Product Information

Now featuring REMS Information

 

Opioids: Short-Acting Agents

Capital® and Codeine, Tylenol® with Codeine (Codeine and Acetaminophen: Short-Acting Combination Agent)

Dosage form and route of administration: Oral (tablets, capsules)

Indications: These agents are indicated for the relief of mild to moderately severe pain. In patients receiving opioids, the dose and duration of analgesia will vary substantially depending on the patient's opioid tolerance.

Contraindications: Codeine and acetaminophen are contraindicated in patients who have previously exhibited hypersensitivity to codeine and acetaminophen. 

Drug interactions: The effects of other opioid analgesics, antipsychotics, antianxiety agents, or central nervous sytem (CNS) depressants may be enhanced when used concomitantly with codeine and acetaminophen.

Adverse events: The most frequently reported adverse events associated with this pharmacologic treatment include lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, and constipation. Other adverse reactions include allergic reactions, including anaphylactic symptoms and asthmatic episodes.1-2

Other cautions: Regular acetaminophen use is associated with hepatocellular enzyme changes. Hepatotoxicity can occur with excessive use of acetaminophen, and practitioners need to educate and caution patients about all the various sources of acetaminophen in over-the-counter (OTC) and prescription medications. Patients using alcohol on a regular basis or with a past history of alcohol abuse should limit acetaminophen use by at least 50%.1-2

1Capital and Codeine [package insert]. Aliso Viejo, California: Valeant Pharmaceuticals North America; 2007.
2Tylenol with Codeine [package insert]. Raritan, New Jersey: PriCara; 2009.


Prescribing Information for Capital and Codeine
Prescribing Information for Tylenol with Codeine


Actiq®, Fentora® Onsolis (Fentanyl: Rapid-Onset Formulation)

Dosage form and route of administration: Oral (oral transmucosal units [Actiq]; buccal tablets [Fentora]; buccal soluble film [Onsolis])

 

Indications: These agents are indicated only for the management of patients with breakthrough cancer pain with malignancies who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. In patients receiving opioids, the dose and duration of analgesia will vary substantially depending on the patient’s opioid tolerance.

 

Contraindications: These agents are contraindicated in opioid-intolerant patients and should only be taken by patients who are opioid tolerant.

 

Drug interactions: The effects of CNS depressants, monamine oxidase (MAO) inhibitors, and agents that affect CYP 3A4 and P450 3A4 activity may be enhanced when used concomitantly with fentanyl.

 

Adverse events: The most frequently reported adverse events associated with this treatment include headache, dizziness, nausea, vomiting, constipation, itching/hives, urinary hesitancy, and sexual dysfunction due to decreased sex hormone levels with chronic use.1-3 Other adverse events include respiratory depression (rare in opioid-tolerant patients) and potential for psychological dependence.1-3

 

Other cautions: Usual dosing is no more often than every two hours to avoid dose accumulation. Since these formulations are indicated for breakthrough pain, more than 4 doses in 24 hours suggests a need to reevaluate the baseline analgesic dose.

 

1Actiq [package insert]. Salt Lake City, Utah: Cephalon, Inc.; 2007.

2Fentora [package insert]. Salt Lake City, Utah: Cephalon, Inc.; 2007.

3Onsolis [package insert]. Somerset, New Jersey: Meda Pharmaceuticals Inc.; 2009.


Slide Library Click here for Onsolis Risk Evaluation and Mitigation Strategy (REMS)
Med Guide: Click here for Onsolis patient Medication Guide.


Warning: Serious Side Effects with use of Fentora. September 26, 2007.
Prescribing Information for Actiq
Prescribing Information for Fentora
Prescribing Information for Onsolis


Anexsia®, Lortab®, Vicodin® (Hydrocodone and Acetaminophen: Short-Acting Combination Agent)

Dosage form and route of administration: Oral (tablets, capsules)

 

Indications: These agents are indicated for the relief of moderate to moderately severe pain. In patients receiving opioids, the dose and duration of analgesia will vary substantially depending on the patient’s opioid tolerance.

 

Contraindications: These agents are contraindicated in patients with known intolerance or hypersensitivity to hydrocodone and acetaminophen.

 

Drug interactions: The effects of other opioid analgesics, antihistamines, antipsychotics, antianxiety agents, CNS depressants, MAO inhibitors, and tricyclic antidepressants (TCAs) may be enhanced when used concomitantly with hydrocodone and acetaminophen.

 

Adverse events: The most frequently reported adverse events associated with these agents include lightheadedness, dizziness, sedation, nausea, vomiting, and respiratory depression.1-3

 

Other cautions: Regular acetaminophen use is associated with hepatocellular enzyme changes. Hepatotoxicity can occur with excessive use of acetaminophen and practitioners need to educate and caution patients about all the various sources of acetaminophen in OTC and prescription medications. Patients using alcohol on a regular basis, or with a past history of alcohol abuse, should limit acetaminophen use by at least 50%.1-3

 

1Anexsia [package insert]. St. Louis, Missouri: Mallinckrodt Inc.; 2009.
2Lortab [package insert]. Smyrna, Georgia: UCB Pharma, Inc.; 2009.
3Vicodin [package insert]. North Chicago, Illinois: Abbott Laboratories; 2008.


Prescribing Information for Anexsia
Prescribing Information for Lortab
Prescribing Information for Vicodin


Dilaudid® (Hydromorphone: Short-Acting Agent)

Dosage form and route of administration: Oral (tablets, capsules, oral solution); Parenteral (injection);
Rectal (suppositories)

 

Indications: This agent is indicated for the management of pain in patients for whom an opioid analgesic is appropriate. In patients receiving opioids, the dose and duration of analgesia will vary substantially depending on the patient’s opioid tolerance.

