STEMETIL prochlorperazine maleate 5mg suppositories blister pack

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

prochlorperazine maleate

Disponível em:

Sanofi-Aventis Australia Pty Ltd

Classe:

Medicine Registered

Status de autorização:

Registered

Características técnicas

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AUSTRALIAN PRODUCT INFORMATION– STEMETIL
®
(PROCHLORPERAZINE)
1
NAME OF THE MEDICINE
Stemetil Tablets – prochlorperazine maleate
Stemetil Solution for injection – prochlorperazine mesilate
Stemetil Suppositories – prochlorperazine base
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Stemetil tablets: each tablet contains 5mg prochlorperazine maleate.
Excipients of known effect: wheat starch (gluten).
Stemetil injection ampoules: each 1mL ampoule contains 12.5mg
prochlorperazine mesilate.
Excipients of known effect: sodium metabisulfite, sodium sulfite
(sulfites).
Stemetil suppositories: The suppositories come in two strengths, 5mg
or 25mg. Each
suppository contains 5mg or 25mg prochlorperazine maleate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Stemetil 5 mg tablets are off-white to pale cream coloured circular
tablets, not more than
slightly mottled or specked, one side impressed with 'S' and reverse
face plain.
Stemetil 12.5 mg/mL solution for injection is clean, bright and not
more than very pale
yellow.
Stemetil suppositories contain prochlorperazine base equivalent to 5
mg and 25 mg
prochlorperazine maleate. Stemetil suppositories are cream, smooth,
torpedo-shaped
suppositories.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nausea and vomiting due to various causes including migraine; vertigo
due to Meniere's
syndrome, labyrinthitis and other causes.
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4.2
DOSE AND METHOD OF ADMINISTRATION
NAUSEA AND VOMITING
_ADULTS _
If oral administration is not practical, a deep intramuscular
injection of 1 mL (12.5 mg) or a
25 mg suppository should be used, followed if required, by normal oral
medication six hours
later.
Do not use a darkened solution for injection (more than pale yellow).
Dosage should be adjusted to suit the response of the individual,
beginning with lowest
recommended dosage.
Oral:
5 or 10 mg two or three times daily.
Acute:
20 mg at once, followed, if necessary by 10 mg