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DEA NFLIS-Drug Category -> Narcotic Analgesics

DEA Schedule II Controlled Substance -> Opiates

Pharmaceuticals -> Synthetic Cannabinoids or Psychoactive Compounds

Manufacturers, packers, and distributors of drug and drug products for human use are responsible for complying with the labeling, certification, and usage requirements as prescribed by the Federal Food, Drug, and Cosmetic Act, as amended (secs 201-902, 52 Stat. 1040 et seq., as amended; 21 U.S.C. 321-392).

Schedules of controlled substances are established by section 202 of the Controlled Substances Act (21 U.S.C. 812). Schedule II includes alphaprodine, DEA Code #9010; Drug class: Opiate.

Drugs; statement of required warning. The label of any drug listed as a "controlled substance" in schedule II, III, or IV of the Federal Controlled Substances Act shall, when dispensed to or for a patient, contain the following warning: "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed." This statement is not required to appear on the label of a controlled substance for use in clinical investigations which are "blind".

DEPRESSANT EFFECTS OF ALPHAPRODINE HYDROCHLORIDE ARE POTENTIATED BY BARBITURATES, GENERAL ANESTHETIC AGENTS, & SOME PHENOTHIAZINES. THUS, THE DOSE SHOULD BE REDUCED WHEN USED CONCOMITANTLY WITH SUCH AGENTS. /ALPHAPRODINE HYDROCHLORIDE/

CONCURRENT ADMIN OF MEPERIDINE & PHENELZINE OR OTHER MONOAMINE OXIDASE INHIBITORS MAY RESULT IN EXCITATORY & DEPRESSANT EFFECTS ON THE CNS LEADING TO DEEP COMA & DEATH. /MEPERIDINE/

May be habit forming.

ADVERSE EFFECTS INCLUDE OCCASIONAL RESP DEPRESSION, DIZZINESS, DROWSINESS, SWEATING & URTICARIA; RARELY, NAUSEA, VOMITING, RESTLESSNESS, & CONFUSION MAY OCCUR. /ALPHAPRODINE HYDROCHLORIDE/

ALLERGIC PHENOMENA OCCUR WITH OPIOID ANALGESICS, BUT ... NOT COMMON. THEY ARE USUALLY MANIFESTED AS URTICARIA & OTHER TYPES OF SKIN RASHES SUCH AS FIXED ERUPTIONS CONTACT DERMATITIS IN NURSES & PHARMACEUTICAL WORKERS ALSO OCCURS. WHEALS @ SITE OF INJECTION OF MORPHINE ... & RELATED DRUGS ARE PROBABLY CAUSED BY THE RELEASED HISTAMINE. /OPIOIDS/

Compounds with activity like OPIATE ALKALOIDS, acting at OPIOID RECEPTORS. Properties include induction of ANALGESIA or NARCOSIS.

Agents that induce NARCOSIS. Narcotics include agents that cause somnolence or induced sleep (STUPOR); natural or synthetic derivatives of OPIUM or MORPHINE or any substance that has such effects. They are potent inducers of ANALGESIA and OPIOID-RELATED DISORDERS.

FOLLOWING IV ADMIN TO DOGS, RAPID DISAPPEARANCE OF ALPHAPRODINE FROM PLASMA & LARGE DISTRIBUTION VOL WERE IN KEEPING WITH ITS RAPID ONSET & SHORT DURATION OF ACTION. THERE APPEARED TO BE RAPID EQUILIBRIUM BETWEEN BRAIN & PLASMA.

The elimination half-life of alphaprodine is 131 minutes (approximately 2 hours) compared with 247 minutes for meperidine. Plasma clearances for alphaprodine and meperidine are nearly identical: 1.04 and 1.01 l/kg/min, respectively. Although meperidine undergoes extensive biotransformation in the liver to form N-demethylated derivatives and meperidinic acid (see Meperidine) no information is available relating to alphaprodine biotransformation in man.

Alphaprodine is immediately absorbed from parenteral sites. Thirty-five milligrams of alphaprodine intravenously produces plasma concentrations similar to those following 100 mg meperidine. The half-life (absorption) is 4.6 minutes for alphaprodine compared with 17.2 minutes for meperidine.

One-milliliter ampules contain alphaprodine hydrochloride, 40 mg/ml, citric acid, and sodium citrate, 0.0875%, adjusted to a pH of 4.6 (Nisentil). Ten-milliliter ampules contain alphaprodine hydrochloride, 60 mg/ml, phenol preservative, 0.45%, citric acid, and sodium citrate, 0.0875%, adjusted to a pH of 4.6 (Nisentil). /Alphaprodine hydrochloride/