Search

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.
Click to view Abstral detailed prescribing information
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.
Click to view Abstral detailed prescribing information
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 sublingual 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.
Click to view Abstral detailed prescribing information
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 intracranial pressure, 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.
Click to view Abstral detailed prescribing information
Adverse Reactions
Nausea. Dizziness, headache, somnolence; dyspnoea; stomatitis, vomiting, constipation, dry mouth; hyperhidrosis; fatigue.
Click to view Abstral detailed prescribing information
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.
Click to view Abstral detailed prescribing information
Caution For Usage
For caution against possible variation of physical aspect of medicine... Click to view Abstral detailed prescribing information
Storage
View Abstral storage conditions for details to ensure optimal shelf-life.
Description
View Abstral description for details of the chemical structure and excipients (inactive components).
Action
View Abstral mechanism of action for pharmacodynamics and pharmacokinetics details.
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 (P312.49/sublingual tab)
Form
Abstral SL tab 200 mcg
Packing/Price
10's (P312.49/sublingual tab)
Form
Abstral SL tab 300 mcg
Packing/Price
10's (P312.49/sublingual tab)
Form
Abstral SL tab 400 mcg
Packing/Price
10's (P312.49/sublingual tab)
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in