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GEODON Capsule, hard (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Geodon 40 mg capsules, hard.

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 ...

Pharmaceutical form

Capsule, hard. 40 mg – No 4, blue capsules, marked Pfizer and ZDX 40

Therapeutic indications

Ziprasidone is indicated for the treatment of schizophrenia in adults. Ziprasidone is indicated for the treatment of manic or mixed episodes of moderate severity in bipolar disorder in adults and children ...

Posology and method of administration

Posology Adults The recommended dose, in acute treatment of schizophrenia and bipolar mania, is 40 mg twice daily taken with food. Daily dosage may subsequently be adjusted on the basis of individual clinical ...

Contraindications

Hypersensitivity to the active substance or any of the excipients listed in section 6.1. Known QT-interval prolongation. Congenital long QT syndrome. Recent acute myocardial infarction. Uncompensated heart ...

Special warnings and precautions for use

A medical history, including assessment of family history, and physical examination should be undertaken to identify patients for whom ziprasidone treatment is not recommended (see section 4.3). QT interval ...

Interaction with other medicinal products and other forms of interaction

Pharmacokinetic and pharmacodynamic studies between ziprasidone and other medicinal products that prolong the QT interval have not been performed. An additive effect of ziprasidone and these medicinal ...

Fertility, pregnancy and lactation

Reproductive toxicity studies have shown undesirable effects on the reproductive process, at doses associated with maternal toxicity and/or sedation. There was no evidence of teratogenicity (see section ...

Effects on ability to drive and use machines

Ziprasidone may cause somnolence and may influence on the ability to drive and use machines. Patients likely to drive or operate machines should be cautioned appropriately.

Undesirable effects

Oral ziprasidone has been administered in clinical trials (see section 5.1) to approximately 6500 adult subjects. The most common adverse drug reactions in schizophrenia clinical trials were insomnia, ...

Overdose

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 ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antipsychotic, indole derivatives ATC code: NO5AE04 Ziprasidone has a high affinity for dopamine type 2 (D<sub>2</sub>) receptors and substantially higher affinity for serotonin ...

Pharmacokinetic properties

Absorption Following oral administration of multiple doses of ziprasidone with food, peak serum concentrations typically occur 6 to 8 hours post-dose. The absolute bioavailability of a 20 mg dose is 60% ...

Preclinical safety data

Preclinical safety data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and carcinogenic potential. In reproductive studies in rats and rabbits, ziprasidone ...

List of excipients

<u>Contents:</u> Lactose monohydrate Pregelatinised maize starch Magnesium stearate. <u>Capsule shell:</u> Gelatin Titanium dioxide (E171) Sodium laurilsulfate (sodium dodecylsulfate) Indigotin (E132, ...

Incompatibilities

Not applicable.

Shelf life

4 years.

Special precautions for storage

Do not store above 30°C.

Nature and contents of container

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.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization number(s)

PA 0822/214/002

Date of first authorization / renewal of the authorization

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

Date of revision of the text

11/2019

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