Apresoline 20mg powder for solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Hydralazine hydrochloride

Available from:

Advanz Pharma

ATC code:

C02DB02

INN (International Name):

Hydralazine hydrochloride

Dosage:

20mg

Pharmaceutical form:

Powder for solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02050100; GTIN: 5021730005740

Patient Information leaflet

Package leaflet: Information for the patient
LF-117706-01
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions ask your
doctor, pharmacist or nurse.
-
This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
-
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Apresoline Ampoules 20 mg are and what
they are used for
2.
What you need to know before you are given
Apresoline Ampoules 20 mg
3.
How Apresoline Ampoules 20 mg are given
4.
Possible side effects
5.
How to store Apresoline Ampoules 20 mg
6.
Contents of the pack and other information
1.
WHAT APRESOLINE AMPOULES 20 MG ARE
AND WHAT THEY ARE USED FOR
The name of your medicine is Apresoline Ampoules
20 mg.
The active ingredient is hydralazine hydrochloride in
the form of a powder.
Hydralazine hydrochloride belongs to a group of
medicines called antihypertensives.
Apresoline is used to treat very high blood pressure,
particularly when this condition occurs in pregnancy
or in people with kidney disease.
It works by relaxing blood vessels which increases
the supply of blood and oxygen to the heart.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE
GIVEN APRESOLINE AMPOULES 20 MG
YOU SHOULD NOT BE GIVEN THIS MEDICINE IF YOU:
•
are ALLERGIC to HYDRALAZINE, DIHYDRALAZINE or
any of the other ingredients in this medicine
(listed in section 6) (allergic reactions include
mild symptoms such as itching and/or rash.
More severe symptoms include swelling of the
face, lips, tongue and/or throat with difficulty in
swallowing or breathing);
•
have or have ever had a condition called
Systemic Lupus Erythematosus (SLE), an
autoimmune condition which causes joint pain,
skin rashes and fever;
•
suffer from severe

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Apresoline Ampoules 20 mg
Hydralazine 20mg Powder for Concentrate for Solution for
Injection/Infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient is 1-hydralainophthalazine hydrochloride
(hydralazine hydrochloride). Each
2 ml ampoule contains 20mg hydralazine hydrochloride.
Excipient(s) with Known effect
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Ampoules containing powder for concentrate for solution for
injection/infusion_ _
White to yellow lyophilisate (pellet)
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1.
Treatment of hypertensive emergencies, particularly those associated
with pre-eclampsia
and toxaemia of pregnancy.
2.
Treatment of hypertension with renal complications
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Elderly_:
Clinical evidence would indicate that no special dosage regime is
necessary. Advancing age does
not affect either blood concentration or systemic clearance. Renal
elimination may however be
affected in so far as kidney function diminishes with age.
_Adults_:
Initially 5 to 10 mg by slow intravenous injection, to avoid
precipitous decreases in arterial
pressure with a critical reduction in cerebral or utero-placental
perfusion. If necessary a repeat
injection can be given after an interval of 20-30 minutes, throughout
which blood pressure and
heart rate should be monitored. A satisfactory response can be defined
as a decrease in diastyloic
blood pressure to 90/100 mmHg. The contents of the vial should be
reconstituted by dissolving in
1 ml of water for injection BP. This should then be further diluted
with 10 ml of Sodium Chloride
injection BP 0.9% and be administered by slow intravenous injection.
The injection must be
given immediately and any remainder discarded. Hydralazine may also be
given by continuous
intravenous infusion, beginning with a flow rate of 200-300µg/min.
Maintenance flow rates must
be determined individually and are usually within the range
50-150µg/min. The produc