Fluphenazine decanoate injection usp monograph

Decanoic acid acts as a non-competitive AMPA receptor antagonist at therapeutically relevant concentrations, in a voltage- and subunit-dependent manner, and this is sufficient to explain its antiseizure effects. [12] This direct inhibition of excitatory neurotransmission by decanoic acid in the brain contributes to the anticonvulsant effect of the MCT ketogenic diet . [12] Decanoic acid and the AMPA receptor antagonist drug perampanel act at separate sites on the AMPA receptor, and so it is possible that they have a cooperative effect at the AMPA receptor, suggesting that perampanel and the ketogenic diet could be synergistic. [12]

Oral:
-Initial dose: to 10 mg orally in divided doses every 6 to 8 hours
-Maintenance dose: 1 to 5 mg/day
-Maximum dose: Up to 40 mg/day

Oral Comments:
-Maintenance doses may be given as single daily doses.
-Many patients achieve therapeutic effect with doses of less than 20 mg. Patients who are severely disturbed or inadequately controlled may require a dose of up to 40 mg/day.

Parenteral:
Fluphenazine Decanoate for Injection:
-Initial dose: to 25 mg deep IM injection into the gluteal region
-Maintenance dose: to 100 mg IM, usually every 3 to 4 weeks
-Maximum dose: 100 mg/injection

Fluphenazine HCl for Injection:
-Initial dose: to 10 mg IM, given as divided doses every 6 to 8 hours
-Maximum dose: Up to 10 mg/day

Parenteral Comments:
-Patients may switch from Fluphenazine HCl for Injection to oral formulations when symptoms are controlled. The dose of an oral formulation is approximately 2 to 3 times the dose of fluphenazine HCl for injection.

-Fluphenazine decanoate for injection may be given subcutaneously.

Uses:
-Management of manifestations of schizophrenia
-Management of patients requiring prolonged parenteral neuroleptic therapy (., patients with chronic schizophrenia)

The intravenous route is not FDA approved and is generally not recommended except when no other alternatives are available. Intravenous administration appears to be associated with a higher risk of QT prolongation and torsade de pointes (TdP) than other forms of administration. The manufacturer recommends ECG monitoring for QT prolongation and arrhythmias if IV administration is required. A dose in the range of 1 to 5 mg IV has been suggested, with the dose being repeated at 30 to 60 minute intervals, if needed. A maximum IV dose has not been established. The lowest effective dose should be used in conjunction with conversion to oral therapy as soon as possible.

Fluphenazine decanoate injection usp monograph

fluphenazine decanoate injection usp monograph

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