Reviews Fentanyl Transdermal


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Duragesic Drug Description
DURAGESIC®
(fentanyl transdermal system)

FOR USE IN OPIOID-TOLERANT PATIENTS ONLY
DURAGESIC® contains a high concentration of a potent Schedule II opioid
agonist, fentanyl. Schedule II opioid substances which include fentanyl, hydromorphone,
methadone, morphine, oxycodone, and oxymorphone have the highest potential for
abuse and associated risk of fatal overdose due to respiratory depression. Fentanyl
can be abused and is subject to criminal diversion. The high content of fentanyl
in the patches (DURAGESIC®) may be a particular target for abuse and diversion.
DURAGESIC® is indicated for management of persistent moderate to severe
chronic pain that:

requires continuous, around-the-clock opioid administration for an extended
period of time, and
cannot be managed by other means such as non-steroidal analgesics, opioid
combination products, or immediate-release opioids

DURAGESIC® should ONLY be used in patients who are already receiving
opioid therapy, who have demonstrated opioid tolerance, and who require a total
daily dose at least equivalent to DURAGESIC® 25 mcg/h. Patients who are
considered opioid-tolerant are those who have been taking, for a week or longer,
at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily,
or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another
opioid.
Because serious or life-threatening hypoventilation could occur, DURAGESIC®
(fentanyl transdermal system) is contraindicated:

in patients who are not opioid-tolerant
in the management of acute pain or in patients who require opioid analgesia
for a short period of time
in the management of post-operative pain, including use after out-patient
or day surgeries (e.g., tonsillectomies)
in the management of mild pain
in the management of intermittent pain [e.g., use on an as needed basis
(prn)]

(See CONTRAINDICATIONS for further information.)
Since the peak fentanyl levels occur between 24 and 72 hours of treatment,
prescribers should be aware that serious or life threatening hypoventilation
may occur, even in opioid-tolerant patients, during the initial application
period.
The concomitant use of DURAGESIC® with potent cytochrome P450 3A4
inhibitors (ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin,
nelfinavir, and nefazodone) may result in an increase in fentanyl plasma concentrations,
which could increase or prolong adverse drug effects and may cause potentially
fatal respiratory depression. Patients receiving DURAGESIC® and potent
CYP3A4 inhibitors should be carefully monitored for an extended period of
time and dosage adjustments should be made if warranted. (See CLINICAL
PHARMACOLOGY - Drug Interactions, WARNINGS,
PRECAUTIONS and DOSAGE
AND ADMINISTRATION for further information.)
The safety of DURAGESIC® has not been established in children under
2 years of age. DURAGESIC® should be administered to children only if
they are opioid-tolerant and 2 years of age or older (see PRECAUTIONS
- Pediatric Use).
DURAGESIC® is ONLY for use in patients who are already tolerant to opioid
therapy of comparable potency. Use in non-opioid tolerant patients may lead
to fatal respiratory depression. Overestimating the DURAGESIC® dose when
converting patients from another opioid medication can result in fatal overdose
with the first dose. Due to the mean elimination half-life of 17 hours of DURAGESIC®,
patients who are thought to have had a serious adverse event, including overdose,
will require monitoring and treatment for at least 24 hours.
DURAGESIC® can be abused in a manner similar to other opioid agonists,
legal or illicit. This risk should be considered when administering, prescribing,
or dispensing DURAGESIC® in situations where the healthcare professional
is concerned about increased risk of misuse, abuse or diversion.
Persons at increased risk for opioid abuse include those with a personal
or family history of substance abuse (including drug or alcohol abuse or addiction)
or mental illness (e.g., major depression). Patients should be assessed for
their clinical risks for opioid abuse or addiction prior to being prescribed
opioids. All patients receiving opioids should be routinely monitored for signs
of misuse, abuse and addiction. Patients at increased risk of opioid abuse may
still be appropriately treated with modified-release opioid formulations; however,
these patients will require intensive monitoring for signs of misuse, abuse,
or addiction.
DURAGESIC® patches are intended for transdermal use (on intact skin)
only. Using damaged or cut DURAGESIC® patches can lead to the rapid release
of the contents of the DURAGESIC® patch and absorption of a potentially
fatal dose of fentanyl.