 

Contraindications: Dilaudid is contraindicated in patients with known intolerance or hypersensitivity
to hydromorphone.

 

Drug interactions: The effects of MAO inhibitors, antihistamines, TCAs, anticholinergics, phenothiazines, tranquilizers, and sedatives may be enhanced when used concomitantly with hydromorphone.

 

Adverse events: The most frequently reported adverse events associated with this pharmacologic treatment include sedation, drowsiness, dizziness, nausea, constipation, itching/hives, urinary hesitancy, sexual dysfunction due to decreased sex hormone levels with regular use, and respiratory depression.1

 

Other cautions: Use with other CNS-depressant drugs, including alcohol, can cause potentially life-threatening respiratory depression, especially during sleep.

 

1Dilaudid [package insert]. Stamford, Connecticut: Purdue Pharma L.P.; 2009.


Prescribing Information for Dilaudid


Morphine Sulfate Immediate Release® (MSIR), Roxanol
(Morphine: Immediate-Release Formulation)


Dosage form and route of administration: Oral (tablets and capsules swallowed whole, oral solution); Rectal (suppositories)

 

Indications: These agents are indicated for the relief of moderate to severe pain and severe acute pain (Roxanol only). In patients receiving opioids, the dose and duration of analgesia will vary substantially depending on the patient’s opioid tolerance.

 

Contraindications: These agents are contraindicated in patients with known intolerance or hypersensitivity to morphine.

 

Drug interactions: The effects of MAO inhibitors, antihistamines, TCAs, anticholinergics, phenothiazines, tranquilizers, and sedatives may be enhanced when concomitantly used with morphine.

 

Adverse events: The most frequently reported adverse events associated with these agents include sedation, drowsiness, dizziness, nausea, constipation, itching/hives, urinary hesitancy, and sexual dysfunction due to decreased sex hormone levels with regular use. Other adverse events include respiratory depression, physical and psychological dependence, and opioid tolerance.1-2

 

1Roxanol [package insert]. Newport, Kentucky: Xanodyne Pharmaceuticals, Inc.; 2005.

2MSIR [package insert]. Stamford, Connecticut: Purdue Pharma L.P.; 2004.


Prescribing Information for MSIR
Prescribing Information for Roxanol


OxyIR®, Percocet®, Percodan®, Roxicodone (Oxycodone: Immediate-Release Formulation, Used Alone or in Combination with Acetaminophen or Aspirin)

Important Update :: January 2012
FDA issued a public health advisory alerting patients and healthcare professionals of a potential safety risk associated with opioid medications manufactured and packaged for Endo Pharmaceuticals by Novartis Consumer Health; tablets from one product type may have carried over into packaging of another product.

Click
here for additional information.

Dosage form and route of administration: Oral (oral solution, tablets, and capsules)

 

Indications: These agents are indicated for the relief of moderate to moderately severe pain. In patients receiving opioids, the dose and duration of analgesia will vary substantially depending on the patient’s opioid tolerance.

 

Contraindications: These agents are contraindicated in patients with known intolerance or hypersensitivity to oxycodone.

 

Drug interactions: The effects of other opioid analgesics, CNS depressants, anticholinergics, phenothiazines, tranquilizers, sedatives, amiodarone, quinidine, and polycyclic antidepressants may be enhanced when concomitantly used with oxycodone.

 

Adverse events: The most frequently reported adverse events associated with this treatment include sedation, drowsiness, dizziness, nausea, constipation, itching/hives, urinary hesitancy, and sexual dysfunction due to decreased sex hormone levels with regular use. Other adverse events include respiratory depression, physical and psychological dependence, and opioid tolerance.1-4

 

Other cautions: Regular acetaminophen use is associated with hepatocellular enzyme changes. Hepatotoxicity can occur with excessive use of acetaminophen and practitioners need to educate and caution patients about all the various sources of acetaminophen in OTC and prescription medications. Patients using alcohol on a regular basis, or with a past history of alcohol abuse, should limit acetaminophen use by at least 50%.

 

1OxyIR [package insert]. Stamford, Connecticut: Purdue Pharma L.P.; 2007.

2Percocet [package insert]. Chadds Ford, Pennsylvania: Endo Pharmaceuticals Inc.; 2006.

3Percodan [package insert]. Chadds Ford, Pennsylvania: Endo Pharmaceuticals Inc.; 2010.

4Roxicodone [package insert]. Newport, Kentucky: Xanodyne Pharmaceuticals, Inc.; 2009.


Prescribing Information for OxyIR
Prescribing Information for Percocet
Prescribing Information for Percodan
Prescribing Information for Roxicodone


Numorphan®, Opana® (Oxymorphone: Short-Acting Agent)

Important Update :: January 2012
FDA issued a public health advisory alerting patients and healthcare professionals of a potential safety risk associated with opioid medications manufactured and packaged for Endo Pharmaceuticals by Novartis Consumer Health; tablets from one product type may have carried over into packaging of another product.

Click
here for additional information.

Dosage form and route of administration: Oral (tablets [Opana]); Parenteral (injection [Numorphan]); Rectal (suppositories [Numorphan])

 

Indications: These agents are indicated for the relief of moderate to severe pain. Opana is indecated for relief of moderate to sever acute pain. Numorphan injection is also indicated for preoperative medication, for support of anesthesia, for obstetrical analgesia, and for relief of anxiety in patients with dyspnea associated with pulmonary edema secondary to acute left ventricular dysfunction. In patients receiving opioids, the dose and duration of analgesia will vary substantially depending on the patient’s opioid tolerance.

 

Contraindications: These agents are contraindicated in patients with known intolerance or hypersensitivity
to oxymorphone.

