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Butrans
Overview
What is Butrans?
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 6,14-ethenomorphinan-7-methanol,
17-(cyclopropylmethyl)- α-(1,1-dimethylethyl)-4, 5-epoxy-18, 19-dihydro-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 CHNO. 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
Table 6: BUTRANS Product Specifications
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.
What does Butrans look like?
What are the available doses of Butrans?
Transdermal system: 5 mcg/hour,
7.5 mcg/hour, 10 mcg/hour, 15 mcg/hour, and 20 mcg/hour. ()
What should I talk to my health care provider before I take Butrans?
How should I use Butrans?
BUTRANS is indicated for the management of pain
severe enough to require daily, around-the-clock, long-term opioid
treatment and for which alternative treatment options are inadequate.
Limitations of Use
BUTRANS should be prescribed only by healthcare professionals who
are knowledgeable in the use of potent opioids for the management
of chronic pain.
BUTRANS doses
of 7.5, 10, 15, and 20 mcg/hour are only for use in patients who are
opioid experienced and in whom tolerance to an opioid of comparable
potency has been established. Patients who are opioid-experienced
are those receiving, for one week or longer, daily opioid doses up
to 80 mg/day of oral morphine or an equianalgesic dose of another
opioid.
BUTRANS is for transdermal
use (on intact skin) only. Each BUTRANS patch is intended to be worn
for 7 days.
What interacts with Butrans?
Sorry No Records found
What are the warnings of Butrans?
Sorry No Records found
What are the precautions of Butrans?
Sorry No Records found
What are the side effects of Butrans?
Sorry No records found
What should I look out for while using Butrans?
BUTRANS is contraindicated in patients with:
p2984281398262680
Addiction, Abuse,
and Misuse
[see Warnings and Precautions () and Overdosage ()].
Life-Threatening Respiratory Depression
[see Warnings and Precautions ()]
Accidental Exposure
[see Warnings and Precautions
()]
Neonatal Opioid Withdrawal Syndrome
[see Warnings and Precautions ()]
Risks From Concomitant Use With Benzodiazepines
Or Other CNS Depressants
[see Warnings and Precautions
(), Drug Interactions ()]
What might happen if I take too much Butrans?
Clinical Presentation
[see Clinical Pharmacology
()]
Treatment of Overdose
Naloxone may not be effective in reversing
any respiratory depression produced by buprenorphine. High doses
of naloxone, 10-35 mg/70 kg, may be of limited value in the management
of buprenorphine overdose. The onset of naloxone effect may be delayed
by 30 minutes or more. Doxapram hydrochloride (a respiratory stimulant)
has also been used.
Remove BUTRANS
immediately. Because the duration of reversal would be expected to
be less than the duration of action of buprenorphine from BUTRANS,
carefully monitor the patient until spontaneous respiration is reliably
re-established. Even in the face of improvement, continued medical
monitoring is required because of the possibility of extended effects
as buprenorphine continues to be absorbed from the skin. After removal
of BUTRANS, the mean buprenorphine concentrations decrease approximately
50% in 12 hours (range 10-24 hours) with an apparent terminal half-life
of approximately 26 hours. Due to this long apparent terminal half-life,
patients may require monitoring and treatment for at least 24 hours.
In an individual physically dependent on
opioids, administration of an opioid receptor antagonist may precipitate
an acute withdrawal syndrome. The severity of the withdrawal symptoms
experienced will depend on the degree of physical dependence and the
dose of the antagonist administered. If a decision is made to treat
serious respiratory depression in the physically dependent patient,
administration of the antagonist should be begun with care and by
titration with smaller than usual doses of the antagonist.
How should I store and handle Butrans?
Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. BUTRANS Transdermal System is supplied in cartons containing 4 individually-packaged systems and a pouch containing 4 Patch-Disposal Units.BUTRANS (buprenorphine) 5 mcg/hour Transdermal Systems are square, beige-colored adhesive patches measuring 45 mm by 45 mm. Each system is printed in blue with the BUTRANS logo and 5 mcg/hr and are supplied in a 4-count carton ().BUTRANS (buprenorphine) 7.5 mcg/hour Transdermal Systems are rectangular, beige-colored adhesive patches measuring 58 mm by 45 mm. Each system is printed in blue with the BUTRANS logo and 7.5 mcg/hr and are supplied in a 4-count carton ().BUTRANS (buprenorphine) 10 mcg/hour Transdermal Systems are rectangular, beige-colored adhesive patches measuring 68 mm by 45 mm. Each system is printed in blue with the BUTRANS logo and 10 mcg/hr and are supplied in a 4-count carton ().BUTRANS (buprenorphine) 15 mcg/hour Transdermal Systems are rectangular, beige-colored adhesive patches measuring 72 mm by 59 mm Each system is printed in blue with the BUTRANS logo and 15 mcg/hr and are supplied in a 4-count carton ().BUTRANS (buprenorphine) 20 mcg/hour Transdermal Systems are square, beige-colored adhesive patches measuring 72 mm by 72 mm, Each system is printed in blue with the BUTRANS logo and 20mcg/hr and are supplied in a 4-count carton ().Store at 25°C (77°F); excursions permitted between 15°C - 30°C (59°F - 86°F).BUTRANS Transdermal System is supplied in cartons containing 4 individually-packaged systems and a pouch containing 4 Patch-Disposal Units.BUTRANS (buprenorphine) 5 mcg/hour Transdermal Systems are square, beige-colored adhesive patches measuring 45 mm by 45 mm. Each system is printed in blue with the BUTRANS logo and 5 mcg/hr and are supplied in a 4-count carton ().BUTRANS (buprenorphine) 7.5 mcg/hour Transdermal Systems are rectangular, beige-colored adhesive patches measuring 58 mm by 45 mm. Each system is printed in blue with the BUTRANS logo and 7.5 mcg/hr and are supplied in a 4-count carton ().BUTRANS (buprenorphine) 10 mcg/hour Transdermal Systems are rectangular, beige-colored adhesive patches measuring 68 mm by 45 mm. Each system is printed in blue with the BUTRANS logo and 10 mcg/hr and are supplied in a 4-count carton ().BUTRANS (buprenorphine) 15 mcg/hour Transdermal Systems are rectangular, beige-colored adhesive patches measuring 72 mm by 59 mm Each system is printed in blue with the BUTRANS logo and 15 mcg/hr and are supplied in a 4-count carton ().BUTRANS (buprenorphine) 20 mcg/hour Transdermal Systems are square, beige-colored adhesive patches measuring 72 mm by 72 mm, Each system is printed in blue with the BUTRANS logo and 20mcg/hr and are supplied in a 4-count carton ().Store at 25°C (77°F); excursions permitted between 15°C - 30°C (59°F - 86°F).BUTRANS Transdermal System is supplied in cartons containing 4 individually-packaged systems and a pouch containing 4 Patch-Disposal Units.BUTRANS (buprenorphine) 5 mcg/hour Transdermal Systems are square, beige-colored adhesive patches measuring 45 mm by 45 mm. Each system is printed in blue with the BUTRANS logo and 5 mcg/hr and are supplied in a 4-count carton ().BUTRANS (buprenorphine) 7.5 mcg/hour Transdermal Systems are rectangular, beige-colored adhesive patches measuring 58 mm by 45 mm. Each system is printed in blue with the BUTRANS logo and 7.5 mcg/hr and are supplied in a 4-count carton ().BUTRANS (buprenorphine) 10 mcg/hour Transdermal Systems are rectangular, beige-colored adhesive patches measuring 68 mm by 45 mm. Each system is printed in blue with the BUTRANS logo and 10 mcg/hr and are supplied in a 4-count carton ().BUTRANS (buprenorphine) 15 mcg/hour Transdermal Systems are rectangular, beige-colored adhesive patches measuring 72 mm by 59 mm Each system is printed in blue with the BUTRANS logo and 15 mcg/hr and are supplied in a 4-count carton ().BUTRANS (buprenorphine) 20 mcg/hour Transdermal Systems are square, beige-colored adhesive patches measuring 72 mm by 72 mm, Each system is printed in blue with the BUTRANS logo and 20mcg/hr and are supplied in a 4-count carton ().Store at 25°C (77°F); excursions