Buprenorphine

BUPRENORPHINE

Manufacturer: American Health Packaging

Score: 141.0

Quick Summary

Buprenorphine transdermal system is a partial opioid agonist indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. The system is available in five strengths: 5 mcg/hour, 7.5 mcg/hour, 10 mcg/hour, 15 mcg/hour, and 20 mcg/hour. It is essential to use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals. The drug has several warnings, including addiction, abuse, and misuse, life-threatening respiratory depression, and neonatal opioid withdrawal syndrome. Contraindications include significant respiratory depression, acute or severe bronchial asthma, and known or suspected gastrointestinal obstruction. Common adverse reactions include nausea, headache, application site pruritus, dizziness, constipation, somnolence, vomiting, application site erythema, dry mouth, and application site rash.

Key Clinical Findings and Indications

Management of severe and persistent pain
Extended treatment period with a daily opioid analgesic
Alternative treatment options are inadequate

Important Safety Information

Warning

Addiction, abuse, and misuse; life-threatening respiratory depression; neonatal opioid withdrawal syndrome

Contraindications

Significant respiratory depression
Acute or severe bronchial asthma
Known or suspected gastrointestinal obstruction
Hypersensitivity to buprenorphine

Adverse Reactions

Nausea
Headache
Application site pruritus
Dizziness
Constipation
Somnolence
Vomiting
Application site erythema
Dry mouth
Application site rash

Dosing Recommendations

General Guidance

Titrate the dosage of buprenorphine transdermal system slowly in geriatric patients and frequently reevaluate the patient for signs of central nervous system and respiratory depression

Opioid-naive patients

Adult Dose

Initiate treatment with a 5 mcg/hour patch

Pediatric Dose

Not recommended for use in patients under 18 years of age

Opioid-experienced patients

Adult Dose

Initiate treatment with a 10 mcg/hour patch

Pediatric Dose

Not recommended for use in patients under 18 years of age

Special Population Considerations

Pregnancy

Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome
Available data with buprenorphine transdermal system in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage

Nursing Mothers

Buprenorphine is present in maternal milk
Caution should be exercised when buprenorphine transdermal system is administered to a nursing woman

Pediatric Use

The safety and efficacy of buprenorphine transdermal system in patients under 18 years of age has not been established
Not recommended for use in patients under 18 years of age

Geriatric Use

Of the total number of subjects in the clinical trials (5,415), buprenorphine transdermal system was administered to 1,377 patients aged 65 years and older
Respiratory depression is the chief risk for elderly patients treated with opioids and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration