Reviews Fentanyl Buccal Soluble Film


No reviews yet.

Onsolis Drug Description
Onsolis
(fentanyl buccal soluble film)

WARNINGS
IMPORTANCE OF PROPER PATIENT SELECTION AND POTENTIAL FOR
ABUSE
Onsolis contains fentanyl, an opioid agonist and a Schedule II controlled
substance, with abuse liability similar to other opioid analgesics. This should
be considered when prescribing or dispensing Onsolis in situations where the
physician or pharmacist is concerned about an increased risk of misuse, abuse
or diversion. Schedule II opioid substances, which include morphine, oxycodone,
hydromorphone, oxymorphone, and methadone, have the highest potential for abuse
and risk of fatal overdose due to respiratory depression.
Serious adverse events, including deaths, in patients treated with other
oral transmucosal fentanyl products have been reported. Deaths occurred as a
result of improper patient selection (e.g., use in opioid non-tolerant patients)
and/or improper dosing. The substitution of Onsolis for any other fentanyl product
may result in fatal overdose.
Onsolis is indicated only for the management of breakthrough pain in patients
with cancer, 18 years of age and older, who are already receiving and who are
tolerant to opioid therapy for their underlying persistent cancer pain.
Patients considered opioid tolerant are those who are taking at least: 60 mg
oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day,
8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic
dose of another opioid for one week or longer.
Onsolis is contraindicated for use in opioid non-tolerant patients including
those using opioids intermittently, on an as needed basis.
Onsolis is contraindicated in the management of acute or postoperative pain,
including headache/migraine, dental pain, or use in the emergency room. Life-threatening
respiratory depression could occur at any dose in opioid non-tolerant patients.
Deaths have occurred in opioid non-tolerant patients treated with other fentanyl
products.
When prescribing, do not convert patients on a mcg per mcg basis from any
other oral transmucosal fentanyl product to Onsolis. Patients beginning treatment
with Onsolis must begin with titration from the 200 mcg dose [see DOSAGE
AND ADMINISTRATION].
When dispensing, do not substitute an Onsolis prescription for any other
fentanyl product. Substantial differences exist in the pharmacokinetic profile
of Onsolis compared to other fentanyl products that result in clinically important
differences in the extent of absorption of fentanyl. As a result of these differences,
the substitution of Onsolis for any other fentanyl product may result in fatal
overdose.
Special care must be used when dosing Onsolis. If the breakthrough pain episode
is not relieved, patients should wait at least 2 hours before taking another
dose [see DOSAGE AND ADMINISTRATION].
Onsolis is intended to be used only in the care of opioid tolerant patients
with cancer and only by healthcare professionals who are knowledgeable of, and
skilled in, the use of Schedule II opioids to treat cancer pain.
Patients and their caregivers must be instructed that Onsolis contains a
medicine in an amount which can be fatal in children, in individuals for whom
it is not prescribed, and in those who are not opioid tolerant. All Onsolis
films must be kept out of the reach of children [see PATIENT
INFORMATION].
The concomitant use of Onsolis with CYP3A4 inhibitors may result in an increase
in fentanyl plasma concentrations and may cause potentially fatal respiratory
depression [see DRUG INTERACTIONS].
Because of the risk for misuse, abuse, and overdose, Onsolis is available only
through a restricted distribution program, called the FOCUS Program. Under the
FOCUS Program, only prescribers, pharmacies, and patients registered with the
program are able to prescribe, dispense, and receive Onsolis. To enroll in the
FOCUS Program, call 1-877-466-7654 (1-877-4Onsolis) or visit www.OnsolisFocus.com
[see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION
Onsolis (fentanyl buccal soluble film) is an oral transmucosal form of the
potent opioid analgesic, fentanyl citrate, intended for application to the buccal mucosa. Onsolis uses the BioErodible MucoAdhesive (BEMA™) bilayer delivery technology
which is comprised of water-soluble polymeric films. Onsolis consists of a pink
bioadhesive layer bonded onto a white inactive layer. The active ingredient,
fentanyl citrate, is incorporated into the bioadhesive layer, which adheres
to the moist buccal mucosa. The amount of fentanyl delivered transmucosally
is proportional to the film surface area. It is believed that the inactive layer
isolates the bioadhesive layer from the saliva, which may optimize delivery
of fentanyl across the buccal mucosa.
Active Ingredient: Fentanyl citrate, USP is N-(1-Phenethyl-4-piperidyl)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. Fentanyl citrate has the following structural formula:








Inactive Ingredients: Carboxymethylcellulose, citric acid, hydroxyethyl
cellulose, hydroxypropyl cellulose, methylparaben, monobasic sodium phosphate,
peppermint oil, polycarbophil, propylene glycol, propylparaben, red iron oxide,
sodium benzoate, sodium hydroxide, sodium saccharin, titanium dioxide, tribasic
sodium phosphate, vitamin E acetate, and water.Last reviewed on RxList: 7/29/2010




Onsolis Drug Description
Onsolis
(fentanyl buccal soluble film)

WARNINGS
IMPORTANCE OF PROPER PATIENT SELECTION AND POTENTIAL FOR
ABUSE
Onsolis contains fentanyl, an opioid agonist and a Schedule II controlled
substance, with abuse liability similar to other opioid analgesics. This should
be considered when prescribing or dispensing Onsolis in situations where the
physician or pharmacist is concerned about an increased risk of misuse, abuse
or diversion. Schedule II opioid substances, which include morphine, oxycodone,
hydromorphone, oxymorphone, and methadone, have the highest potential for abuse
and risk of fatal overdose due to respiratory depression.
Serious adverse events, including deaths, in patients treated with other
oral transmucosal fentanyl products have been reported. Deaths occurred as a
result of improper patient selection (e.g., use in opioid non-tolerant patients)
and/or improper dosing. The substitution of Onsolis for any other fentanyl product
may result in fatal overdose.
Onsolis is indicated only for the management of breakthrough pain in patients
with cancer, 18 years of age and older, who are already receiving and who are
tolerant to opioid therapy for their underlying persistent cancer pain.
Patients considered opioid tolerant are those who are taking at least: 60 mg
oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day,
8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic
dose of another opioid for one week or longer.
Onsolis is contraindicated for use in opioid non-tolerant patients including
those using opioids intermittently, on an as needed basis.
Onsolis is contraindicated in the management of acute or postoperative pain,
including headache/migraine, dental pain, or use in the emergency room. Life-threatening
respiratory depression could occur at any dose in opioid non-tolerant patients.
Deaths have occurred in opioid non-tolerant patients treated with other fentanyl
products.
When prescribing, do not convert patients on a mcg per mcg basis from any
other oral transmucosal fentanyl product to Onsolis. Patients beginning treatment
with Onsolis must begin with titration from the 200 mcg dose [see DOSAGE
AND ADMINISTRATION].
When dispensing, do not substitute an Onsolis prescription for any other
fentanyl product. Substantial differences exist in the pharmacokinetic profile
of Onsolis compared to other fentanyl products that result in clinically important
differences in the extent of absorption of fentanyl. As a result of these differences,
the substitution of Onsolis for any other fentanyl product may result in fatal
overdose.
Special care must be used when dosing Onsolis. If the breakthrough pain episode
is not relieved, patients should wait at least 2 hours before taking another
dose [see DOSAGE AND ADMINISTRATION].
Onsolis is intended to be used only in the care of opioid tolerant patients
with cancer and only by healthcare professionals who are knowledgeable of, and
skilled in, the use of Schedule II opioids to treat cancer pain.
Patients and their caregivers must be instructed that Onsolis contains a
medicine in an amount which can be fatal in children, in individuals for whom
it is not prescribed, and in those who are not opioid tolerant. All Onsolis
films must be kept out of the reach of children [see PATIENT
INFORMATION].
The concomitant use of Onsolis with CYP3A4 inhibitors may result in an increase
in fentanyl plasma concentrations and may cause potentially fatal respiratory
depression [see DRUG INTERACTIONS].
Because of the risk for misuse, abuse, and overdose, Onsolis is available only
through a restricted distribution program, called the FOCUS Program. Under the
FOCUS Program, only prescribers, pharmacies, and patients registered with the
program are able to prescribe, dispense, and receive Onsolis. To enroll in the
FOCUS Program, call 1-877-466-7654 (1-877-4Onsolis) or visit www.OnsolisFocus.com
[see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION
Onsolis (fentanyl buccal soluble film) is an oral transmucosal form of the
potent opioid analgesic, fentanyl citrate, intended for application to the buccal mucosa. Onsolis uses the BioErodible MucoAdhesive (BEMA™) bilayer delivery technology
which is comprised of water-soluble polymeric films. Onsolis consists of a pink
bioadhesive layer bonded onto a white inactive layer. The active ingredient,
fentanyl citrate, is incorporated into the bioadhesive layer, which adheres
to the moist buccal mucosa. The amount of fentanyl delivered transmucosally
is proportional to the film surface area. It is believed that the inactive layer
isolates the bioadhesive layer from the saliva, which may optimize delivery
of fentanyl across the buccal mucosa.
Active Ingredient: Fentanyl citrate, USP is N-(1-Phenethyl-4-piperidyl)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. Fentanyl citrate has the following structural formula:








Inactive Ingredients: Carboxymethylcellulose, citric acid, hydroxyethyl
cellulose, hydroxypropyl cellulose, methylparaben, monobasic sodium phosphate,
peppermint oil, polycarbophil, propylene glycol, propylparaben, red iron oxide,
sodium benzoate, sodium hydroxide, sodium saccharin, titanium dioxide, tribasic
sodium phosphate, vitamin E acetate, and water.Last reviewed on RxList: 7/29/2010




Onsolis Drug Description
Onsolis
(fentanyl buccal soluble film)

WARNINGS
IMPORTANCE OF PROPER PATIENT SELECTION AND POTENTIAL FOR
ABUSE
Onsolis contains fentanyl, an opioid agonist and a Schedule II controlled
substance, with abuse liability similar to other opioid analgesics. This should
be considered when prescribing or dispensing Onsolis in situations where the
physician or pharmacist is concerned about an increased risk of misuse, abuse
or diversion. Schedule II opioid substances, which include morphine, oxycodone,
hydromorphone, oxymorphone, and methadone, have the highest potential for abuse
and risk of fatal overdose due to respiratory depression.
Serious adverse events, including deaths, in patients treated with other
oral transmucosal fentanyl products have been reported. Deaths occurred as a
result of improper patient selection (e.g., use in opioid non-tolerant patients)
and/or improper dosing. The substitution of Onsolis for any other fentanyl product
may result in fatal overdose.
Onsolis is indicated only for the management of breakthrough pain in patients
with cancer, 18 years of age and older, who are already receiving and who are
tolerant to opioid therapy for their underlying persistent cancer pain.
Patients considered opioid tolerant are those who are taking at least: 60 mg
oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day,
8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic
dose of another opioid for one week or longer.
Onsolis is contraindicated for use in opioid non-tolerant patients including
those using opioids intermittently, on an as needed basis.
Onsolis is contraindicated in the management of acute or postoperative pain,
including headache/migraine, dental pain, or use in the emergency room. Life-threatening
respiratory depression could occur at any dose in opioid non-tolerant patients.
Deaths have occurred in opioid non-tolerant patients treated with other fentanyl
products.
When prescribing, do not convert patients on a mcg per mcg basis from any
other oral transmucosal fentanyl product to Onsolis. Patients beginning treatment
with Onsolis must begin with titration from the 200 mcg dose [see DOSAGE
AND ADMINISTRATION].
When dispensing, do not substitute an Onsolis prescription for any other
fentanyl product. Substantial differences exist in the pharmacokinetic profile
of Onsolis compared to other fentanyl products that result in clinically important
differences in the extent of absorption of fentanyl. As a result of these differences,
