Reviews Buprenorphine Transdermal System


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Butrans Drug Description
Butrans
(buprenorphine) Transdermal System for Transdermal Administration

WARNING
IMPORTANCE OF PROPER PATIENT SELECTION, POTENTIAL FOR ABUSE, AND LIMITATIONS
OF USE
Proper Patient Selection
Butrans is a transdermal formulation of buprenorphine indicated for the
management of moderate to severe chronic pain in patients requiring a continuous,
around-the-clock opioid analgesic for an extended period of time.
Potential for Abuse
Butrans contains buprenorphine which is a mu opioid partial agonist and
a Schedule III controlled substance. Butrans can be abused in a manner similar
to other opioid agonists, legal or illicit. Consider the abuse potential when
prescribing or dispensing Butrans in situations where the physician or pharmacist
is concerned about an 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). Assess patients for their clinical
risks for opioid abuse or addiction prior to being prescribed opioids. Routinely
monitor all patients receiving opioids for signs of misuse, abuse and addiction.

Limitations of Use
Do not exceed a dose of one 20 mcg/hour Butrans system due to the risk of
QTc interval prolongation.
Avoid exposing the Butrans application site and surrounding area to direct
external heat sources. Temperature-dependent increases in buprenorphine release
from the system may result in overdose and death.

DRUG DESCRIPTION
Butrans is a transdermal system providing systemic delivery of buprenorphine,
a mu opioid partial agonist analgesic, continuously for 7 days. The chemical
name of buprenorphine is 6,14ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)-
α-(1,1-dimethylethyl)-4, 5-epoxy-18, 19dihydro-3-hydroxy-6-methoxy-α-methyl-,
[5α, 7α, (S)]. The structural formula is:








The molecular weight of buprenorphine is 467.6; the empirical formula is C29H41NO4.
Buprenorphine occurs as a white or almost white powder and is very slightly
soluble in water, freely soluble in acetone, soluble in methanol and ether,
and slightly soluble in cyclohexane. The pKa is 8.5 and the melting point is
about 217°C.
System Components and Structure
Three different strengths of Butrans are available: 5, 10, and 20 mcg/hour
(Table 5). The active component of the system is buprenorphine. The remaining
components are pharmacologically inactive. The proportion of buprenorphine mixed
in the adhesive matrix is the same in each of the 3 strengths. The amount of
buprenorphine released from each system per hour is proportional to the active
surface area of the system. The skin is the limiting barrier to diffusion from
the system into the bloodstream.
Table 5: Butrans Product Specifications



Buprenorphine Delivery Rate (mcg/hour)
Active Surface
Area (cm²)
Total Buprenorphine
Content (mg)


Butrans 5
6.25
5


Butrans 10
12.5
10


Butrans 20
25
20



Butrans is a rectangular or square, beige-colored system consisting of a protective
liner and functional layers. Proceeding from the outer surface toward the surface
adhering to the skin, the layers are (1) a beige-colored web backing layer;
(2) an adhesive rim without buprenorphine; (3) a separating layer over the buprenorphine-containing
adhesive matrix; (4) the buprenorphine-containing adhesive matrix; and (5) a
peel-off release liner. Before use, the release liner covering the adhesive
layer is removed and discarded.
Figure 1 : Cross Section Diagram of Butrans (not to scale).








The active ingredient in Butrans is buprenorphine. The inactive ingredients
in each system are: levulinic acid, oleyl oleate, povidone, and polyacrylate
cross-linked with aluminum.
Last reviewed on RxList: 8/2/2010




Butrans Drug Description
Butrans
(buprenorphine) Transdermal System for Transdermal Administration

WARNING
IMPORTANCE OF PROPER PATIENT SELECTION, POTENTIAL FOR ABUSE, AND LIMITATIONS
OF USE
Proper Patient Selection
Butrans is a transdermal formulation of buprenorphine indicated for the
management of moderate to severe chronic pain in patients requiring a continuous,
around-the-clock opioid analgesic for an extended period of time.
Potential for Abuse
Butrans contains buprenorphine which is a mu opioid partial agonist and
a Schedule III controlled substance. Butrans can be abused in a manner similar
to other opioid agonists, legal or illicit. Consider the abuse potential when
prescribing or dispensing Butrans in situations where the physician or pharmacist
is concerned about an 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). Assess patients for their clinical
risks for opioid abuse or addiction prior to being prescribed opioids. Routinely
monitor all patients receiving opioids for signs of misuse, abuse and addiction.

