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- Patient Information:
Details with Side Effects
Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day or an equianalgesic dose of another opioid, for a week or longer.
Limitations of Use
EXALGO is not for use
DOSAGE AND ADMINISTRATION
Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. Overestimating the EXALGO dose when converting patients from another opioid medication can result in fatal overdose with the first dose. Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with EXALGO [see WARNINGS AND PRECAUTIONS].
Consider the following factors when selecting an initial dose of EXALGO:
- Total daily dose and potency of the opioid the patient has been taking previously;
- Reliability of the relative potency estimate used to calculate the equivalent dose of hydromorphone needed (Note: potency estimates may vary with the route of administration);
- Patient's degree of opioid experience and opioid tolerance;
- General condition and medical status of the patient;
- Concurrent medication;
- Type and severity of the patient's pain.
EXALGO is administered at a frequency of once daily (every 24 hours), approximately the same time every day, with or without food.
To avoid medication errors, prescribers and pharmacists must be aware that hydromorphone is available as both immediate-release 8 mg tablets and extended-release 8 mg tablets.
Discontinue or taper all other extended-release opioids when beginning EXALGO therapy. As EXALGO is only for use in opioid-tolerant patients, do not begin any patient on EXALGO as the first opioid.
Conversion from Other Oral Hydromorphone Formulations to EXALGO
Patients receiving oral immediate-release hydromorphone may be converted to EXALGO by administering a starting dose equivalent to the patient's total daily oral hydromorphone dose, taken once daily.
Conversion from Oral Opioids to EXALGO
While there are useful tables of oral and parenteral equivalents, there is substantial inter-patient variation in the relative potency of different opioid drugs and formulations. Specific recommendations of equianalgesic doses are not available because of a lack of systematic evidence for these types of analgesic substitutions. Published relative potency data are available, but such ratios are approximations. As such, it is safer to underestimate a patient's 24-hour oral hydromorphone requirement and provide rescue medication (e.g. immediate-release hydromorphone) than to overestimate and manage an adverse reaction.
The following table was used in a clinical trial of EXALGO. The recommended starting dose of EXALGO is 50% of the calculated estimate of daily hydromorphone requirement. Calculate the estimated daily hydromorphone requirement using Table 1.
- The conversion ratios in this Table 1 are only to be used for the conversion from current oral opioid therapy to EXALGO. Do not use this table to convert patients from EXALGO to another opioid. Doing so may result in fatal overdose.
- For patients on a single opioid, sum the total daily dose of the opioid and then multiply the total daily dose by the conversion ratio to calculate the approximate oral hydromorphone equivalent.
- For patients on a regimen of mixed opioids, calculate the approximate oral hydromorphone dose for each opioid and sum the totals.
- For patients on a regimen of fixed-ratio opioid/non-opioid analgesic medications, only the opioid component of these medications should be used in the conversion.
- It is extremely important to monitor all patients closely when converting from methadone to other opioid agonists. The ratio between methadone and other opioid agonists may vary widely as a function of previous dose exposure. Methadone has a long half-life and tends to accumulate in the plasma.
- Monitor patients for signs or symptoms of opioid withdrawal when converting patients to EXALGO.
Example conversion from a single opioid to EXALGO:
Step 1: Sum the total daily dose of the opioid
- 30 mg of oxycodone twice daily equals a total daily dose of 60 mg of oxycodone
Step 2: Calculate the approximately equivalent dose of oral hydromorphone based on the total daily dose of the opioid
- Multiply the 60 mg total daily dose of oxycodone by the conversion factor of 0.4 for a result of 24 mg of oral hydromorphone
Step 3: Calculate the starting dose of EXALGO, which is 50% of the calculated oral hydromorphone dose
- 50% of 24 mg results in an initial dose of 12 mg of EXALGO once daily
- Adjust individually for each patient
Table 1: Conversion Ratios
|Previous Opioid||Approximate Equivalent Oral Dose||Approximate Oral Conversion Ratio|
|* The conversion ratios and
approximate equivalent doses in this conversion table are only to be used for
the conversion from current opioid therapy to EXALGO.
