Nalmefene Hydrochloride Injection Dosage & Rx Info

Nalmefene Hydrochloride Injection Generic Name & Formulations

Legal Class

General Description

Nalmefene hydrochloride 1mg/mL (equivalent to 1mg nalmefene base); per vial; soln for IV, IM, or SC inj.

Pharmacological Class

Opioid antagonist.

How Supplied

Single-dose vials (2mL)—10

Manufacturer

Purdue Pharma L.P.

Mechanism of Action

Nalmefene hydrochloride prevents or reverses the effects of opioids, including respiratory depression, sedation, and hypotension.

Nalmefene Hydrochloride Injection Indications

Indications

Reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids. Management of known or suspected opioid overdose.

Nalmefene Hydrochloride Injection Dosage and Administration

Adult

IV route preferable: see full labeling. Reversal of opioid effects: see full labeling. Suspected opioid overdose (non-opioid dependent): initially 0.5mg/70kg, may follow with 2^nd dose of 1mg/70kg if needed, 2–5mins later; do not give additional doses if no response after a total dose of 1.5mg/70kg. If opioid dependency suspected, may use an initial challenge of 0.1mg/70kg; if no evidence of withdrawal in 2mins, administer 0.5mg/70kg. Renal failure: give incremental doses more slowly (over 60secs).

Children

Not established.

Nalmefene Hydrochloride Injection Contraindications

Not Applicable

Nalmefene Hydrochloride Injection Boxed Warnings

Not Applicable

Nalmefene Hydrochloride Injection Warnings/Precautions

Warnings/Precautions

Risk of recurrent respiratory depression. Cardiovascular disease or risk. Known or suspected opioid dependence. Caution when administering after high doses of opioids. Seizure disorders. Elderly. Pregnancy. Nursing mothers.

Nalmefene Hydrochloride Injection Pharmacokinetics

Metabolism

Hepatic (glucuronide conjugation).

Elimination

Renal (major), fecal (17%). Half-life: 10.8 ± 5.2 hours.

Nalmefene Hydrochloride Injection Interactions

Interactions

Caution with concomitant cardiotoxic drugs. Incomplete reversal of buprenorphine. Possible risk of seizures with flumazenil.

Nalmefene Hydrochloride Injection Adverse Reactions

Adverse Reactions

Nausea, vomiting, tachycardia, hypertension, post-op pain, fever, dizziness, headache, chills, hypotension, vasodilation; acute withdrawal symptoms.

Nalmefene Hydrochloride Injection Clinical Trials

See Literature

Nalmefene Hydrochloride Injection Note

Notes

Formerly known under the brand name Revex.

Nalmefene Hydrochloride Injection Patient Counseling