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Purdue Pharma Lp Drugs

Hysingla Er

Hysingla Er

2.1 Initial Dosing

HYSINGLA ER should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.

Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experienceand risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.1)]. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with HYSINGLA ER [see Warnings and Precautions (5.2)].

HYSINGLA ER is administered orally once daily (every 24 hours).

HYSINGLA ER tablets must be taken whole, one tablet at a time, with enough water to ensure complete swallowing immediately after placing in the mouth [see Patient Counseling Information (17)]. Crushing, chewing, or dissolving HYSINGLA ER tablets will result in uncontrolled delivery of hydrocodone and can lead to overdose or death [see Warnings and Precautions (5.1)].

Use of HYSINGLA ER as the First Opioid Analgesic Initiate therapy with HYSINGLA ER 20 mg orally every 24 hours.

Use of HYSINGLA ER in Patients who are not Opioid Tolerant The starting dose for patients who are not opioid tolerant is HYSINGLA ER 20 mg orally every 24 hours. Opioid tolerant patients are those receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, or an equianalgesic dose of another opioid.

Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression [see Warnings and Precautions (5.2)].

Daily doses of HYSINGLA ER greater than or equal to 80 mg are only for use in opioid tolerant patients.

Conversion from Oral Hydrocodone Formulations to HYSINGLA ER Patients receiving other oral hydrocodone-containing formulations may be converted to HYSINGLA ER by administering the patient's total daily oral hydrocodone dose as HYSINGLA ER once daily.

Conversion from Other Oral Opioids to HYSINGLA ER Discontinue all other around-the-clock opioid drugs when HYSINGLA ER therapy is initiated.

Although tables of oral and parenteral equivalents are readily available, there is substantial inter-patient variability in the relative potency of different opioid drugs and formulations. As such, it is preferable to underestimate a patient’s 24-hour oral hydrocodone requirements and provide rescue medication (e.g., immediate-release opioid) than to overestimate the 24-hour oral hydrocodone requirements and manage an adverse reaction.

To obtain the initial HYSINGLA ER dose, first use Table 1 to convert the prior oral opioids to a total hydrocodone daily dose and then reduce the calculated daily hydrocodone dose by 25% to account for interpatient variability in relative potency of different opioids.

Consider the following when using the information found in Table 1.
This is not a table of equianalgesic doses. The conversion factors in this table are only for the conversion from one of the listed oral opioid analgesics to HYSINGLA ER. The table cannot be used to convert from HYSINGLA ER to another opioid. Doing so will result in an over-estimation of the dose of the new opioid and may result in fatal overdose Table 1. Conversion factors to HYSINGLA ER (Not Equianalgesic Doses) Opioid Oral dose (mg) Approximate oral conversion factor Codeine 133 0.15 Hydromorphone 5 4 Methadone 13.3 1.5 Morphine 40 0.5 Oxycodone 20 1 Oxymorphone 10 2 Tramadol 200 0.1
To calculate the estimated total hydrocodone daily dose using Table 1:
For patients on a single opioid, sum the current total daily dose of the opioid and then multiply the total daily dose by the approximate oral conversion factor to calculate the approximate oral hydrocodone daily dose. For patients on a regimen of more than one opioid, calculate the approximate oral hydrocodone dose for each opioid and sum the totals to obtain the approximate oral hydrocodone daily dose. For patients on a regimen of fixed-ratio opioid/non-opioid analgesic products, use only the opioid component of these products in the conversion. Reduce the calculated daily oral hydrocodone dose by 25%
Always round the dose down, if necessary, to the nearest HYSINGLA ER tablet strength available and initiate therapy with that dose. If the converted HYSINGLA ER dose using Table 1 is less than 20 mg, initiate therapy with HYSINGLA ER 20 mg.

Example conversion from a single opioid to HYSINGLA ER:For example, a total daily dose of oxycodone 50 mg would be converted to hydrocodone 50 mg based on the table above, and then multiplied by 0.75 (ie, take a 25 % reduction) resulting in a dose of 37.5 mg hydrocodone. Round this down to the nearest dose strength available, HYSINGLA ER 30 mg, to initiate therapy.

Close observation and frequent titration are warranted until pain management is stable on the new opioid. Monitor patients for signs and symptoms of opioid withdrawal or for signs of over-sedation/toxicity after converting patients to HYSINGLA ER.

The dose of HYSINGLA ER can be gradually adjusted every three to five days, using increments of 10 to 20 mg, until adequate pain relief and acceptable tolerability have been achieved.

Conversion from Methadone to HYSINGLA ER Close monitoring is of particular importance 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 can accumulate in the plasma.