DRUG DESCRIPTION



What are the possible side effects of a fentanyl transdermal skin patch?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Remove the skin patch and call your doctor at once if you have any of these serious side effects:

weak, shallow breathing;
severe weakness, feeling light-headed or fainting;
cold, clammy skin; or
pale skin, easy bruising or bleeding.

Less serious side effects may...
Read All Potential Side Effects for Duragesic »




DURAGESIC® (fentanyl transdermal system) is a transdermal system providing
continuous systemic delivery of fentanyl, a potent opioid analgesic, for 72
hours. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide.
The structural formula is:







The molecular weight of fentanyl base is 336.5, and the empirical formula is
C22H28N2O. The n-octanol:water partition coefficient
is 860:1. The pKa is 8.4.
System Components and Structure
The amount of fentanyl released from each system per hour is proportional to
the surface area (25 mcg/h per 10 cm2). The composition per unit
area of all system sizes is identical. Each system also contains 0.1 mL of alcohol
USP per 10 cm2.



Dose*
(mcg/h)
Size
(cm2)
Fentanyl
Content
(mg)


12**
5
1.25


25
10
2.5


50
20
5


75
30
7.5


100
40
10


* Nominal delivery rate per hour
** Nominal delivery rate is 12.5 mcg/hr



 
DURAGESIC® is a rectangular transparent unit comprising a protective liner and four functional layers. Proceeding from the outer surface toward the surface adhering to skin, these layers are:
1) a backing layer of polyester film; 2) a drug reservoir of fentanyl and alcohol
USP gelled with hydroxyethyl cellulose; 3) an ethylene-vinyl acetate copolymer
membrane that controls the rate of fentanyl delivery to the skin surface; and
4) a fentanyl containing silicone adhesive. Before use, a protective liner covering
the adhesive layer is removed and discarded.







The active component of the system is fentanyl. The remaining components are pharmacologically inactive. Less than 0.2 mL of alcohol is also released from the system during use.
Do not cut or damage DURAGESIC®. If the DURAGESIC® system is cut or damaged, controlled drug delivery will not be possible, which can lead to the rapid release and absorption of a potentially fatal dose of fentanyl.Last reviewed on RxList: 6/29/2007




Duragesic Drug Description
DURAGESIC®
(fentanyl transdermal system)

FOR USE IN OPIOID-TOLERANT PATIENTS ONLY
DURAGESIC® contains a high concentration of a potent Schedule II opioid
agonist, fentanyl. Schedule II opioid substances which include fentanyl, hydromorphone,
methadone, morphine, oxycodone, and oxymorphone have the highest potential for
abuse and associated risk of fatal overdose due to respiratory depression. Fentanyl
can be abused and is subject to criminal diversion. The high content of fentanyl
in the patches (DURAGESIC®) may be a particular target for abuse and diversion.
DURAGESIC® is indicated for management of persistent moderate to severe
chronic pain that:

requires continuous, around-the-clock opioid administration for an extended
period of time, and
cannot be managed by other means such as non-steroidal analgesics, opioid
combination products, or immediate-release opioids

DURAGESIC® should ONLY be used in patients who are already receiving
opioid therapy, who have demonstrated opioid tolerance, and who require a total
daily dose at least equivalent to DURAGESIC® 25 mcg/h. Patients who are
considered opioid-tolerant are those who have been taking, for a week or longer,
at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily,
or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another
opioid.
Because serious or life-threatening hypoventilation could occur, DURAGESIC®
(fentanyl transdermal system) is contraindicated:

in patients who are not opioid-tolerant
in the management of acute pain or in patients who require opioid analgesia
for a short period of time
in the management of post-operative pain, including use after out-patient
or day surgeries (e.g., tonsillectomies)
in the management of mild pain
in the management of intermittent pain [e.g., use on an as needed basis
(prn)]