the substitution of Onsolis for any other fentanyl product may result in fatal
overdose.
Special care must be used when dosing Onsolis. If the breakthrough pain episode
is not relieved, patients should wait at least 2 hours before taking another
dose [see DOSAGE AND ADMINISTRATION].
Onsolis is intended to be used only in the care of opioid tolerant patients
with cancer and only by healthcare professionals who are knowledgeable of, and
skilled in, the use of Schedule II opioids to treat cancer pain.
Patients and their caregivers must be instructed that Onsolis contains a
medicine in an amount which can be fatal in children, in individuals for whom
it is not prescribed, and in those who are not opioid tolerant. All Onsolis
films must be kept out of the reach of children [see PATIENT
INFORMATION].
The concomitant use of Onsolis with CYP3A4 inhibitors may result in an increase
in fentanyl plasma concentrations and may cause potentially fatal respiratory
depression [see DRUG INTERACTIONS].
Because of the risk for misuse, abuse, and overdose, Onsolis is available only
through a restricted distribution program, called the FOCUS Program. Under the
FOCUS Program, only prescribers, pharmacies, and patients registered with the
program are able to prescribe, dispense, and receive Onsolis. To enroll in the
FOCUS Program, call 1-877-466-7654 (1-877-4Onsolis) or visit www.OnsolisFocus.com
[see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION
Onsolis (fentanyl buccal soluble film) is an oral transmucosal form of the
potent opioid analgesic, fentanyl citrate, intended for application to the buccal mucosa. Onsolis uses the BioErodible MucoAdhesive (BEMA™) bilayer delivery technology
which is comprised of water-soluble polymeric films. Onsolis consists of a pink
bioadhesive layer bonded onto a white inactive layer. The active ingredient,
fentanyl citrate, is incorporated into the bioadhesive layer, which adheres
to the moist buccal mucosa. The amount of fentanyl delivered transmucosally
is proportional to the film surface area. It is believed that the inactive layer
isolates the bioadhesive layer from the saliva, which may optimize delivery
of fentanyl across the buccal mucosa.
Active Ingredient: Fentanyl citrate, USP is N-(1-Phenethyl-4-piperidyl)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. Fentanyl citrate has the following structural formula:








Inactive Ingredients: Carboxymethylcellulose, citric acid, hydroxyethyl
cellulose, hydroxypropyl cellulose, methylparaben, monobasic sodium phosphate,
peppermint oil, polycarbophil, propylene glycol, propylparaben, red iron oxide,
sodium benzoate, sodium hydroxide, sodium saccharin, titanium dioxide, tribasic
sodium phosphate, vitamin E acetate, and water.Last reviewed on RxList: 7/29/2010




Onsolis Drug Description
Onsolis
(fentanyl buccal soluble film)

