【藥品性質提示】 #高警訊藥品 #特殊劑型：不建議磨粉、管灌藥品 【藥品訊息】 Fentora 口頰錠 衛教單張

 

鴉片類止痛 Pain management, acute and chronic pain

Opioid Analgesic
Binds with stereospecific receptors at many sites within the CNS, increases pain threshold, alters pain reception, inhibits ascending pain pathways

1. Onset of action: 5-15 minutes
2. Duration: Related to blood level; respiratory depressant effect may last longer than analgesic effect
3. Absorption: Rapid, ~50% from the buccal mucosa; remaining 50% swallowed with saliva and slowly absorbed from GI tract
4. Distribution: Highly lipophilic, redistributes into muscle and fat; (Vdss, Children) ~15 L/kg; (Vdss, Adults) 4 to 6 L/kg; (Protein binding) 79% to 87%, primarily to alpha-1 acid glycoprotein; also binds to albumin and erythrocytes
5. Metabolism: Hepatic, primarily via CYP3A4 by N-dealkylation (to norfentanyl) and hydroxylation to other inactive metabolites
6. Bioavailability: 65%
7. Half-life elimination: (100-200 mcg) 3 to 4 hours; (400 to 800 mcg) 11 to 12 hours
8. Time to peak: 20 to 240 minutes
9. Excretion: Urine 75% (primarily as metabolites, <7% to 10% as unchanged drug); feces ~9%

1. Hypersensitivity (eg, anaphylaxis, hypersensitivity) to fentanyl or any component of the formulation.
2. Significant respiratory depression
3. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
4. Gastrointestinal obstruction, including paralytic ileus
5. Acute or postoperative pain (including headache, migraine, or dental pain); Acute pain management in the emergency room
6. Patients who are not opioid tolerant

Fentanyl crosses the placenta; Maternal use of opioids may be associated with birth defects (including neural tube defects, congenital heart defects, and gastroschisis), poor fetal growth, stillbirth, and preterm delivery.

Fentanyl and norfentanyl are present in breast milk; Current guidelines note that nonopioid analgesics are preferred for postpartum pain in breastfeeding women.

Confusion, dizziness, drowsiness, fatigue, headache, sedated state, dehydration, constipation, nausea, vomiting, asthenia, dyspnea

Note:
Patients previously using another fentanyl product should be initiated at a dose of 100 mcg; individually titrate to provide adequate analgesia while minimizing adverse effects.
Dose:
1. Initial: 100 mcg for all patients
2. Titration: May be increased to 200 mcg (two 100 mcg tablets, one on each side of mouth); If 200 mcg dose is not successful, patient can use four 100 mcg tablets (two on each side of mouth); If requires >400 mcg per dose, titrate using 200 mcg tablets
3. Do not use more than 4 tablets simultaneously (maximum single dose: 800 mcg)
4. Maintenance: Following titration, the effective maintenance dose using 1 tablet of the appropriate strength should be administered once per episode; Re-evaluate the around-the-clock opioid therapy in patients experiencing >4 breakthrough pain episodes per day.
Administration:
1. If adequate relief is not achieved after 30 minutes, a second dose of same strength per breakthrough pain episode may be used.
2. Must wait at least 4 hours before treating another episode with Fentora buccal tablet.

There are no dosage adjustments provided in the manufacturer's labeling; use with caution.

There are no dosage adjustments provided in the manufacturer's labeling; use with caution.