Severe acne due to amineptine was first reported in 1988 by various authors—Grupper, Thioly-Bensoussan, Vexiau, Fiet, Puissant, Gourmel, Teillac, Levigne, to name a few—simultaneously in the same issue of Annales de dermatologie et de vénéréologie and in the 12 March 1988 issue of The Lancet. A year later, Dr Martin-Ortega and colleagues in Barcelona, Spain reported a case of "acneiform eruption" in a 54-year-old woman whose intake of amineptine was described as "excessive." One year after that, Vexiau and colleagues reported six women, one of whom never admitted to using amineptine, getting severe acne concentrated in the face, back and thorax, the severity of which varied with the dosage. Most of them were treated unsuccessfully with isotretinoin for about 18 months; two of the three that discontinued amineptine experienced a reduction in cutaneous symptoms, with the least affected patient going into remission.
Psychiatric
Psychomotor excitation can very rarely occur with this drug.
Suicidal ideation. Seen early in the treatment, by lifting of psychomotor inhibition.
Abuse and dependence
The risk of addiction is low, but exists nonetheless. Between 1978 and 1988, there were 186 cases of amineptine addiction reported to the French Regional Centres of Pharmacovigilance; an analysis of 155 of those cases found that they were predominantly female, and that two-thirds of cases had known risk factors for addiction. However, a 1981 study of known opiate addicts and schizophrenia patients found no drug addiction in any of the subjects. In a 1990 study of eight amineptine dependence cases, the gradual withdrawal of amineptine could be achieved without problems in six people; in two others, anxiety, psychomotor agitation, and/or bulimia appeared.
Withdrawal
Pharmacodependence is very common with amineptine compared to other antidepressants. A variety of psychological symptoms can occur during withdrawal from amineptine, such as anxiety and agitation.
Amineptine can rarely cause hepatitis, of the cytolytic, cholestatic varieties. Amineptine-induced hepatitis, which is sometimes preceded by a rash, is believed to be due to an allergic reaction. It resolves upon discontinuation of the offending drug. The risk of getting this may or may not be genetically determined. Additionally, amineptine is known to rarely elevate transaminases, alkaline phosphatase, and bilirubin. Mixed hepatitis, which is very rare, generally occurs between the 15th and 30th day of treatment. Often preceded by sometimes intense abdominal pains, nausea, vomiting or a rash, the jaundice is variable. Hepatitis is either of mixed type or with cholestatic prevalence. The evolution was, in all the cases, favorable to the discontinuation of the drug. The mechanism is discussed. In circa 1994 Spain, there was a case associating acute pancreatitis and mixed hepatitis, after three weeks of treatment. Lazaros and colleagues at the Western Attica General Hospital in Athens, Greece reported two cases of drug induced hepatitis 18 and 15 days of treatment. One case of cytolytic hepatitis occurred after ingestion of only one tablet.
Gastrointestinal
Acute pancreatitis A case associating acute pancreatitis and mixed hepatitis after three weeks of treatment.
Amineptine inhibits the reuptake of dopamine and, to a much lesser extent, of norepinephrine. In addition, it has been found to induce the release of dopamine. However, amineptine is much less efficacious as a dopamine releasing agent relative to D-amphetamine, and the drug appears to act predominantly as a dopamine reuptake inhibitor. In contrast to the case for dopamine, amineptine does not induce the release of norepinephrine, and hence acts purely as a norepinephrine reuptake inhibitor. Unlike other TCAs, amineptine interacts very weakly or not at all with the serotonin, adrenergic, dopamine, histamine, and muscarinic acetylcholine receptors. The major metabolites of amineptine have similar activity to that of the parent compound, albeit with lower potency. No human data appear to be available for binding or inhibition of the monoamine transporters by amineptine.
Pharmacokinetics
of amineptine following a single 100 mg oral dose have been found to range between 277 and 2,215 ng/mL, with a mean of 772 ng/mL, whereas maximal plasma concentrations of its major metabolite ranged between 144 and 1,068 ng/mL, with a mean of 471 ng/mL. After a single 200 mg oral dose of amineptine, mean peak plasma levels of amineptine were around 750 to 940 ng/mL, while those of its major metabolite were about 750 to 970 ng/mL. The time to peak concentrations is about 1 hour for amineptine and 1.5 hours for its major metabolite. The elimination half-life of amineptine is about 0.80 to 1.0 hours and that of its major metabolite is about 1.5 to 2.5 hours. Due to their very short elimination half-lives, amineptine and its major metabolite do not accumulate significantly with repeated administration.
Society and culture
Brand names
Amineptine has been sold under a variety of brand names including Survector, Maneon, Directim, Neolior, Provector, and Viaspera.