 

Drug interactions: Patients using oxymorphone concomitantly with CNS depressants and opioid agonist and antagonist analgesics may exhibit an additive CNS depression.

 

Adverse events: The most frequently reported adverse events associated with this treatment include sedation, drowsiness, dizziness, nausea, constipation, itching/hives, urinary hesitancy, and sexual dysfunction due to decreased sex hormone levels with regular use. Other adverse events include respiratory depression, physical and psychological dependence, and opioid tolerance.1-2

 

1Numorphan [package insert]. Chadds Ford, Pennsylvania: Endo Pharmaceuticals Inc.; 2004.

2Opana [package insert]. Chadds Ford, Pennsylvania: Endo Pharmaceuticals Inc.; 2006.


Prescribing Information for Numorphan
Prescribing Information for Opana


Darvocet®, Darvon® (Propoxyphene: Short-Acting Agent, Used Alone or in Combination with Acetaminophen or Aspirin)

Important Update :: November 2010
Propoxyphene has been withdrawn from the US market at the request of the FDA due to new data showing that the drug can cause serious toxicity to the heart, even when used at therapeutic doses.

Click
here for additional information.

Dosage form and route of administration: Oral (capsules, oral suspension, tablets)

 

Indications: These agents are indicated for the relief of mild to moderate pain. In patients receiving opioids, the dose and duration of analgesia will vary substantially depending on the patient’s opioid tolerance.

 

Contraindications: These agents are contraindicated in patients with known intolerance or hypersensitivity
to propoxyphene.

 

Drug interactions: The effects of CNS depressants, anticonvulsants, and antidepressants may be enhanced when used concomitantly with propoxyphene.

 

Adverse events: The most frequently reported adverse events associated with this treatment include dizziness, sedation, nausea, vomiting, and psychotomimetic effects in older patients. Other adverse events include respiratory depression, physical and psychological dependence, and opioid tolerance.1-2

 

Other cautions: Regular acetaminophen use is associated with hepatocellular enzyme changes. Hepatotoxicity can occur with excessive use of acetaminophen and practitioners need to educate and caution patients about all the various sources of acetaminophen in OTC and prescription medications. Patients using alcohol on a regular basis, or with a past history of alcohol abuse, should limit acetaminophen use by at least 50%.1-2

 

1Darvocet [package insert]. Newport, Kentucky: Xanodyne Pharmaceuticals Inc.; 2006.

2Darvon [package insert]. Newport, Kentucky: Xanodyne Pharmaceuticals Inc.; 2009.


Slide Library Click here for Darvon Risk Evaluation and Mitigation Strategy (REMS)
Med Guide: Click here for Darvon patient Medication Guide.


Prescribing Information for Darvocet
Prescribing Information Darvon
FDA Takes Actions on Darvon, Other Pain Medications Containing Propoxyphene


Ultracet®, Ultram® (Tramadol: Immediate-Release Formulation, Used Alone or in Combination with Acetaminophen or Aspirin)

Dosage form and route of administration: Oral (tablets)

 

Indications: Ultram is indicated for the relief of moderate to moderately severe pain. Ultracet is indicated for short-term (5 days or less) management of acute pain. In patients receiving opioids, the dose and duration of analgesia will vary substantially depending on the patient’s opioid tolerance.

 

Contraindications: These agents are contraindicated in patients with hypersensitivity, and in any situation in which opioids are contraindicated, including acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids, or psychotropics.

 

Drug interactions: The effects of CYP 3A4 inhibitors, CYP 2D6 inhibitors, quinidine, carbamazepine, and cimetidine may be enhanced when used concomitantly with tramadol.

 

Adverse events: The most frequently reported adverse events associated with these agents include drowsiness, dizziness, gastrointestinal upset, nausea, agitation, and constipation. Other adverse events include seizures (usually with overdosage), serotonin syndrome with antidepressants, respiratory depression, and anaphylactoid reactions.1-2

 

Other cautions: One-half of a 50-mg tablet may be ineffective for many patients, but slow dose escalation is recommended in older and frail patients to avoid untoward cognitive effects. Patients who are elderly or have hepatic dysfunction should take smaller doses at longer intervals. Regular acetaminophen use is associated with hepatocellular enzyme changes. Hepatotoxicity can occur with excessive use of acetaminophen, and practitioners need to educate and caution patients about all the various sources of acetaminophen in OTC and prescription medications. Patients using alcohol on a regular basis, or with a past history of alcohol abuse, should limit acetaminophen use by at least 50%.1-2

 

1Ultracet [package insert]. Titusville, New Jersey: Ortho-McNeil-Janssen Pharmaceuticals, Inc.; 2003.

2Ultram [package insert]. Titusville, New Jersey: Ortho-McNeil-Janssen Pharmaceuticals, Inc.; 2009.


Prescribing Information for Ultracet
Prescribing Information for Ultram


Opioids: Long-Acting Agents

Levo-Dromoran® (Levorphanol: Pharmacologically Long-Acting Agent With Long Half-Life)

Dosage form and route of administration: Oral (tablets); Parenteral (intravenous [IV], intramuscular, or subcutaneous injection)

 

Indications: Levo-Dromoran is indicated for the management of moderate to severe pain or as a preoperative medication in a setting in which an opioid analgesic is appropriate. In patients receiving opioids, the dose and duration of analgesia will vary substantially depending on the patient’s opioid tolerance.

 

Contraindications: Levo-Dromoran is contraindicated in patients with known intolerance or hypersensitivity
to levorphanol.

 

Drug interactions: The effects of other opioid analgesics, antihistamines, antipsychotics, antianxiety agents, CNS depressants, MAO inhibitors, or TCAs may be enhanced when used concomitantly with levorphanol.