WARNINGS
IMPORTANCE OF PROPER PATIENT SELECTION AND POTENTIAL FOR
ABUSE
Onsolis contains fentanyl, an opioid agonist and a Schedule II controlled
substance, with abuse liability similar to other opioid analgesics. This should
be considered when prescribing or dispensing Onsolis in situations where the
physician or pharmacist is concerned about an increased risk of misuse, abuse
or diversion. Schedule II opioid substances, which include morphine, oxycodone,
hydromorphone, oxymorphone, and methadone, have the highest potential for abuse
and risk of fatal overdose due to respiratory depression.
Serious adverse events, including deaths, in patients treated with other
oral transmucosal fentanyl products have been reported. Deaths occurred as a
result of improper patient selection (e.g., use in opioid non-tolerant patients)
and/or improper dosing. The substitution of Onsolis for any other fentanyl product
may result in fatal overdose.
Onsolis is indicated only for the management of breakthrough pain in patients
with cancer, 18 years of age and older, who are already receiving and who are
tolerant to opioid therapy for their underlying persistent cancer pain.
Patients considered opioid tolerant are those who are taking at least: 60 mg
oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day,
8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic
dose of another opioid for one week or longer.
Onsolis is contraindicated for use in opioid non-tolerant patients including
those using opioids intermittently, on an as needed basis.
Onsolis is contraindicated in the management of acute or postoperative pain,
including headache/migraine, dental pain, or use in the emergency room. Life-threatening
respiratory depression could occur at any dose in opioid non-tolerant patients.
Deaths have occurred in opioid non-tolerant patients treated with other fentanyl
products.
When prescribing, do not convert patients on a mcg per mcg basis from any
other oral transmucosal fentanyl product to Onsolis. Patients beginning treatment
with Onsolis must begin with titration from the 200 mcg dose [see DOSAGE
AND ADMINISTRATION].
When dispensing, do not substitute an Onsolis prescription for any other
fentanyl product. Substantial differences exist in the pharmacokinetic profile
of Onsolis compared to other fentanyl products that result in clinically important
differences in the extent of absorption of fentanyl. As a result of these differences,
the substitution of Onsolis for any other fentanyl product may result in fatal
overdose.
Special care must be used when dosing Onsolis. If the breakthrough pain episode
is not relieved, patients should wait at least 2 hours before taking another
dose [see DOSAGE AND ADMINISTRATION].
Onsolis is intended to be used only in the care of opioid tolerant patients
with cancer and only by healthcare professionals who are knowledgeable of, and
skilled in, the use of Schedule II opioids to treat cancer pain.
Patients and their caregivers must be instructed that Onsolis contains a
medicine in an amount which can be fatal in children, in individuals for whom
it is not prescribed, and in those who are not opioid tolerant. All Onsolis
films must be kept out of the reach of children [see PATIENT
INFORMATION].
The concomitant use of Onsolis with CYP3A4 inhibitors may result in an increase
in fentanyl plasma concentrations and may cause potentially fatal respiratory
depression [see DRUG INTERACTIONS].
Because of the risk for misuse, abuse, and overdose, Onsolis is available only
through a restricted distribution program, called the FOCUS Program. Under the
FOCUS Program, only prescribers, pharmacies, and patients registered with the
program are able to prescribe, dispense, and receive Onsolis. To enroll in the
FOCUS Program, call 1-877-466-7654 (1-877-4Onsolis) or visit www.OnsolisFocus.com
[see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION
Onsolis (fentanyl buccal soluble film) is an oral transmucosal form of the
potent opioid analgesic, fentanyl citrate, intended for application to the buccal mucosa. Onsolis uses the BioErodible MucoAdhesive (BEMA™) bilayer delivery technology
which is comprised of water-soluble polymeric films. Onsolis consists of a pink
bioadhesive layer bonded onto a white inactive layer. The active ingredient,
fentanyl citrate, is incorporated into the bioadhesive layer, which adheres
to the moist buccal mucosa. The amount of fentanyl delivered transmucosally
is proportional to the film surface area. It is believed that the inactive layer
isolates the bioadhesive layer from the saliva, which may optimize delivery
of fentanyl across the buccal mucosa.
Active Ingredient: Fentanyl citrate, USP is N-(1-Phenethyl-4-piperidyl)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. Fentanyl citrate has the following structural formula:








Inactive Ingredients: Carboxymethylcellulose, citric acid, hydroxyethyl
cellulose, hydroxypropyl cellulose, methylparaben, monobasic sodium phosphate,
peppermint oil, polycarbophil, propylene glycol, propylparaben, red iron oxide,
sodium benzoate, sodium hydroxide, sodium saccharin, titanium dioxide, tribasic
sodium phosphate, vitamin E acetate, and water.Last reviewed on RxList: 7/29/2010




