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DOLOPHINE
Addiction/dependence
Narcotic analgesics
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Drug Name:

DOLOPHINE CII

Generic Name and Formulations:
Methadone HCl 5mg, 10mg; scored tabs.

Company:
Roxane Laboratories, Inc.

Therapeutic Use:

Indications for DOLOPHINE:

Detoxification treatment of opioid addiction (heroin or other morphine-like drugs). For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.

Adult:

See full labeling. Particular vigilance is necessary during treatment initiation, during conversion from one opioid to another, and during dose titration. Peak respiratory depressant effects typically occur later, and persist longer than peak analgesic effects. Induction/initial dosing: 20–30mg, an additional 5–10mg may be given if withdrawal symptoms not suppressed. Total daily dose on first day of treatment: max 40mg. Adjust dose cautiously. Short-term detoxification: titrate to total daily dose of 40mg in divided doses, continue for 2–3 days, then gradually decrease dose. Maintenance treatment: titrate to dose at which opioid symptoms are prevented for 24hrs, drug hunger/craving is reduced, euphoric effects are blocked/attenuated, and patient is tolerant to sedative effects; usual range: 80–120mg/day. Medically supervised withdrawal after a period of maintenance treatment: dose reduction should be <10% of maintenance dose, 10–14 day intervals should elapse between dose reductions.

Children:

<18yrs: not established.

Pharmacological Class:

Opioid.

Contraindications:

Significant respiratory depression. Acute or severe bronchial asthma (in the absence of resuscitative equipment or in unmonitored settings). Known or suspected paralytic ileus.

Warnings/Precautions:

May only be dispensed by opioid treatment programs certified by the Substance Abuse and Mental Health Services Administration and approved by designated state authority. Increased risk of fatal respiratory depression (esp. when initiating therapy and during dose increases); monitor. Abuse potential (monitor routinely). Accidental exposure may result in fatal overdose (esp. children). Life-threatening QT prolongation. Risk of neonatal opioid withdrawal syndrome. Deaths, cardiac and respiratory, have been reported during initiation and conversion of pain patients to methadone from other opioids. A high degree of opioid tolerance does not eliminate the possibility of overdose, iatrogenic or otherwise. Pulmonary disease (eg, COPD, cor pulmonale); monitor for respiratory depression (esp. within the first 24–72hrs of initiating therapy and after dose increases); consider alternative non-opioid analgesics. Head injury. Impaired consciousness, coma, GI obstruction; avoid. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. Severe volume depletion. Cardiac hypertrophy, concomitant diuretic use, hypokalemia, hypomagnesemia: increased risk of QT prolongation; monitor cardiovascular status. Impaired renal or hepatic function. Acute pancreatitis. Biliary tract disease. Avoid abrupt cessation. Elderly. Cachectic. Debilitated. Pregnancy (Cat.C). Labor and delivery, nursing mothers: not recommended.

Interactions:

Avoid mixed agonist/antagonist opioids (eg, butorphanol, nalbuphine, pentazocine) or partial agonist (eg, buprenorphine); may reduce effects and precipitate withdrawal symptoms. Increased CNS effects with concomitant CNS depressants (eg, sedatives, hypnotics, anxiolytics, neuroleptics, tranquilizers, other opioids), alcohol; consider reducing dose for one or both drugs. Potentiated by CYP3A4 and/or CYP2C9 inhibitors (eg, voriconazole); monitor, adjust dose. Antagonized by abacavir, amprenavir, darunavir+ritonavir, telaprevir, saquinavir+ritonavir, tipranivir+ritonavir, efavirenz, nelfinavir, nevirapine, ritonavir, lopinavir+ritonavir, rifampin, phenytoin, St. John's Wort, phenobarbital, carbamazepine, other CYP450 inducers; monitor; adjust methadone dose. Potentiates zidovudine, desipramine. Antagonizes didanosine, stavudine. Concomitant MAOIs: perform sensitivity test with small doses of methadone; monitor. Caution with drugs that prolong the QT interval (eg, Class I and III antiarrhythmics, neuroleptics, tricyclic antidepressants, calcium channel blockers) and drugs capable of inducing electrolyte disturbances (eg, diuretics, laxatives, mineralcorticoid hormones). Increased risk of urinary retention and/or severe constipation with anticholinergics; monitor. May interfere with lab tests. May increase serum amylase.

Adverse Reactions:

Heroin withdrawal, lightheadedness, dizziness, sedation, nausea, vomiting, sweating, orthostatic hypotension, syncope; respiratory depression, QT interval prolongation, torsades de pointes (esp. with high doses), neonatal opioid withdrawal syndrome.

Metabolism:

Hepatic (CYP3A4, CYP2B6, CYP2C19; also CYP2C9 and CYP2D6).

