Fentanyl

Registered South African indications:

• Pain

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Acute or postoperative pain
• Severe respiratory depression
• Severe impairment of central nervous system

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Respiratory depression
• Suspected serotonin syndrome
• Chronic obstructive or other pulmonary diseases
• History of addiction or dependance
• Raised intracranial pressure
• Impaired consciousness or coma
• Cerebral tumour
• Bradyarrhythmias  
• Symptomatic hypotension
• Hypovolaemia
• Fever
• External heat source application 
• Myasthenia gravis
• Accidental exposure by patch transfer 
• Children 
• May impair ability to drive & operate machinery

Forms avail. in SA and covered in this monograph: pat

Pain - severe
- Opioid-naive patients

• Transdermal patch (pat): Patients should be titrated with low dose of immediate release opioids (morphine, hydromorphone, oxycodone, tramadol) then converted to 25μg/hr patch; Patch to be changed every 48-72hrs; Dose adjustments should be done in 12-25μg/hr intervals; Max initial dose: 25μg/hr

- Opioid-tolerant patients

• Transdermal patch (pat): Patients should be converted from oral or parenteral opioids to fentanyl patch according to equianalgesic potency conversion; Patch to be changed every 48-72hrs; Dose adjustments should be done in 12-25μg/hr intervals

Forms avail. in SA and covered in this monograph: pat

Pain - severe
Younger than 2 years

• Not established for use

Older than 2 years

• See adult dosage

Pregnancy 

• Caution
• There are no adequate data from the use of fentanyl patches in pregnant women. Studies in animals have shown some reproductive toxicity. The potential risk for humans is unknown, although fentanyl as an IV anaesthetic has been found to cross the placenta in human pregnancies. Neonatal-withdrawal syndrome has been reported in newborn infants with chronic maternal use of fentanyl patches during pregnancy. Fentanyl patches should not be used during pregnancy unless clearly necessary
• Use of fentanyl patches during childbirth is not recommended because it should not be used in the management of acute or postoperative pain. Moreover, because fentanyl passes through the placenta, the use of fentanyl patches during childbirth might result in respiratory depression in the newborn infant

Breastfeeding

• Caution; not recommended
• Fentanyl is excreted into human milk and may cause sedation/respiratory depression in a breastfed infant. Breastfeeding should, therefore, be discontinued during treatment with fentanyl patches and for at least 72 hours after removal of the patch

Renal Impairment

• Caution; dose adjustment recommended

Hepatic Impairment

• Caution; dose adjustment recommende

Elderly 

• Caution; dose adjustment recommended
  Opioid-tolerant: Dose should be individualised based upon the status of the patient
  Opioid-naive: Initial dose: 12μg/hr

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Prohibited - In competition

Central Nervous System Disorders

• Sedation
• Insomnia
• Depression
• Anxiety
• Confusion
• Hallucination
• Agitation
• Disorientation
• Euphoric mood
• Somnolence
• Dizziness
• Headache
• Tremor
• Paraesthesia
• Hypoaesthesia
• Seizures 
• Amnesia
• Speech disorder  

Cardiovascular Disorders

• Palpitations
• Tachycardia
• Bradycardia
• Cyanosis
• Arrhythmia
• Hypertension
• Hypotension
• Vasodilation

Respiratory Disorders

• Dyspnoea
• Respiratory depression
• Respiratory distress 
• Apnoea
• Hypoventilation 
• Bradypnoea

Gastrointestinal Disorders

• Nausea and vomiting
• Constipation
• Diarrhoea
• Dry mouth
• Abdominal pain
• Upper abdominal pain 
• Dyspepsia
• Ileus
• Subileus
• Painful flatulence

Genitourinary Disorders

• Urinary retention
• Oliguria
• Cystalgia
• Erectile dysfunction
• Sexual dysfunction  

Endocrine and Metabolic Disorders

• Anorexia

Musculoskeletal Disorders

• Muscle spasms
• Muscle twitching

Skin and Subcutaneous Tissue Disorders

• Hyperhidrosis
• Pruritus
• Rash
• Erythema
• Eczema
• Allergic dermatitis 
• Skin disorder
• Dermatitis
• Contact dermatitis  

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity
• Anaphylactic shock
• Anaphylactic reactions
• Anaphylactoid reactions

Sensory Disorders

• Conjunctiviis
• Miosis
• Vertigo

• Central nervous system depressants
• CYP3A4 inhibitors
• CYP3A4 inducers
• Monoamine oxidase inhibitors
• Selective serotonin reuptake inhibitors
• Serotonin norepinephrine reuptake inhibitors  
• Buprenorphine
• Nalbuphine
• Pentazocine

• Respiratory depression especially during the 1st 24-48 hours  

Specific cases may require

• Renal function
• Hepatic function

Equianalgesic potency conversion

• Calculate previous 24hr analgesic requirement
• Convert this amount to the equianalgesic oral morphine dose (Table 1). All IM and oral doses are equivalent to 10mg IM morphine in analgesic effect

• Table 2 displays the range of 24hr oral morphine doses that are recommended for conversion to each patch dose

Fentanyl is an opioid analgesic that interacts predominately with the opioid mu-receptor but also binds to kappa and delta-type opioid receptors. These mu-binding sites are discretely distributed in the human brain, spinal cord, and other tissues. Its primary actions of therapeutic value are analgesia and sedation. Fentanyl may increase the patient's tolerance for pain and decrease the perception of suffering, although the presence of the pain itself may still be recognized.

Transdermal patch (per h) 12μg

• Durogesic (Janssen) originator

Transdermal patch (per h) 25μg

• Adco Tenyl (Adcock Ingram)
• Durogesic (Janssen) originator
• Fendermal (Sandoz)

Transdermal patch (per h) 50μg

• Adco Tenyl (Adcock Ingram)
• Durogesic (Janssen) originator
• Fendermal (Sandoz)

Transdermal patch (per h) 75μg

• Adco Tenyl (Adcock Ingram)
• Durogesic (Janssen) originator
• Fendermal (Sandoz)

Transdermal patch (per h) 100μg

• Adco Tenyl (Adcock Ingram)
• Durogesic (Janssen) originator
• Fendermal (Sandoz)