Cats

For the treatment of systemic hypertension in cats.

Do not use in the case of cardiogenic shock and severe aortic stenosis. Do not use in cases of severe hepatic failure. Do not use in cases of known hypersensitivity to the active substance or to any of the excipients.

The primary cause and/or co-morbidities of hypertension, such as hyperthyroidism, chronic kidney disease and diabetes, should be identified and treated.

In cats situational hypertension (also called white coat hypertension) occurs as a consequence of the in-clinic measurement process in an otherwise normotensive animal. In case of high stress levels measurement of systolic blood pressure may lead to incorrect diagnosis of hypertension. It is recommended that stable hypertension is confirmed by repeated measurement of systolic blood pressure on different days before commencing therapy.

Continued administration of the product over an extended period of time should be in accordance with an ongoing benefit/ risk evaluation, performedby the prescribing veterinarian that includes measurement of systolic blood pressure routinely during treatment (e.g. every 6 to 8 weeks).

Special caution is required in patients with hepatic disease as amlodipine is highly metabolised by the liver. As no studies have been conducted in animals with liver disease, use of the product in these animals should be based on a benefit-risk assessment by the attending veterinarian. Administration of amlodipine may sometimes result in a decrease in serum potassium and chloride levels. Monitoring of those levels is recommended during treatment. Older cats with hypertension and chronic kidney disease (CKD) may also suffer from hypokalaemia as a result of their underlying disease. The safety of amlodipine has not been established in cats weighing less than 2.5 kg. Safety has not been tested in cats with cardiac failure. Use in these cases should be based on a benefit risk assessment by the veterinarian. The chewable tablets are flavoured. In order to avoid any accidental ingestion, store tablets out of reach of the animals.

This product may decrease blood pressure. In order to reduce the risk of accidental ingestion by children, do not take the tablets out of blisters until ready to administer to the animal. Return part-used tablets into the blister and carton. In case of accidental oral ingestion, seek medical advice and show the label or the package leaflet to the physician. People with known hypersensitivity to amlodipine should avoid contact with the veterinary medicinal product. Wash hands after use.

Mild and transient emesis was a very common adverse event in the clinical trial (13%). Common adverse events were mild and transient digestive tract disorders (e.g. anorexia or diarrhoea), lethargy and dehydration. At the dose of 0.25 mg/kg, mild hyperplastic gingivitis with some enlargement of submandibular lymph nodes has been very commonly observed in healthy young adult cats in clinical trials and very rarely in elderly cats based on the post-marketing experience. This does not usually require stopping the treatment.

Laboratory studies in rodents have not produced any evidence of teratogenicity or reproductive toxicity. The safety of amlodipine has not been established during pregnancy or lactation in cats. Use only in accordance with the risk-benefit assessment by the responsible veterinarian.

Concomitant use of amlodipine with other agents that may reduce blood pressure may cause hypotension. These agents include: diuretics, beta-blockers, other calcium channel blockers, inhibitors of the renin angiotensin aldosterone system (renin inhibitors, angiotensin II receptor blockers, angiotensin converting enzyme inhibitors (ACEI), and aldosterone antagonists), other vasodilators and alpha-2 agonists. It is advised to measure blood pressure before administering amlodipine with these agents and to ensure cats are adequately hydrated. However, in clinical cases of feline hypertension, no evidence of hypotension occurring as a result of combining amlodipine with the ACEI benazepril was observed. Concomitant use of amlodipine with negative chronotropes and inotropes (such as beta-blockers, cardioselective calcium channel blockers and antifungal azoles (e.g itraconazole) may reduce force and rate of contraction of the heart muscle. Particular attention must be paid before administering amlodipine with these drugs in cats with ventricular dysfunction. The safety of concomitant use of amlodipine and the anti-emetic agents dolasetron and ondansetron has not been evaluated in cats.

Oral use. Amlodipine tablets should be administered orally at a recommended starting dose of 0.125 - 0.25 mg/kg/day.

After 14 days of treatment, the dose may subsequently be doubled or increased up to 0.5 mg/kg once daily if adequate clinical response has not been achieved (e.g. systolic blood pressure remaining over 150 mmHg or a decrease of less than 15% from the pre-treatment measurement).

The tablets can be given directly to the animals or administered with a small quantity of food.

Reversible hypotension may occur in cases of accidental overdose. Therapy is symptomatic.

After administration of 0.75 mg/kg and 1.25 mg/kg once daily for 6 months to healthy young adult cats, hyperplastic gingivitis, reactive lymphoid hyperplasia in mandibular lymph nodes, and increased Leydig cell vacuolisation and hyperplasia were seen. At the same dose levels plasma potassium and chloride levels were decreased and an increase in urinary volume associated with decreased urinary specific gravity was observed. These effects are unlikely to be observed under clinical conditions with short term accidental overdosing. In a small two-week tolerance study of healthy cats (n=4), doses between 1.75 mg/kg and 2.5 mg/kg were administered, and mortality (n=1) and severe morbidity (n=1) occurred.

Not applicable.