Vasotop 1.25 mg tablets, 2.5 mg tablets and 5 mg tablets Data Sheet

Presentation
- Vasotop  1.25 mg tablets: beige oblong flavoured tablets half scored on both sides.  Each tablet contains 1.25 mg ramipril.

- Vasotop  2.5 mg tablets: yellow oblong flavoured tablets half scored on both sides.  Each tablet contains 2.5 mg ramipril and 0.5 mg yellow ferric oxide (E 172).

- Vasotop  5 mg tablets: light pink oblong flavoured tablets half scored on both sides.  Each tablet contains 5 mg ramipril and 0.25 mg red ferric oxide (E 172).

Uses

For the treatment of congestive heart failure (NYHA decompensation grades II-IV) in dogs.  Vasotop  can be used 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).

Dosage and administration

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 per day.  Treatment is once daily per os.

Dosage Schedule: 

The table provides a suggested tablet regime only. To ensure accurate dosing, each individual should be carefully weighed before calculating the dose.

The product may also be used in combination with the diuretic furosemide/frusemide and/or the cardiac glycosides digoxin or methyl-digoxin.
See Dosage schedule.
 

Contra-indications, warnings, etc.

Substances that deplete blood volume, such as diuretics, or which vasodilate, 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.

At the start of treatment with ACE inhibitors or after a dosage increase, reduced blood pressure can occur in rare cases, which may manifest itself by fatigue, lethargy or ataxia.  In such cases treatment should be discontinued until the patient’s condition has returned to normal and then resumed with 50% of the original dose.  As high doses of diuretics can also lead to a fall in blood pressure, the concurrent administration of diuretics in the early phase of treatment with ACE inhibitors should be avoided in these patients.

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 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 diuretic can be reduced to achieve the same diuretic effect as with furosemide alone.

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.

Not to be used in clinical cases of vascular stenosis (e.g. aortic stenosis) or obstructive hypertrophic cardiomyopathy.

Do not administer potassium-sparing diuretics.

Withdrawal period

Not applicable

FOR ANIMAL TREATMENT ONLY.KEEP OUT OF REACH AND SIGHT OF CHILDREN.

Pharmaceutical precautions

Do not store above 30°C. Store in a dry place.

After each opening, replace the cap tightly.

Do not remove the desiccant capsule.

Dispose of used packaging in the household refuse.  Unused product should be returned to the veterinary surgeon.

Legal category

POM-V

Package quantities

All tablet strengths:

1 x 28 tablets in HD polyethylene container per box.

3 x 28 tablets in HD polyethylene container per box.

6 x 28 tablets in HD polyethylene container per box.

Not all pack sizes may be marketed.

Further information

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 metabolite, ramiprilat.  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 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 increase in local prostacyclin (PGI₂) and nitric oxide (NO), both inhibiting smooth muscle proliferation.  The effects of local ACE inhibition act synergistically in reducing myotropic 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 of 50% of the initial value by 24 hours post administration.

Marketing Authorisation numbers

Vasotop 1.25 mg tablets          Vm 01708/4403

Vasotop 2.5 mg tablets            Vm 01708/4404

Vasotop 5 mg tablets               Vm 01708/4400