Capoten

País: Nova Zelândia

Língua: inglês

Origem: Medsafe (Medicines Safety Authority)

Ingredientes ativos:

Captopril 5.5 mg/mL (includes 10% excess);  ;  ; Captopril 5.5 mg/mL

Disponível em:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

DCI (Denominação Comum Internacional):

Captopril 5.5 mg/mL (includes 10% excess)

Dosagem:

5 mg/mL

Forma farmacêutica:

Oral solution

Composição:

Active: Captopril 5.5 mg/mL (includes 10% excess)     Excipient: Citric acid Disodium edetate dihydrate Hydrochloric acid Purified water Sodium benzoate Sodium citrate dihydrate Sodium hydroxide Active: Captopril 5.5 mg/mL Excipient: Citric acid Disodium edetate dihydrate Hydrochloric acid Purified water Sodium benzoate Sodium citrate dihydrate Sodium hydroxide

Unidades em pacote:

Bottle, glass, 95 mL

Classe:

Prescription

Tipo de prescrição:

Prescription

Fabricado por:

Bristol-Myers Squibb Barceloneta Inc

Indicações terapêuticas:

CAPOTEN (captopril) is indicated for the treatment of hypertension. In using CAPOTEN, consideration should be given to the risk of neutropenia/agranulocytosis. CAPOTEN is effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive.

Resumo do produto:

Package - Contents - Shelf Life: Bottle, glass, - 95 mL - 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 28 days opened stored at 2° to 8°C (Refrigerate, do not freeze)

Data de autorização:

1991-04-08

Folheto informativo - Bula

CAPOTEN- Consumer Medicine Information
Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
CAPOTEN

_captopril _
WHAT IS IN THIS LEAFLET
Read this leaflet carefully before
taking
Capoten.
This
leaflet
answers
some
common
questions
about
Capoten.
It
does
not
contain
all
the
available information. Some of
the information it contains may
not apply to you. It does not
take the place of talking to your
doctor or pharmacist.
ALWAYS
FOLLOW
THE
INSTRUCTIONS THAT YOUR DOCTOR
AND
PHARMACIST
GIVE
YOU
ABOUT CAPOTEN.
ASK
YOUR
DOCTOR
OR
PHARMACIST IF YOU HAVE ANY
CONCERNS
ABOUT
TAKING
CAPOTEN.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE. You may need to
read it again
WHAT
CAPOTEN
IS
USED FOR
Capoten
is
used
for
treating
high
blood
pressure
(hypertension),
certain
heart
conditions, and certain kidney
conditions
associated
with
diabetes. These are long term
(chronic
diseases)
so
it
is
important that you continue to
take your Capoten every day.
Capoten
contains
captopril.
Captopril belongs to a class of
medicines
known
as
Angiotensin Converting Enzyme
(ACE) inhibitors. ACE inhibitors
work
to
lower
your
blood
pressure to normal levels if it is
too high. Capoten also acts to
help your heart or kidneys to
work better. Your doctor will tell
you
why
you
need
to
take
Capoten. Never let anyone else
take your medicine.
It may harm
them,
even
if
their
signs
of
illness are the same as yours.
There is no evidence that it is
addictive or habit forming.
This medicine is only_ _available
only with a doctor’s prescription.
Capoten is not recommended
for use in children as there have
been not enough studies of its
effects in children. However it
may be necessary for a child
with hypertension and kidney
problems to take this medicine,
if this is the case your doctor will
discuss all the possible risks
and benefits to the child before
starting therapy.
BEFORE
YOU
TAKE
CAPOTEN
_ _
_WHEN YOU MUST NOT TAKE _
_IT _
YOU MUST NOT TAKE CAPOTEN IF:
•
you are pregnant or may
become pregnant
•
you have ever had medical
conditions
know
as
idiopathic
angio

Características técnicas

1
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
CAPOTEN Captopril Oral Solution 5mg/mL
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CAPOTEN oral solution comes in one strength and contains 5 mg of
captopril per mL of
solution.
Excipients with known effect: sodium benzoate
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
CAPOTEN ORAL SOLUTION contains captopril 5 mg/mL, clear, colourless,
unsweetened, flavour
free.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
HYPERTENSION: CAPOTEN (captopril) is indicated for the treatment of
hypertension.
In using CAPOTEN, consideration should be given to the risk of
neutropenia/agranulocytosis (see
section 4.4 Special warnings and precautions for use).
CAPOTEN is effective alone and in combination with other
antihypertensive agents, especially
thiazide-type diuretics. The blood pressure lowering effects of
captopril and thiazides are
approximately additive.
MYOCARDIAL INFARCTION: CAPOTEN is indicated to improve survival
following myocardial infarction in
clinically stable patients with left ventricular dysfunction,
manifested as an ejection fraction less than
or equal to 40% and to reduce the incidence of overt heart failure,
and subsequent hospitalisations
for congestive heart failure in these patients. The efficacy data for
the use of CAPOTEN following
myocardial infarction are strongest for initiation of therapy beyond 3
days post-infarct.
HEART FAILURE: CAPOTEN (captopril) is indicated for the treatment of
heart failure. In symptomatic
patients it is recommended that CAPOTEN be administered together with
a diuretic.
2
DIABETIC NEPHROPATHY: CAPOTEN is indicated for the treatment of
diabetic nephropathy in patients
with Type 1 insulin-dependent diabetes mellitus.
4.2
D
OSE AND METHOD OF ADMINISTRATION
A first dose hypotensive effect, severe in some patients may occur. To
minimise this effect, the
dosage should be individualised and titrated from a low starting dose
to the maintenance dose.
CAPOTEN (captopril) should be taken one hour befo