Elimination:

Renal, fecal.

REMS:

YES

Generic Availability:

YES

How Supplied:

Tabs—100

DOLOPHINE

  • 10mg tablets (Qty:45)
  • appx. price $33.00
GoodRx

Indications for DOLOPHINE:

Management of pain severe enough to require daily, around-the-clock, long-term analgesia for which alternative opioid therapies are inadequate.

Limitations Of use:

Not for use as an as-needed (prn) analgesic. Use only if alternative treatment options (eg, non-opioid analgesics, immediate-release opioids) are ineffective, not tolerated, or otherwise inadequate to provide sufficient management of pain.

Adult:

See full labeling. Particular vigilance is necessary during treatment initiation, during conversion from one opioid to another, and during dose titration. Peak respiratory depressant effects typically occur later, and persist longer than peak analgesic effects. Opioid-naive: initially 2.5mg every 8–12hrs. Dosage adjustments may be done every 1 to 2 days. Converting from other oral opioids, parenteral methadone: see full labeling. Discontinue all other around-the-clock opioids when Dolophine is initiated; deaths have occurred in opioid-tolerant patients during conversion to methadone.

Children:

<18yrs: not established.

Pharmacological Class:

Opioid.

Contraindications:

Significant respiratory depression. Acute or severe bronchial asthma (in the absence of resuscitative equipment or in unmonitored settings). Known or suspected paralytic ileus.

Warnings/Precautions:

Increased risk of fatal respiratory depression (esp. when initiating therapy and during dose increases); monitor. Abuse potential (monitor routinely). Accidental exposure may result in fatal overdose (esp. children). Life-threatening QT prolongation. Risk of neonatal opioid withdrawal syndrome. Deaths, cardiac and respiratory, have been reported during initiation and conversion of pain patients to methadone from other opioids. A high degree of opioid tolerance does not eliminate the possibility of overdose, iatrogenic or otherwise. Pulmonary disease (eg, COPD, cor pulmonale); monitor for respiratory depression (esp. within the first 24–72hrs of initiating therapy and after dose increases); consider alternative non-opioid analgesics. Head injury. Impaired consciousness, coma, GI obstruction; avoid. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. Severe volume depletion. Cardiac hypertrophy, concomitant diuretic use, hypokalemia, hypomagnesemia: increased risk of QT prolongation; monitor cardiovascular status. Impaired renal or hepatic function. Acute pancreatitis. Biliary tract disease. Avoid abrupt cessation. Elderly. Cachectic. Debilitated. Pregnancy (Cat.C). Labor and delivery, nursing mothers: not recommended.

Interactions:

Avoid mixed agonist/antagonist opioids (eg, butorphanol, nalbuphine, pentazocine) or partial agonist (eg, buprenorphine); may reduce effects and precipitate withdrawal symptoms. Increased CNS effects with concomitant CNS depressants (eg, sedatives, hypnotics, anxiolytics, neuroleptics, tranquilizers, other opioids), alcohol; consider reducing dose for one or both drugs. Potentiated by CYP3A4 and/or CYP2C9 inhibitors (eg, voriconazole); monitor, adjust dose. Antagonized by abacavir, amprenavir, darunavir+ritonavir, telaprevir, saquinavir+ritonavir, tipranivir+ritonavir, efavirenz, nelfinavir, nevirapine, ritonavir, lopinavir+ritonavir, rifampin, phenytoin, St. John's Wort, phenobarbital, carbamazepine, other CYP450 inducers; monitor; adjust methadone dose. Potentiates zidovudine, desipramine. Antagonizes didanosine, stavudine. Concomitant MAOIs: perform sensitivity test with small doses of methadone; monitor. Caution with drugs that prolong the QT interval (eg, Class I and III antiarrhythmics, neuroleptics, tricyclic antidepressants, calcium channel blockers) and drugs capable of inducing electrolyte disturbances (eg, diuretics, laxatives, mineralcorticoid hormones). Increased risk of urinary retention and/or severe constipation with anticholinergics; monitor. May interfere with lab tests. May increase serum amylase.

Adverse Reactions:

Lightheadedness, dizziness, sedation, nausea, vomiting, sweating, orthostatic hypotension, syncope; respiratory depression, QT interval prolongation, torsades de pointes (esp. with high doses), neonatal opioid withdrawal syndrome.

Metabolism:

Hepatic (CYP3A4, CYP2B6, CYP2C19; also CYP2C9 and CYP2D6).

Elimination:

Renal, fecal.

REMS:

YES

Generic Availability:

YES

How Supplied:

Tabs—100

DOLOPHINE

  • 10mg tablets (Qty:45)
  • appx. price $33.00
GoodRx

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