Conversion from Transdermal Fentanyl to HYSINGLA ER Eighteen hours following the removal of the transdermal fentanyl patch, HYSINGLA ER treatment can be initiated. For each 25 mcg/hr fentanyl transdermal patch, a dose of HYSINGLA ER 20 mg every 24 hours represents a conservative initial dose. Follow the patient closely during conversion from transdermal fentanyl to HYSINGLA ER, as there is limited experience with this conversion.

Conversion from Transdermal Buprenorphine to HYSINGLA ER All patients receiving transdermal buprenorphine (≤ 20 mcg/hr) should initiate therapy with HYSINGLA ER 20 mg every 24 hours. Follow the patient closely during conversion from transdermal buprenorphine to HYSINGLA ER, as there is limited experience with this conversion.

2.2 Titration and Maintenance of Therapy

Individually titrate HYSINGLA ER to a dose that provides adequate analgesia and minimizes adverse reactions. Continually re-evaluate patients receiving HYSINGLA ER to assess the maintenance of pain control and the relative incidence of adverse reactions as well as monitoring for the development of addiction, abuse, or misuse. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. During chronic therapy, periodically reassess the continued need for the use of opioid analgesics.

Adjust the dose of HYSINGLA ER in increments of 10 mg to 20 mg every 3 to 5 days as needed to achieve adequate analgesia.

Patients who experience breakthrough pain may require a dose increase of HYSINGLA ER, or may need rescue medication with an appropriate dose of an immediate-release analgesic. If the level of pain increases after dose stabilization, attempt to identify the source of increased pain before increasing the HYSINGLA ER dose.

If unacceptable opioid-related adverse reactions are observed, the next daily dose may be reduced. Adjust the dose to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

2.3 Administration of HYSINGLA ER

HYSINGLA ER is administered once daily (every 24 hours).

HYSINGLA ER must be taken whole, one tablet at a time, with enough water to ensure complete swallowing immediately after placing in the mouth [see Patient Counseling Information (17)].

Crushing, chewing, or dissolving HYSINGLA ER tablets will result in uncontrolled delivery of hydrocodone and can lead to overdose or death [see Warnings and Precautions (5.1)].

Multiple tablets of lower dose strengths that provide the desired total daily dose can be taken as a once daily dose.

2.4 Patients with Hepatic Impairment

Patients with severe hepatic impairment may have higher plasma concentrations than those with normal function. Initiate therapy with ½ the initial dose of HYSINGLA ER in these patients and monitor closely for respiratory depression and sedation [see Clinical Pharmacology (12.3)].

2.5 Patients with Renal Impairment

Patients with moderate to severe renal impairment and end-stage renal disease may have higher plasma concentrations than those with normal function. Initiate therapy with ½ the initial dose of HYSINGLA ER in these patients and monitor closely for respiratory depression and sedation [see Clinical Pharmacology (12.3)].

2.6 Discontinuation of HYSINGLA ER

Do not abruptly discontinue HYSINGLA ER. When the patient no longer requires opioid therapy, use a gradual downward titration of the dose to prevent signs and symptoms of withdrawal in the physically dependent patient. The dose may be reduced every 2-4 days. The next dose should be at least 50% of the prior dose. After reaching HYSINGLA ER 20 mg dose for 2-4 days, HYSINGLA ER can be discontinued.
Dilaudid

Dilaudid

2.1 General Dosing Considerations

Take care when prescribing and administering Dilaudid and Dilaudid-HP Injection to avoid dosing errors due to confusion between the different concentrations and between mg and mL, which could result in accidental overdose and death. Take care to ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total volume of the dose.

Selection of patients and administration of Dilaudid and Dilaudid-HP injection should be governed by the same principles that apply to the use of similar opioid analgesics to treat patients with acute or chronic pain, and depends upon a comprehensive assessment of the patient. Individualize treatment in every case, using non-opioid analgesics, opioids on an as-needed basis and/or combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality, and the American Pain Society.

The nature of the pain (severity, frequency, etiology, and pathophysiology), as well as the medical status of the patient, will affect selection of the starting dosage. Opioid analgesics, including DILAUDID INJECTION and DILAUDID-HP INJECTION, have a narrow therapeutic index in certain patient populations, especially when combined with CNS depressant drugs, and should be reserved for cases where the benefits of opioid analgesia outweigh the known risks.

2.2 Individualization of Dosing

Initiate the dosing regimen for each patient individually, taking into account the patient’s prior analgesic treatment. Give attention to the following:
the age, general condition, and medical status of the patient; the patient's degree of opioid tolerance; the daily dose, potency, and specific characteristics of the opioid the patient has been taking previously; concurrent medications the type and severity of the patient’s pain risk factors for abuse or addiction; including whether the patient has a previous or current substance abuse problem, a family history of substance abuse, or a history of mental illness or depression; the balance between pain control and adverse reactions.
Periodic reassessment after the initial dosing of DILAUDID INJECTION and DILAUDID-HP INJECTION is required. If pain management is not satisfactory, and opioid-induced adverse events are tolerable, the hydromorphone dose may be increased gradually. If excessive opioid side effects are observed early in the dosing interval, reduce the hydromorphone hydrochloride dose. If this results in breakthrough pain at the end of the dosing interval, the dosing interval may need to be shortened. Dose titration should be guided more by the need for analgesia and the severity of adverse events than the absolute dose of opioid employed.