 

Adverse events: The most frequently reported adverse events associated with Levo-Dromoran include sedation, drowsiness, dizziness, nausea, constipation, itching/hives, urinary hesitancy, and sexual dysfunction due to decreased sex hormone levels with regular use. Other adverse events include respiratory depression, physical and psychological dependence, and opioid tolerance.1

 

1Levo-Dromoran [package insert]. Aliso Viejo, California: Valeant Pharmaceuticals International; 2004.


Prescribing Information for Levo-Dromoran


Dolophine®, Methadose (Methadone: Pharmacologically Long-Acting Agent With Long Half-Life)

Dosage form and route of administration: Oral (tablets, oral concentrate, and dispersible tablets)

 

Indications: Dolophine is indicated for the treatment of moderate to severe pain not responsive to non-narcotic analgesics. These agents are also indicated for detoxification treatment of opioid addiction (heroin or other morphine-like drugs); and for maintenance treatment of opioid addiction in conjunction with appropriate social and medical services. In patients receiving opioids, the dose and duration of analgesia will vary substantially depending on the patient’s opioid tolerance.

 

Contraindications: These agents are contraindicated in patients with known intolerance or hypersensitivity
to methadone.

 

Drug interactions: The effects of pentazocine, desipramine, MAO inhibitors, CNS depressants, anti-retroviral agents, and CYP 3A4 inducers and inhibitors may be enhanced when used concomitantly with methadone.

 

Adverse events: The most frequently reported adverse events associated with this treatment include sedation, drowsiness, dizziness, nausea, constipation, itching/hives, urinary hesitancy, and sexual dysfunction due to decreased sex hormone levels with regular use. Other adverse events include respiratory depression, physical and psychological dependence, and opioid tolerance.1-2

 

Other cautions: Dolophine and Methadose have a highly variable half-life that makes titration and related pharmacodynamic effects unpredictable. Doses may accumulate, leading to accidental overdose, especially during sleep. Concomitant use of other CNS depressants increases this risk. Methadone has dose-related effects on cardiac QT interval that can lead to fatal arrhythmias. Use of methadone for acute or chronic pain control should be under the supervision of a physician with considerable experience with methadone and outpatient administration.

 

1Dolophine [package insert]. Columbus, Ohio: Roxane Laboratories, Inc.; 2009.

2Methadose [package insert]. Hazelwood, Missouri: Mallinckrodt Inc.; 2009.


Advisory: Methadone Use May Result in Death and Life-Threatening Changes. Updated Januray 21, 2010
Prescribing Information for Dolophine
Prescribing Information for Methadose


Avinza®, Duramorph®, Kadian® (Morphine: Controlled-, Extended-, and
Sustained-Release Formulations)


Dosage form and route of administration: Oral (tablets and capsules swallowed whole); Parenteral (injection [IV, epidural, intrathecal])

 

Indications: These agents are indicated for the relief of moderate to severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time. Avinza and Kadian are note intended for use as PRN analgesicis. Duramorph is a systemic narcotic analgesic for administration by the IV, epidural, or intrathecal routes. It is used for the management of pain not responsive to non-narcotic analgesics. Duramorph administered epidurally or intrathecally provides pain relief for extended periods without attendant loss of motor, sensory, or sympathetic function. In patients receiving opioids, the dose and duration of analgesia will vary substantially depending on the patient’s opioid tolerance.

 

Contraindications: These agents are contraindicated in patients with known intolerance or hypersensitivity
to morphine.

 

Drug interactions: The effects of MAO inhibitors, antihistamines, TCAs, anticholinergics, phenothiazines, tranquilizers, and sedatives may be enhanced when used concomitantly with morphine.

 

Adverse events: The most frequently reported adverse events associated with this treatment include sedation, drowsiness, dizziness, nausea, constipation, itching/hives, urinary hesitancy, and sexual dysfunction due to decreased sex hormone levels with regular use. Other adverse events include respiratory depression, physical and psychological dependence, and opioid tolerance.1-3

 

Other cautions: Concomitant use of modified-release opioids (ie, CR, SR, or ER formulations) with alcohol may result in increased plasma levels, leading to accidental overdose.

 

1Avinza [package insert].San Diego, California: Ligand Pharmaceuticals Incorporated; 2003.

2Duramorph [package insert]. Deerfield, Illinois: Baxter Healthcare Corporation; 2005.

3Kadian [package insert]. Piscataway, New Jersey: Alpharma Pharmaceuticals LLC; 2009.


Prescribing Information for Avinza
Prescribing Information for Duramorph
Prescribing Information for Kadian


OxyContin® (Oxycodone: Controlled-, Sustained-Released Formulation)

Dosage form and route of administration: Oral (tablets swallowed whole)

 

Indications: OxyContin is indicated for the management of relief of moderate-to-severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. In patients receiving opioids, the dose and duration of analgesia will vary substantially depending on the patient’s opioid tolerance.

 

Contraindications: These agents are contraindicated in patients with known intolerance or hypersensitivity
to oxycodone.

 

Drug interactions: The effects of other opioid analgesics, CNS depressants, anticholinergics, phenothiazines, tranquilizers, sedatives, amiodarone, quinidine, and polycyclic antidepressants may be enhanced when used concomitantly with oxycodone.

 

Adverse events: The most frequently reported adverse events associated with this treatment include sedation, drowsiness, dizziness, nausea, constipation, itching/hives, urinary hesitancy, and sexual dysfunction due to decreased sex hormone levels with regular use. Other adverse events include respiratory depression, physical and psychological dependence, and opioid tolerance.1

 

Other cautions: Concomitant use of modified-release opioids (ie, CR, SR, or ER formulations) with alcohol may result in increased plasma levels, leading to accidental overdose.

