section name header

Indications

High Alert

Contraind./Precautions

Contraindicated in:

Use Cautiously in:

Adv. Reactions/Side Effects

CV: bradycardia, hypotension.

Derm: sweating, erythema.

Endo: adrenal insufficiency.

GI: anorexia, constipation, dry mouth, nausea, vomiting.

Local: application site reactions.

MS: skeletal and thoracic muscle rigidity.

Neuro: confusion, sedation, weakness, dizziness, restlessness.

Resp: APNEA, bronchoconstriction, laryngospasm, RESPIRATORY DEPRESSION (INCLUDING CENTRAL SLEEP APNEA AND SLEEP-RELATED HYPOXEMIA).

Misc: physical dependence, psychological dependence.

Interactions

Drug-Drug:

Drug-Natural Products:

Drug-Food:

Availability

(Generic available)

Route/Dosage

Hepatic Impairment

Renal Impairment

US Brand Names

Duragesic

Action

Therapeutic Effects:

Classifications

Therapeutic Classification: opioid analgesics

Pharmacologic Classification: opioid agonists

Pharmacokinetics

Absorption: Well absorbed (92% of dose) through skin surface under transdermal patch, creating a depot in the upper skin layers. Release from transdermal system into systemic circulation ↑ gradually to a constant rate, providing continuous delivery for 72 hr.

Distribution: Crosses the placenta; enters breast milk.

Metabolism/Excretion: Mostly metabolized by the liver via the CYP3A4 isoenzyme; 10–25% excreted unchanged by the kidneys.

Half-life: 17 hr after removal of a single application patch, ↑ to 21 hr after removal of multiple patches (because of continued release from deposition of drug in skin layers).

Contr. Subst. Schedule

Schedule II (C-II)

Time/Action Profile

(↓ pain)

ROUTEONSETPEAKDURATION
Transdermal6 hr†12–24 hr72 hr‡

†Achievement of blood levels associated with analgesia. Maximal response and dose titration may take up to 6 days.

‡While patch is worn.

Patient/Family Teaching

Pronunciation

FEN-ta-nil audio

Code

NDC Code*