for respiratory and neurological system depression during initiation of therapy with EXALGO and during dose titration. Use of alternate analgesics is mandatory for patients with severe hepatic impairment see Use in Specific Populations 8.6.
Start patients with moderate renal impairment on 50% and patients with severe renal impairment on 25% on the EXALGO dose that can be prescribed for patients with normal renal function. Closely monitor patients with renal impairment for respiratory and nerves depression during initiation of therapy with EXALGO and during dose titration. As EXALGO is intended for once daily administration, consider usage of an alternate analgesic which will permit more flexibility with all the dosing interval in patients with severe renal impairment see Use in Specific Populations 8.7.
Instruct patients to swallow EXALGO tablets intact. The tablets usually are not to be crushed, dissolved, or chewed due on the risk of rapid release and absorption of an potentially fatal dose of hydromorphone see Warnings and Precautions 5.2.
EXALGO extended-release tablets come in 8 mg, 12 mg, 16 mg or 32 mg dosage strengths. The 8 mg tablets are round, biconvex, red tablets imprinted with EXH 8 on the one hand. The 12 mg tablets are round, biconvex, dark yellow tablets imprinted with EXH 12 on the one hand. The 16 mg tablets are round, biconvex, yellow tablets imprinted with EXH 16 on the other hand. The 32 mg tablets are round, biconvex, white tablets imprinted with EXH 32 on the other hand.
Opioid non-tolerant patients. Fatal respiratory depression could appear in patients who're not opioid tolerant.
Patients who've had surgical procedures and/or underlying disease producing narrowing with the gastrointestinal tract, or have blind loops on the gastrointestinal tract or gastrointestinal obstruction.
Patients with hypersensitivity, anaphylaxis to hydromorphone or sulfite-containing medications see Warnings and Precautions 5.10
EXALGO contains hydromorphone, a Schedule II controlled substance. As an opioid, EXALGO exposes users for the risks of addiction, abuse, and misuse see Drug Abuse and Dependence 9. As modified-release products for instance EXALGO provide you with the opioid over a protracted period of time, there's a and the higher chances for overdose and death due for the larger level of hydromorphone present.
Although the chance addiction in different individual is unknown, it can happens to patients appropriately prescribed EXALGO along with those who get the drug illicitly. Addiction can take place at recommended doses in case the drug is misused or abused.
Assess each patients risk for opioid addiction, abuse, or misuse before prescribing EXALGO, and monitor all patients receiving EXALGO to build up these behaviors or conditions. Risks are increased in patients having a personal or ancestors and family history of alcohol abuse including drug or alcoholism or abuse or mental illness, major depression. The potential for these risks shouldn't, however, steer clear of the prescribing of EXALGO for your proper control over pain in different given patient. Patients at increased risk can be prescribed modified-release opioid formulations for example EXALGO, but easy use in such patients necessitates intensive counseling concerning the risks and proper usage of EXALGO as well as intensive monitoring for indications of addiction, abuse, and misuse.
Abuse or misuse of EXALGO by crushing, chewing, snorting, or injecting the dissolved product will result inside the uncontrolled delivery of hydromorphone and may result in overdose and death see Overdosage 10.
Opioid agonists like EXALGO are sought by drug abusers and individuals with addiction disorders and they are subject to criminal diversion. Consider these risks when prescribing or dispensing EXALGO. Strategies to reduce these risks include prescribing the drug within the smallest appropriate quantity and advising the affected person on the proper disposal of unused drug see Patient Counseling Information 17. Contact local state professional licensing board or state controlled substances authority for information on how to counteract and detect abuse or diversion of the product.
Serious, life-threatening, or fatal respiratory depression has become reported with the utilization of modified-release opioids, regardless of whether used as recommended. Respiratory depression from opioid use, or else immediately recognized and treated, may bring about respiratory arrest and death. Management of respiratory depression might include close observation, supportive measures, and utilization of opioid antagonists, depending within the patients clinical status see Overdosage 10. Carbon dioxide CO 2 retention from opioid-induced respiratory depression can exacerbate the sedating outcomes of opioids.
While serious, life-threatening, or fatal respiratory depression can take place at any time during the utilization of EXALGO, danger is greatest throughout the initiation of therapy or using a dose increase. Closely monitor patients for respiratory depression when initiating therapy with EXALGO and following dose increases.
To reduce the likelihood of respiratory depression, proper dosing and titration of EXALGO are crucial see Dosage and Administration 2. Overestimating the EXALGO dose when converting patients from another opioid product may lead to fatal overdose while using first dose.
Accidental ingestion of even one dose of EXALGO, especially by children, can lead to respiratory depression and death as a result of an overdose of hydromorphone.
Prolonged usage of EXALGO during pregnancy may lead to withdrawal signs within the neonate. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in grown-ups, might be life-threatening or even recognized and treated, as well as management based on protocols produced by neonatology experts. If opioid use is necessary for a prolonged period within a pregnant woman, advise the person of the probability of neonatal opioid withdrawal syndrome make certain that appropriate treatment will probably be available.
Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to realize weight. The onset, duration, and seriousness of neonatal opioid withdrawal syndrome vary based about the specific opioid used, length of use, timing and level of last maternal use, and rate of elimination from the drug through the newborn.
Hypotension, profound sedation, coma, respiratory depression, and death may result if EXALGO is needed concomitantly with alcohol or other neurological system CNS depressants, sedatives, anxiolytics, hypnotics, neuroleptics, other opioids.
