Apresoline

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Hydralazine hydrochloride 20 mg/mL

Available from:

AFT Pharmaceuticals Ltd

INN (International Name):

Hydralazine hydrochloride 20 mg/mL

Dosage:

20 mg/mL

Pharmaceutical form:

Powder for injection

Composition:

Active: Hydralazine hydrochloride 20 mg/mL

Units in package:

Ampoule, glass, 20mg, 5 dose units

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sumitomo Chemical Company Limited

Therapeutic indications:

For the treatment of chronic congestive heart failure as adjunct to long-acting nitrates, digitalis and other positive-inotropic agents and/or diuretics.

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, 20mg - 5 dose units - 60 months from date of manufacture stored at or below 25°C protect from light 0 hours reconstituted, use immediately

Authorization date:

1969-12-31

Patient Information leaflet

APRESOLINE
HYDRALAZINE HYDROCHLORIDE INJECTION 20 MG
WHAT IS IN THIS LEAFLET
Please read leaflet carefully before you start taking Apresoline
This leaflet answers some common questions about Apresoline.
It does not contain all the available information. It does not take
the place of talking to
your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you using
Apresoline against the benefits it can provide.
IF YOU HAVE ANY CONCERNS ABOUT APRESOLINE, ASK YOUR DOCTOR OR
PHARMACIST. KEEP
THIS LEAFLET WITH THE MEDICINE. You may need to read it again.
WHAT APRESOLINE IS USED FOR
Apresoline is an injection that is used when your blood pressure is
very high and needs
to be brought down quickly.
Apresoline belongs to a group of medicines called vasodilators. It
acts by relaxing and
widening (dilating) the walls of blood vessels. This action helps to
reduce blood
pressure.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY APRESOLINE HAS
BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed Apresoline for another purpose.
Apresoline is only available with a doctor's prescription. It is not
addictive.
BEFORE YOU TAKE APRESOLINE
_WHEN YOU MUST NOT TAKE APRESOLINE_
YOU MUST NOT HAVE APRESOLINE IF YOU HAVE EVER HAD AN ALLERGIC REACTION
TO
HYDRALAZINE, THE ACTIVE INGREDIENT IN APRESOLINE.
Some of the symptoms of an allergic reaction may include shortness of
breath,
wheezing or difficulty breathing; swelling of the face, lips, tongue
or other parts of the
body; rash, itching or hives on the skin.
YOU MUST NOT HAVE APRESOLINE IF YOU HAVE ANY OF THESE MEDICAL
CONDITIONS:
•
idiopathic systemic lupus erythematosus (SLE), a disease affecting the
skin, joints
and kidneys or a related disease
•
recent heart attack or other severe heart problems
•
an overactive thyroid (called thyrotoxicosis)
•
swelling and weakening of part of a large blood vessel (called an
aneurysm)
•
myocardial insufficiency due to mechanical obstruction
•
porphyria (a rare hereditary disease in which the

Summary of Product characteristics

NEW ZEALAND DATA SHEET
1
APRESOLINE
® (20
MG/ML POWDER FOR INJECTION
)
APRESOLINE
®
20 mg/mL powder for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydralazine hydrochloride 20 mg/mL
3
PHARMACEUTICAL FORM
White to yellowish lyophilisate
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypertensive crisis, especially during late pregnancy (pre-eclampsia
and eclampsia)
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
ADULTS
The initial dose is 5-10 mg, administered by slow intravenous
injection in order to avoid
precipitous fall in mean arterial pressure with a critical reduction
in cerebral or utero-
placental perfusion. If it is necessary to repeat the injection, this
should be done after an
interval of 20-30 min, throughout which the blood pressure and heart
rate should be
monitored. A satisfactory response can be defined as a decrease in
diastolic blood pressure
to 90-100 mmHg.
Apresoline may also be given by continuous intravenous infusion,
beginning with a flow
rate of 200-300 µg/min. Maintenance flow rates must be determined
individually and are
usually within the range 50-150 µg/min.
Prior to injection, the powdered active substance should be completely
dissolved in 1 mL
distilled water for injection and the freshly prepared solution should
be used immediately.
For the preparation of infusion solutions, this fresh solution should
be diluted with
physiological saline or with 5% sorbitol solution.
CHILDREN
In the rare cases where rapid treatment proves indispensable in a
child, Apresoline
ampoules should be used with extreme caution.
The initial dose is 0.1-0.5 mg/kg body weight administered
intravenously over 1-2 min with
repeat doses every 30-90 min as required, up to a maximum daily dose
of 3.5 mg/kg body
weight.
METHOD OF ADMINISTRATION
Parenteral treatment with Apresoline should always be carried out
cautiously and under
strict medical surveillance (if possible in hospital).
4.3
CONTRAINDICATIONS

Known hypersensitivity to hydralazine or dihydralazine or to any of
the excipients

Idiopathi