Cat-Only Amlodipine: What the 2026 AMODIP Label Changes

On 29 April 2026 the FDA approved AMODIP, the first amlodipine product licensed for cats: a 1.25 mg chewable tablet from Ceva Santé Animale, filed as NADA 141-613. It is only the second drug ever approved in the United States for feline systemic hypertension, eight years after telmisartan oral solution in 2018. The molecule is not new. What the label fixes is arithmetic — a 4 kg cat needs 0.5 to 1.0 mg of amlodipine a day, and no human tablet divides into that cleanly.

What the approval actually covers

AMODIP is amlodipine besylate in a flavoured chewable tablet of 1.25 mg amlodipine, indicated for the control of systemic hypertension in cats, measured by indirect systolic blood pressure. Amlodipine is a calcium channel blocker: it relaxes arterioles, drops systemic vascular resistance and takes load off the left ventricle. European vets have had the same chewable since Ireland authorised it in December 2016, so the clinical experience is a decade old while the US label is weeks old. The US version is prescription-only, and the FDA states plainly why: pressure has to be diagnosed and monitored by someone who can measure it. Cats under 2.5 kg cannot be dosed accurately with this tablet at all, which is the one exclusion in the announcement.

Why 1.25 mg is the number that matters

Human amlodipine is sold as 5 mg and 10 mg tablets. Quarter a 5 mg tablet and you get 1.25 mg; halve a 2.5 mg tablet and you get 1.25 mg. At the licensed starting range of 0.125 to 0.25 mg/kg, a 3 kg cat needs 0.375 to 0.75 mg and a 6 kg cat needs 0.75 to 1.5 mg per day. That spread does not line up with quarters of anything, and split tablets are imprecise by design — a scored tablet cut by hand typically lands 10 to 20 percent off, and a quarter of a small tablet is worse. Compounding pharmacies can hit the number, but strength, shelf life and flavour vary by pharmacy — the trade-off covered in compounded cat medicine.

Cat weight	0.125 mg/kg	0.25 mg/kg	Nearest 1.25 mg fraction
2.5 kg	0.31 mg	0.63 mg	half tablet (0.625 mg)
4 kg	0.50 mg	1.00 mg	half to one tablet
6 kg	0.75 mg	1.50 mg	one tablet, plus escalation

The 77-cat field study: 64.1 percent against 17.6

The pivotal trial ran from November 2011 to August 2013 across 23 clinics in Finland, France and Germany. Seventy-seven client-owned hypertensive cats were randomised, double-masked, to AMODIP or a vehicle tablet with no active ingredient. By day 28, 64.1 percent of treated cats met the effectiveness criterion of a lowered indirect systolic reading, against 17.6 percent of controls. Mean systolic pressure fell 28.2 mmHg from baseline in the treated group and 9.9 mmHg in controls. Vomiting, inappetence, dehydration and lethargy were the recorded adverse events, and 11 cats stopped treatment because of them.

The 225-cat eye study: what one year of fundic exams showed

A separate open-label study followed 225 hypertensive cats on 0.625 to 1.25 mg once daily, with ophthalmic examinations at baseline and then periodically for a year. Fundic lesions improved on treatment, and the severity of the pressure rise tracked the severity of the retinal damage. The finding that should change how fast owners act: cats that started with severe fundic lesions and absent or severely reduced vision were less likely to regain sight, even when the retina reattached and the haemorrhages cleared. Hypertension is diagnosed late in most cats; the eye is usually the clock, as described in the blindness sign owners miss.

Day 14: the recheck that sets the dose

The label's schedule is 0.125 to 0.25 mg/kg once daily for the first 14 days. If the blood pressure response is inadequate at that point, the dose may be increased up to 0.5 mg/kg once daily according to the dosing table in the insert. Two things make the 14-day visit non-negotiable. First, the label asks for repeat pressure measurement and early monitoring of kidney and liver values, because amlodipine lowers filtration pressure and can shift creatinine. Second, escalation without a number is guesswork: the whole reason to recheck at two weeks is to decide whether the cat is a responder. The wider logic of targets and recheck intervals is set out in senior blood pressure treatment options.

Gingival hyperplasia, found in 32 healthy cats

The target animal safety study dosed 32 healthy cats at 0, 1, 3 or 5 times the maximum starting dose for six months. Every cat that received AMODIP developed gingival hyperplasia, dose-dependent and time-dependent, beginning between weeks 10 and 12. Blood pressure, creatinine and potassium fell as expected pharmacology and stayed inside reference ranges without clinical signs. One cat in the 5-times group had an esophageal ulceration possibly related to tablet administration. Practical translation: lift the lip once a month and look at the gums, and mention any gum overgrowth at the next visit rather than waiting for it to become a dental problem.

Giving a chewable to a cat that will not chew

The tablet is flavoured, but not every cat cooperates. Three rules:

Offer it before the meal, not hidden in a full bowl, so you can see whether it was eaten whole, chewed or dropped.
If the cat swallows it dry and intact, follow with a few millilitres of water or a spoon of wet food — the esophageal finding above is the reason.
Never crush the tablet into a portion the cat may refuse, because the dose then disappears into the bowl.

European packaging runs to boxes of 30, 100 or 200 tablets, so one tablet a day is a box a month. Store it out of reach: a chewed-through blister is a poisoning case.

Amlodipine or telmisartan, and what to measure first

Telmisartan oral solution was the first FDA-approved feline hypertension drug in 2018 and is licensed at 1 mg/kg once daily; it also reduces proteinuria in chronic kidney disease, which amlodipine does not. Roughly 20 to 60 percent of cats with CKD are hypertensive, so the two problems often arrive together and some cats end up on both drugs. Before any pill, the workup is the same: three to five readings with the same device and cuff position, a retinal exam, and kidney and thyroid values. A pressure check is not expensive next to a detached retina: what a check costs is the cheaper half of that decision, and early kidney signs are what put the cat on the table.

This article is for information only and does not replace veterinary diagnosis. Amlodipine is prescription-only; the dose, any increase, and the timing of rechecks are decisions for the vet who measures your cat's blood pressure.

Terms mentioned in this article

CKD

Frequently asked

Is AMODIP the same drug as the amlodipine people take?

Yes — the active ingredient is amlodipine besylate, the same molecule used for human hypertension. The difference is the tablet: 1.25 mg of amlodipine in a flavoured chewable, sized so a 2.5 to 6 kg cat can be dosed at 0.125 to 0.25 mg/kg without splitting a human tablet into unreliable quarters. The FDA approved it on 29 April 2026 under NADA 141-613.

How quickly should blood pressure come down after starting amlodipine?

In the 77-cat pivotal trial the treated group averaged a 28.2 mmHg fall in indirect systolic pressure by day 28, against 9.9 mmHg in controls, and 64.1 percent met the effectiveness criterion at that point. The label builds a recheck at 14 days into the schedule because that is when the decision to escalate to as much as 0.5 mg/kg is made. Do not judge the response by how the cat looks.

What side effects should I watch for in the first month?

The field study recorded vomiting, inappetence or anorexia, dehydration and lethargy, and 11 cats discontinued treatment for those reasons. The six-month safety study in 32 healthy cats found gingival hyperplasia in every treated cat, starting between weeks 10 and 12, so check the gums monthly. Report reduced appetite, vomiting or gum overgrowth rather than waiting for the next scheduled visit.