(See CONTRAINDICATIONS for further information.)
Since the peak fentanyl levels occur between 24 and 72 hours of treatment,
prescribers should be aware that serious or life threatening hypoventilation
may occur, even in opioid-tolerant patients, during the initial application
period.
The concomitant use of DURAGESIC® with potent cytochrome P450 3A4
inhibitors (ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin,
nelfinavir, and nefazodone) may result in an increase in fentanyl plasma concentrations,
which could increase or prolong adverse drug effects and may cause potentially
fatal respiratory depression. Patients receiving DURAGESIC® and potent
CYP3A4 inhibitors should be carefully monitored for an extended period of
time and dosage adjustments should be made if warranted. (See CLINICAL
PHARMACOLOGY - Drug Interactions, WARNINGS,
PRECAUTIONS and DOSAGE
AND ADMINISTRATION for further information.)
The safety of DURAGESIC® has not been established in children under
2 years of age. DURAGESIC® should be administered to children only if
they are opioid-tolerant and 2 years of age or older (see PRECAUTIONS
- Pediatric Use).
DURAGESIC® is ONLY for use in patients who are already tolerant to opioid
therapy of comparable potency. Use in non-opioid tolerant patients may lead
to fatal respiratory depression. Overestimating the DURAGESIC® dose when
converting patients from another opioid medication can result in fatal overdose
with the first dose. Due to the mean elimination half-life of 17 hours of DURAGESIC®,
patients who are thought to have had a serious adverse event, including overdose,
will require monitoring and treatment for at least 24 hours.
DURAGESIC® can be abused in a manner similar to other opioid agonists,
legal or illicit. This risk should be considered when administering, prescribing,
or dispensing DURAGESIC® in situations where the healthcare professional
is concerned about increased risk of misuse, abuse or diversion.
Persons at increased risk for opioid abuse include those with a personal
or family history of substance abuse (including drug or alcohol abuse or addiction)
or mental illness (e.g., major depression). Patients should be assessed for
their clinical risks for opioid abuse or addiction prior to being prescribed
opioids. All patients receiving opioids should be routinely monitored for signs
of misuse, abuse and addiction. Patients at increased risk of opioid abuse may
still be appropriately treated with modified-release opioid formulations; however,
these patients will require intensive monitoring for signs of misuse, abuse,
or addiction.
DURAGESIC® patches are intended for transdermal use (on intact skin)
only. Using damaged or cut DURAGESIC® patches can lead to the rapid release
of the contents of the DURAGESIC® patch and absorption of a potentially
fatal dose of fentanyl.

DRUG DESCRIPTION



What are the possible side effects of a fentanyl transdermal skin patch?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Remove the skin patch and call your doctor at once if you have any of these serious side effects:

weak, shallow breathing;
severe weakness, feeling light-headed or fainting;
cold, clammy skin; or
pale skin, easy bruising or bleeding.

Less serious side effects may...
Read All Potential Side Effects for Duragesic »




DURAGESIC® (fentanyl transdermal system) is a transdermal system providing
continuous systemic delivery of fentanyl, a potent opioid analgesic, for 72
hours. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide.
The structural formula is:







The molecular weight of fentanyl base is 336.5, and the empirical formula is
C22H28N2O. The n-octanol:water partition coefficient
is 860:1. The pKa is 8.4.
System Components and Structure
The amount of fentanyl released from each system per hour is proportional to
the surface area (25 mcg/h per 10 cm2). The composition per unit
area of all system sizes is identical. Each system also contains 0.1 mL of alcohol
USP per 10 cm2.



Dose*
(mcg/h)
Size
(cm2)
Fentanyl
Content
(mg)


12**
5
1.25


25
10
2.5


50
20
5


75
30
7.5


100
40
10


* Nominal delivery rate per hour
** Nominal delivery rate is 12.5 mcg/hr



 
DURAGESIC® is a rectangular transparent unit comprising a protective liner and four functional layers. Proceeding from the outer surface toward the surface adhering to skin, these layers are:
1) a backing layer of polyester film; 2) a drug reservoir of fentanyl and alcohol
USP gelled with hydroxyethyl cellulose; 3) an ethylene-vinyl acetate copolymer
membrane that controls the rate of fentanyl delivery to the skin surface; and
4) a fentanyl containing silicone adhesive. Before use, a protective liner covering
the adhesive layer is removed and discarded.