When considering the usage of EXALGO within a patient having a CNS depressant, measure the duration of usage of the CNS depressant as well as the patients response, such as the degree of tolerance containing developed to CNS depression. Additionally, look at the patients using alcohol or illicit drugs that creates CNS depression. If the decision to start EXALGO is produced, focus on one third to a single half the calculated starting dose, monitor patients for indications of sedation and respiratory depression, and get one of these lower dose on the concomitant CNS depressant see Drug Interactions 7.1.
Life-threatening respiratory depression is a bit more likely to exist in elderly, cachectic, or debilitated patients since they may have altered pharmacokinetics or altered clearance in comparison to younger, healthier patients. Monitor such patients closely, in particular when initiating and titrating EXALGO when EXALGO has concomitantly for some other drugs that depress respiration see Warnings and Precautions 5.2.
Monitor patients with significant chronic obstructive pulmonary disease or cor pulmonale, and patients developing a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression for respiratory depression, particularly if initiating therapy and titrating with EXALGO, just as these patients, even usual therapeutic doses of EXALGO may decrease respiratory drive on the point of apnea see Warnings and Precautions 5.2. Consider the utilization of alternative non-opioid analgesics over these patients if you can.
EXALGO could potentially cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is undoubtedly an increased risk in patients whose power to maintain high blood pressure has already been compromised by a lower blood volume or concurrent administration of certain CNS depressant drugs phenothiazines or general anesthetics see Drug Interactions 7.1. Monitor these patients for symptoms of hypotension after initiating or titrating the dose of EXALGO.
Monitor patients taking EXALGO who can be susceptible towards the intracranial outcomes of CO 2 retention, people with evidence of increased intracranial pressure or brain tumors for signs and symptoms of sedation and respiratory depression, specially when initiating therapy with EXALGO. EXALGO may reduce respiratory drive, as well as the resultant CO 2 retention can further increase intracranial pressure. Opioids can also obscure the clinical course inside a patient that has a head injury. Avoid the using EXALGO in patients with impaired consciousness or coma.
EXALGO is contraindicated in patients with paralytic ileus. Avoid the utilization of EXALGO in patients along with other GI obstruction.
Because the EXALGO tablet is nondeformable and appreciably difference in shape from the GI tract, EXALGO is contraindicated in patients with preexisting severe gastrointestinal narrowing pathologic or iatrogenic, for instance: esophageal motility disorders, small bowel inflammatory disease, short gut syndrome caused by adhesions or decreased transit time, past record of peritonitis, cystic fibrosis, chronic intestinal pseudoobstruction, or Meckels diverticulum. There have been reports of obstructive symptoms in patients with known strictures or likelihood of strictures, including previous GI surgery, in association together with the ingestion of medicine in nondeformable extended-release formulations.
It may be possible that EXALGO tablets might be visible on abdominal x-rays under certain situations, specially when digital enhancing techniques are used.
The hydromorphone in EXALGO might cause spasm with the sphincter of Oddi. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.
EXALGO contains sodium metabisulfite, a sulfite that could cause allergic-type reactions including anaphylactic symptoms and life-threatening or more gentle asthmatic episodes in some susceptible people. The overall prevalence of sulfite sensitivity from the general human population are unknown and doubtless low. Sulfite sensitivity is viewed more frequently in asthmatic in comparison to nonasthmatic people.
The hydromorphone in EXALGO may aggravate convulsions in patients with convulsive disorders, and will induce or aggravate seizures in a few clinical settings. Monitor patients using a history of seizure disorders for worsened seizure control during EXALGO therapy.
Avoid the utilization of mixed agonist/antagonist, pentazocine, nalbuphine, and butorphanol or partial agonist buprenorphine analgesics in patients that have received or are experiencing a course of therapy using a full opioid agonist analgesic, including EXALGO. In these patients, mixed agonist/antagonist and partial agonist analgesics may slow up the analgesic effect and/or may precipitate withdrawal symptoms see Drug Interactions 7.2.
When discontinuing EXALGO, gradually taper the dose see Dosage and Administration 2.3. Do not abruptly discontinue EXALGO.
EXALGO may impair the mental and/or physical abilities required to perform potentially hazardous activities for instance driving a car or operating machinery. Warn patients never to drive or operate dangerous machinery unless these are tolerant on the effects of EXALGO and discover how they will react to your medication.
Addiction, Abuse, and Misuse see Warnings and Precautions 5.1
Life Threatening Respiratory Depression see Warnings and Precautions 5.2
Neonatal Opioid Withdrawal Syndrome see Warnings and Precautions 5.3
Interactions with Other CNS Depressants see Warnings and Precautions 5.4
Hypotensive Effect see Warnings and Precautions 5.7
Gastrointestinal Effects see Warnings and Precautions 5.9
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed inside clinical trials of the drug can not be directly in comparison with rates from the clinical trials of one other drug and might not reflect the rates noticed in clinical practice.
EXALGO was administered with a total of 2, 524 patients in 15 controlled and uncontrolled scientific studies. Of these, 423 patients were encountered with EXALGO for higher than 6 months and 141 exposed for over one year.
The most common effects leading to study discontinuation were nausea, vomiting, constipation, somnolence, and dizziness. The most popular treatment-related serious negative effects from controlled and uncontrolled chronic pain studies were drug withdrawal syndrome, overdose, confusional state, and constipation.
The overall incidence of negative effects in patients over 65 years old was higher, that has a greater than 5% difference in rates for constipation and nausea in comparison with younger patients. The overall incidence of effects in female patients was higher, using a greater than 5% difference in rates for nausea, vomiting, constipation and somnolence in comparison to male patients.