Limitations of Use
Do not exceed a dose of one 20 mcg/hour Butrans system due to the risk of
QTc interval prolongation.
Avoid exposing the Butrans application site and surrounding area to direct
external heat sources. Temperature-dependent increases in buprenorphine release
from the system may result in overdose and death.

DRUG DESCRIPTION
Butrans is a transdermal system providing systemic delivery of buprenorphine,
a mu opioid partial agonist analgesic, continuously for 7 days. The chemical
name of buprenorphine is 6,14ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)-
α-(1,1-dimethylethyl)-4, 5-epoxy-18, 19dihydro-3-hydroxy-6-methoxy-α-methyl-,
[5α, 7α, (S)]. The structural formula is:








The molecular weight of buprenorphine is 467.6; the empirical formula is C29H41NO4.
Buprenorphine occurs as a white or almost white powder and is very slightly
soluble in water, freely soluble in acetone, soluble in methanol and ether,
and slightly soluble in cyclohexane. The pKa is 8.5 and the melting point is
about 217°C.
System Components and Structure
Three different strengths of Butrans are available: 5, 10, and 20 mcg/hour
(Table 5). The active component of the system is buprenorphine. The remaining
components are pharmacologically inactive. The proportion of buprenorphine mixed
in the adhesive matrix is the same in each of the 3 strengths. The amount of
buprenorphine released from each system per hour is proportional to the active
surface area of the system. The skin is the limiting barrier to diffusion from
the system into the bloodstream.
Table 5: Butrans Product Specifications



Buprenorphine Delivery Rate (mcg/hour)
Active Surface
Area (cm²)
Total Buprenorphine
Content (mg)


Butrans 5
6.25
5


Butrans 10
12.5
10


Butrans 20
25
20



Butrans is a rectangular or square, beige-colored system consisting of a protective
liner and functional layers. Proceeding from the outer surface toward the surface
adhering to the skin, the layers are (1) a beige-colored web backing layer;
(2) an adhesive rim without buprenorphine; (3) a separating layer over the buprenorphine-containing
adhesive matrix; (4) the buprenorphine-containing adhesive matrix; and (5) a
peel-off release liner. Before use, the release liner covering the adhesive
layer is removed and discarded.
Figure 1 : Cross Section Diagram of Butrans (not to scale).








The active ingredient in Butrans is buprenorphine. The inactive ingredients
in each system are: levulinic acid, oleyl oleate, povidone, and polyacrylate
cross-linked with aluminum.
Last reviewed on RxList: 8/2/2010




Butrans Drug Description
Butrans
(buprenorphine) Transdermal System for Transdermal Administration

WARNING
IMPORTANCE OF PROPER PATIENT SELECTION, POTENTIAL FOR ABUSE, AND LIMITATIONS
OF USE
Proper Patient Selection
Butrans is a transdermal formulation of buprenorphine indicated for the
management of moderate to severe chronic pain in patients requiring a continuous,
around-the-clock opioid analgesic for an extended period of time.
Potential for Abuse
Butrans contains buprenorphine which is a mu opioid partial agonist and
a Schedule III controlled substance. Butrans can be abused in a manner similar
to other opioid agonists, legal or illicit. Consider the abuse potential when
prescribing or dispensing Butrans in situations where the physician or pharmacist
is concerned about an 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). Assess patients for their clinical
risks for opioid abuse or addiction prior to being prescribed opioids. Routinely
monitor all patients receiving opioids for signs of misuse, abuse and addiction.