The active component of the system is fentanyl. The remaining components are pharmacologically inactive. Less than 0.2 mL of alcohol is also released from the system during use.
Do not cut or damage DURAGESIC®. If the DURAGESIC® system is cut or damaged, controlled drug delivery will not be possible, which can lead to the rapid release and absorption of a potentially fatal dose of fentanyl.Last reviewed on RxList: 6/29/2007




Duragesic Drug Description
DURAGESIC®
(fentanyl transdermal system)

FOR USE IN OPIOID-TOLERANT PATIENTS ONLY
DURAGESIC® contains a high concentration of a potent Schedule II opioid
agonist, fentanyl. Schedule II opioid substances which include fentanyl, hydromorphone,
methadone, morphine, oxycodone, and oxymorphone have the highest potential for
abuse and associated risk of fatal overdose due to respiratory depression. Fentanyl
can be abused and is subject to criminal diversion. The high content of fentanyl
in the patches (DURAGESIC®) may be a particular target for abuse and diversion.
DURAGESIC® is indicated for management of persistent moderate to severe
chronic pain that:

requires continuous, around-the-clock opioid administration for an extended
period of time, and
cannot be managed by other means such as non-steroidal analgesics, opioid
combination products, or immediate-release opioids

DURAGESIC® should ONLY be used in patients who are already receiving
opioid therapy, who have demonstrated opioid tolerance, and who require a total
daily dose at least equivalent to DURAGESIC® 25 mcg/h. Patients who are
considered opioid-tolerant are those who have been taking, for a week or longer,
at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily,
or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another
opioid.
Because serious or life-threatening hypoventilation could occur, DURAGESIC®
(fentanyl transdermal system) is contraindicated:

in patients who are not opioid-tolerant
in the management of acute pain or in patients who require opioid analgesia
for a short period of time
in the management of post-operative pain, including use after out-patient
or day surgeries (e.g., tonsillectomies)
in the management of mild pain
in the management of intermittent pain [e.g., use on an as needed basis
(prn)]

(See CONTRAINDICATIONS for further information.)
Since the peak fentanyl levels occur between 24 and 72 hours of treatment,
prescribers should be aware that serious or life threatening hypoventilation
may occur, even in opioid-tolerant patients, during the initial application
period.
The concomitant use of DURAGESIC® with potent cytochrome P450 3A4
inhibitors (ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin,
nelfinavir, and nefazodone) may result in an increase in fentanyl plasma concentrations,
which could increase or prolong adverse drug effects and may cause potentially
fatal respiratory depression. Patients receiving DURAGESIC® and potent
CYP3A4 inhibitors should be carefully monitored for an extended period of
time and dosage adjustments should be made if warranted. (See CLINICAL
PHARMACOLOGY - Drug Interactions, WARNINGS,
PRECAUTIONS and DOSAGE
AND ADMINISTRATION for further information.)
The safety of DURAGESIC® has not been established in children under
2 years of age. DURAGESIC® should be administered to children only if
they are opioid-tolerant and 2 years of age or older (see PRECAUTIONS
- Pediatric Use).
DURAGESIC® is ONLY for use in patients who are already tolerant to opioid
therapy of comparable potency. Use in non-opioid tolerant patients may lead
to fatal respiratory depression. Overestimating the DURAGESIC® dose when
converting patients from another opioid medication can result in fatal overdose
with the first dose. Due to the mean elimination half-life of 17 hours of DURAGESIC®,
patients who are thought to have had a serious adverse event, including overdose,
will require monitoring and treatment for at least 24 hours.
DURAGESIC® can be abused in a manner similar to other opioid agonists,
legal or illicit. This risk should be considered when administering, prescribing,
or dispensing DURAGESIC® in situations where the healthcare professional
is concerned about increased risk of misuse, abuse or diversion.
Persons at increased risk for opioid abuse include those with a personal
or family history of substance abuse (including drug or alcohol abuse or addiction)
or mental illness (e.g., major depression). Patients should be assessed for
their clinical risks for opioid abuse or addiction prior to being prescribed
opioids. All patients receiving opioids should be routinely monitored for signs
of misuse, abuse and addiction. Patients at increased risk of opioid abuse may
still be appropriately treated with modified-release opioid formulations; however,
these patients will require intensive monitoring for signs of misuse, abuse,
or addiction.
DURAGESIC® patches are intended for transdermal use (on intact skin)
only. Using damaged or cut DURAGESIC® patches can lead to the rapid release
of the contents of the DURAGESIC® patch and absorption of a potentially
fatal dose of fentanyl.

