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Dosage and administration

To be prescribed only by healthcare providers knowledgeable in use of potent opioids for management of chronic pain.Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. Individualize dosing based on the severity of pain, patient response,prior analgesic experience, and risk factors for addiction, abuse, andmisuse.Initial dose selection: consult conversion instructions.Each transdermal system is intended to be worn for 72 hours. Adhere to instructions concerning administration and disposal of DURAGESIC.Mild to Moderate Hepatic and Renal Impairment: Initiate treatment with one half the usual starting dose, titrate slowly, and monitor for signs of respiratory and central nervous system depression.Do not abruptly discontinue DURAGESIC in a physically-dependent patient.

Transdermal system: 12 mcg/hour, 25 mcg/hour, 50 mcg/hour, 75 mcg/hour, 100 mcg/hour.

Side Effects

• headache
• mood changes
• feeling cold
• drowsiness
• depression
• difficulty falling asleep or staying asleep
• uncontrollable shaking of a part of the body
• pain, burning, tingling, or numbness in the hands or feet
• dry mouth
• stomach pain
• indigestion
• back pain
• difficulty urinating
• itching
• skin irritation, redness, itching, or swelling in the area where you wore the patch

• nausea, vomiting, loss of appetite, weakness, or dizziness
• inability to get or keep an erection
• irregular menstruation
• decreased sexual desire
• chest pain
• seizure
• rash

CONTRAINDICATIONS

• Opioid non-tolerant patients.
• Acute or intermittent pain, postoperative pain, mild pain.
• Significant respiratory depression.
• Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment.
• Known or suspected gastrointestinal obstruction, including paralytic ileus.
• Known hypersensitivity to fentanyl or any of the components of the transdermal system.

Warnings

-Risk of Increased Fentanyl Absorption with Elevated Body Temperature: Monitor patients with fever closely for sedation and respiratory depression and reduce the dose if necessary. Warn patients to avoid strenuous exertion that may lead to increased body temperature

-Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury or Impaired Consciousness: Monitor for sedation and respiratory depression. Avoid use of DURAGESIC in patients with impaired consciousness or coma.

-Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid

-Severe Hypotension: Monitor during dose initiation and titration. Avoidthe use of DURAGESIC in patients with circulatory shock.

-Serotonin Syndrome with Concomitant Use of Serotonergic Drugs:-Potentially life-threatening condition could result from concomitant serotonergic drug administration. Discontinue DURAGESIC immediately if serotonin syndrome is suspected . WIKI

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