GEODON Capsule, hard Ref.[8280] Active ingredients: Ziprasidone

Source: Health Products Regulatory Authority (IE)  Revision Year: 2023  Publisher: Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Netherlands

Product name and form

Geodon 40 mg capsules, hard.

Pharmaceutical Form

Capsule, hard.

40 mg – No 4, blue capsules, marked “Pfizer” and ZDX 40.

Qualitative and quantitative composition

Each hard capsule contains ziprasidone hydrochloride monohydrate equivalent to 40 mg, of ziprasidone.

Excipient(s) with known effects: Each 40 mg capsule contains 87.83 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ziprasidone

Ziprasidone has been shown to be an antagonist at both serotonin type 2A (5HT2A) and dopamine type 2 (D2) receptors. It is proposed that the therapeutic activity is mediated, in part, through this combination of antagonist activities. Ziprasidone is also a potent antagonist at 5HT2C and 5HT1D receptors, a potent agonist at the 5HT1A receptor and inhibits neuronal reuptake of norepinephrine and serotonin.

List of Excipients

Contents:

Lactose monohydrate
Pregelatinised maize starch
Magnesium stearate

Capsule shell:

Gelatin
Titanium dioxide (E171)
Sodium laurilsulfate (sodium dodecylsulfate)
Indigotin (E132, only in 20 mg, 40 mg, 80 mg capsules)

Printing ink:

Shellac
Propylene glycol (E1520)
Ammonium hydroxide (E527)
Potassium hydroxide (E525)
Black iron oxide (E172)

Pack sizes and marketing

Blister: Ziprasidone capsules are presented in aluminium PVC/PVA blisters with aluminium foil lids, in cartons containing 14, 20, 30, 50, 56, 60 or 100 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Netherlands

Marketing authorization dates and numbers

PA23055/015/002

Date of first authorisation: 10 June 1998
Date of last renewal: 01 August 2010

Drugs

Drug Countries
GEODON Brazil, Cyprus, Ireland, Israel, Mexico, United States, South Africa

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