DRUG DESCRIPTION



What are the possible side effects of a fentanyl transdermal skin patch?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Remove the skin patch and call your doctor at once if you have any of these serious side effects:

weak, shallow breathing;
severe weakness, feeling light-headed or fainting;
cold, clammy skin; or
pale skin, easy bruising or bleeding.

Less serious side effects may...
Read All Potential Side Effects for Duragesic »




DURAGESIC® (fentanyl transdermal system) is a transdermal system providing
continuous systemic delivery of fentanyl, a potent opioid analgesic, for 72
hours. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide.
The structural formula is:







The molecular weight of fentanyl base is 336.5, and the empirical formula is
C22H28N2O. The n-octanol:water partition coefficient
is 860:1. The pKa is 8.4.
System Components and Structure
The amount of fentanyl released from each system per hour is proportional to
the surface area (25 mcg/h per 10 cm2). The composition per unit
area of all system sizes is identical. Each system also contains 0.1 mL of alcohol
USP per 10 cm2.



Dose*
(mcg/h)
Size
(cm2)
Fentanyl
Content
(mg)


12**
5
1.25


25
10
2.5


50
20
5


75
30
7.5


100
40
10


* Nominal delivery rate per hour
** Nominal delivery rate is 12.5 mcg/hr



 
DURAGESIC® is a rectangular transparent unit comprising a protective liner and four functional layers. Proceeding from the outer surface toward the surface adhering to skin, these layers are:
1) a backing layer of polyester film; 2) a drug reservoir of fentanyl and alcohol
USP gelled with hydroxyethyl cellulose; 3) an ethylene-vinyl acetate copolymer
membrane that controls the rate of fentanyl delivery to the skin surface; and
4) a fentanyl containing silicone adhesive. Before use, a protective liner covering
the adhesive layer is removed and discarded.







The active component of the system is fentanyl. The remaining components are pharmacologically inactive. Less than 0.2 mL of alcohol is also released from the system during use.
Do not cut or damage DURAGESIC®. If the DURAGESIC® system is cut or damaged, controlled drug delivery will not be possible, which can lead to the rapid release and absorption of a potentially fatal dose of fentanyl.Last reviewed on RxList: 6/29/2007




Duragesic Drug Description
DURAGESIC®
(fentanyl transdermal system)

FOR USE IN OPIOID-TOLERANT PATIENTS ONLY
DURAGESIC® contains a high concentration of a potent Schedule II opioid
agonist, fentanyl. Schedule II opioid substances which include fentanyl, hydromorphone,
methadone, morphine, oxycodone, and oxymorphone have the highest potential for
abuse and associated risk of fatal overdose due to respiratory depression. Fentanyl
can be abused and is subject to criminal diversion. The high content of fentanyl
in the patches (DURAGESIC®) may be a particular target for abuse and diversion.
DURAGESIC® is indicated for management of persistent moderate to severe
chronic pain that:

requires continuous, around-the-clock opioid administration for an extended
period of time, and
cannot be managed by other means such as non-steroidal analgesics, opioid
combination products, or immediate-release opioids

DURAGESIC® should ONLY be used in patients who are already receiving
opioid therapy, who have demonstrated opioid tolerance, and who require a total
daily dose at least equivalent to DURAGESIC® 25 mcg/h. Patients who are
considered opioid-tolerant are those who have been taking, for a week or longer,
at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily,
or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another
opioid.
Because serious or life-threatening hypoventilation could occur, DURAGESIC®
(fentanyl transdermal system) is contraindicated:

in patients who are not opioid-tolerant
in the management of acute pain or in patients who require opioid analgesia
for a short period of time
in the management of post-operative pain, including use after out-patient
or day surgeries (e.g., tonsillectomies)
in the management of mild pain
in the management of intermittent pain [e.g., use on an as needed basis
(prn)]

