GEODON Powder for solution for injection Ref.[51057] Active ingredients: Ziprasidone

Posology

For intramuscular use only.

Intravenous administration must be avoided.

Treatment with the intramuscular formulation should only be used in patients, where treatment with an oral formulation is considered to be inappropriate.

Adults

The recommended dose is 10 mg administered as required up to a maximum dose of 40 mg per day. Doses of 10 mg may be administered every 2 hours. Some patients may require an initial dose of 20mg, which can be followed by a further dose of 10 mg after 4 hours. Thereafter, doses of 10 mg may be given every 2 hours up to the maximum daily dose of 40 mg. Intramuscular administration of ziprasidone for more than 3 consecutive days has not been studied.

If long-term therapy is indicated, oral ziprasidone hydrochloride capsules, up to 80 mg twice daily, should replace the intramuscular administration as soon as possible.

Elderly

The clinical experience with intramuscular treatment in elderly patients (> 65 years) is limited. Treatment with intramuscular injection is not recommended to these patients (see section 4.4).

Patients with renal impairment

Ziprasidone intramuscular injection should be administered with caution in patients with impaired renal function (see section 5.2).

Patients with hepatic impairment

In patients with hepatic insufficiency, lower doses should be considered (see section 4.4 and 5.2).

For instructions for reconstitution, see section 6.6.

Experience with ziprasidone in overdose is limited. The largest confirmed single ingestion of ziprasidone is 12,800 mg. In this case extrapyramidal symptoms and a QTc interval of 446 msec (with no cardiac sequelae) were reported. In general, the most commonly reported symptoms following overdose are, extrapyramidal symptoms, somnolence, tremor and anxiety.

The possibility of obtundation, seizures or dystonic reaction of the head and neck following overdosage may create a risk of aspiration with induced emesis. Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias. There is no specific antidote to ziprasidone.

3 years.

Chemical and physical in-use stability of the reconstituted product has been demonstrated for 24 hours up to 25°C and 7 days at 2 to 8°C. However from a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.

Do not store above 30°C.

Keep container in the outer carton.

Do not freeze.

Type 1 flint glass vials containing powder (ziprasidone mesilate). The vials are sealed with butyl rubber lyophile stoppers and flip-off aluminium seals.

Type 1 flint glass ampoules containing solvent (Water for Injections).

Pack size: 1 vial and 1 ampoule per carton.

The contents of the vial (powder) should be reconstituted by introduction of 1.2 ml of the supplied Water for Injections (solvent), affording a concentration of 20 mg ziprasidone per ml, and shaking until complete dissolution has occurred. Only clear solutions, free of visible particles, should be used. Only one dose (0.5 ml corresponding to 10 mg ziprasidone, or 1 ml corresponding to 20 mg ziprasidone) should be withdrawn from each vial and the remainder discarded.