Vasotop 5 mg Tablets

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Ramipril

Available from:

MSD Animal Health UK Limited

ATC code:

QC09AA05

INN (International Name):

Ramipril

Pharmaceutical form:

Tablet

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Dogs

Therapeutic area:

Cardio Vascular ACE inhibitor

Authorization status:

Expired

Authorization date:

1999-02-25

Summary of Product characteristics

Revised: February 2022
AN: 01810/2021
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Vasotop 5 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
Each tablet contains Ramipril 5mg
Excipient:
Red ferric oxide (E 172) 0.25 mg
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablet.
Brownish pink oblong flavoured tablets with dark spots, half scored on
both
sides with embossing of “V” and “5.0” on both sides of score
line.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of congestive heart failure (NYHA: decompensation
grades
II-IV). The product can be used in combination with diuretics, and the
cardiac
glycosides digoxin or methyl-digoxin.
4.3
CONTRAINDICATIONS
Not to be used in haemodynamically relevant vascular stenosis (e.g.
aortic
stenosis) or obstructive hypertrophic cardiomyopathy.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The use of ACE inhibitors in dogs with hypovolaemia/dehydration (e.g.
due to
large
doses
of
a
diuretic,
vomiting
or
diarrhoea)
can
lead
to
acute
hypotension. In such cases the fluid and electrolyte status should
first be
balanced and treatment suspended until it is stabilised.
This also applies if clinical signs of apathy or ataxia occur during
treatment
with the product (potential signs of hypotension). After these
symptoms have
subsided, the treatment should be continued at 50% of the original
dose.
Substances that deplete blood volume, such as diuretics, or which
vasodilate,
Revised: February 2022
AN: 01810/2021
Page 2 of 6
such as angiotensin-converting enzyme (ACE) inhibitors, may contribute
to
lowering
systemic
blood
pressure.
This
may
result
in
pre-renal
uraemia
(azotaemia). Renal function should be monitored both before and seven
days
after commencement of treatment with ACE inhibitors. This also applies
when
the dosage of ACE inhibitor or of a concurrently administered diuretic
is
increased. It is advisable to perio