(See CONTRAINDICATIONS for further information.)
Since the peak fentanyl levels occur between 24 and 72 hours of treatment,
prescribers should be aware that serious or life threatening hypoventilation
may occur, even in opioid-tolerant patients, during the initial application
period.
The concomitant use of DURAGESIC® with potent cytochrome P450 3A4
inhibitors (ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin,
nelfinavir, and nefazodone) may result in an increase in fentanyl plasma concentrations,
which could increase or prolong adverse drug effects and may cause potentially
fatal respiratory depression. Patients receiving DURAGESIC® and potent
CYP3A4 inhibitors should be carefully monitored for an extended period of
time and dosage adjustments should be made if warranted. (See CLINICAL
PHARMACOLOGY - Drug Interactions, WARNINGS,
PRECAUTIONS and DOSAGE
AND ADMINISTRATION for further information.)
The safety of DURAGESIC® has not been established in children under
2 years of age. DURAGESIC® should be administered to children only if
they are opioid-tolerant and 2 years of age or older (see PRECAUTIONS
- Pediatric Use).
DURAGESIC® is ONLY for use in patients who are already tolerant to opioid
therapy of comparable potency. Use in non-opioid tolerant patients may lead
to fatal respiratory depression. Overestimating the DURAGESIC® dose when
converting patients from another opioid medication can result in fatal overdose
with the first dose. Due to the mean elimination half-life of 17 hours of DURAGESIC®,
patients who are thought to have had a serious adverse event, including overdose,
will require monitoring and treatment for at least 24 hours.
DURAGESIC® can be abused in a manner similar to other opioid agonists,
legal or illicit. This risk should be considered when administering, prescribing,
or dispensing DURAGESIC® in situations where the healthcare professional
is concerned about increased risk of misuse, abuse or diversion.
Persons at increased risk for opioid abuse include those with a personal
or family history of substance abuse (including drug or alcohol abuse or addiction)
or mental illness (e.g., major depression). Patients should be assessed for
their clinical risks for opioid abuse or addiction prior to being prescribed
opioids. All patients receiving opioids should be routinely monitored for signs
of misuse, abuse and addiction. Patients at increased risk of opioid abuse may
still be appropriately treated with modified-release opioid formulations; however,
these patients will require intensive monitoring for signs of misuse, abuse,
or addiction.
DURAGESIC® patches are intended for transdermal use (on intact skin)
only. Using damaged or cut DURAGESIC® patches can lead to the rapid release
of the contents of the DURAGESIC® patch and absorption of a potentially
fatal dose of fentanyl.

DRUG DESCRIPTION



What are the possible side effects of a fentanyl transdermal skin patch?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Remove the skin patch and call your doctor at once if you have any of these serious side effects:

weak, shallow breathing;
severe weakness, feeling light-headed or fainting;
cold, clammy skin; or
pale skin, easy bruising or bleeding.

Less serious side effects may...
Read All Potential Side Effects for Duragesic »




DURAGESIC® (fentanyl transdermal system) is a transdermal system providing
continuous systemic delivery of fentanyl, a potent opioid analgesic, for 72
hours. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide.
The structural formula is:







The molecular weight of fentanyl base is 336.5, and the empirical formula is
C22H28N2O. The n-octanol:water partition coefficient
is 860:1. The pKa is 8.4.
System Components and Structure
The amount of fentanyl released from each system per hour is proportional to
the surface area (25 mcg/h per 10 cm2). The composition per unit
area of all system sizes is identical. Each system also contains 0.1 mL of alcohol
USP per 10 cm2.



Dose*
(mcg/h)
Size
(cm2)
Fentanyl
Content
(mg)


12**
5
1.25


25
10
2.5


50
20
5


75
30
7.5


100
40
10


* Nominal delivery rate per hour
** Nominal delivery rate is 12.5 mcg/hr



 
DURAGESIC® is a rectangular transparent unit comprising a protective liner and four functional layers. Proceeding from the outer surface toward the surface adhering to skin, these layers are:
1) a backing layer of polyester film; 2) a drug reservoir of fentanyl and alcohol
USP gelled with hydroxyethyl cellulose; 3) an ethylene-vinyl acetate copolymer
membrane that controls the rate of fentanyl delivery to the skin surface; and
4) a fentanyl containing silicone adhesive. Before use, a protective liner covering
the adhesive layer is removed and discarded.