Limitations of Use
Do not exceed a dose of one 20 mcg/hour Butrans system due to the risk of
QTc interval prolongation.
Avoid exposing the Butrans application site and surrounding area to direct
external heat sources. Temperature-dependent increases in buprenorphine release
from the system may result in overdose and death.

DRUG DESCRIPTION
Butrans is a transdermal system providing systemic delivery of buprenorphine,
a mu opioid partial agonist analgesic, continuously for 7 days. The chemical
name of buprenorphine is 6,14ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)-
α-(1,1-dimethylethyl)-4, 5-epoxy-18, 19dihydro-3-hydroxy-6-methoxy-α-methyl-,
[5α, 7α, (S)]. The structural formula is:








The molecular weight of buprenorphine is 467.6; the empirical formula is C29H41NO4.
Buprenorphine occurs as a white or almost white powder and is very slightly
soluble in water, freely soluble in acetone, soluble in methanol and ether,
and slightly soluble in cyclohexane. The pKa is 8.5 and the melting point is
about 217°C.
System Components and Structure
Three different strengths of Butrans are available: 5, 10, and 20 mcg/hour
(Table 5). The active component of the system is buprenorphine. The remaining
components are pharmacologically inactive. The proportion of buprenorphine mixed
in the adhesive matrix is the same in each of the 3 strengths. The amount of
buprenorphine released from each system per hour is proportional to the active
surface area of the system. The skin is the limiting barrier to diffusion from
the system into the bloodstream.
Table 5: Butrans Product Specifications



Buprenorphine Delivery Rate (mcg/hour)
Active Surface
Area (cm²)
Total Buprenorphine
Content (mg)


Butrans 5
6.25
5


Butrans 10
12.5
10


Butrans 20
25
20



Butrans is a rectangular or square, beige-colored system consisting of a protective
liner and functional layers. Proceeding from the outer surface toward the surface
adhering to the skin, the layers are (1) a beige-colored web backing layer;
(2) an adhesive rim without buprenorphine; (3) a separating layer over the buprenorphine-containing
adhesive matrix; (4) the buprenorphine-containing adhesive matrix; and (5) a
peel-off release liner. Before use, the release liner covering the adhesive
layer is removed and discarded.
Figure 1 : Cross Section Diagram of Butrans (not to scale).








The active ingredient in Butrans is buprenorphine. The inactive ingredients
in each system are: levulinic acid, oleyl oleate, povidone, and polyacrylate
cross-linked with aluminum.
Last reviewed on RxList: 8/2/2010




Butrans Drug Description
Butrans
(buprenorphine) Transdermal System for Transdermal Administration

WARNING
IMPORTANCE OF PROPER PATIENT SELECTION, POTENTIAL FOR ABUSE, AND LIMITATIONS
OF USE
Proper Patient Selection
Butrans is a transdermal formulation of buprenorphine indicated for the
management of moderate to severe chronic pain in patients requiring a continuous,
around-the-clock opioid analgesic for an extended period of time.
Potential for Abuse
Butrans contains buprenorphine which is a mu opioid partial agonist and
a Schedule III controlled substance. Butrans can be abused in a manner similar
to other opioid agonists, legal or illicit. Consider the abuse potential when
prescribing or dispensing Butrans in situations where the physician or pharmacist
is concerned about an 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). Assess patients for their clinical
risks for opioid abuse or addiction prior to being prescribed opioids. Routinely
monitor all patients receiving opioids for signs of misuse, abuse and addiction.

Limitations of Use
Do not exceed a dose of one 20 mcg/hour Butrans system due to the risk of
QTc interval prolongation.
Avoid exposing the Butrans application site and surrounding area to direct
external heat sources. Temperature-dependent increases in buprenorphine release
from the system may result in overdose and death.