permitted between 15°C - 30°C (59°F - 86°F).BUTRANS Transdermal System is supplied in cartons containing 4 individually-packaged systems and a pouch containing 4 Patch-Disposal Units.BUTRANS (buprenorphine) 5 mcg/hour Transdermal Systems are square, beige-colored adhesive patches measuring 45 mm by 45 mm. Each system is printed in blue with the BUTRANS logo and 5 mcg/hr and are supplied in a 4-count carton ().BUTRANS (buprenorphine) 7.5 mcg/hour Transdermal Systems are rectangular, beige-colored adhesive patches measuring 58 mm by 45 mm. Each system is printed in blue with the BUTRANS logo and 7.5 mcg/hr and are supplied in a 4-count carton ().BUTRANS (buprenorphine) 10 mcg/hour Transdermal Systems are rectangular, beige-colored adhesive patches measuring 68 mm by 45 mm. Each system is printed in blue with the BUTRANS logo and 10 mcg/hr and are supplied in a 4-count carton ().BUTRANS (buprenorphine) 15 mcg/hour Transdermal Systems are rectangular, beige-colored adhesive patches measuring 72 mm by 59 mm Each system is printed in blue with the BUTRANS logo and 15 mcg/hr and are supplied in a 4-count carton ().BUTRANS (buprenorphine) 20 mcg/hour Transdermal Systems are square, beige-colored adhesive patches measuring 72 mm by 72 mm, Each system is printed in blue with the BUTRANS logo and 20mcg/hr and are supplied in a 4-count carton ().Store at 25°C (77°F); excursions permitted between 15°C - 30°C (59°F - 86°F).BUTRANS Transdermal System is supplied in cartons containing 4 individually-packaged systems and a pouch containing 4 Patch-Disposal Units.BUTRANS (buprenorphine) 5 mcg/hour Transdermal Systems are square, beige-colored adhesive patches measuring 45 mm by 45 mm. Each system is printed in blue with the BUTRANS logo and 5 mcg/hr and are supplied in a 4-count carton ().BUTRANS (buprenorphine) 7.5 mcg/hour Transdermal Systems are rectangular, beige-colored adhesive patches measuring 58 mm by 45 mm. Each system is printed in blue with the BUTRANS logo and 7.5 mcg/hr and are supplied in a 4-count carton ().BUTRANS (buprenorphine) 10 mcg/hour Transdermal Systems are rectangular, beige-colored adhesive patches measuring 68 mm by 45 mm. Each system is printed in blue with the BUTRANS logo and 10 mcg/hr and are supplied in a 4-count carton ().BUTRANS (buprenorphine) 15 mcg/hour Transdermal Systems are rectangular, beige-colored adhesive patches measuring 72 mm by 59 mm Each system is printed in blue with the BUTRANS logo and 15 mcg/hr and are supplied in a 4-count carton ().BUTRANS (buprenorphine) 20 mcg/hour Transdermal Systems are square, beige-colored adhesive patches measuring 72 mm by 72 mm, Each system is printed in blue with the BUTRANS logo and 20mcg/hr and are supplied in a 4-count carton ().Store at 25°C (77°F); excursions permitted between 15°C - 30°C (59°F - 86°F).BUTRANS Transdermal System is supplied in cartons containing 4 individually-packaged systems and a pouch containing 4 Patch-Disposal Units.BUTRANS (buprenorphine) 5 mcg/hour Transdermal Systems are square, beige-colored adhesive patches measuring 45 mm by 45 mm. Each system is printed in blue with the BUTRANS logo and 5 mcg/hr and are supplied in a 4-count carton ().BUTRANS (buprenorphine) 7.5 mcg/hour Transdermal Systems are rectangular, beige-colored adhesive patches measuring 58 mm by 45 mm. Each system is printed in blue with the BUTRANS logo and 7.5 mcg/hr and are supplied in a 4-count carton ().BUTRANS (buprenorphine) 10 mcg/hour Transdermal Systems are rectangular, beige-colored adhesive patches measuring 68 mm by 45 mm. Each system is printed in blue with the BUTRANS logo and 10 mcg/hr and are supplied in a 4-count carton ().BUTRANS (buprenorphine) 15 mcg/hour Transdermal Systems are rectangular, beige-colored adhesive patches measuring 72 mm by 59 mm Each system is printed in blue with the BUTRANS logo and 15 mcg/hr and are supplied in a 4-count carton ().BUTRANS (buprenorphine) 20 mcg/hour Transdermal Systems are square, beige-colored adhesive patches measuring 72 mm by 72 mm, Each system is printed in blue with the BUTRANS logo and 20mcg/hr and are supplied in a 4-count carton ().Store at 25°C (77°F); excursions