2.3 Initiation of Therapy in Opioid-Naïve Patients

Always initiate dosing in opioid-naïve patients using Dilaudid Injection. Never administer Dilaudid-HP injection to opioid-naïve patients.

2.3.1 Subcutaneous or Intramuscular Administration

The usual starting dose of Dilaudid Injection is 1 mg to 2 mg every 2 to 3 hours as necessary. Depending on the clinical situation, the initial starting dose may be lowered in patients who are opioid naïve. Adjust the dose according to the severity of pain, the severity of adverse events, as well as the patient's underlying disease and age.

2.3.2 Intravenous Administration

The initial starting dose is 0.2 to 1 mg every 2 to 3 hours. Intravenous administration should be given slowly, over at least 2 to 3 minutes, depending on the dose. Titrate the dose to achieve acceptable analgesia and tolerable adverse events. The initial dose should be reduced in the elderly or debilitated and may be lowered to 0.2 mg.

2.3.3 Hepatic Impairment

Start patients with hepatic impairment on one-fourth to one-half the usual DILAUDID INJECTION starting dose depending on the extent of impairment [see CLINICAL PHARMACOLOGY, Pharmacokinetics (12.2)].

2.3.4 Renal Impairment

Start patients with renal impairment on one-fourth to one-half the usual DILAUDID INJECTION starting dose depending on the degree of impairment [see CLINICAL PHARMACOLOGY, Pharmacokinetics (12.2)].

2.4 Conversion From Prior Opioid

Use the equianalgesic dose table below (Table 1) as a guide to determine the appropriate dose of DILAUDID INJECTION. Convert the current total daily amount(s) of opioid(s) received to an equivalent total daily dose of DILAUDID INJECTION and reduce by one-half due to the possibility of incomplete cross tolerance. Divide the new total amount by the number of doses permitted based on dosing interval (e.g., 8 doses for every-three-hour dosing). Titrate the dose according to the patient's response. For opioids not in Table 1, first estimate the daily amount of morphine that is equivalent to the current total daily amount of other opioid(s) received, then use Table 1 to find the approximate equivalent total daily dose of DILAUDID INJECTION.
Table 1. OPIOID ANALGESIC EQUIVALENTS WITH APPROXIMATELY EQUIANALGESIC POTENCY FOR CONVERSION TO DILAUDID INJECTION* DRUG SUBSTANCE PARENTERAL DOSE ORAL DOSE * Dosages, and ranges of dosages represented, are a compilation of estimated equipotent dosages from published references comparing opioid analgesics in cancer and severe pain. Morphine sulfate 10 mg 40 – 60 mg Hydromorphone HCl 1.3 – 2 mg 6.5 – 7.5 mg Oxymorphone HCl 1 – 1.1 mg 6.6 mg Levorphanol tartrate 2 – 2.3 mg 4 mg Meperidine HCl (Pethidine HCl) 75 – 100 mg 300 – 400 mg Methadone HCl 10 mg 10 – 20 mg Nalbuphine HCl 10 – 12 mg – Butorphanol tartrate 1.5 – 2.5 mg –
2.5 DILAUDID-HP Injection (for use in opioid-tolerant patients only)

Do not use DILAUDID-HP for patients who are not tolerant to the respiratory depressant or sedating effects of opioids. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/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 one week or longer.

Use DILAUDID-HP ONLY for patients who require the higher concentration and lower total volume of DILAUDID-HP.

Because of its high concentration, the delivery of precise doses of DILAUDID-HP INJECTION may be difficult if low doses of hydromorphone are required. Therefore, use DILAUDID-HP INJECTION only if the amount of hydromorphone required can be delivered accurately with this formulation.

Base the starting dose for DILAUDID-HP INJECTION on the prior dose of DILAUDID INJECTION or on the prior dose of an alternate opioid as described above in Section 2.4 Conversion From Prior Opioid and Table 1.

2.6 Administration and Reconstitution

Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. A slight yellowish discoloration may develop in DILAUDID INJECTION and DILAUDID-HP INJECTION ampules. No loss of potency has been demonstrated. DILAUDID INJECTION and DILAUDID-HP INJECTION are physically compatible and chemically stable for at least 24 hours at 25°C, protected from light in most common large-volume parenteral solutions.