Onsolis Drug Description
Onsolis
(fentanyl buccal soluble film)

WARNINGS
IMPORTANCE OF PROPER PATIENT SELECTION AND POTENTIAL FOR
ABUSE
Onsolis contains fentanyl, an opioid agonist and a Schedule II controlled
substance, with abuse liability similar to other opioid analgesics. This should
be considered when prescribing or dispensing Onsolis in situations where the
physician or pharmacist is concerned about an increased risk of misuse, abuse
or diversion. Schedule II opioid substances, which include morphine, oxycodone,
hydromorphone, oxymorphone, and methadone, have the highest potential for abuse
and risk of fatal overdose due to respiratory depression.
Serious adverse events, including deaths, in patients treated with other
oral transmucosal fentanyl products have been reported. Deaths occurred as a
result of improper patient selection (e.g., use in opioid non-tolerant patients)
and/or improper dosing. The substitution of Onsolis for any other fentanyl product
may result in fatal overdose.
Onsolis is indicated only for the management of breakthrough pain in patients
with cancer, 18 years of age and older, who are already receiving and who are
tolerant to opioid therapy for their underlying persistent cancer pain.
Patients considered opioid tolerant are those who are taking at least: 60 mg
oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day,
8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic
dose of another opioid for one week or longer.
Onsolis is contraindicated for use in opioid non-tolerant patients including
those using opioids intermittently, on an as needed basis.
Onsolis is contraindicated in the management of acute or postoperative pain,
including headache/migraine, dental pain, or use in the emergency room. Life-threatening
respiratory depression could occur at any dose in opioid non-tolerant patients.
Deaths have occurred in opioid non-tolerant patients treated with other fentanyl
products.
When prescribing, do not convert patients on a mcg per mcg basis from any
other oral transmucosal fentanyl product to Onsolis. Patients beginning treatment
with Onsolis must begin with titration from the 200 mcg dose [see DOSAGE
AND ADMINISTRATION].
When dispensing, do not substitute an Onsolis prescription for any other
fentanyl product. Substantial differences exist in the pharmacokinetic profile
of Onsolis compared to other fentanyl products that result in clinically important
differences in the extent of absorption of fentanyl. As a result of these differences,
the substitution of Onsolis for any other fentanyl product may result in fatal
overdose.
Special care must be used when dosing Onsolis. If the breakthrough pain episode
is not relieved, patients should wait at least 2 hours before taking another
dose [see DOSAGE AND ADMINISTRATION].
Onsolis is intended to be used only in the care of opioid tolerant patients
with cancer and only by healthcare professionals who are knowledgeable of, and
skilled in, the use of Schedule II opioids to treat cancer pain.
Patients and their caregivers must be instructed that Onsolis contains a
medicine in an amount which can be fatal in children, in individuals for whom
it is not prescribed, and in those who are not opioid tolerant. All Onsolis
films must be kept out of the reach of children [see PATIENT
INFORMATION].
The concomitant use of Onsolis with CYP3A4 inhibitors may result in an increase
in fentanyl plasma concentrations and may cause potentially fatal respiratory
depression [see DRUG INTERACTIONS].
Because of the risk for misuse, abuse, and overdose, Onsolis is available only
through a restricted distribution program, called the FOCUS Program. Under the
FOCUS Program, only prescribers, pharmacies, and patients registered with the
program are able to prescribe, dispense, and receive Onsolis. To enroll in the
FOCUS Program, call 1-877-466-7654 (1-877-4Onsolis) or visit www.OnsolisFocus.com
[see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION
Onsolis (fentanyl buccal soluble film) is an oral transmucosal form of the
potent opioid analgesic, fentanyl citrate, intended for application to the buccal mucosa. Onsolis uses the BioErodible MucoAdhesive (BEMA™) bilayer delivery technology
which is comprised of water-soluble polymeric films. Onsolis consists of a pink
bioadhesive layer bonded onto a white inactive layer. The active ingredient,
fentanyl citrate, is incorporated into the bioadhesive layer, which adheres
to the moist buccal mucosa. The amount of fentanyl delivered transmucosally
is proportional to the film surface area. It is believed that the inactive layer
isolates the bioadhesive layer from the saliva, which may optimize delivery
of fentanyl across the buccal mucosa.
Active Ingredient: Fentanyl citrate, USP is N-(1-Phenethyl-4-piperidyl)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. Fentanyl citrate has the following structural formula:








