Amlodipine

AMODIP® is indicated for the control of systemic hypertension in cats.

AMODIP®

Indication: AMODIP® is indicated for the control of systemic hypertension in cats.

AMODIP®

Clinical Pharmacology:

AMODIP®

Contraindications: Do not use in cats with a hypersensitivity to amlodipine.

AMODIP®

Warnings: User Safety Warnings: Not for use in humans. Keep out of reach of children. Wash hands after handling. If accidentally ingested, seek medical attention immediately and show the package insert or the label to the physician. Animal Safety Warnings: Keep AMODIP® in a secure location out of reach of dogs, cats and other animals to prevent accidental ingestion or overdose.

AMODIP®

Adverse Reactions: Seventy-seven client-owned cats were enrolled in the field study that evaluated the safety and effectiveness of AMODIP® compared to a vehicle control tablet (no active ingredients) for a 28-day masked phase, followed by an unmasked open label phase. During the unmasked, open label phase, cats in the AMODIP® group continued on AMODIP® for an additional 62 days (total of 90 days), and the control group cats were administered AMODIP® from Days 28 to 120 (92 days total). In the masked phase a total of 23 adverse reactions were reported in 12 cats (28.6%) in the AMODIP® group, and 17 adverse reactions were reported in 10 cats (28.6%) in the control group. The adverse reactions that occurred during the field study are presented in Tables 1 and 2. Table 1. Adverse Reactions by Treatment Group from Day 0-28 (Masked Phase)Recurrent adverse reactions for the same cat are only counted once Adverse Reaction AMODIP® N=42 n (%) Vehicle Control N=35 n (%) Vomiting 2 (4.8) 3 (8.6) Alopecia 1 (2.4) 1 (2.9) Conjunctivitis 1 (2.4) 0 Cystitis 1 (2.4) 2 (5.7) Diarrhea 1 (2.4) 0 Gingivitis 1 (2.4) 0 Hypertrophic Cardiomyopathy 1 (2.4) 0 Glomerulonephritis 1 (2.4) 0 Renal Insufficiency 1 (2.4) 1 (2.9) Weight loss 1 (2.4) 0 Arrhythmia 0 1 (2.9) Hyperactivity 0 1 (2.9) Anorexia 0 1 (2.9) Lethargy 0 1 (2.9) Table 2. Adverse Reactions Reported After Day 28 (Unmasked, Open Label Phase)Recurrent adverse reactions for the same cat are only counted once Adverse Reaction AMODIP® N=77 n (%) Vomiting 8 (10.4) Anorexia and Inappetence 6 (7.8) Dehydration 4 (5.2) Lethargy 4 (5.2) Worsening Renal Disease 4 (5.2) Cystitis/UTI 3 (3.9) Diarrhea 2 (2.6) Hematemesis 2 (2.6) During the entire study, seven serious adverse reactions occurred (5 AMODIP® group cats, 2 control group cats). Six of the serious adverse reactions were determined to be unrelated to treatment, and one was deemed possibly related. One cat started AMODIP® while receiving methimazole for hyperthyroidism. The cat received a steroid and an NSAID 40 days after starting AMODIP®, developed anorexia and a hepatopathy and was euthanized.

AMODIP®

Administer initially at the standard dose of 0.125-0.25 mg/kilogram (kg) per day. After 2 weeks, if there is an inadequate clinical response to treatment, the dose may be increased to the high dose of 0.25-0.5 mg/kg per day. Cats less than 2.5 kg cannot be accurately dosed.

Oral

AMODIP®

Dosage and Administration: AMODIP® should be administered initially at the standard dose of 0.125-0.25 mg/kg per day according to the dosing table below. After 2 weeks, if there is an inadequate clinical response to treatment, the dose may be increased to the high dose of 0.25-0.5 mg/kg per day according to the dosing table. Cats less than 2.5 kg cannot be accurately dosed with AMODIP®. Weight (kg) Standard dose High dose 2.5-5.0 0.5 tablet (0.625 mg) 1 tablet (1.25 mg) 5.1-10 1 tablet (1.25 mg) 2 tablets (2.5 mg) Only remove tablets from the blister card just before dosing. After a half tablet is administered, return the remaining half tablet to the blister card and administer the next day.

ORAL

AMODIP®