500 mg/50 mL Vial To use this single dose presentation, do not penetrate the stopper with a syringe. Instead, remove both the aluminum flipseal and rubber stopper in a suitable work area such as under a laminar flow hood (or equivalent clean air compounding area). The contents may then be withdrawn for preparation of a single, large-volume parenteral solution. Discard any unused portion in an appropriate manner.

Reconstitution of Sterile Lyophilized DILAUDID-HP INJECTION 250 mg Reconstitute immediately prior to use with 25 mL of Sterile Water for Injection USP to provide a sterile solution containing 10 mg/mL of hydromorphone hydrochloride.
Dilaudid

Dilaudid

Dilaudid Oral Liquid

The usual adult oral dosage of DILAUDID ORAL LIQUID is one-half (2.5 mL) to two teaspoonfuls (10 mL) (2.5 mg - 10 mg) every 3 to 6 hours as directed by the clinical situation. Oral dosages higher than the usual dosages may be required in some patients.

Dilaudid Tablets

The usual starting dose for DILAUDID tablets is 2 mg to 4 mg, orally, every 4 to 6 hours. Appropriate use of the DILAUDID TABLETS must be decided by careful evaluation of each clinical situation.

A gradual increase in dose may be required if analgesia is inadequate, as tolerance develops, or if pain severity increases. The first sign of tolerance is usually a reduced duration of effect. Patients with hepatic and renal impairment should be started on a lower starting dose (See CLINICAL PHARMACOLOGY - Pharmacokinetics and Metabolism).
Montelukast Sodium

Montelukast Sodium

2.1 Important Administration Instructions

Intermezzo is to be taken in bed when a patient wakes in the middle of the night and has difficulty returning to sleep. Intermezzo should only be taken if the patient has at least 4 hours of bedtime remaining before the planned time of waking [see Warnings and Precautions (5.1)].

Intermezzo should be placed under the tongue and allowed to disintegrate completely before swallowing. The tablet should not be swallowed whole. For optimal effect, Intermezzo should not be administered with or immediately after a meal. The tablet should be removed from the pouch just prior to dosing.

2.2 Basic Dosing Information

The recommended and maximum dose of Intermezzo is 1.75 mg for women and 3.5 mg for men, taken only once per night as needed if a middle-of-the-night awakening is followed by difficulty returning to sleep. The recommended doses for women and men are different because women clear zolpidem from the body at a lower rate than men[see Use in Specific Populations (8.6)].

2.3 Use with CNS Depressants

The recommended Intermezzo dose for men and women who are taking concomitant CNS depressants is 1.75 mg. Dose adjustment of concomitant CNS depressants may be necessary when co-administered with Intermezzo because of potentially additive effects. The use of Intermezzo with other sedative-hypnotics (including other zolpidem products) at bedtime or the middle of the night is not recommended [see Warnings and Precautions (5.1)].

2.4 Use in Geriatric Patients

Geriatric patients may be especially sensitive to the effects of zolpidem. The recommended dose of Intermezzo in men and women over 65 years old is 1.75 mg, taken only once per night if needed [see Use in Specific Populations (8.5)].

2.5 Use in Patients with Hepatic Impairment

The recommended dose of Intermezzo in patients with hepatic impairment is 1.75 mg, taken only once per night if needed [see Clinical Pharmacology (12.3)].
Oxycontin

Oxycontin

2.1 Important Dosage and Administration Instructions

OXYCONTIN should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.
Initiate the dosing regimen for each patient individually, taking into account the patient's 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 within the first 24-72 hours of initiating OXYCONTIN therapy [see Warnings and Precautions (5.2)]. Must take OXYCONTIN tablets whole, with enough water to ensure complete swallowing immediately after placing in the mouth. Must take OXYCONTIN tablets one tablet at a time and must not pre-soak, lick or otherwise wet the tablet prior to placing in the mouth [see Warnings and Precautions (5.9)]. Cutting, breaking, crushing, chewing, or dissolving OXYCONTIN tablets will result in uncontrolled delivery of oxycodone and can lead to overdose or death. [see Warnings and Precautions (5.1)]. OXYCONTIN 60 mg and 80 mg tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are only for use in patients in whom tolerance to an opioid of comparable potency has been established.
2.2 Initial Dosage in Adults who are not Opioid-Tolerant

The starting dosage for patients who are not opioid tolerant is OXYCONTIN 10 mg orally every 12 hours. Adult patients who are opioid tolerant are those receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, or an equianalgesic dose of another opioid.

Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression [see Warnings and Precautions (5.2)].

2.3 Conversion from Opioids to OXYCONTIN in Adults

Conversion from Other Oral Oxycodone Formulations to OXYCONTIN If switching from other oral oxycodone formulations to OXYCONTIN, administer one half of the patient's total daily oral oxycodone dose as OXYCONTIN every 12 hours

Conversion from other Opioids to OXYCONTIN There are no established conversion ratios for conversion from other opioids to OXYCONTIN defined by clinical trials. Discontinue all other around-the-clock opioid drugs when OXYCONTIN therapy is initiated and initiate dosing using OXYCONTIN 10 mg orally every 12 hours.

