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Date/Time:  1/23/21 21:39 GMT
 

Buy Fentora 800mcg Tablets (Fentanyl buccal Tablets) 28 Tabs/Box

Buy Fentora Tablets, 800 mcg (28 tabs/Box)
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Fentora (fentanyl buccal tablets) is a an opioid pain medication used for the
treatment of breakthrough pain in cancer patients receiving opioid treatment
and who have become tolerant to it.

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FENTORA (fentanyl buccal tablet) is a potent opioid analgesic, intended for
buccal mucosal administration.

FENTORA is designed to be placed and retained within the buccal cavity for a
period sufficient to allow disintegration of the tablet and absorption of
fentanyl across the oral mucosa.

FENTORA employs the OraVescent® drug delivery technology, which generates a
reaction that releases carbon dioxide when the tablet comes in contact with
saliva. It is believed that transient pH changes accompanying the reaction may
optimize dissolution (at a lower pH) and membrane permeation (at a higher pH)
of fentanyl through the buccal mucosa.

Active Ingredient: Fentanyl citrate, USP is N-(1-Phenethyl-4piperidyl)
propionanilide citrate (1:1). Fentanyl is a highly lipophilic compound
(octanol-water partition coefficient at pH 7.4 is 816:1) that is freely soluble
in organic solvents and sparingly soluble in water (1:40). The molecular weight
of the free base is 336.5 (the citrate salt is 528.6). The pKa of the tertiary
nitrogens are 7.3 and 8.4.

All tablet strengths are expressed as the amount of fentanyl free base, e.g.,
the 800 microgram strength tablet contains 800 micrograms of fentanyl free
base.

Inactive Ingredients: Mannitol, sodium starch glycolate, sodium bicarbonate,
sodium carbonate, citric acid, and magnesium stearate.

INDICATIONS
FENTORA is 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
around-the-clock opioid therapy for their underlying persistent cancer pain.
Patients considered opioid tolerant are those who are taking around-the-clock
medicine consisting of at least 60 mg of oral morphine daily, at least 25
mcg/hr of transdermal fentanyl, at least 30 mg of oral oxycodone daily, at
least 8 mg of oral hydromorphone daily, at least 25 mg oral oxymorphone daily,
or an equianalgesic dose of another opioid daily for a week or longer. Patients
must remain on around-the-clock opioids while taking FENTORA.

This product must not be used in opioid non-tolerant patients because life-
threatening hypoventilation and death could occur at any dose in patients not
on a chronic regimen of opioids. For this reason, FENTORA is contraindicated in
the management of acute or postoperative pain.

FENTORA is intended to be used only in the care of opioid tolerant cancer
patients and only by healthcare professionals who are knowledgeable of and
skilled in the use of Schedule II opioids to treat cancer pain.

Limitations of Use

As a part of the TIRF REMS Access program, FENTORA may be dispensed only to
outpatients enrolled in the program [see WARNINGS AND PRECAUTIONS]. For
inpatient administration of FENTORA (e.g., hospitals, hospices, and long-term
care facilities that prescribe for inpatient use), patient and prescriber
enrollment is not required.

DOSAGE AND ADMINISTRATION
Healthcare professionals who prescribe FENTORA on an outpatient basis must
enroll in the TIRF REMS Access program and comply with the requirements of the
REMS to ensure safe use of FENTORA [see WARNINGS AND PRECAUTIONS].

As with all opioids, the safety of patients using such products is dependent on
health care professionals prescribing them in strict conformity with their
approved labeling with respect to patient selection, dosing, and proper
conditions for use.

It is important to minimize the number of strengths available to patients at
any time to prevent confusion and possible overdose.

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Buy Fentora 800mcg Tablets (Fentanyl buccal Tablets) 28 Tabs/Box
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