Inactive Ingredients: Carboxymethylcellulose, citric acid, hydroxyethyl
cellulose, hydroxypropyl cellulose, methylparaben, monobasic sodium phosphate,
peppermint oil, polycarbophil, propylene glycol, propylparaben, red iron oxide,
sodium benzoate, sodium hydroxide, sodium saccharin, titanium dioxide, tribasic
sodium phosphate, vitamin E acetate, and water.Last reviewed on RxList: 7/29/2010





Other reviews about Fentanyl Buccal Soluble Film on wordpress

Anesthesia Memos
  by mwhauser
AAA: ENDOVASCULAR The endovascular AAA repair is typically performed under high lumbar or low thoracic epidural anesthesia with MAC. LIDOCAINE is often a good choice as these patients […]


Onsolis Approved for Severe Cancer Pain
  by timeinctemp
THURSDAY, July 16 (HealthDay News) — The potent opioid medication Onsolis (fentanyl buccal soluble film) has been approved by the U.S. Food and Drug Administration to treat breakthrough […]


Strange Conspiracy in a Land of Freedom, Honor and Integrity 2 - Do these people in Washington even know what human rights and civil rights are?
  by cricketdiane
*** Edgewood Arsenal experiments From Wikipedia, the free encyclopedia The Edgewood Arsenal experiments (also known as Project 112) are said to be related to or part of CIA mind control programs […]


BioDelivery Sciences (BDSI) Granted a Meeting with FDA to Discuss the Clinical Development of BEMA Granisetron
  by Biotechtrader
RALEIGH, N.C., Jan 12, 2010 (BUSINESS WIRE) -- BioDelivery Sciences International, Inc. (BDSI) announced that the company has been granted a meeting with the U.S. Food and Drug […]


5-10-10 Daily Small Cap Market News and Stock Highlights from SmallCapVoice.com
  by SmallCapVoice
Stocks surge on global effort to ease European debt crunch Stocks rocketed higher Monday after European leaders agreed to a nearly $1 trillion rescue plan to avoid a major […]


Administering drugs - Routes of administration
  by ZoSoTRUTHTALK
Insufflation (medicine)   For other uses, see Insufflation (disambiguation). This article needs additional citations for verification. Please help improve […]


Cove Road lay close by, an
  by iqhyigdjfnvful
All breathed the same polluted reek and all died the same death of corruption. Still, though it was, they said, very silly for a boy to do more […]



Other reviews about Fentanyl Buccal Soluble Film on web:

Meda Launches Onsolis(TM) (Fentanyl Buccal Soluble Film) for the Treatment of Breakthrough Cancer Pain in Opioid Tolerant Patients Meda's FOCUS(TM) Program, First Opioid REMS ... Meda Launches Onsolis(TM) (Fentanyl Buccal Soluble Film) for the ...


Onsolis™ (fentanyl buccal soluble film) BDSI ® 's first application of the lead BEMA ® technology is Onsolis ® (fentanyl buccal soluble film). BioDelivery Sciences International | Onsolis™


Questions and Answers about Onsolis (fentanyl buccal soluble film) About Today's FDA Action; About Onsolis; About the Onsolis Risk Evaluation and Mitigation Strategy (REMS) Questions and Answers about Onsolis (fentanyl buccal soluble film)


NDA 22-266 ONSOLIS™ (fentanyl buccal soluble film) BioDelivery Sciences International, Inc. NDA 22-266 ONSOLIS™ (fentanyl buccal soluble film) Opioid Analgesic BioDelivery Sciences ... Onsolis (fentanyl) Buccal Soluble Film, BioDelivery Sciences ...


