Amodip 1.25mg Chewable Tablets

Amodip 1.25mg Chewable Tablets for Cats are for the treatment of systemic hypertension in cats. They are flavoured for easier administration and can be given directly or with a small amount of food.

Uses
For the treatment of systemic hypertension in cats.

Dosage and administration
Oral use. Amlodipine tablets should be administered orally with or without food at a recommended starting dose of 0.125 - 0.25 mg/kg. 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).
Weight of cat (kg)
Starting dose (number of tablets)
2.5 - 5.0
0.5
5.1 - 10.0
1
10.1 and above
2
The tablets are flavoured. They can be given directly to the animals or administered with a small quantity of food.

Contra-indications, warnings, etc
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.

Special warnings for each target species
The primary cause and/or co-morbidities of hypertension, such as hyperthyroidism, chronic kidney disease and diabetes, should be identified and treated. It is recommended that hypertension is confirmed by measurement of systolic blood pressure before commencing therapy. Continued administration of the product over an extended period of time should be in accordance with an ongoing benefit/risk evaluation, performed by the prescribing veterinarian that includes measurement of systolic blood pressure routinely during treatment (e.g. every 6 to 8 weeks).

Special precautions for use in animals
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.

Special precautions to be taken by the person administering the veterinary medicinal product to 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.

Adverse reactions
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 but not in the clinical trial with older hypertensive cats. This does not usually require stopping the treatment.

Use during pregnancy, lactation or lay
There has been no evidence of teratogenicity or reproductive toxicity in rodent studies. The safety of amlodipine has not been established during pregnancy or lactation in cats. Use of the product should be based on a benefit-risk assessment by the attending veterinarian.
Interaction with other medicinal products and other forms of interaction
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.

Overdose
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.

Pharmaceutical precautions
Do not store above 30°C.
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life of halved tablets: 24 hours
Any unused half tablets should be returned to the blister pack.

Legal category
Legal category: POM-V

Packaging quantities
10 tablets per blister.
Cardboard box with 30, 100 and 200 tablets.
Not all pack sizes may be marketed.