ZELDOX ziprasidone hydrochloride 40mg, 60mg & 80mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ziprasidone hydrochloride monohydrate, Quantity: 90.6 mg

Available from:

Viatris Pty Ltd

INN (International Name):

Ziprasidone hydrochloride

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: titanium dioxide; pregelatinised maize starch; lactose monohydrate; Gelatin; indigo carmine; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Administration route:

Oral

Units in package:

6 capsules (2x 40mg, 2x 60mg, 2x 80mg)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ZELDOX (ziprasidone) is indicated for the treatment of schizophrenia, related psychoses, prevention of relapse and for maintenance of clinical improvement during continuation therapy; as monotherapy for the short term treatment of acute manic or mixed episodes associated with bipolar I disorder.

Product summary:

Visual Identification: No. 2 blue cap/white body capsule marked "Pfizer" & "ZDX 80".; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2007-02-13

Summary of Product characteristics

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AUSTRALIAN PRODUCT
INFORMATION -
ZELDOX
 (ZIPRASIDONE HYDROCHLORIDE
MONOHYDRATE) CAPSULES
1. NAME OF THE MEDICINE
Ziprasidone hydrochloride monohydrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ZELDOX capsules containing ziprasidone hydrochloride monohydrate
equivalent to 20 mg,
40 mg, 60 mg or 80 mg ziprasidone.
EXCIPIENT(S) WITH KNOWN EFFECT
•
Lactose monohydrate
For the full list of excipients, see Section 6.1 - List of excipients.
3.
PHARMACEUTICAL FORM
ZELDOX is supplied for oral administration as capsules.
ZELDOX 20 mg capsules: No.4 blue/white capsules, marked “Pfizer”
and “ZDX 20”.
ZELDOX 40 mg capsules: No.4 blue capsules, marked “Pfizer” and
“ZDX 40”.
ZELDOX 60 mg capsules: No.3 white capsules, marked “Pfizer” and
“ZDX 60”.
ZELDOX 80 mg capsules: No.2 blue/white capsules, marked “Pfizer”
and “ZDX 80”.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ZELDOX (ziprasidone) is indicated:
•
for the treatment of schizophrenia, related psychoses, prevention of
relapse and for
maintenance of clinical improvement during continuation therapy;
_ _
•
as monotherapy for the short term treatment of acute manic or mixed
episodes associated
with bipolar I disorder.
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Supersedes: ujpzeldc10221
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4.2 DOSE AND METHOD OF ADMINISTRATION
USE OF ZELDOX CAPSULES
For oral use. ZELDOX capsules should be taken with food and swallowed
whole without
chewing, crushing or opening beforehand.
SCHIZOPHRENIA
The recommended dose in treatment of schizophrenia is 40 mg twice
daily taken with food.
Daily dosage may subsequently be adjusted on the basis of individual
clinical status up to
80 mg twice daily. Dosage adjustments, if indicated, should generally
occur at intervals of not
less than 2 days. The maximum recommended dose of 80 mg twice daily
may be reached as
early as Day 3 of treatment.
Ziprasidone is effective in the treatment of acutely exacerbated
patients and in maintaining the
clinical imp