Product Dossier

NEULACTIL

Product Dossier for NEULACTIL (periciazine, Clinect). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

Neulactil contains periciazine and is available as tablets in strengths of 2.5 mg and 10 mg. Periciazine is a phenothiazine with a piperidine side chain that has similar antipsychotic action to other phenothiazines but produces more sedation.

Approved indications

— Severe anxiety and tension states — Maintenance treatment of the psychotic patient

Dosing overview

Dosage may be progressively increased until the most effective level is reached, after which the dosage should be adjusted to maintain control of symptoms.

Key safety warnings

Periciazine may cause a mild leukopenia or agranulocytosis in some patients. Regular monitoring of the complete blood count is recommended. Hypersensitivity reactions including urticaria and angioedema have been reported with Neulactil use. Patients with cardiovascular disorders, bradycardia, hypokalaemia or familial history of prolongation of QT should be monitored closely during treatment because of a risk of worsening of long QT-syndrome, which may also elevate the risk for developing torsade de pointes, tachycardia and sudden death. Cases of QT interval prolongation have been reported with periciazine. Periciazine treatment should be discontinued in the event of unexplained fever as this may be one of the signs of neuroleptic malignant syndrome, the clinical manifestations of which include pallor, hyperthermia, autonomic disturbances, altered consciousness and muscle rigidity. Activities such as the control of vehicles or machinery should not be undertaken until it is evident that any soporific effect has subsided. Patients should be warned about drowsiness, slowing of reaction time and impaired judgement.

Contraindications

Periciazine should never be used in circulatory collapse, acute intoxication with central depression and coma, previous history of blood dyscrasias or agranulocytosis, or hypersensitivity to periciazine, other phenothiazines or to any of the other ingredients contained in the tablets. Periciazine is also contraindicated in risk of angle-closure glaucoma and risk of urinary retention due to urethroprostatic disorders. Use in children younger than 1 year is contraindicated due to a possible association between use of phenothiazine-containing products and Sudden Infant Death Syndrome.

PBS listing

Neulactil tablets 2.5 mg and 10 mg are each listed on the PBS with a restriction of restricted, with ex-manufacturer prices of A$4.56 and A$8.32 respectively.

Regulatory history

Neulactil was first registered on the ARTG on 21 October 1991, with two registered variants: the 10 mg tablet blister pack (ARTG 27523) and the 2.5 mg tablet blister pack (ARTG 27524).