DRUG DESCRIPTION
Butrans is a transdermal system providing systemic delivery of buprenorphine,
a mu opioid partial agonist analgesic, continuously for 7 days. The chemical
name of buprenorphine is 6,14ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)-
α-(1,1-dimethylethyl)-4, 5-epoxy-18, 19dihydro-3-hydroxy-6-methoxy-α-methyl-,
[5α, 7α, (S)]. The structural formula is:








The molecular weight of buprenorphine is 467.6; the empirical formula is C29H41NO4.
Buprenorphine occurs as a white or almost white powder and is very slightly
soluble in water, freely soluble in acetone, soluble in methanol and ether,
and slightly soluble in cyclohexane. The pKa is 8.5 and the melting point is
about 217°C.
System Components and Structure
Three different strengths of Butrans are available: 5, 10, and 20 mcg/hour
(Table 5). The active component of the system is buprenorphine. The remaining
components are pharmacologically inactive. The proportion of buprenorphine mixed
in the adhesive matrix is the same in each of the 3 strengths. The amount of
buprenorphine released from each system per hour is proportional to the active
surface area of the system. The skin is the limiting barrier to diffusion from
the system into the bloodstream.
Table 5: Butrans Product Specifications



Buprenorphine Delivery Rate (mcg/hour)
Active Surface
Area (cm²)
Total Buprenorphine
Content (mg)


Butrans 5
6.25
5


Butrans 10
12.5
10


Butrans 20
25
20



Butrans is a rectangular or square, beige-colored system consisting of a protective
liner and functional layers. Proceeding from the outer surface toward the surface
adhering to the skin, the layers are (1) a beige-colored web backing layer;
(2) an adhesive rim without buprenorphine; (3) a separating layer over the buprenorphine-containing
adhesive matrix; (4) the buprenorphine-containing adhesive matrix; and (5) a
peel-off release liner. Before use, the release liner covering the adhesive
layer is removed and discarded.
Figure 1 : Cross Section Diagram of Butrans (not to scale).








The active ingredient in Butrans is buprenorphine. The inactive ingredients
in each system are: levulinic acid, oleyl oleate, povidone, and polyacrylate
cross-linked with aluminum.
Last reviewed on RxList: 8/2/2010




Butrans Drug Description
Butrans
(buprenorphine) Transdermal System for Transdermal Administration

WARNING
IMPORTANCE OF PROPER PATIENT SELECTION, POTENTIAL FOR ABUSE, AND LIMITATIONS
OF USE
Proper Patient Selection
Butrans is a transdermal formulation of buprenorphine indicated for the
management of moderate to severe chronic pain in patients requiring a continuous,
around-the-clock opioid analgesic for an extended period of time.
Potential for Abuse
Butrans contains buprenorphine which is a mu opioid partial agonist and
a Schedule III controlled substance. Butrans can be abused in a manner similar
to other opioid agonists, legal or illicit. Consider the abuse potential when
prescribing or dispensing Butrans in situations where the physician or pharmacist
is concerned about an 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). Assess patients for their clinical
risks for opioid abuse or addiction prior to being prescribed opioids. Routinely
monitor all patients receiving opioids for signs of misuse, abuse and addiction.

Limitations of Use
Do not exceed a dose of one 20 mcg/hour Butrans system due to the risk of
QTc interval prolongation.
Avoid exposing the Butrans application site and surrounding area to direct
external heat sources. Temperature-dependent increases in buprenorphine release
from the system may result in overdose and death.

DRUG DESCRIPTION
Butrans is a transdermal system providing systemic delivery of buprenorphine,
a mu opioid partial agonist analgesic, continuously for 7 days. The chemical
name of buprenorphine is 6,14ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)-
α-(1,1-dimethylethyl)-4, 5-epoxy-18, 19dihydro-3-hydroxy-6-methoxy-α-methyl-,
[5α, 7α, (S)]. The structural formula is:








The molecular weight of buprenorphine is 467.6; the empirical formula is C29H41NO4.
Buprenorphine occurs as a white or almost white powder and is very slightly
soluble in water, freely soluble in acetone, soluble in methanol and ether,
and slightly soluble in cyclohexane. The pKa is 8.5 and the melting point is
about 217°C.
System Components and Structure
Three different strengths of Butrans are available: 5, 10, and 20 mcg/hour
(Table 5). The active component of the system is buprenorphine. The remaining
components are pharmacologically inactive. The proportion of buprenorphine mixed
in the adhesive matrix is the same in each of the 3 strengths. The amount of
buprenorphine released from each system per hour is proportional to the active
surface area of the system. The skin is the limiting barrier to diffusion from
the system into the bloodstream.
Table 5: Butrans Product Specifications



Buprenorphine Delivery Rate (mcg/hour)
Active Surface
Area (cm²)
Total Buprenorphine
Content (mg)


Butrans 5
6.25
5


Butrans 10
12.5
10


Butrans 20
25
20



Butrans is a rectangular or square, beige-colored system consisting of a protective
liner and functional layers. Proceeding from the outer surface toward the surface
adhering to the skin, the layers are (1) a beige-colored web backing layer;
(2) an adhesive rim without buprenorphine; (3) a separating layer over the buprenorphine-containing
adhesive matrix; (4) the buprenorphine-containing adhesive matrix; and (5) a
peel-off release liner. Before use, the release liner covering the adhesive
layer is removed and discarded.
Figure 1 : Cross Section Diagram of Butrans (not to scale).








The active ingredient in Butrans is buprenorphine. The inactive ingredients
in each system are: levulinic acid, oleyl oleate, povidone, and polyacrylate
cross-linked with aluminum.
Last reviewed on RxList: 8/2/2010





Other reviews about Buprenorphine Transdermal System on wordpress

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September 28, 2010 (Las Vegas, Nevada) — A transdermal application system containing the partial μ-opioid receptor agonist buprenorphine showed analgesic efficacy in the treatment of low […]


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Other reviews about Buprenorphine Transdermal System on web:

Transdermal buprenorphine has a half-life of approximately thirty hours, and a ... intoxicated via other opioids when buprenorphine is in the system. If enough buprenorphine is ... Buprenorphine - Wikipedia, the free encyclopedia


PURDUE PHARMA L.P. RECEIVES FDA APPROVAL FOR BUTRANS™ (buprenorphine) TRANSDERMAL SYSTEM CIII. Stamford, CT – July 1st, 2010 – Purdue Pharma L.P. announced today that the U.S ... Purdue Pharma L.P. Receives FDA Approval for Butrans ...


Butrans (buprenorphine) Transdermal System is used to treat chronic pain. Includes Butrans side effects, interactions and indications. Purdue Pharma L.P. Receives FDA Approval for Butrans ...


BUPRENORPHINE TRANSDERMAL SYSTEM (TDS) IN AN OPEN LONG-TERM STUDY WITH CHRONIC PAIN PATIENTS Michael Kopp Palliative Care Unit, Augsburg, Germany BUPRENORPHINE TRANSDERMAL SYSTEM (TDS) IN AN OPEN LONG-TERM STUDY ...


The objective of this study is to determine the analgesic efficacy and safety of Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve subjects ... Buprenorphine Transdermal System (BTDS) in Subjects With Moderate ...


Buprenorphine Transdermal System (BTDS) in Subjects w/Moderate-severe Chronic Pain Due to Osteoarthritis (OA) of Knee Buprenorphine Transdermal System (BTDS) in Subjects w/Moderate ...


Purdue Pharma L.P. announced that the U.S. Food and Drug Administration (FDA) approved Butrans™ (buprenorphine) Transdermal System CIII for the management of moderate to severe ... Purdue Pharma L.P. Receives FDA Approval For Butrans ...


Purdue Pharma L.P. to Present Data From Clinical Program for Butrans™ (buprenorphine) Transdermal System CIII at PAINWeek® 2010. Purdue Pharma L.P. to Present Data From Clinical Program for ...


... 20% of buprenorphine base or of a pharmaceutically acceptable salt thereof and 0.1 to 30% of a solvent for the buprenorphine or salt thereof. 2. The transdermal therapeutic system ... Transdermal therapeutic system ... - Google Patent Search


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





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