For Animal Treatment Only
Vasotop 1.25: white, oblong tablets half scored on one side. Each tablet contains 1.25mg Ramipril PhEur.
Vasotop 2.5: yellow, oblong tablets half scored on one side. Each tablet contains 2.5mg Ramipril PhEur and 0.1mg yellow ferric oxide (E 172).
Vasotop 5: red, oblong tablets half scored on one side. Each tablet contains 5mg Ramipril PhEur and 0.05mg red ferric oxide (E 172).
For the treatment of congestive heart failure (NYHA decompensation grades II-IV) in dogs. Vasotop can be used alone or in combination with diuretics and the cardiac glycosides, digoxin or methyl-digoxin.
Administration of ramipril in patients with congestive heart failure improves cardiovascular function the related clinical signs and the prognosis. Ramipril has also been shown to reduce the mortality rate among patients with persistent or transient heart failure following an acute myocardial infarction (man, dog).
The therapeutic dose in the dog is 0.125 mg ramipril per kg bw per day. Depending on the severity of pulmonary congestion the dose may be increased after 2 weeks to 0.25 mg ramipril per kg bw per day. Treatment is once daily per os.
Suggested dosage schedule for standard dose (0.125 mg/kg/day):
| Bodyweight (Kg) | Vasotop Standard Dose | ||
| 1.25 | 2.5 | 5.0 | |
| 5 - 10 | 1 | ||
| 11 – 20 | 1 | ||
| 21 – 40 | 1 | ||
| 41 – 50 | 1 | 1 |
Not to be used in clinical cases of vascular stenosis (e. g. aortic stenosis) or obstructive hypertrophic cardiomyopathy.
Substances that deplete blood volume such as diuretics, or which cause vasodilation, 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 an ACE inhibitor or of a concurrently administered diuretic is increased. It is advisable to periodically monitor renal function throughout treatment.
If signs of hypotension occur, treatment with Vasotop should be suspended until fluid and electrolyte status is corrected. Treatment with Vasotop should then be continued at 50% of the original dose. In patients at risk of hypotension it is advisable to introduce Vasotop gradually over one week (starting with half the therapeutic dose).
Diuretics and a low-sodium diet both potentiate the effect of ACE inhibitors by activating the renin-angiotensin-aldosterone system. High doses of diuretics and a low sodium diet should therefore be avoided during treatment with ACE inhibitors in order to prevent hypotension (with clinical signs such as apathy, ataxia, rarely syncope or acute renal failure). In patients treated concurrently with Vasotop and furosemide the dose of the diuretic can be reduced to achieve the same diuretic effect as with furosemide alone.
Do not administer with potassium-sparing diuretics.
The concomitant administration of ACE inhibitors with non-steroidal anti-inflammatory drugs (NSAIDs) leads to poor autoregulation of the glomerular blood pressure and can therefore trigger acute renal failure.
No data are available thus far on the use of the drug in bitches during pregnancy and lactation. In the absence of such data, prudence suggests that Vasotop should not be used in pregnant or lactating bitches.
Keep out of reach of children.
Use before the expiry date printed on the pack.
POM.
Nil. Not for use in food producing animals.
Boxes of 2 x 14 scored tablets in PVC/Aluminium foil blister packs.
Ramipril is rapidly and completely absorbed in the gastrointestinal tract after oral administration. Ramipril is a pro-drug and is metabolised in the liver to its active form. This conversion may be reduced in dogs with impaired liver function. Ramiprilat inhibits angiotensin-converting enzyme (ACE). This enzyme catalyses the conversion of angiotensin I to angiotensin II in blood plasma and in vascular endothelial tissues and degrades bradykinin. As angiotensin II acts as a strong vasoconstrictor and bradykinin as a vasodilator, the net effect of Ramipril administration is systemic vasodilation. Angiotensin II also causes the release of aldosterone (via the renin-angiotensin-aldosterone-system). Consequently ramiprilat reduces aldosterone secretion. This in turn leads to an increase in the serum potassium concentration.
Inhibition of tissue ACE in the heart results in locally reduced levels of angiotensin II and in potentiation of bradykinin effects. Angiotensin II induces cell proliferation in smooth muscle while bradykinin leads to increases in local prostacyclin (PGI2) and nitric oxide (NO), both inhibiting smooth muscle cell proliferation. The two effects of local ACE inhibition act synergistically in reducing myotrophic factors and result in distinct reduction of cardiac and vascular smooth muscle cell proliferation. In this way ramipril prevents or reduces, with lasting effect, myogenous hypertrophy in patients with congestive heart failure (CHF) and results in reduction of peripheral vascular resistance.
The plasma ACE-activity was measured as the principal criterion of the pharmacodynamic effect. After oral administration of ramipril a significant inhibition of this activity occurs quickly and gradually increases again during the dosage interval, reaching 50 % of the initial value by 24 hours post administration.
Unused Vasotop may be disposed of with domestic waste or returned to the veterinary surgery for disposal.
| Vasotop 1.25 | Vm 01708/4403 |
| Vasotop 2.5 | Vm 01708/4404 |
| Vasotop 5 | Vm 01708/4400 |
Name and address:
Intervet UK Limited
Walton Manor
Walton
Milton Keynes
MK7 7AJ