permitted between 15°C - 30°C (59°F - 86°F).BUTRANS Transdermal System is supplied in cartons containing 4 individually-packaged systems and a pouch containing 4 Patch-Disposal Units.BUTRANS (buprenorphine) 5 mcg/hour Transdermal Systems are square, beige-colored adhesive patches measuring 45 mm by 45 mm. Each system is printed in blue with the BUTRANS logo and 5 mcg/hr and are supplied in a 4-count carton ().BUTRANS (buprenorphine) 7.5 mcg/hour Transdermal Systems are rectangular, beige-colored adhesive patches measuring 58 mm by 45 mm. Each system is printed in blue with the BUTRANS logo and 7.5 mcg/hr and are supplied in a 4-count carton ().BUTRANS (buprenorphine) 10 mcg/hour Transdermal Systems are rectangular, beige-colored adhesive patches measuring 68 mm by 45 mm. Each system is printed in blue with the BUTRANS logo and 10 mcg/hr and are supplied in a 4-count carton ().BUTRANS (buprenorphine) 15 mcg/hour Transdermal Systems are rectangular, beige-colored adhesive patches measuring 72 mm by 59 mm Each system is printed in blue with the BUTRANS logo and 15 mcg/hr and are supplied in a 4-count carton ().BUTRANS (buprenorphine) 20 mcg/hour Transdermal Systems are square, beige-colored adhesive patches measuring 72 mm by 72 mm, Each system is printed in blue with the BUTRANS logo and 20mcg/hr and are supplied in a 4-count carton ().Store at 25°C (77°F); excursions permitted between 15°C - 30°C (59°F - 86°F).
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Buprenorphine is a partial agonist at the
mu-opioid receptor and an antagonist at the kappa-opioid receptors,
an agonist at delta-opioid receptors, and a partial agonist at ORL-1
(nociceptin) receptors. The contributions of these actions to its
analgesic profile are unclear.
Non-Clinical Toxicology
BUTRANS is contraindicated in patients with:p2984281398262680
Addiction, Abuse, and Misuse
[see Warnings and Precautions () and Overdosage ()].
Life-Threatening Respiratory Depression
[see Warnings and Precautions ()]
Accidental Exposure
[see Warnings and Precautions ()]
Neonatal Opioid Withdrawal Syndrome
[see Warnings and Precautions ()]
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
[see Warnings and Precautions (), Drug Interactions ()]
Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.
Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracyclines in conjunction with penicillin.
Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and iron-containing preparations.
Absorption of tetracyclines is impaired by bismuth subsalicylate.
Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.
The concurrent use of tetracycline and Penthrane (methoxyflurane) has been reported to result in fatal renal toxicity.
Concurrent use of tetracycline may render oral contraceptives less effective.
BUTRANS contains buprenorphine, a Schedule III controlled substance. As an opioid, BUTRANS exposes users to the risks of addiction, abuse, and misuse . Because extended-release products such as BUTRANS deliver the opioid over an extended period of time, there is a greater risk for overdose and death, due to the larger amount of buprenorphine present.
Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed BUTRANS. Addiction can occur at recommended doses and if the drug is misused or abused.
Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing BUTRANS, and monitor all patients receiving BUTRANS for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as BUTRANS, but use in such patients necessitates intensive counseling about the risks and proper use of BUTRANS, along with intensive monitoring for signs of addiction, abuse, or misuse.
Abuse or misuse of BUTRANS by placing it in the mouth, chewing it, swallowing it, or using it in ways other than indicated may cause choking, overdose and death .
Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing BUTRANS. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug . Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.
The following serious adverse reactions are described elsewhere in the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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