Instruction for use: Zeldox

Dosage form: capsules

Active substance: Ziprasidone*

ATX

N05AE04 Ziprasidone

Pharmacological group:

Neuroleptics

The nosological classification (ICD-10)

F20 Schizophrenia: Schizophrenic Conditions; An exacerbation of schizophrenia; Schizophrenia; Chronic schizophrenia; Dementia praecox; Bleuler's disease; Psychotic discordant; Dementia early; The febrile form of schizophrenia; Chronic schizophrenic disorder; Psychosis of the schizophrenic type; Acute form of schizophrenia; Acute schizophrenic disorder; Cerebral Organic Insufficiency in Schizophrenia; Acute attack of schizophrenia; Schizophrenic psychosis; Acute schizophrenia; Sluggish schizophrenia; Sluggish schizophrenia with apathoabulic disorders; Acute stage of schizophrenia with agitation

Composition

Lyophilizate for the preparation of solution for intramuscular injection 1 fl.

active substance:

ziprasidone mesylate trihydrate 40.93 mg

(equivalent to 30 mg of ziprasidone)

excipients: cyclodextrin sodium sulfobutylate (SBECD)

solvent: water for injection - 1.4 ml (taking into account the necessary excess in 0.2 ml for guaranteed withdrawal of 1.2 ml)

Pharmachologic effect

Pharmacological action - antipsychotic.

Dosing and Administration

IM. Do not enter IV!

Adults. Recommended doses are from 10 to 20 mg (maximum - 40 mg / day). Doses of 10 mg can be administered every 2 hours; a dose of 20 mg can be administered every 4 hours. The effectiveness of ziprasidone with an IM injection for more than 3 days has not been studied.

If long-term therapy is required, the patient should be transferred as soon as possible from the IM in the administration of ziprasidone capsules inside.

Application for violations of the liver. In patients with hepatic insufficiency, the dose of the drug should be reduced in proportion to the severity of the disease.

The use of smoking people. A dose change in smokers is not required.

Instructions for preparing a solution

The contents of the vial are dissolved in 1.2 ml of the supplied water for injection; the concentration of the resulting solution is 20 mg / ml. The vial is shaken until the powder is completely dissolved. You can use only a transparent solution that does not contain any visible inclusions. From each vial, you should only take one dose of the drug, and the remainder must be poured.

Release form

Lyophilizate for solution for intramuscular injection, 30 mg. 30 mg of lyophilizate in a 5 ml vial of transparent clear glass (type I) with a rubber stopper and an aluminum sealed cap with a plastic cap of the flip-off type.

Solvent (water for injection), 1.4 ml, in an ampoule of clear, colorless glass.

1 bottle and 1 ampoule are placed in a cardboard box.

Manufacturer

Pfizer PGM, France.

"Pharmacy and Upjohn", USA were produced.