 

1OxyContin [package insert]. Stamford, Connecticut: Purdue Pharma L.P.; 2009.


Slide Library Click here for OxyContin Risk Evaluation and Mitigation Strategy (REMS)
Med Guide: Click
here for OxyContin patient Medication Guide.


Warning: FDA Strengthens Warnings for OxyContin. July 25, 2001.
FDA approved reformulation of OxyContin, April 5, 2010
Prescribing Information for OxycContin


Opana® ER (Oxymorphone: Extended-Release Formulation)

Important Update :: January 2012
FDA issued a public health advisory alerting patients and healthcare professionals of a potential safety risk associated with opioid medications manufactured and packaged for Endo Pharmaceuticals by Novartis Consumer Health; tablets from one product type may have carried over into packaging of another product.

Click
here for additional information.

Dosage form and route of administration: Oral (tablets swallowed whole)

 

Indications: Opana ER is indicated for the relief of moderate-to-severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time. In patients receiving opioids, the dose and duration of analgesia will vary substantially depending on the patient’s opioid tolerance.

 

Contraindications: Opana ER is contraindicated in patients with known intolerance or hypersensitivity to the agents, and in patients with pain in the immediate post-operative period (first 12–24 hours), mild pain, paralytic ileus, and moderate and severe hepatic impairment.

 

Drug interactions: The effects of opioid analgesics, CNS depressants and opioid agonist and antagonist analgesics may be enhanced when used concomitantly with Opana ER.

 

Adverse events: The most frequently reported adverse events associated with this treatment include sedation, drowsiness, dizziness, nausea, constipation, itching/hives, urinary hesitancy, and sexual dysfunction due to decreased sex hormone levels with regular use. Other adverse events include respiratory depression, physical and psychological dependence, and opioid tolerance.1

 

Other cautions: Concomitant use of modified-release opioids (ie, CR, SR, or ER formulations) with alcohol may result in increased plasma levels, leading to accidental overdose.

 

1Opana ER [package insert]. Chadds Ford, Pennsylvania: Endo Pharmaceuticals Inc.; 2008.


Prescribing Information for Opana ER


Ultram®, ER (Tramadol: Extended-Release Formulation)

Dosage form and route of administration: Oral (tablets swallowed whole)

 

Indications: Ultram ER is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time. In patients receiving opioids, the dose and duration of analgesia will vary substantially depending on the patient’s opioid tolerance.

 

Contraindications: Ultram ER is contraindicated in patients with hypersensitivity and in any situation in which opioids are contraindicated, including acute intoxication with alcohol, hypnotics, and use of centrally acting analgesics, opioids, or psychotropics.

 

Drug Interactions: The effects of CYP 3A4 inhibitors, CYP 2D6 inhibitors, quinidine, carbamazepine, and cimetidine may be enhanced when used concomitantly with tramadol.

 

Adverse events: The most frequently reported adverse events associated with this treatment include drowsiness, dizziness, gastrointestinal upset, nausea, agitation, and constipation. Other adverse events include seizures (usually with overdosage), serotonin syndrome with antidepressants, respiratory depression, and anaphylactoid reactions.1

 

1Ultram ER [package insert]. Titusville, New Jersey: Ortho-McNeil-Janssen Pharmaceuticals, Inc.; 2006.


Prescribing Information for Ultram ER


MS Contin® (Morphine: Control-Release Formulation)

Dosage form and route of administration: Oral (tablets swallowed whole)

 

Indications: MS Contin is indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.  It is indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate-to-severe and persist for an extended period of time.

 

Contraindications: MS Contin is contraindicated in patients with known hypersensitivity, and in any situation in which opioids are contraindicated, including patients with respiratory depression and acute or severe bronchial asthma or hypercarbia. It is also contraindicated in any patient who has or is suspected of having a paralytic ileus.

 

Drug interactions: The effects of other opioid analgesics, CNS depressants, sedatives, hypnotics, phenothiazines, tranquilizers, or general anesthetics or may be enhanced when used concomitantly with MS Contin.

 

Adverse events: The frequently reported adverse events associated with MS Contin include respiratory depression, apnea, constipation, lightheadedness, dizziness, sedation, nausea, vomiting, sweating, dysphoria, and euphoria.1

 

Other cautions: Concomitant use of alcohol and other opioids may result in additive effects when used concomitantly with morphine. Profound sedation or coma may result.

 

1MS Contin [package insert]. Stamford, Connecticut: Purdue Pharma L.P.; 2009.


Prescribing Information for MS Contin


Butrans™ (Buprenorphine Transdermal System)

Dosage form and route of administration: transdermal

Indications: This agent is indicated for the management of moderate to severe chronic pain in patients requiring a continuous, around-the-clock opioid analgesic for an extended period of time.

Contraindications: Butrans is contraindicated in patients with significant respiratory depression, severe bronchial asthma, known or suspected paralytic ileus, and known hypersensitivity to any of the components or the active ingredient in Butrans. It is also contraindicated for the management of acute pain or in patients who require opioid analgesia for a short period of time, post-operative pain, mild pain, and intermittent pain (eg, use on an as-needed basis).

Drug interactions: Agents that induce CYP34A enzymatic activity may alter the metabolism of buprenorphine. CNS depressants and muscle relaxants may increase the risk for CNS and/or respiratory depression.

Adverse events: The most frequently reported adverse events associated with this treatment include nausea, headache, application site pruritus, dizziness, constipation, somnolence, vomiting, application site erythema, dry mouth, and application site rash.1

Other cautions: Do not exceed a dose of one 20 mcg/hour Butrans system due to the risk of QTc interval prolongation. Avoid exposing the Butrans application site and surrounding area to direct external heat sources. Temperature-dependent increases in buprenorphine release from the system may result in overdose and death.

