Butrans 10 ug/h

buprenorphine · PATCH, EXTENDED RELEASE · Knoa Pharma LLC

No Recall History

Plain English

Butrans is a patch, extended release containing buprenorphine at 10 ug/h, taken transdermal. Manufactured by Knoa Pharma LLC.

Key Facts

Brand Name: Butrans
Generic Name: buprenorphine
NDC Code (Product): 59011-751
Manufacturer: Knoa Pharma LLC
Strength: 10 ug/h
Dosage Form: PATCH, EXTENDED RELEASE
Route: TRANSDERMAL
Marketing Status
DEA Schedule: Schedule III (Controlled)
Application #: NDA021306
Drug Class: Partial Opioid Agonist [EPC]
Marketing Start: 02/14/2011

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE BUTRANS is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1) ] , reserve opioid analgesics, including BUTRANS, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. BUTRANS is not indicated as an as-needed (prn) analgesic. BUTRANS is a partial opioid agonist indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. ( 1 ) Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including BUTRANS, for use in patients for whom alternat…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION BUTRANS should be prescribed only by healthcare professionals who are knowledgeable about the use of extended release/long-acting opioids and how to mitigate the associated risks. ( 2.1 ) BUTRANS doses of 7.5, 10, 15, and 20 mcg/hour are only for use in patients receiving, for one week or longer, daily opioid doses up to 80 mg/day of oral morphine or an equianalgesic dose of another opioid. ( 2.1 ) Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals. Reserve titration to higher doses of BUTRANS for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. ( 2.1 , 5 ) Initiate the dosing regimen for each patient's individually, taking into account the patients underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse. ( 2.1 , 5.1 ) Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with BUTRANS. Consider this risk when selecting an initial dose a…

Contraindications

4 CONTRAINDICATIONS BUTRANS is contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions (5.2) ] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.10) ] Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.15) ] Hypersensitivity (e.g., anaphylaxis) to buprenorphine [see Warnings and Precautions (5.18) , Adverse Reactions (6) ] Significant respiratory depression ( 4 ) Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment ( 4 ) Known or suspected gastrointestinal obstruction, including paralytic ileus ( 4 ) Hypersensitivity to buprenorphine ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Table 5 Includes clinically significant drug interactions with BUTRANS. Table 5: Clinically Significant Drug Interactions with BUTRANS Benzodiazepines Clinical Impact: There have been a number of reports regarding coma and death associated with the misuse and abuse of the combination of buprenorphine and benzodiazepines. In many, but not all of these cases, buprenorphine was misused by self-injection of crushed buprenorphine tablets. Preclinical studies have shown that the combination of benzodiazepines and buprenorphine altered the usual ceiling effect on buprenorphine-induced respiratory depression, making the respiratory effects of buprenorphine appear similar to those of full opioid agonists. Intervention: Regularly evaluate patients with concurrent use of BUTRANS and benzodiazepines. Warn patients that it is extremely dangerous to self-administer benzodiazepines while taking BUTRANS, and warn patients to use benzodiazepines concurrently with BUTRANS only as directed by their physician. Benzodiazepines and Other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effects, the concomitant use of benzodiazepines or other CNS…

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1) ] Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2) ] Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.3) ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4) ] Application Site Skin Reactions [see Warnings and Precautions (5.8) ] Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.9) ] Adrenal Insufficiency [see Warnings and Precautions (5.11) ] Severe Hypotension [see Warnings and Precautions (5.12) ] Hepatotoxicity [see Warnings and Precautions (5.14) ] Gastrointestinal Effects [see Warnings and Precautions (5.15) ] Seizures [see Warnings and Precautions (5.16) ] QTc Prolongation [see Warnings and Precautions (5.17) ] Anaphylactic/Allergic Reactions [see Warnings and Precautions (5.18) ] Most common adverse reactions (≥5%) include: nausea, headache, application site pruritus, dizziness, constipation, somnolence, vomiting, application site erythema, dry mouth, and application site rash. ( 6.1 ) To report S…

Frequently Asked Questions

What is Butrans used for?

Butrans contains buprenorphine. It is a patch, extended release taken transdermal. Consult your doctor for specific uses.

Is Butrans a controlled substance?

Yes, Butrans is classified as CIII under the DEA Controlled Substances Act.

What is the generic name for Butrans?

The generic name for Butrans is buprenorphine. There are 12 other brand versions of buprenorphine.

What is the NDC code for Butrans 10 ug/h?

The NDC (National Drug Code) for Butrans 10 ug/h is 59011-751, listed by Knoa Pharma LLC.

Product NDC

59011-751

Package NDC

59011-751-04

Other Buprenorphine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)