Abstral (Fentanyl) [Sublingual tablet] 800 mcg

Abstral (Fentanyl) [Sublingual tablet] 800 mcg


Abstral (Fentanyl Sublingual Tablets) may treat, uses, dosage, side effects, drug interactions, warnings, patient labeling, reviews, and related … For patients converting from Actiq doses of 1200 and 1600 mcg, initiate titration with 200 mcg and 400 mcg Abstral, respectively and proceed using multiples of this …



Indications for ABSTRAL:

Breakthrough pain, in opioid-tolerant patients already receiving and who are tolerant to continuous opioid therapy for underlying persistent cancer pain. Opioid-tolerant patients are those taking oral morphine ≥60mg/day, transdermal fentanyl ≥25mcg/hr, oral oxycodone ≥30mg/day, oral hydromorphone ≥8mg/day, oral oxymorphone ≥25mg/day, oral hydrocodone ≥60mg/day, or equianalgesic dose of another opioid for ≥1 week. Abstral (Fentanyl) [Sublingual tablet] 800 mcg


Do not substitute with other fentanyl products; not equivalent to other fentanyl products on a mcg to mcg basis. Use lowest effective dose for shortest duration. ≥18yrs: Do not chew, suck, swallow tablets. Allow tablets to dissolve in sublingual cavity. Do not eat or drink until tablet completely dissolves. Individualize. Initially one 100mcg dose; if adequate analgesia is obtained within 30min, continue to treat subsequent episodes with this dose. If inadequate, give 2nd dose (after 30min). For future episodes, if analgesia is not obtained with 100mcg dose, titrate in increments of 100mcg up to 400mcg as needed; if 400mcg dose is inadequate, titrate to 600mcg dose, then 800mcg dose if needed. May use 100mcg or 200mcg tablets for any single dose; max 4 tabs at one time. Max 2 doses/episode, up to 4 episodes/day. Wait at least 2hrs before treating another episode. Maintenance: use only one tablet of appropriate strength. Rescue medication may be used. Concomitant use or discontinuation of CYP3A4 inhibitors or inducers: monitor closely and consider dose adjustments (see full labeling). Conversion from Actiq: see full labeling. Abstral (Fentanyl) [Sublingual tablet] 800 mcg


<18yrs: not established.


Opioid non-tolerant patients. Acute or post-op pain (including headache/migraine, dental pain, or ER). Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. Known or suspected GI obstruction, including paralytic ileus. Abstral (Fentanyl) [Sublingual tablet] 800 mcg

Life-threatening respiratory depression; monitor within first 24–72hrs of initiating therapy and following dose increases. Accidental exposure may cause fatal overdose (esp. in children). COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. Abuse potential (monitor). Adrenal insufficiency. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. CNS depression. Impaired consciousness, coma, shock; avoid. Biliary tract disease. Acute pancreatitis. Bradyarrhythmias. Drug abusers. Renal or hepatic impairment. Reevaluate periodically. Avoid abrupt cessation. Elderly. Cachectic. Debilitated. Pregnancy (Cat.C); potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery, nursing mothers: not recommended. Abstral (Fentanyl) [Sublingual tablet] 800 mcg


Increased risk of hypotension, respiratory depression, sedation with benzodiazepines or other CNS depressants (eg, non-benzodiazepine sedatives/hypnotics, anxiolytics, general anesthetics, phenothiazines, tranquilizers, muscle relaxants, antipsychotics, alcohol, other opioids); reserve concomitant use in those for whom alternative options are inadequate; limit dosages/durations to minimum required; monitor. During or within 14 days of MAOIs: not recommended. Risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, 5-HT3 antagonists, mirtazapine, trazodone, tramadol, MAOIs, linezolid, IV methylene blue); monitor and discontinue if suspected. Avoid concomitant mixed agonist/antagonist opioids (eg, butorphanol, nalbuphine, pentazocine) or partial agonist (eg, buprenorphine); may reduce effects and precipitate withdrawal symptoms. Potentiated by CYP3A4 inhibitors (eg, macrolides, azole antifungals, protease inhibitors, grapefruit juice). Antagonized by CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin). May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics. Abstral (Fentanyl) [Sublingual tablet] 800 mcg


ABSTRAL (fentanyl) sublingual tablets are indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioidtherapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking around-theclock medicine consisting of at least 60 mg of oral morphine daily, or at least 25 mcg of transdermal fentanyl/hour, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or at least 25 mg oral oxymorphone daily, or an equianalgesic dose of another opioid medication daily for a week or longer. Patients must remain on around-the-clock opioids when taking ABSTRAL. Abstral (Fentanyl) [Sublingual tablet] 800 mcg

ABSTRAL is contraindicated for patients who are not already tolerant to opioids because life-threatening respiratory depression and death could result at any dose in patients not on a chronic regimen of opioids. For this reason, ABSTRAL is contraindicated in the management of acute or postoperative pain, including headache/migraine, dental pain, or use in the emergency room. Abstral (Fentanyl) [Sublingual tablet] 800 mcg