Important Warnings and Precautions
Please read the following information carefully before administering Lodisure Tablet for Cats 1mg and always consult your veterinarian regarding any concerns.
Contraindications
- Do not use in animals with severe hepatic (liver) disease.
- Do not use in cases of known hypersensitivity to Amlodipine or any of the excipients.
- Do not use in the case of cardiogenic shock and severe aortic stenosis.
Special Warnings for Cats
Situational hypertension (also known as "white coat hypertension") can occur in cats due to stress during clinic visits. It is recommended that stable hypertension is confirmed by multiple blood pressure measurements on different days before starting therapy. If hypertension is secondary to another condition (e.g., hyperthyroidism, chronic kidney disease, diabetes), the primary cause should also be treated. Long-term administration should be in accordance with an ongoing benefit/risk evaluation by your veterinarian, including routine systolic blood pressure measurements (e.g., every 2 to 3 months).
Special Precautions for Use in Animals
- Hepatic Disease: Special caution is required in patients with hepatic disease as Amlodipine is highly metabolised by the liver. Consequently, Amlodipine half-life may be prolonged and a lower dose may be required. Use of the product in these animals should be based on a benefit-risk assessment by the attending veterinarian.
- Older Cats with Severe Hypertension & Chronic Kidney Disease (CKD): These cats may suffer from hypokalaemia. Administration of Amlodipine may sometimes result in a decrease in serum potassium and chloride levels. Monitoring of those concentrations is recommended before and during treatment.
- Severe Unstable CKD: No animals with severe unstable CKD were included in the clinical trials. Use of the product in these animals should be based on a benefit-risk assessment by the attending veterinarian.
- Cardiac Patients: Because Amlodipine may have slight negative inotropic effects, the use of the product in cardiac patients should be based on a benefit-risk assessment by the veterinarian. Safety has not been tested in cats with known heart disease.
- Weight: Animals weighing less than 2.5 kg were not included in the clinical trials. Animals weighing between 2-2.5 kg should be treated with caution and based on a benefit-risk assessment by the responsible veterinarian.
- High Doses: Doses above 0.47 mg/kg body weight have not been examined in clinical trials and should only be administered with caution and based on a benefit-risk assessment by the attending veterinarian.
- Flavouring: The tablets are flavoured. To avoid accidental ingestion, store tablets out of reach of animals.
Adverse Reactions (Commonly Reported)
The following adverse events were commonly reported in clinical trials:
- Mild and transient digestive tract disorders (e.g., vomiting, decreased appetite, diarrhoea)
- Lethargy
- Weight loss
- Reduced serum levels of potassium
- Hypotension (uncommonly observed)
The frequency of adverse reactions is defined as: very common (more than 1 in 10 animals treated), common (more than 1 but less than 10 animals in 100), uncommon (more than 1 but less than 10 animals in 1,000), rare (more than 1 but less than 10 animals in 10,000), very rare (less than 1 animal in 10,000).
Use During Pregnancy and Lactation
The safety of Amlodipine has not been established during pregnancy or lactation in cats. Use only in accordance with the benefit/risk assessment by the responsible veterinarian.
Interactions
Concomitant use of diuretics, beta-blockers, other calcium channel blockers, inhibitors of the renin angiotensin aldosterone system, other vasodilators, alpha-2 agonists or other agents that may reduce blood pressure may cause hypotension. Concomitant use of cyclosporin or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole) may cause increased Amlodipine levels.
Overdose
Reduced appetite and weight loss occurred at a dose of 1 mg/day (corresponding to 0.32 mg/kg). Lethargy started to occur in some cats receiving 3 mg Amlodipine/daily (0.63-1.11 mg/kg/day). An overall shift in electrolyte balance (lowered potassium and chloride concentrations) was detected in all animals receiving 3-5 mg Amlodipine/daily (0.49-1.56 mg/kg). Conjunctivitis and watery discharge from the eyes was noted in the highest dosed animals (1.02-1.47 mg/kg), though its relation to treatment is unclear. Reversible gingival hyperplasia has been described in literature after treatment with 2.5 mg of Amlodipine per day for more than 300 days. In case of suspected overdose, contact your veterinarian immediately.
Special Precautions for People Administering the Product
This product may cause hypersensitivity reactions. People with known hypersensitivity to Amlodipine should avoid contact with the veterinary medicinal product. Wash hands after use. Accidental ingestion by children may cause a decrease in blood pressure. Unused tablet parts should be placed back into the blister and carton and carefully kept away from children. In case of accidental ingestion by a child, seek medical advice immediately and show the package leaflet or the label to the physician.