... 4 tablets 300mcg 65100025100325 4 tablets 400mcg 65100025100330 4 tablets 600mcg 65100025100340 4 tablets 800mcg 65100025100350 4 tablets Onsolis (fentanyl buccal soluble film) 200mcg ... Fentanyl Oral Prior Authorization/Quantity Limit Coverage Criteria


HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ONSOLIS safely and effectively. See full prescribing information for ONSOLIS Onsolis (fentanyl) Buccal Soluble Film, BioDelivery Sciences ...


NDA 22-266 ONSOLIS™ (fentanyl buccal soluble film) * Meda Pharmaceuticals Inc. NDA 22-266 ONSOLIS™ (fentanyl buccal soluble film) Opioid Analgesic Meda Pharmaceuticals Inc. (Meda) ... NDA 22-266 ONSOLIS™ (fentanyl buccal soluble film)


A new Fentanyl product has been approved by the FDA for breakthrough cancer pain called Onsolis. It uses a new drug delivery technology called BEMA (fentanyl buccal soluble film ... Fentanyl - Wikipedia, the free encyclopedia


Learn about the prescription medication Onsolis (Fentanyl Buccal Soluble Film), drug uses, dosage, side effects, drug interactions, warnings, reviews and patient labeling. Onsolis (Fentanyl Buccal Soluble Film) Drug Information: Uses ...


Free Online Library: BioDelivery Sciences and Meda Launch ONSOLIS (fentanyl buccal soluble film). by "Business Wire"; Business, international Cancer Care and treatment Cancer ... BioDelivery Sciences and Meda Launch ONSOLIS (fentanyl buccal ...





Featured Reviews

Reviews Sectral

Sectral Drug Description Sectral® (acebutolol hydrochloride) Capsules DRUG DESCRIPTION What are the possible side effects of acebutolol (Sectral)? Get emergency medical help if you have any of these signs of an allergic reaction:...
Read More  |  Review This
Reviews Hectorol

Hectorol Drug Description HECTOROL (doxercalciferol) Capsule, Liquid Filled DRUG DESCRIPTION What are the possible side effects of doxercalciferol (Hectorol)? If you experience any of the following serious side effects, stop taking...
Read More  |  Review This
Reviews Estrostep Fe

Estrostep Fe Drug Description Estrostep®Fe (norethindrone acetate and ethinyl estradiol) Tablets, USP and (ferrous fumarate) Tablets* *Ferrous fumarate tablets are not USP for dissolution and assay. ESTROSTEP®Fe (Each white...
Read More  |  Review This
Reviews Vusion

Vusion Drug Description VUSION® (miconazole nitrate, zinc oxide, and white petrolatum) Ointment, for Topical Use Only DRUG DESCRIPTION VUSION contains the synthetic antifungal agent, miconazole nitrate (0.25%) USP, zinc oxide (15%)...
Read More  |  Review This
Reviews Apriso

Apriso Drug Description APRISO™ (mesalamine) Extended-Release Capsules DRUG DESCRIPTION What are the possible side effects of mesalamine oral (Apriso, Asacol, Lialda, Pentasa)? Get emergency medical help if you have any of...
Read More  |  Review This
Recent News
59sec - the BEST lead management system around!
We tested 59sec - THE lead management system and we love it. 59sec helps small and medium companies to answer leads in maximum 59 seconds. Why...
MOVEorPAY - our favorite facebook app
We do love MOVEorPAY motivational facebook app, because it is very cool and useful. It makes you finish stuff that you know are good for you, but from various reasons, you never do...
ReviewsAZ is almost ready to be officially launched
yes, we have just a few loose ends to tie and we are ready to go :) meanwhile, I am putting some reviews on the site, so people will not get an empty site at the launch....