† It is extremely important to monitor all patients closely when converting from methadone to other opioid agonists. The ratio between methadone and other opioid agonists may vary widely as a function of previous dose exposure. Methadone has a long half-life and tends to accumulate in the plasma.
Conversion from Transdermal Fentanyl to EXALGO
Eighteen hours following the removal of the transdermal fentanyl patch, EXALGO treatment can be initiated. For each 25 mcg/hr fentanyl transdermal dose, the equianalgesic dose of EXALGO is 12 mg every 24 hours. An appropriate starting dose of EXALGO is 50% of the calculated total daily dose every 24 hours.
Titration and Maintenance of Therapy
Individually titrate EXALGO to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving EXALGO to assess the maintenance of pain control and the relative incidence of adverse reactions. During chronic therapy, especially for non-cancer-related pain (or pain associated with other terminal illnesses), periodically reassess the continued need for the use of opioid analgesics.
If the level of pain increases, attempt to identify the source of increased pain, while adjusting the EXALGO dose to decrease the level of pain. Plasma levels of EXALGO are sustained for 18 to 24 hours. Dosage adjustments may be made every 3 to 4 days. Patients who experience breakthrough pain may require dosage adjustment or rescue medication.
If signs of excessive opioid-related adverse reactions are observed, the next dose may be reduced. Adjust the dose to obtain an appropriate balance between management of pain and opioid-related adverse reactions.
Discontinuation of EXALGO
When a patient no longer requires therapy with EXALGO, taper doses gradually, by 25% to 50% every 2 or 3 days down to a dose of 8 mg before discontinuation of therapy, to prevent signs and symptoms of withdrawal in the opioid-tolerant patient.
To dispose of unused EXALGO flush all remaining tablets down the toilet or remit to authorities at a certified drug take-back program.
Start patients with moderate hepatic impairment on 25% of the EXALGO dose that would be prescribed for patients with normal hepatic function. Closely monitor patients with moderate hepatic impairment for respiratory and central nervous system depression during initiation of therapy with EXALGO and during dose titration. Use of alternate analgesics is recommended for patients with severe hepatic impairment [see Use in Specific Populations].
Start patients with moderate renal impairment on 50% and patients with severe renal impairment on 25% of the EXALGO dose that would be prescribed for patients with normal renal function. Closely monitor patients with renal impairment for respiratory and central nervous system depression during initiation of therapy with EXALGO and during dose titration. As EXALGO is only intended for once daily administration, consider use of an alternate analgesic that may permit more flexibility with the dosing interval in patients with severe renal impairment [see Use In Specific Populations].
Administration of EXALGO
Instruct patients to swallow EXALGO tablets intact. The tablets are not to be crushed, dissolved, or chewed due to the risk of rapid release and absorption of a potentially fatal dose of hydromorphone [see WARNINGS AND PRECAUTIONS].
Dosage Forms And Strengths
EXALGO is available 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 one side. The 12 mg tablets are round, biconvex, dark yellow tablets imprinted with “EXH 12” on one side. The 16 mg tablets are round, biconvex, yellow tablets imprinted with “EXH 16” on one side. The 32 mg tablets are round, biconvex, white tablets imprinted with “EXH 32” on one side.
Storage And Handling
EXALGO Tablet Strengths
|Strength||Color||Tablet Description||Bottle Count||NDC|
|8 mg||Red||Round, biconvex, printed with “EXH 8”||100||23635-408-01|
|12 mg||Dark yellow||Round, biconvex, printed with “EXH 12”||100||23635-412-01|
|16 mg||Yellow||Round, biconvex, printed with “EXH 16”||100||23635-416-01|
|32 mg||White||Round, biconvex, printed with “EXH 32”||100||23635-432-01|
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Distributed by: Mallinckrodt Brand Pharmaceuticals, Inc. Hazelwood, MO 63042 USA. Revised: 03/2013
Last reviewed on RxList: 3/27/2013
This monograph has been modified to include the generic and brand name in many instances.
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