1Butrans [package insert]. Stamford, Connecticut: Purdue Pharma L.P.; 2010.

Slide Library Click here for Butrans Risk Evaluation and Mitigation Strategy (REMS)
Med Guide: Click
here for Butrans patient Medication Guide.

Prescribing Information for Butrans




Transient Receptor Potential Vanilloid 1 (TRPV1) Channel Agonist

Qutenza® (Capsaicin 8% patch)

Dosage form and route of administration: Topical (patch)

Indications: This agent is indicated for the management of neuropathic pain associated with postherpetic neuralgia.

Contraindications: Qutenza has no contraindications.

Drug interactions: Interactions with systemic medicinal products are unlikely with use of Qutenza.

Adverse events: The most frequently reported adverse events associated with Qutenza include application site erythema, pain, pruritus, and papules.1

Other cautions: Do not use Qutenza near eyes or mucous membranes. Inhalation of airborne Qutenza can cause coughing or sneezing. Transient increases in blood pressure may occur in patients during and shortly after using Qutenza.

1Qutenza [package insert]. San Mateo, California: NeurogesX, Inc.; 2009.


Prescribing Information for Qutenza


Anticonvulsants

Tegretol®, Tegretol® XR (Carbamazepine)

Dosage form and route of administration: Oral (chewable tablets, capsule [Tegretol]; tablets [Tegretol XR])

Indications: These agents are indicated for patients with epilepsy and in the treatment of pain associated with trigeminal neuralgia.

Contraindications: Tegretol is contraindicated in patients with a history of previous bone marrow depression, hypersensitivity to these agents, or known sensitivity to any of the tricyclic compounds such as amitriptyline, desipramine, imipramine, protriptyline, nortriptyline, etc. Coadministration of carbamazepine with nefazodone is contraindicated.

Drug interactions: The effects of MAO inhibitors, diuretics and hormonal contraceptives, and agents that affect CYP 3A4 activity may be enhanced when used concomitantly with Tegretol.

Adverse events: The most frequently reported adverse events associated with Tegretol include dizziness, drowsiness, nausea, unsteadiness, and vomiting. Other adverse reactions may affect the liver, pancreas, eyes, and the hemopoietic, cardiovascular, respiratory, genitourinary, nervous, digestive, and musculoskeletal systems.1

Other cautions: Serious and sometimes fatal dermatologic reactions have been reported with the use of Tegretol, including toxic epidermal necrolysis and Stevens-Johnson Syndrome. Aplastic anemia and agranulocytosis, as well as increased risk of suicidal thoughts and behavior, have been reported in association with the use of Tegretol.

1Tegretol and Tegretol XR [package insert]. East Hanover, New Jersey: Novartis Pharmaceuticals Corporation; 2009.

Slide Library Click here for Tegretol Risk Evaluation and Mitigation Strategy (REMS)
Med Guide: Click
here for Tegretol patient Medication Guide.


Prescribing Information for Tegretol and Tegretol XR


Lyrica® (Pregabalin)

Dosage form and route of administration: Oral (capsules, solution)

Indications: This agent is indicated for patients with neuropathic pain associated with diabetic peripheral neuropathy, fibromylagia, and post herpetic neuralgia. it is also indicated as adjunctive therapy for adult patients with partial onset seizures.

Contraindications: Lyrica is contraindicated in patients with hypersensitivity to pregabalin or any of its components. 

Drug interactions: Thiazolidinedione may cause peripheral edema when used concomitantly with Lyrica. Additive effects on cognitive and gross motor functioning were reported when Lyrica was co-administered with oxycodone, lorazepam, or ethanol. There are no effects from hypoglycemics, diuretics, and antiepileptic drugs when used concomitantly with this treatment.

Adverse events: The most frequently reported adverse events associated with Lyrica include abdominal pain, gastroenteritis, increased appetite, ecchymosis, anxiety, hypertonia, hypesthesia, paresthesia, twitching, pruritus, conjunctivitis, diplopia, otitis media, anorgasmia, impotence, dizziness, leg cramps, dry mouth, edema, blurred vision, and abnormal abnormal.1

Other cautions: Angioedema (eg, swelling of the throat, head, and neck) can occur, and may be associated with life-threatening respiratory compromise with use of Lyrica. Hypersensitivity reactions (eg, hives, dyspnea, and wheezing) and an increased risk of suicidal thoughts or behavior may occur when using Lyrica.

1Lyrica [package insert]. New York, New York: Pfizer Inc; 2009.

Slide Library Click here for Lyrica Risk Evaluation and Mitigation Strategy (REMS)
Med Guide: Click
here for Lyrica patient Medication Guide.


Prescribing Information for Lyrica


Neurontin® (Gabapentin)

Dosage form and route of administration: Oral (capsule, tablets, solution)

Indications: Neurontin is indicated for the management of postherpetic neuralgia and adjunctive therapy in the treatment of seizures with and without secondary generalization in patients over 12 with epiepsy. 

Contraindications: Neurontin is contraindicated in patients with hypersensitivity to gabapentin or any of its components.

Drug interactions: The effects of morphine may increase gabapentin concentrations. The highest concentrations of gabapentin showed a slight degree of inhibition of isoform CYP2A6. Gabapentin is not appreciably metabolized nor does it interfere with the metabolism of coadministered antiepileptic drugs. Hydrocodone can increase gabapentin AUC values when used concomitantly.