The active component of the system is fentanyl. The remaining components are pharmacologically inactive. Less than 0.2 mL of alcohol is also released from the system during use.
Do not cut or damage DURAGESIC®. If the DURAGESIC® system is cut or damaged, controlled drug delivery will not be possible, which can lead to the rapid release and absorption of a potentially fatal dose of fentanyl.Last reviewed on RxList: 6/29/2007




Duragesic Drug Description
DURAGESIC®
(fentanyl transdermal system)

FOR USE IN OPIOID-TOLERANT PATIENTS ONLY
DURAGESIC® contains a high concentration of a potent Schedule II opioid
agonist, fentanyl. Schedule II opioid substances which include fentanyl, hydromorphone,
methadone, morphine, oxycodone, and oxymorphone have the highest potential for
abuse and associated risk of fatal overdose due to respiratory depression. Fentanyl
can be abused and is subject to criminal diversion. The high content of fentanyl
in the patches (DURAGESIC®) may be a particular target for abuse and diversion.
DURAGESIC® is indicated for management of persistent moderate to severe
chronic pain that:

requires continuous, around-the-clock opioid administration for an extended
period of time, and
cannot be managed by other means such as non-steroidal analgesics, opioid
combination products, or immediate-release opioids

DURAGESIC® should ONLY be used in patients who are already receiving
opioid therapy, who have demonstrated opioid tolerance, and who require a total
daily dose at least equivalent to DURAGESIC® 25 mcg/h. Patients who are
considered opioid-tolerant are those who have been taking, for a week or longer,
at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily,
or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another
opioid.
Because serious or life-threatening hypoventilation could occur, DURAGESIC®
(fentanyl transdermal system) is contraindicated:

in patients who are not opioid-tolerant
in the management of acute pain or in patients who require opioid analgesia
for a short period of time
in the management of post-operative pain, including use after out-patient
or day surgeries (e.g., tonsillectomies)
in the management of mild pain
in the management of intermittent pain [e.g., use on an as needed basis
(prn)]

(See CONTRAINDICATIONS for further information.)
Since the peak fentanyl levels occur between 24 and 72 hours of treatment,
prescribers should be aware that serious or life threatening hypoventilation
may occur, even in opioid-tolerant patients, during the initial application
period.
The concomitant use of DURAGESIC® with potent cytochrome P450 3A4
inhibitors (ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin,
nelfinavir, and nefazodone) may result in an increase in fentanyl plasma concentrations,
which could increase or prolong adverse drug effects and may cause potentially
fatal respiratory depression. Patients receiving DURAGESIC® and potent
CYP3A4 inhibitors should be carefully monitored for an extended period of
time and dosage adjustments should be made if warranted. (See CLINICAL
PHARMACOLOGY - Drug Interactions, WARNINGS,
PRECAUTIONS and DOSAGE
AND ADMINISTRATION for further information.)
The safety of DURAGESIC® has not been established in children under
2 years of age. DURAGESIC® should be administered to children only if
they are opioid-tolerant and 2 years of age or older (see PRECAUTIONS
- Pediatric Use).
DURAGESIC® is ONLY for use in patients who are already tolerant to opioid
therapy of comparable potency. Use in non-opioid tolerant patients may lead
to fatal respiratory depression. Overestimating the DURAGESIC® dose when
converting patients from another opioid medication can result in fatal overdose
with the first dose. Due to the mean elimination half-life of 17 hours of DURAGESIC®,
patients who are thought to have had a serious adverse event, including overdose,
will require monitoring and treatment for at least 24 hours.
DURAGESIC® can be abused in a manner similar to other opioid agonists,
legal or illicit. This risk should be considered when administering, prescribing,
or dispensing DURAGESIC® in situations where the healthcare professional
is concerned about increased risk of misuse, abuse or diversion.
Persons at increased risk for opioid abuse include those with a personal
or family history of substance abuse (including drug or alcohol abuse or addiction)
or mental illness (e.g., major depression). Patients should be assessed for
their clinical risks for opioid abuse or addiction prior to being prescribed
opioids. All patients receiving opioids should be routinely monitored for signs
of misuse, abuse and addiction. Patients at increased risk of opioid abuse may
still be appropriately treated with modified-release opioid formulations; however,
these patients will require intensive monitoring for signs of misuse, abuse,
or addiction.
DURAGESIC® patches are intended for transdermal use (on intact skin)
only. Using damaged or cut DURAGESIC® patches can lead to the rapid release
of the contents of the DURAGESIC® patch and absorption of a potentially
fatal dose of fentanyl.