It is safer to underestimate a patient’s 24-hour oral oxycodone requirements and provide rescue medication (e.g., immediate-release opioid) than to overestimate the 24-hour oral oxycodone requirements which could result in adverse reactions. While useful tables of opioid equivalents are readily available, there is substantial inter-patient variability in the relative potency of different opioids.

Conversion from Methadone to OXYCONTIN Close monitoring is of particular importance 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 can accumulate in the plasma.

Conversion from Transdermal Fentanyl to OXYCONTIN If switching from transdermal fentanyl patch to OXYCONTIN, ensure that the patch has been removed for at least 18 hours prior to starting OXYCONTIN. Although there has been no systematic assessment of such conversion, start with a conservative conversion: substitute 10 mg of OXYCONTIN every 12 hours for each 25 mcg per hour fentanyl transdermal patch. Follow the patient closely during conversion from transdermal fentanyl to OXYCONTIN, as there is limited documented experience with this conversion.

2.4 Initial Dosage in Pediatric Patients 11 Years and Older

The following dosing information is for use only in pediatric patients 11 years and older already receiving and tolerating opioids for at least five consecutive days. For the two days immediately preceding dosing with OXYCONTIN, patients must be taking a minimum of 20 mg per day of oxycodone or its equivalent. OXYCONTIN is not appropriate for use in pediatric patients requiring less than a 20 mg total daily dose. Table 1, based on clinical trial experience, displays the conversion factor when switching pediatric patients 11 years and older (under the conditions described above) from opioids to OXYCONTIN.

Discontinue all other around-the-clock opioid drugs when OXYCONTIN therapy is initiated.

Although tables of oral and parenteral equivalents are readily available, there is substantial inter-patient variability in the relative potency of different opioid drugs and formulations. As such, it is preferable to underestimate a patient’s 24-hour oral oxycodone requirements and provide rescue medication (e.g., immediate-release opioid) than to overestimate the 24-hour oral oxycodone requirements and manage an adverse reaction.

Consider the following when using the information in Table 1.
This is not a table of equianalgesic doses. The conversion factors in this table are only for the conversion from one of the listed oral opioid analgesics to OXYCONTIN. The table cannot be used to convert from OXYCONTIN to another opioid. Doing so will result in an over-estimation of the dose of the new opioid and may result in fatal overdose. The formula for conversion from prior opioids, including oral oxycodone, to the daily dose of OXYCONTIN is mg per day of prior opioid x factor = mg per day of OXYCONTIN. Divide the calculated total daily dose by 2 to get the every-12-hour OXYCONTIN dose. If rounding is necessary, always round the dose down to the nearest OXYCONTIN tablet strength available. Table 1: Conversion Factors When Switching Pediatric Patients 11 Years and Older to OXYCONTIN *For patients receiving high-dose parenteral opioids, a more conservative conversion is warranted. For example, for high-dose parenteral morphine, use 1.5 instead of 3 as a multiplication factor. Prior Opioid Conversion Factor Oral Parenteral* Oxycodone 1 -- Hydrocodone 0.9 -- Hydromorphone 4 20 Morphine 0.5 3 Tramadol 0.17 0.2
Step #1: To calculate the estimated total OXYCONTIN daily dose using Table 1:
For pediatric patients taking a single opioid, sum the current total daily dosage of the opioid and then multiply the total daily dosage by the approximate conversion factor to calculate the approximate OXYCONTIN daily dosage. For pediatric patients on a regimen of more than one opioid, calculate the approximate oxycodone dose for each opioid and sum the totals to obtain the approximate OXYCONTIN daily dosage. For pediatric patients on a regimen of fixed-ratio opioid/non-opioid analgesic products, use only the opioid component of these products in the conversion.
Step #2: If rounding is necessary, always round the dosage down to the nearest OXYCONTIN tablet strength available and initiate OXYCONTIN therapy with that dose. If the calculated OXYCONTIN total daily dosage is less than 20 mg, there is no safe strength for conversion and do not initiate OXYCONTIN.

Example conversion from a single opioid (e.g., hydrocodone) to OXYCONTIN: Using the conversion factor of 0.9 for oral hydrocodone in Table 1, a total daily hydrocodone dosage of 50 mg is converted to 45 mg of oxycodone per day or 22.5 mg of OXYCONTIN every 12 hours. After rounding down to the nearest strength available, the recommended OXYCONTIN starting dosage is 20 mg every 12 hours.

Step #3: Close observation and titration are warranted until pain management is stable on the new opioid. Monitor patients for signs and symptoms of opioid withdrawal or for signs of over-sedation/toxicity after converting patients to OXYCONTIN. See Dosage and Administration (2.5) for important instructions on titration and maintenance of therapy.

