Prochlorperazine 12.5mg/1ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Prochlorperazine mesilate

Available from:

Advanz Pharma

ATC code:

N05AB04

INN (International Name):

Prochlorperazine mesilate

Dosage:

12.5mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intramuscular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04060000; GTIN: 5099602334281

Patient Information leaflet

The name of your medicine is Prochlorperazine Mesilate 12.5mg/ml
Solution for Injection. It will
be referred to as Prochlorperazine Injection for ease hereafter.
In this leaflet:
1. What Prochlorperazine Injection is and what it is used for
2. Before you are given Prochlorperazine Injection
3. How you are given Prochlorperazine Injection
4. Possible side effects
5. How to store Prochlorperazine Injection
6. Further information
1. WHAT PROCHLORPERAZINE INJECTION IS AND WHAT IT IS USED FOR
Prochlorperazine Injection belongs to a class of drugs called
phenothiazine neuroleptics. It
influences the activity of certain brain cells by decreasing the
effect of dopamine, a natural
chemical in the brain.
Prochlorperazine Injection may be used to improve the symptoms of
major mental disorders
such as in schizophrenia, acute mania, and short term treatment of
anxiety. It may also be used
to treat the symptoms of nausea (feeling sick) and vomiting (being
sick), as well as symptoms
of vertigo due to Menieres syndrome or labyrinthitis (inner ear
disorders).
2. BEFORE YOU ARE GIVEN PROCHLORPERAZINE INJECTION
YOU SHOULD NOT BE GIVEN PROCHLORPERAZINE INJECTION IF:
• you know that you are allergic to Prochlorperazine Mesilate or any
of the other ingredients of
Prochlorperazine Injection (see section 6 of this leaflet)
• the person is a child. This is because children may develop
unusual face and body
movements (dystonic reactions).
BEFORE YOU ARE GIVEN PROCHLORPERAZINE INJECTION, YOUR DOCTOR WILL TAKE
SPECIAL CARE IF ANY
OF THE FOLLOWING SITUATIONS APPLY TO YOU. MAKE SURE YOUR DOCTOR IS
AWARE IF YOU SUFFER FROM
ANY OF THE FOLLOWING:
• you suffer from any disease involving the heart and blood vessels
(cardiovascular disease)
including chest pain (angina) and irregular heart beats
• you have a problem with your liver or kidneys
• you have high blood pressure due to a tumour of a gland situated
on top of the kidney (a
condition known as phaeochromocytoma)
• you
suffer
from
a
brain
disorder
causing
tremors,
rigidity
and
slo

Summary of Product characteristics

OBJECT 1
PROCHLORPERAZINE INJECTION BP 12.5MG/ML, 1ML &
2ML
Summary of Product Characteristics Updated 23-Mar-2015 | Concordia
International - formerly AMCo
1. Name of the medicinal product
Prochlorperazine Mesilate 12.5mg/ml Solution for Injection
2. Qualitative and quantitative composition
Each 1ml of solution contains 12.5mg (1.25% w/v) of Prochlorperazine
Mesilate
3. Pharmaceutical form
Colourless or almost colourless sterile solution for injection
intended for parenteral administration to
human beings
4. Clinical particulars
4.1 Therapeutic indications
It is used in the symptomatic treatment of vertigo due to Meniere's
syndrome or labyrinthitis and for
nausea and vomiting from whatever cause including that associated with
migraine, schizophrenia
(especially in the chronic stage), acute mania and as an adjunct to
the short term management of anxiety.
4.2 Posology and method of administration
Prochlorperazine injection is for administration by intramuscular
injection.
Treatment of nausea and vomiting: 12.5mg by deep I.M. injection
followed by oral medication six hours
later, if necessary.
Schizophrenia and other psychotic disorders: 12.5 to 25mg two or three
times a day by deep I.M.
injection until oral treatment becomes possible.
Intramuscular prochlorperazine should not be administered to children.
Elderly: Prochlorperazine should be used with caution in the elderly
with psychotic disorders. Because
elderly patients are susceptible to centrally-acting drugs, lower
initial dosage is recommended. Correct
initial diagnosis of the disorder is important. Care should also be
taken not to confuse adverse effects of
prochlorperazine e.g. orthostatic hypotension with effects due to the
primary disorder.
4.3 Contraindications
Should not be used in patients who are known to be hypersensitive to
the active ingredient or to any of the
other ingredients.
The use of Prochlorperazine injection is contraindicated in children
as it has been associated with
dystonic reactions after the cumulative dose of 0.5mg/kg.
4.4 Special