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Abstral

Abstral

fentanyl

Manufacturer:

Aesica Queenborough

Distributor:

A. Menarini
Concise Prescribing Info
Contents
Fentanyl citrate
Indications/Uses
Breakthrough pain in adult patient w/ cancer who are already receiving & who are tolerant to regular opioid therapy for underlying persistent/background cancer pain. Opioid tolerance: Patients considered opioid-tolerant are those who are taking, for 1 wk or longer, at least: Morphine 60 mg/day; transdermal fentanyl 25 mcg/hr; oxycodone 30 mg/day; oral hydromorphone 8 mg/day; oral oxymorphone 25 mg/day; equianalgesic dose of another oral opioid.
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Dosage/Direction for Use
Initially 100 mcg single dose. If adequate analgesia is not obtained w/in 15-30 min, a supplemental 100 mcg may be administered. If adequate analgesia is not obtained w/in 15-30 min of the 1st dose, increase dose to the next tab strength for the next episode of breakthrough pain during titration phase. Supplemental dose should be 100-200 mcg at dose of ≥400 mcg. No >2 doses be administered for a single episode during titration phase. Maintenance: Administer after at least 2 hr before treating another episode.
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Overdosage
View Abstral overdosage for action to be taken in the event of an overdose.
Administration
May be taken with or without food: Place tab under the tongue & allow to dissolve completely in the SL cavity, do not chew/suck/swallow. Do not eat or drink anything until tab is completely dissolved. For patient w/ dry mouth, use water to moisten the buccal mucosa before administration.
Contraindications
Hypersensitivity. Patients w/o maintenance therapy (increased risk of resp depression). Severe resp depression or severe obstructive lung conditions. Treatment of acute pain other than breakthrough pain.
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Special Precautions
Tolerance, physical &/or psychological dependence may develop. Discontinue if serotonin syndrome is suspected. Resp depression; patients w/ COPD or other medical conditions predisposing to resp depression (eg, myasthenia gravis). Patients susceptible to intracranial effects of hyperkapnia eg, evidence of raised ICP, reduced consciousness, coma or brain tumours; previous or preexisting bradyarrhythmias; liver or kidney dysfunction. Patients w/ mouth wounds or mucositis. May impair mental or physical ability to perform potentially hazardous tasks eg, driving or operating machinery. Pregnancy & lactation. Childn <18 yr. Elderly, cachectic or debilitated patients.
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Adverse Reactions
Nausea. Dizziness, headache, somnolence; dyspnoea; stomatitis, vomiting, constipation, dry mouth; hyperhidrosis; fatigue.
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Drug Interactions
May potentially enhance or prolong effects w/ macrolide antibiotics (eg, erythromycin), azole antifungals (eg, ketoconazole, itraconazole) or certain PIs (eg, ritonavir). Increased CNS depressant effects w/ CNS depressants eg, other morphine derivatives (analgesics & antitussives), general anaesth, skeletal muscle relaxants, sedative antidepressants, sedative H1 antihistamines, barbiturates, anxiolytics (ie, benzodiazepines), hypnotics, antipsychotics, clonidine & related substances. Potentiation of sedative effects w/ alcohol. Severe & unpredictable potentiation w/ MAOIs. Antagonism & induce w/drawal symptoms w/ partial opioid agonists/antagonists (eg, buprenorphine, nalbuphine, pentazocine). May increase risk of serotonin syndrome w/ SSRI or SNRI or MAOI.
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Caution For Usage
For caution against possible variation of physical aspect of medicine... Click to view Abstral detailed prescribing information
Storage
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Description
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Action
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MIMS Class
Analgesics (Opioid)
ATC Classification
N02AB03 - fentanyl ; Belongs to the class of phenylpiperidine derivative opioids. Used to relieve pain.
N01AH01 - fentanyl ; Belongs to the class of opioid anesthetics. Used as general anesthetics.
Presentation/Packing
Form
Abstral SL tab 100 mcg
Packing/Price
10's (P321.5/sublingual tab)
Form
Abstral SL tab 200 mcg
Packing/Price
10's (P321.5/sublingual tab)
Form
Abstral SL tab 300 mcg
Packing/Price
10's (P321.5/sublingual tab)
Form
Abstral SL tab 400 mcg
Packing/Price
10's (P321.5/sublingual tab)
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