How is Abstralsupplied?
Dosage Forms And Strengths ABSTRAL is formulated as a sublingual tablet and is available in six strengths, distinguishable by the shape of the tablet and by de- bossing on the tablet surface. All tablets are white: 100 microgram tablet is a round tablet marked with the number “1” 200 microgram tablet is an oval-shaped tablet marked with the number “2” 300 microgram tablet is a triangle-shaped tablet marked with the number “3” 400 microgram tablet is a diamond-shaped tablet marked with the number “4” 600 microgram tablet is a “D”-shaped tablet marked with the number “6” 800 microgram tablet is a capsule-shaped tablet marked with the number “8” [see HOW SUPPLIED/Storage and Handling]. Storage And Handling ABSTRAL is supplied in individually sealed child-resistant blister packages contained in a cardboard outer carton, in pack sizes of 12 (100 mcg, 200 mcg, 300 mcg and 400 mcg strengths) or 32 (all strengths) tablets. The packaging is color-coded for each ABSTRAL tablet strength. The amount of fentanyl contained in ABSTRAL can be fatal to a child, individual for whom it is not prescribed or non-opioid tolerant adult. Patients and their caregivers must be instructed to keep ABSTRAL out of the reach of children [see BOXED WARNING - WARNINGS: Potential For Abuse and Importance Of Proper Patient Selection and WARNINGS AND PRECAUTIONS, and PATIENT INFORMATION]. Store at 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture. Disposal Of ABSTRAL Patients and their household members must be advised to dispose of any tablets remaining from a prescription as soon as they are no longer needed. Instructions are included in Patient Counseling Information and in the Medication Guide. To dispose of any unused ABSTRAL tablets, remove them from the blister cards and flush down the toilet. Do Page 18 of 21 not dispose of the ABSTRAL blister cards or cartons down the toilet. If additional assistance is required, call Galena Biopharma, Inc. at 1-888-227-8725. How Supplied ABSTRAL is supplied in six dosage strengths. Tablets are supplied in child-resistant, protective blister cards with peelable foil. Each blister card contains 4 tablets, in pack sizes of 12 (100 mcg, 200 mcg, 300 mcg and 400 mcg strengths) or 32 (all strengths) tablets. Each tablet is white in color, with the strength distinguishable by the shape of the dosage unit and by de-bossing on the tablet surface: Dosage Strength (fentanyl base) Tablet Shape Tablet Markings Carton/Blister Package Color Pack size NDC Number 100 mcg Round “1” Light blue 12
32 57881-331-12 57881-331-32 200 mcg Oval “2” Dark orange 12
32 57881-332-12 57881-332-32 300 mcg Triangle “3” Brown 12
32 57881-333-12 57881-333-32 400 mcg Diamond “4” Violet 12
32 57881-334-12 57881-334-32 600 mcg “D” “6” Turquoise 32 57881-336-32 800 mcg Capsule “8” Indigo 32 57881-338-32 Note: Colors and shapes are a secondary aid in product identification. Please be sure to confirm the printed dosage before dispensing. Manufactured by: Pharmaceutics International, Inc., Hunt Valley, MD 21031. Manufactured for: Galena Biopharma, Inc. Portland, OR 97239. Issued: July 2014 Last reviewed on RxList: 11/12/2014
This monograph has been modified to include the generic and brand name in many instances.