benzenesulfonic acidAmlodipine Chewingpiece（(For cats)explainMing Shu

                                                           Pet

【Veterinary drug name】

Generic Name: Amlodipine Besylate Chewable Tablets (for Cats)

Product Name:Bangchongping

English name:Amlodipine Besilate Chewable Tablets for Cats

Pinyin:Benhuangsuan Anlüdiping Jujuepian (Maoyong)

【Main ingredients】Amlodipine besylate

【Properties】This product is a white or slightly yellow score sheet.

【Pharmacological effects】PharmacodynamicsAmlodipine is a voltage-dependent calcium channel blocker belonging to the dihydropyridine class. It selectively binds to calcium channels in vascular smooth muscle, myocardium, and cardiac nodule tissue.L-channel binding. The primary antihypertensive effect of amlodipine is related to its vasodilatory effect on arteries and arterioles, with little effect on veins. The duration and attenuation of the antihypertensive effect are dose-dependent. Amlodipine binds slowly to L-type calcium channels, thus avoiding a rapid drop in blood pressure and preventing reflex tachycardia caused by activation of baroreceptors due to a rapid decrease in blood pressure. In cats with hypertension, once-daily administration of amlodipine besylate chewable tablets significantly reduces blood pressure.

PharmacokineticsSingle dose for catsAfter administration of 0.25 mg/kg, amlodipine was well absorbed, with a peak plasma concentration (Tmax) of 5.39 ± 2.45 h and a peak concentration (Cmax) of 24.7 ± 9.29 ng/ml. The elimination half-life (T..._1/2)for46.6±11.4h.

【Indications】Used to treat systemic hypertension in cats.

【Usage and dosage】Calculated as amlodipine. Oral administration: per dose...For cats, the dosage is 0.125–0.25 mg per kg of body weight, once daily for 14 consecutive days. If systolic blood pressure remains above 150 mmHg or the blood pressure decreases by less than 15% compared to pre-treatment levels, the dosage may be doubled or increased to 0.5 mg per kg of body weight. This product can be taken directly orally or with food.

【Adverse reactions】

（1) Mild and transient vomiting may occur (occurrence rate is approximately 13%).

（2) Mild and transient gastrointestinal disorders (such as anorexia or diarrhea), drowsiness, and dehydration may occur.

（3) In clinical trials, mild hyperplastic gingivitis was commonly observed in healthy young adult cats when administered at a dose of 0.25 mg/kg, accompanied by some degree of mandibular lymphadenopathy. Discontinuation of the drug was usually not required.

【Precautions】

（1) Not for use in cats with cardiogenic shock or severe aortic stenosis.

（2) Because amlodipine is primarily metabolized by the liver, a benefit/risk assessment should be performed by a veterinarian before administering this product to cats with liver disease. It should not be used in cats with severe liver failure.

（3) This product must not be used on cats that are allergic to it.

（4) If it is necessary to extend the course of this product, a benefit/risk assessment should be conducted by a veterinarian, and systolic blood pressure should be monitored periodically during treatment.

（5) Amlodipine administration may cause a decrease in serum potassium and chloride levels; serum potassium and chloride levels should be monitored during treatment. Older cats with hypertension and chronic kidney disease may develop hypokalemia.

（6) The safety of this product in cats weighing less than 2.5 kg and cats with heart failure has not been established. A benefit/risk assessment should be conducted by a veterinarian before administration.

（7) In rodent studies, no teratogenicity or reproductive toxicity has been found in this product, and its safety during pregnancy or lactation in cats has not been determined.

（8) Amlodipine may cause hypotension when used in combination with other antihypertensive drugs. It is recommended to measure the cat's blood pressure before using them in combination and ensure that the cat has adequate fluid intake. However, in clinical cases of feline hypertension, there is no evidence that the combined use of amlodipine and benazepril causes hypotension.

（9) When amlodipine is used in combination with β-blockers, cardiac selective calcium channel blockers and azole antifungals (such as itraconazole), it can reduce myocardial contractility and contraction rate. Special care must be taken before administering this product to cats with ventricular dysfunction.

（10) The safety of taking amlodipine and the antiemetics dolasetron and ondansetron concurrently has not been established.

（11) In the event of an accidental overdose, reversible hypotension may occur.

（12) These chewable tablets are flavored tablets. To avoid accidental ingestion, they should be stored out of reach of animals.

（13) This product may cause hypotension. To reduce the risk of accidental ingestion by children, the tablets should be removed from the blister pack before administration to animals. Any unused half tablets should be returned to the blister pack.

（14) People with known allergies to this product should avoid contact with the drug and wash their hands after use.

【withdrawal period】 noneIt needs to be formulated.

【Specification】   according toAmlodipinecount 1.25mg

【Package】

【Storage】   25℃The following should be sealed and stored.

【Validity period】   24 months; once the blister pack is opened, half a piece is valid for 24 hours at 25°C.

【Approval number】Veterinary drug050308055

Production Date

[Product Batch Number]

[Expiration Date]

【manufacturing enterprises】Inner Mongolia Federal Animal Health Pharmaceutical Co., Ltd.

Address: Fuyuan South Road, Bayannur Economic and Technological Development Zone, Inner MongoliaNo. 1

post code:015000

Telephone:400-033-8999