There is limited experience with conversion from transdermal fentanyl to OXYCONTIN in pediatric patients 11 years and older. If switching from transdermal fentanyl patch to OXYCONTIN, ensure that the patch has been removed for at least 18 hours prior to starting OXYCONTIN. Although there has been no systematic assessment of such conversion, start with a conservative conversion: substitute 10 mg of OXYCONTIN every 12 hours for each 25 mcg per hour fentanyl transdermal patch. Follow the patient closely during conversion from transdermal fentanyl to OXYCONTIN.

If using asymmetric dosing, instruct patients to take the higher dose in the morning and the lower dose in the evening

2.5 Titration and Maintenance of Therapy in Adults and Pediatric Patients 11 Years and Older

Individually titrate OXYCONTIN to a dosage that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving OXYCONTIN to assess the maintenance of pain control, signs and symptoms of opioid withdrawal, and adverse reactions, as well as monitoring for the development of addiction, abuse and misuse. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. During chronic therapy, periodically reassess the continued need for the use of opioid analgesics.

Patients who experience breakthrough pain may require a dosage increase of OXYCONTIN or may need rescue medication with an appropriate dose of an immediate-release analgesic. If the level of pain increases after dose stabilization, attempt to identify the source of increased pain before increasing the OXYCONTIN dosage. Because steady-state plasma concentrations are approximated in 1 day, OXYCONTIN dosage may be adjusted every 1 to 2 days. If unacceptable opioid-related adverse reactions are observed, the subsequent dose may be reduced. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

There are no well-controlled clinical studies evaluating the safety and efficacy with dosing more frequently than every 12 hours. As a guideline for pediatric patients 11 years and older, the total daily oxycodone dosage usually can be increased by 25% of the current total daily dosage. As a guideline for adults, the total daily oxycodone dosage usually can be increased by 25% to 50% of the current total daily dosage, each time an increase is clinically indicated.

2.6 Dosage Modifications with Concomitant Use of Central Nervous System Depressants

If the patient is currently taking a central nervous system (CNS) depressant and the decision is made to begin OXYCONTIN, start with 1/3 to 1/2 the recommended starting dosage of OXYCONTIN and monitor patients for signs of respiratory depression, sedation, and hypotension [see Warnings and Precautions (5.4), Drug Interactions (7.1)].

2.7 Dosage Modifications in Geriatric Patients who are Debilitated and not Opioid-Tolerant

For geriatric patients who are debilitated and not opioid tolerant, start dosing patients at 1/3 to 1/2 the recommended starting dosage and titrate the dosage cautiously [see Use in Specific Populations (8.5)].

2.8 Dosage Modifications in Patients with Hepatic Impairment

For patients with hepatic impairment, start dosing patients at 1/3 to 1/2 the recommended starting dosage followed by careful dosage titration [see Clinical Pharmacology (12.3)].

2.9 Discontinuation of OXYCONTIN

When the patient no longer requires therapy with OXYCONTIN, gradually titrate the dosage downward to prevent signs and symptoms of withdrawal in the physically dependent patient. Do not abruptly discontinue OXYCONTIN.
Ms Contin

Ms Contin

2.1 Initial Dosing

MS CONTIN should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.

Initiate the dosing regimen for each patient individually, taking into account the patient's 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 within the first 24-72 hours of initiating therapy with MS CONTIN [see Warnings and Precautions (5.2)].

MS CONTIN tablets must be taken whole. Crushing, chewing, or dissolving MS CONTIN tablets will result in uncontrolled delivery of morphine and can lead to overdose or death [see Warnings and Precautions (5.1)].

Use of MS CONTIN as the First Opioid Analgesic

Initiate treatment with MS CONTIN with 15 mg tablets orally every 8 or 12 hours.

Use of MS CONTIN in Patients who are not Opioid Tolerant

The starting dose for patients who are not opioid tolerant is MS CONTIN 15 mg orally every 12 hours. Patients who are opioid tolerant are those receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, or an equianalgesic dose of another opioid.

Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression.

Conversion from Other Oral Morphine to MS CONTIN

Patients receiving other oral morphine formulations may be converted to MS CONTIN by administering one-half of the patient's 24-hour requirement as MS CONTIN on an every-12-hour schedule or by administering one-third of the patient's daily requirement as MS CONTIN on an every-8-hour schedule.

Conversion from Other Opioids to MS CONTIN

There are no established conversion ratios for conversion from other opioids to MS CONTIN defined by clinical trials. Discontinue all other around-the-clock opioid drugs when MS CONTIN therapy is initiated and initiate dosing using MS CONTIN 15 mg orally every 8 to 12 hours.