DRUG DESCRIPTION



What are the possible side effects of a fentanyl transdermal skin patch?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Remove the skin patch and call your doctor at once if you have any of these serious side effects:

weak, shallow breathing;
severe weakness, feeling light-headed or fainting;
cold, clammy skin; or
pale skin, easy bruising or bleeding.

Less serious side effects may...
Read All Potential Side Effects for Duragesic »




DURAGESIC® (fentanyl transdermal system) is a transdermal system providing
continuous systemic delivery of fentanyl, a potent opioid analgesic, for 72
hours. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide.
The structural formula is:







The molecular weight of fentanyl base is 336.5, and the empirical formula is
C22H28N2O. The n-octanol:water partition coefficient
is 860:1. The pKa is 8.4.
System Components and Structure
The amount of fentanyl released from each system per hour is proportional to
the surface area (25 mcg/h per 10 cm2). The composition per unit
area of all system sizes is identical. Each system also contains 0.1 mL of alcohol
USP per 10 cm2.



Dose*
(mcg/h)
Size
(cm2)
Fentanyl
Content
(mg)


12**
5
1.25


25
10
2.5


50
20
5


75
30
7.5


100
40
10


* Nominal delivery rate per hour
** Nominal delivery rate is 12.5 mcg/hr



 
DURAGESIC® is a rectangular transparent unit comprising a protective liner and four functional layers. Proceeding from the outer surface toward the surface adhering to skin, these layers are:
1) a backing layer of polyester film; 2) a drug reservoir of fentanyl and alcohol
USP gelled with hydroxyethyl cellulose; 3) an ethylene-vinyl acetate copolymer
membrane that controls the rate of fentanyl delivery to the skin surface; and
4) a fentanyl containing silicone adhesive. Before use, a protective liner covering
the adhesive layer is removed and discarded.







The active component of the system is fentanyl. The remaining components are pharmacologically inactive. Less than 0.2 mL of alcohol is also released from the system during use.
Do not cut or damage DURAGESIC®. If the DURAGESIC® system is cut or damaged, controlled drug delivery will not be possible, which can lead to the rapid release and absorption of a potentially fatal dose of fentanyl.Last reviewed on RxList: 6/29/2007





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Other reviews about Fentanyl Transdermal on web:

Manufacturers of fentanyl transdermal pain patches have voluntarily recalled numerous lots of their patches, and the U.S. Food and Drug Administration (FDA) has issued Public Health ... Fentanyl - Wikipedia, the free encyclopedia


Learn about the prescription medication Duragesic (Fentanyl Transdermal), drug uses, dosage, side effects, drug interactions, warnings, reviews and patient labeling. Duragesic (Fentanyl Transdermal) Drug Information: Uses, Side ...


Accurate, FDA approved Fentanyl Transdermal information for healthcare professionals and patients - brought to you by Drugs.com. Fentanyl Transdermal Official FDA information, side effects and uses.


Consumer information about the medication FENTANYL - TRANSDERMAL (Duragesic), includes side effects, drug interactions, recommended dosages, and storage information. Read more ... FENTANYL - TRANSDERMAL (Duragesic) side effects, medical uses, and ...


Read about Fentanyl Transdermal System (Duragesic) medication for severe chronic pain such as cancer. Side effects, drug interactions, dosage, and warnings are included in the ... Fentanyl Transdermal System (Duragesic)Drug Information by ...


Features information about dosage, usage, warnings, and side effects. Fentanyl Transdermal: MedlinePlus Drug Information


fentanyl Transdermal (fentanyl) patient information. Detailed drug information for the consumer, includes dosage, fentanyl Transdermal side effects and more. fentanyl Transdermal consumer information from Drugs.com


Product information for US health care providers and consumers. DURAGESIC® (fentanyl transdermal system) CII Pain Patch


Mayo Clinic offers award-winning medical and health information and tools for healthy living. Fentanyl (Transdermal Route) - MayoClinic.com


fentanyl transdermal system Duragesic-25, Duragesic-50, Duragesic-75, Duragesic-100. fentanyl transmucosal Fentanyl Oralet. Controlled Substance Schedule II fentanyl transdermal system





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