Adverse events: The most frequently reported adverse events associated with Neurontin include dizziness, somnolence, and peripheral edema, asthenia, nausea, vomiting, infection, diarrhea, fatigue, ataxia, nystagmus, tremors, and diplopia, among others.1

Other cautions: Antiepileptic drugs, including Neurontin, increase the risk of suicidal thoughts or behavior. Patients should be monitored for the emergence or worsening of depression, suicidal thoughts, or behavior, and/or any unusual changes in mood or behavior. Neurontin use in pediatric patients with epilepsy 3–12 years of age is associated with the occurrence of CNS-related adverse events including behavioral problems, hostility, thought disorder, and hyperkinesia.

1Neurontin [package insert]. New York, New York: Pfizer Inc; 2009.

Slide Library Click here for Neurotin Risk Evaluation and Mitigation Strategy (REMS)
Med Guide: Click
here for Neurontin patient Medication Guide.


Prescribing Information for Neurontin


Nonsteroidal Antiinflammatory Drugs (NSAIDs)

Cataflam® (Diclofenac); Voltaren® Gel (Diclofenac Gel)

Dosage form and route of administration: Oral (immediate-release tablet [Cataflam]); Topical (gel [Voltaren])

Indications: These agents are indicated in patients with osteoarthritis (OA), rheumatoid arthritis, and acute pain. Cataflam is indicated for patients with primary dysmenorrhea. Voltaren Gel is not approved for OA of the spine, hip, or shoulder.

Contraindications: These agents are contraindicated in patients with known hypersensitivity to NSAIDs or sulfonamides; history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs; and use during the perioperative period in the setting of coronary artery bypass graft surgery. 

Drug interactions: The effects of warfarin, ACE inhibitors, angiotensin II antagonists and drugs known to inhibit P450 2C9 may be enhanced when used concomitantly with this treatment. Voltaren Gel should not be used concomitantly with sunscreens, cosmetics, lotions, insect repellants, or other topical medications on the same skin sites.

Adverse events: The most frequently reported adverse events associated with these agents include abdominal pain, diarrhea, dyspepsia, flatulence, peripheral edema, dizziness, and rhinitis. Voltaren Gel can cause application site reactions, including dermatitis.1-2

Other cautions: Serious and potentially fatal cardiovascular thrombotic events, myocardial infarction (MI), and stroke have been reported with this treatment. In addition, serious gastrointestinal adverse events, elevated liver enzymes, onset or worsening of hypertension, fluid retention and edema, renal papillary necrosis, anaphylactoid reactions, and serious skin adverse events may occur.

1Cataflam [package insert]. East Hanover, New Jersey: Novartis Pharmaceuticals Company; 2009.
2Voltaren Gel [package insert]. Chadds Ford, Pennsylvania: Endo Pharmaceuticals Inc; 2009.


Prescribing Information for Cataflam
Prescribing Information for Voltaren Gel


Celebrex® (Celecoxib)

Dosage form and route of administration: Oral (capsule)

Indications: Celebrex is indicated in patients with osteoarthritis (OA), rheumatoid arthritis, and acute pain. It is also indicated in patients with primary dysmenorrhea, ankylosing spondylitis, and familial adenomatous polyposis.

Contraindications: Celebrex is contraindicated in patients with known hypersensitivity to NSAIDs or sulfonamides; history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs; and use during the perioperative period in the setting of coronary artery bypass graft surgery. 

Drug interactions: The effects of warfarin, ACE inhibitors, angiotensin II antagonists and drugs known to inhibit P450 2C9 may be enhanced when used concomitantly with this treatment.

Adverse events: The most frequently reported adverse events associated with this agent include abdominal pain, diarrhea, dyspepsia, flatulence, peripheral edema, dizziness, pharyngitis, rhinitis, sinusitis, and upper respiratory tract infection.1

Other cautions: Serious and potentially fatal cardiovascular thrombotic events, (MI), and stroke have been reported with this treatment. In addition, serious gastrointestinal adverse events, elevated liver enzymes, onset or worsening of hypertension, fluid retention and edema, renal papillary necrosis, anaphylactoid reactions, and serious skin adverse events may occur.

1Celebrex [package insert]. New York, New York: Pfizer Inc; 2009.


Prescribing Information for Celebrex
FDA Warning for COX-2 Selective and Non-Selective NSAIDs


SPRIX® (ketorolac tromethamine) Nasal Spray

Dosage form and route of administration: Nasal (spray)

Indications: This agent is indicated in adult patients for the short term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level.

Contraindications: This agent is contraindicated in patients with known hypersensitivity to ketorolac, aspirin, other NSAIDs, or edetate disodium (EDTA); advanced renal disease or risk for renal failure; suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, and those at high risk of bleeding; active peptic ulcer disease, recent GI bleeding or perforation, or history of peptic ulcers or GI bleeding; and asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. SPRIX is also contraindicated for use as a prophylactic analgesic before major surgery, use during the perioperative period in the setting of coronary artery bypass graft (CABG) surgery, and use in labor and delivery.  

Drug interactions: Concomitant use with anticoagulants may increase the risk of serious GI bleeding.

Adverse events: The most common adverse reactions (incidence >2%) in patients treated with SPRIX and occurring at a rate at least twice that of placebo are nasal discomfort, rhinalgia, increased lacrimation, throat irritation, oliguria, rash, bradycardia, decreased urine output, increased ALT and/or AST, hypertension, and rhinitis.1

Other cautions: The total duration of use of SPRIX and other ketorolac formulations should not exceed 5 days. SPRIX should not be used concomitantly with IM/IV or oral ketorolac, aspirin, or other NSAIDs.

1SPRIX [package insert]. Shirley, New York: American Regent, Inc.; 2011.

Prescribing Information for SPRIX.




Antidepressants, Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs)

Cymbalta® (Duloxetine: Delayed-Release Formulation)
Dosage form and route of administration: Oral (capsules)
 
Indications: This agent is indicated for patients with chronic musculoskeletal pain, diabetic peripheral neuropathic pain, fibromyalgia, major depressive disorder, and generalized anxiety disorder.
 