It is safer to underestimate a patient’s 24-hour oral morphine requirements and provide rescue medication (e.g., immediate-release morphine) than to overestimate the 24-hour oral morphine requirements and manage an adverse reaction. While useful tables of opioid equivalents are readily available, there is substantial inter-patient variability in the relative potency of different opioid drugs and products.

Conversion from Parenteral Morphine or Other Opioids (Parenteral or Oral) to MS CONTIN

When converting from parenteral morphine or other non-morphine opioids (parenteral or oral) to MS CONTIN, consider the following general points:
Parenteral to oral morphine ratio: Between 2 to 6 mg of oral morphine may be required to provide analgesia equivalent to 1 mg of parenteral morphine. Typically, a dose of morphine that is approximately three times the previous daily parenteral morphine requirement is sufficient. Other parenteral or oral non-morphine opioids to oral morphine sulfate: Specific recommendations 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. In general, begin with half of the estimated daily morphine requirement as the initial dose, managing inadequate analgesia by supplementation with immediate-release morphine.
Conversion from Methadone to MS CONTIN

Close monitoring is of particular importance when converting 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 can accumulate in the plasma.

2.2 Titration and Maintenance of Therapy

Individually titrate MS CONTIN to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving MS CONTIN to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. During chronic therapy periodically reassess the continued need for the use of opioid analgesics.

Patients who experience breakthrough pain may require a dose increase of MS CONTIN, or may need rescue medication with an appropriate dose of an immediate-release analgesic. If the level of pain increases after dose stabilization, attempt to identify the source of increased pain before increasing the MS CONTIN dose. Because steady-state plasma concentrations are approximated in 1 day, MS CONTIN dosage adjustments may be done every 1 to 2 days.

If unacceptable opioid-related adverse reactions are observed, the subsequent doses may be reduced. Adjust the dose to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

2.3 Discontinuation of MS CONTIN

When the patient no longer requires therapy with MS CONTIN tablets, use a gradual downward titration of the dose to prevent signs and symptoms of withdrawal in the physically-dependent patient. Do not abruptly discontinue MS CONTIN.

2.4 Administration of MS CONTIN

MS CONTIN tablets must be taken whole. Crushing, chewing, or dissolving MS CONTIN tablets will result in uncontrolled delivery of morphine and can lead to overdose or death [see Warnings and Precautions (5.1)].
Butrans

Butrans

2.1 Initial Dosing

BUTRANS should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.

BUTRANS doses of 7.5, 10, 15, and 20 mcg/hour are for opioid-experienced patients only.

Initiate the dosing regimen for each patient individually; take into account the patient's 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 within the first 24-72 hours of initiating therapy with BUTRANS [see Warnings and Precautions (5.2)].

BUTRANS is for transdermal use (on intact skin) only. Each BUTRANS patch is intended to be worn for 7 days.

Instruct patients not to use BUTRANS if the pouch seal is broken or the patch is cut, damaged, or changed in any way and not to cut BUTRANS.

Use of BUTRANS as the First Opioid Analgesic Initiate treatment with BUTRANS with a 5 mcg/hour patch.

Conversion from Other Opioids to BUTRANS Discontinue all other around-the-clock opioid drugs when BUTRANS therapy is initiated.

There is a potential for buprenorphine to precipitate withdrawal in patients who are already on opioids.

Prior Total Daily Dose of Opioid Less than 30 mg of Oral Morphine Equivalents per Day: Initiate treatment with BUTRANS 5 mcg/hour at the next dosing interval (see Table 1 below, middle column).

Prior Total Daily Dose of Opioid Between 30 mg to 80 mg of Oral Morphine Equivalents per Day: Taper the patient’s current around-the-clock opioids for up to 7 days to no more than 30 mg of morphine or equivalent per day before beginning treatment with BUTRANS. Then initiate treatment with BUTRANS 10 mcg/hour at the next dosing interval (see Table 1 below, right column). Patients may use short-acting analgesics as needed until analgesic efficacy with BUTRANS is attained.

Prior Total Daily Dose of Opioid Greater than 80 mg of Oral Morphine Equivalents per Day: BUTRANS 20 mcg/hour may not provide adequate analgesia for patients requiring greater than 80 mg/day oral morphine equivalents. Consider the use of an alternate analgesic.

Table 1: Initial BUTRANS Dose
Previous Opioid Analgesic Daily Dose (Oral Morphine Equivalent) <30 mg 30-80 mg Recommended BUTRANS Starting Dose 5 mcg/hour 10 mcg/hour
Conversion from Methadone to BUTRANS Close monitoring is of particular importance 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 can accumulate in the plasma.

2.2 Titration and Maintenance of Therapy

Individually titrate BUTRANS to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving BUTRANS to assess the maintenance of pain control and the relative incidence of adverse reactions, and monitor for the development of addiction, abuse, or misuse. Frequent communication is important among the prescriber, other members of healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. During chronic therapy, periodically reassess the continued need for opioid analgesics.

