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ABSTRAL

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ABSTRAL (fentanyl) transmucosal immediate-release tablets by ProStrakan

Generic Name for ABSTRAL

Fentanyl 100mcg, 200mcg, 300mcg, 400mcg, 600mcg, 800mcg; sublingual tablets.

Legal Classification:

CII

Pharmacological Class for ABSTRAL

Opioid.

Manufacturer of ABSTRAL

ProStrakan, Inc.

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, oxycodone ≥30mg/day, hydromorphone ≥8mg/day, oxymorphone ≥25mg/day, or equianalgesic dose of another opioid for ≥1 week; or transdermal fentanyl ≥25mcg/hr.

Adult dose for ABSTRAL

≥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. Do not convert from other fentanyl products on a mcg per mcg basis or interchange with other fentanyl products. Rescue medication may be used.

Children's dosing for ABSTRAL

<18yrs: not recommended.

Contraindications for ABSTRAL

Not for opioid non-tolerant patients. Acute or post-op pain (including headache/migraine, dental pain, or ER).

Warnings/Precautions for ABSTRAL

Respiratory disorders or depression. Head injury. Increased intracranial pressure. Bradyarrhythmias. Impaired pulmonary, cardio, renal, or hepatic function. Elderly. Debilitated. Pregnancy (Cat. C). Labor & delivery, nursing mothers: not recommended.

Interactions for ABSTRAL

Not recommended within 14 days of MAOIs. Potentiates CNS depression with alcohol, other CNS depressants (eg, phenothiazines, skeletal muscle relaxants, antihistamines, hypnotics). Potentiated by CYP3A4 inhibitors (eg, macrolides, azole antifungals, aprepitant, protease inhibitors, nefazodone, verapamil, diltiazem). Antagonized by CYP3A4 inducers (eg, barbiturates, efavirenz, modafinil, nevirapine, anticonvulsants, pioglitazone, troglitazone, rifabutin, rifampin, St John’s wort).

Adverse Reactions for ABSTRAL

Nausea, somnolence, headache, constipation; respiratory/circulatory depression.

Notes for ABSTRAL

Available by restricted distribution program. Call (888) 227-8725 to enroll. Properly handle and dispose; may be fatal to children.

How is ABSTRAL supplied?

Sublingual tabs—32

Related Disease:

Pain, general~narcotics

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