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ABSTRAL
Narcotic analgesics
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Drug Name:

ABSTRAL CII

Generic Name and Formulations:
Fentanyl 100mcg, 200mcg, 300mcg, 400mcg, 600mcg, 800mcg; sublingual tabs.

Company:
Sentynl Therapeutics

Therapeutic Use:

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.

Adult:

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.

Children:

<18yrs: not established.

Contraindications:

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.

Warnings/Precautions:

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.

Interactions:

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.

Pharmacological Class:

Opioid agonist.

Adverse Reactions:

Nausea, somnolence, headache, constipation; respiratory depression, severe hypotension, syncope.

Note:

Available by restricted distribution program. Call (866) 822-1483 to enroll. Properly handle and dispose; may be fatal to children.

REMS:

YES

How Supplied:

Sublingual tabs—32

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