The minimum BUTRANS titration interval is 72 hours, based on the pharmacokinetic profile and time to reach steady state levels [see Clinical Pharmacology (12.3)].

The maximum BUTRANS dose is 20 mcg/hour. Do not exceed a dose of one 20 mcg/hour BUTRANS system due to the risk of QTc interval prolongation. In a clinical trial, BUTRANS 40 mcg/hour (given as two BUTRANS 20 mcg/hour systems) resulted in prolongation of the QTc interval [see Warnings and Precautions (5.7) and Clinical Pharmacology (12.2)].

If the level of pain increases, attempt to identify the source of increased pain, while adjusting the BUTRANS dose to decrease the level of pain. Because steady-state plasma concentrations are achieved within 72 hours, BUTRANS dosage may be adjusted every 3 days. Dose adjustments may be made in 5 mcg/hour, 7.5 mcg/hour, or 10 mcg/hour increments by using no more than two patches of the 5 mcg/hour, 7.5 mcg/hour, or 10 mcg/hour system(s). The total dose from both patches should not exceed 20 mcg/hour. For the use of two patches, patients should be instructed to remove their current patch, and apply the two new patches at the same time, adjacent to one another at a different application site [see Dosage and Administration (2.5)].

Patients who experience breakthrough pain may require dosage adjustment increase of BUTRANS, or may need rescue medication with an appropriate dose of an immediate-release analgesic. If the level of pain increases after dose stabilization, attempt to identify the source of increased pain before increasing the BUTRANS dose.

If unacceptable opioid-related adverse reactions are observed, the subsequent doses may be reduced. Adjust the dose to obtain an appropriate balance between the management of pain and opioid-related adverse reactions.

2.3 Cessation of Therapy

When the patient no longer requires therapy with BUTRANS, use a gradual downward titration of the dose every 7 days to prevent signs and symptoms of withdrawal in the physically dependent patient; consider introduction of an appropriate immediate-release opioid medication. Do not abruptly discontinue BUTRANS.

2.4 Patients with Hepatic Impairment

BUTRANS has not been evaluated in patients with severe hepatic impairment. As BUTRANS is only intended for 7-day application, consider use of an alternate analgesic that may permit more flexibility with the dosing in patients with severe hepatic impairment [see Warnings and Precautions (5.10), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)].

2.5 Administration of BUTRANS

Instruct patients to apply immediately after removal from the individually sealed pouch. Instruct patients not to use BUTRANS if the pouch seal is broken or the patch is cut, damaged, or changed in any way. See the Instructions for Use for step-by-step instructions for applying BUTRANS.

Apply BUTRANS to the upper outer arm, upper chest, upper back or the side of the chest. These 4 sites (each present on both sides of the body) provide 8 possible application sites. Rotate BUTRANS among the 8 described skin sites. After BUTRANS removal, wait a minimum of 21 days before reapplying to the same skin site [see Clinical Pharmacology (12.3)].

Apply BUTRANS to a hairless or nearly hairless skin site. If none are available, the hair at the site should be clipped, not shaven. Do not apply BUTRANS to irritated skin. If the application site must be cleaned, clean the site with water only. Do not use soaps, alcohol, oils, lotions, or abrasive devices. Allow the skin to dry before applying BUTRANS.

Incidental exposure of the BUTRANS patch to water, such as while bathing or showering is acceptable based on experience during clinical studies.

If problems with adhesion of BUTRANS occur, the edges may be taped with first aid tape. If problems with lack of adhesion continue, the patch may be covered with waterproof or semipermeable adhesive dressings suitable for 7 days of wear.

If BUTRANS falls off during the 7-day dosing interval, dispose of the transdermal system properly and place a new BUTRANS patch on at a different skin site.

When changing the system, instruct patients to remove BUTRANS and dispose of it properly [see Dosage and Administration (2.6)].

If the buprenorphine-containing adhesive matrix accidentally contacts the skin, instruct patients or caregivers to wash the area with water and not to use soap, alcohol, or other solvents to remove the adhesive because they may enhance the absorption of the drug.

2.6 Disposal Instructions

Patients should refer to the Instructions for Use for proper disposal of BUTRANS. Dispose of used and unused patches by following the instructions on the Patch-Disposal Unit that is packaged with the BUTRANS patches.

Alternatively, patients can dispose of used patches by folding the adhesive side of the patch to itself, then flushing the patch down the toilet immediately upon removal. Unused patches should be removed from their pouches, the protective liners removed, the patches folded so that the adhesive side of the patch adheres to itself, and immediately flushed down the toilet.

Patients should dispose of any patches remaining from a prescription as soon as they are no longer needed.

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