Flumazenil- Both flumazenil and nalmefene can induce seizures in animals and therefore potential risk of seizure exists.

Reversal of opoid efects

Nausea, vomiting, Tachycardia, hypertension, Post operative pain, Fever, dizziness, Headache, Chills, Hypotension, Vasodilatation.

Hypersensitivity to the product.

Special precautions:

Cardiovascular risks- pulmonary edema, cardiovascular instability. Risk of precipitated withdrawal- produce acute withdrawal symptoms. Risks of potential withdrawal- Nalmefene is known to produce acute withdrawal symptoms and therefore should be used with extreme caution in p[atients with known physical dependence on opoids or following surgery involoving high uses of opoids. Incomplete reversal of buprenophine - nalmefene may not completely reverse buprenorphine -induced respiratory depression.

Warnings-

Emergency use- inmost emergency settings treatment with nalmefene should follow not precede the establishment of patent airway , ventilatory assistance , administration of uxygen and establisahment of circulatory access. Respiratory depression- observe patient until there is no reasonable risk of recurrrent respiratory depression. Renal function impairment- the elimination half-lfe was prolonged in ESRD patients from 10.2 (contols) to 26.1 hr. Hepatic function impairment- no dosage adjustment is recommended since nalmefene will be administered as acute course of therapy.

Elderly- while initial plasma concentrations transietntly higher in the eldely, it would be not be anticipated that this population would require dosing adjustments.

Pregnancy- excercise caution when nalmefene is administered to a nursing woman.

Lactation- excercise caution when nalmefene is admionistered to a nursing woman.

Children- safety and efficacy have not been established.

Approved by FDA on April 17, 1995

Indications:

Reversal of opoid efects

Dosage:

As directed

Pharmacology:

Malmefene, an opoid antagonist is a 6-methylene analog of naltrexone . Nalmefene prevents or reverses the effects of opoids, including respiratory depression,sedation, and hypotension.

Pharmacokinetics:

Nalmefene is completely bioavailable following IM or SC administration. Nalmefene is metabolised by the liver by glucoronide conjugation and excreted in the urine,less than 5% is excreted in the urine unchanged, and 17% excreted inthe feces.

Pregnancy:

Use only when clearly needed.

Lactation:

Excercise caution when administered to a nursing woman.

Children-

Safety and efficacy have not been established.