Fentora

Fentora

fentanyl

Manufacturer:

Teva

Distributor:

Zuellig
Concise Prescribing Info
Contents
Fentanyl
Indications/Uses
Breakthrough pain in adult w/ cancer who is already receiving maintenance opioid therapy for chronic cancer pain.
Dosage/Direction for Use
Patient not switching from other fentanyl containing products Initially 100 mcg, titrating upwards as necessary through the range of available strengths. Patient switching from other fentanyl containing products Starting dose >100 mcg may be considered.
Administration
Should be taken on an empty stomach: Place & retain the tab w/in the buccal cavity until the tab disintegrate approx 14-25 min. After 30 min, if remnants from the tab remain, drink a glass of water. Alternatively, take sublingually. Do not suck/chew/swallow.
Contraindications
Hypersensitivity; patients w/ maintenance opioid therapy may increase risk of resp depression; severe resp depression or severe obstructive lung conditions; treatment of acute pain other than breakthrough pain.
Special Precautions
Resp depression. Patients w/ non-severe COPD or other medical conditions predisposing to resp depression may further decrease resp drive to the point of resp failure. Patients particularly susceptible to the intracranial effects of CO2 retention (eg, increased ICP or impaired consciousness). May produce bradycardia. Hepatic or renal impairment. Concomitant use of serotonergic drugs eg, SSRIs & serotonin norepinephrine reuptake inhibitors, & w/ drugs which impair metabolism of serotonin including MAOIs. Tolerance & physical &/or psychological dependence may develop. Patients on a controlled Na diet. Anaphylaxis & hypersensitivity. Opioid analgesics impair the mental &/or physical ability required for the performance of potentially dangerous tasks. Pregnancy & lactation. Childn. Elderly >65 yr.
Adverse Reactions
Dizziness, headache; nausea, vomiting; application site reactions. Oral candidiasis; anaemia, neutropenia; anorexia; depression, anxiety, confusional state, insomnia; dysgeusia, somnolence, lethargy, tremor, sedation, hypoaesthesia, migraine; tachycardia; hypotension, HTN; dyspnoea, pharyngolaryngeal pain; constipation, stomatitis, dry mouth, diarrhoea, abdominal pain, GERD, stomach discomfort, dyspepsia, toothache; pruritus, hyperhidrosis, rash; myalgia, back pain; peripheral oedema, fatigue, asthenia, drug w/drawal syndrome, chills; decreased wt; fall.
Drug Interactions
Increased plasma conc w/ strong (eg, ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir) or moderate (eg, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, verapamil) CYP3A4 inhibitors. Additive effects w/ CNS depressants including opioids, sedatives or hypnotics, general anaesth, phenothiazines, tranquillisers, skeletal muscle relaxants, sedating antihistamines & alcohol. Potentiation w/ MAOIs. Partially antagonised analgesic effect w/ partial opioid agonists/antagonists (eg, buprenorphine, nalbuphine, pentazocine). Increased risk of serotonin syndrome w/ SSRIs, serotonin norepinephrine reuptake inhibitors & MAOIs.
MIMS Class
Analgesics (Opioid) / Supportive Care Therapy
ATC Classification
N02AB03 - fentanyl ; Belongs to the class of phenylpiperidine derivative opioids. Used to relieve pain.
Presentation/Packing
Form
Fentora buccal tab 100 mcg
Packing/Price
28's
Form
Fentora buccal tab 200 mcg
Packing/Price
28's
Form
Fentora buccal tab 400 mcg
Packing/Price
28's
Form
Fentora buccal tab 600 mcg
Packing/Price
28's
Form
Fentora buccal tab 800 mcg
Packing/Price
28's
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