Contraindications: This agent is contraindicated in patients with uncontrolled narrow-angle glaucoma. Concomitant use in patients taking MAO inhibitors is contraindicated due to the risk of serious, sometimes fatal, drug interactions with serotenergic drugs.
 
Drug interactions: The effects of MAO inhibitors may be enhanced when used concomitantly with Cymbalta. Co-administration of Cymbalta with potent CYP1A2 inhibitors should be avoided. Because CYP2D6 is involved in duloxetine metabolism, concomitant use of duloxetine with potent inhibitors of CYP2D6 would be expected to, and does, result in higher concentrations of duloxetine. Co-administration of Cymbalta with drugs that are extensively metabolized by CYP2D6 and that have a narrow therapeutic index, including certain antidepressants (tricyclic antidepressants [TCAs], such as nortriptyline, amitriptyline, and imipramine), phenothiazides and Type 1C antiarrhythmics (eg, propafenone, flecainide), should be approached with caution.


Adverse events: The most frequently reported adverse events associated with Cymbalta include nausea, dry mouth, constipation, somnolence, fatigue, hyperhidrosis, and decreased appetite.1

 

Other cautions: Antidepressants increase the risk of suicidal thinking and behavior in children, adolescents, and young adults. Patients of all ages who start antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Cymbalta is not approved for use in pediatric patients. This agent should be discontinued in patients who develop jaundice or other evidence of significant liver dysfunction. It may increase the risk of bleeding events, seizures, urinary hesitation and retention and conditions that slow gastric emptying.

 

1Cymbalta [package insert]. Indianapolis, Indiana: Eli Lilly and Company; 2010.

 
Prescribing Information for Cymbalta


Analgesics

Lidoderm® (Lidocaine patch 5%)

Dosage form and route of administration: Topical (patch)

Indications: This agent is indicated for the relief of pain associated with post-herpetic neuralgia.

Contraindications: Lidoderm is contraindicated in patients with known history of sensitivity to local anesthetics of the amide type, or to any other component of the product.

Drug interactions: The effects of antiarrhythmic drugs and local anesthetic agents may be enhanced and should be used with caution when used concomitantly with Lidoderm.

Adverse events: The most frequently reported adverse events associated with Lidoderm include blisters, bruising, burning sensation, depigmentation, dermatitis, discoloration, edema, erythema, exfoliation, irritation, papules, petechia, pruritus, and vesicles. Other adverse reactions, although rare, include angioedema, bronchospasm, hypersensitivity, shock, and urticaria.1

Other cautions: Patients with severe hepatic disease are at greater risk of developing toxic blood concentrations of lidocaine, because of their inability to metabolize lidocaine normally. Lidoderm is only recommended for use on intact skin. Application to broken and inflamed skin may result in higher blood concentrations of lidocaine from increased absorption. Contact of Lidoderm with eyes should be avoided.

1Lidoderm [package insert]. Chadds Ford Pennsylvania: Endo Pharmaceuticals; 2008.


Prescribing Information for Lidoderm


Talwin® Nx (Pentazocine and Naloxone)

Dosage form and route of administration: Oral (tablet)

 

Indications: Talwin Nx is indicated for the relief of moderate to severe pain (oral use only).

 

Contraindications: Talwin Nx is contraindicated in patients with hypersensitivity to either pentazocine or naloxone.

 

Drug interactions: The effects of MAO inhibitors may be enhanced when used concomitantly with Talwin Nx. The effects of phenothiazine, TCAs, and ethyl alcohol may be enhanced when used concomitantly with pentazocine. Talwin Nx can antagonize the effects of opiate agonists such as diamorphine, morphine, and heroin and is itself antagonized by naloxone.

 

Adverse events: The most frequently reported adverse events associated with Talwin Nx include hypertension, depression, acute CNS manifestations, sweating, nausea, vomiting, constipation, diarrhea, dry mouth, edema of the face, anaphylactic shock, visual blurring, headache, chills, insomnia, weakness, and urinary retention, among others.1

 

Other cautions: Pentazocine can cause a physical and psychological dependence. Alcohol should be used with caution in patients who are currently receiving pentazocine. Particular caution should be used when Talwin Nx is administered to patients prone to seizures, hypothyroidism, adrenocortical insufficiency, prostate hypertrophy, inflammatory or obstructive bowel disease, acute abdominal syndromes, porphyria, and MI who have nausea or vomiting.

 

1Talwin Nx [package insert]. Bridgewater, New Jersey: sanofi-aventis U.S. LLC; 2008.


Prescribing Information for Talwin Nx


Hyaluronic Acid

Euflexxa® (Hyaluronic Acid)

Dosage form and route of administration: Parenteral (injection)

 

Indications: Euflexxa is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non pharmacologic therapy and simple analgesics.

 

Contraindications: This agent is contraindicated in patients who have a known hypersensitivity
to hyaluronan preparations or in patients with knee joint infections, or infections or skin disease in the area of the injection site.

 

Drug interactions: No interactions are currently known.

 

Adverse events: The most frequently reported adverse events associated with Euflexxa include arthralgia, back pain, rhinitis, increased blood pressure, knee pain, and upper respiratory tract infection.1

 

Other cautions: Euflexxa should not be administered through a needle previously used with quaternary ammonium salts such as benzalkonium chloride. Skin disinfectants for skin preparation that contain quaternary ammonium salts should not be used. Injecting Euflexxa intravascularly may cause systemic adverse events. Euflexxa should not be administered through a needle previously used with medical solutions containing benzalkonium chloride.

 

1Eulflexxa [package insert]. North Chicago, Illinois: Abbott Laboratories; 2009.


Prescribing Information for Euflexxa