Composition
TTS Patches 25 mcg: Releasing approximately Fentanyl 25 mcg per hour for 72 hours; self-adhesive, transparent patches. TTS Patches 50 mcg: Releasing approximately Fentanyl 50 mcg per hour for
Indications & Dosage
Chronic intractable malignant and non-malignant pain for patients who have not previously received a strong Opioid analgesic: Adult: Initially 25mcg/hour every 72 hours, when starting, evaluation of the analgesic effect should not be made before 24 hours of application (to allow for the gradual increase in plasma-fentanyl concentration), dose should be adjusted at 48-72 hour intervals in steps of12-25 mcg/hour if necessary, more than one patch may be used at a time (but applied at the same time to avoid confusion), consider additional or alternative analgesic therapy if dose required exceeds 300 mcg/hour. Apply to dry, non-irritated, non-irradiated, non-hairy skin on torso or upper arm, removing after 72 hr and sitting replacement patch on a different area. Chronic intractable pain currently treated with a strong opioid analgesic: BY TRANSDERMAL APPLICATION: Adult: Initial dose based on previous 24-hr opioid requirement (oral morphine sulphate 90 mg over 24 hr is approximately equivalent to one 25 mcg/hr patch).Apply to dry, non-irritated, non-irradiated, non-hairy skin on torso or upper arm, removing after 72 hr and sitting replacement patch on a different area. Children 2-17 yrs: Initial dose based on previous 24-houropioid requirement (consult product literature), for evaluating analgesic efficacy and dose increments. Breakthrough pain in patients receiving opioid therapy for chronic cancer pain: ORAL: Adult & Children 16 yrs: Initially 100 mcg repeated if necessary after 15-30 min; adjust dose according to response, no more than 2 dose units, 15-30 min apart, for each pain episode; max 800 mcg per episode of breakthrough pain. Consult product literature. Spontaneous respiration, analgesia and enhancement of anaesthesia, during operation: BY SLOW IV INJ: Adult& Children 12 yrs: Initially 50-100 mcg (max. per dose200 mcg), then 25-50 mcg as required Children 1 month-12 yr: Initially 1-3 mcg/kg, then 1 mcg/kg as required; slow IV injection over at least 30 sec. BY IV INF: Adult: 3-4.8 mcg/kg/hour, adjusted according to response. Assisted ventilation, analgesia and enhancement of anaesthesia during operation: BY SLOW IV INJ: Adult: Initially 300-3500 mcg, then 100-200 mcg as required Children: Neonate: Initially 1-5 mcg/kg, then 1-3 mcg/kg as required; 1 month-12 yr: initially 1-5 mcg/kg, then 1-3 mcg/kg as required; 12-18 yrs: Initially 1-5 mcg/kg, then 50-200 mcg as required. BY IV INF: Adult: Initially 10 mcg/kg, dose to be given over10 minutes, then 6 mcg/kg/hour, adjusted according to response, may require up to180 mcg/kg/hour during cardiac surgery. Assisted ventilation, analgesia and respiratory depression in intensive care: BY SLOW IV INJ: Adult: Initially 300-3500 mcg, then 100-200 mcg as required Children: Neonate: Initially by IV injection 1-5 mcg/kg, then by IV INF,1.5 mcg/kg/hr adjusted according to response; 1 month-18 yrs: Initially by IV injection 1-5 mcg/kg, then by IV INF, 1-6 mcg/kg/hr adjusted according to response. BY IV INF: Adult: Initially 10 mcg/kg, dose to be given over10 minutes, then 6 mcg/kg/hour, adjusted according to response, may require up to180 mcg/kg/hour during cardiac surgery.
Administration
Administered by IM or IV injection.
Compatibility
Stable in dextrose 5%, NaCI 0.9%.
Stability
Store at controlled room temperature and protect from light.
Contraindications
Severe respiratory depression, severe obstructive lung conditions, comatose patients, head injury and raised intracranial pressure (opioid analgesics interferewith pupillary responses vital for neurological assessment), risk of paralytic ileus
Precautions
Cerebral tumour, diabetes mellitus, impaired consciousness, raised intracranial pressure, impaired consciousness, head injury, bradyarrhythmia, renal or hepatic impairment. Monitor for signs of respiratory depression, risk of dependence, elderly or debilitated patients, and fever. Avoid in renal impairment or reduce dose. Avoid exposure of transdermal application site to direct heat, absorption from oralpreparations may be increased, caution during dosetitration. Important: it takes 17 hours ormore for the plasma-fentanyl concentration todecrease by 50%; replacement opioid therapy shouldbe initiated at a low dose and increased gradually.
Interactions
MAOls, CNS depressants, CYP3A4 inhibitors, grapefruit juice, narcotic antagonists.
Pregnancy
Risk of respiratory depression and withdrawal symptoms in the neonate and risk of gastric stasis and inhalation pneumonia in the mother if opioidanalgesics are used during labour and delivery
Lactation
Not recommended
Side Effects
Aesthenia, anorexia,anxiety, abdominal pain, diarrhoea, dyspepsia, dyspnea, gastrooesophageal reflux disease, hypertension, myoclonus, paraesthesia, pharyngitis, rhinitis, stomatitis, tremor, vasodilation, amnesia, arthralgia, blood disorders, chills, dysgeusia, flatulence, hypoventilation, ileus, impaired concentration and coordination, loss of consciousness, malaise, parosmia, pyrexia, seizures, thrombocytopenia. Rare: Apnoea, arrhythmia, ataxia, bladder pain, delusions, haemoptysis, asystole, insomnia