Product Overview
[Drug Name]
Generic Name: Felodipine Sustained-Release Tablets
Trade Name: Yitexin
English Name: Felodipine Sustained-Release Tablets
Chinese Pinyin: Feiluodiping Huanshipian
[Ingredients]
The active ingredient is felodipine.
[Properties]
This product is a film-coated tablet that appears white or off-white after removal of the film coating.
[Indications]
Hypertension (can be used alone or in combination with other antihypertensive medications).
[Dosage and Administration]
Oral administration; dosage should be individualized. The tablet should be taken in the morning with water. Do not break, crush, or chew the tablet.
1. Treatment of Hypertension: The recommended starting dose is 5 mg once daily. The usual maintenance dose is 5 or 10 mg once daily. The dose may be reduced or increased based on patient response, or other antihypertensive medications may be added. Dose adjustments should generally be made at least every two weeks.
2. Treatment of Angina Pectoris: The recommended starting dose is 5 mg once daily. The usual maintenance dose is 5 or 10 mg once daily.
[Adverse Reactions]
Common adverse reactions after taking this product include peripheral edema (usually occurring 2-3 weeks after use, with the incidence related to age and dosage), headache, and facial flushing. Peripheral edema is usually mild and is related to age and dosage. Other adverse reactions include fatigue, fever, palpitations, nausea, indigestion, constipation, dizziness, paresthesia, upper respiratory tract infection, cough, runny nose, sneezing, rash, and gingival hyperplasia.
[Contraindications]
1. This product is contraindicated in patients with allergies to felodipine or any of its ingredients. 2. This product is contraindicated in patients with decompensated heart failure, acute myocardial infarction, or unstable angina. 3. This product is contraindicated in pregnant women.
[Precautions]
1. This product can cause severe hypotension and syncope, produce reflex tachycardia, and may cause angina in sensitive individuals. Use with caution in patients with hypotension.
2. This product should be used with caution in patients with heart failure and impaired heart function. Attention should be paid to its negative inotropic effects, especially when used in combination with beta-blockers.
3. This product should be used with caution in pregnant and lactating women and children. Elderly patients (over 65 years old) or those with hepatic impairment should start treatment with a low dose (2.5 mg once daily) and closely monitor blood pressure during dose adjustment.
4. Clinical trials have shown that doses exceeding 10 mg daily can increase the antihypertensive effect but also increase the incidence of peripheral edema and other vasodilatory adverse events. Patients with renal impairment generally do not require dose adjustment.
5. This product should be taken orally on an empty stomach or with a small, light meal. The tablet should be swallowed whole and not crushed or chewed. Maintaining good oral hygiene can reduce the incidence and severity of gingival hyperplasia.
[Use in Special Populations]
Precautions for Children: There is limited experience with this product in children. Precautions for Pregnancy and Lactation: Contraindicated in pregnant women.
Precautions for Elderly Patients: The blood concentration of this drug increases with age. Therefore, the recommended initial dose for elderly patients (over 65 years old) is 2.5 mg daily, with dose adjustments based on individual response.
[Drug Interactions]
1. Concomitant use of certain drugs that interfere with the cytochrome P450 3A4 enzyme system may affect the blood concentration of dihydropyridine calcium channel blockers, such as felodipine. Hepatic enzyme inhibitors (such as cimetidine, erythromycin, itraconazole, ketoconazole, and certain flavonoids found in grapefruit juice) may increase the blood concentration of felodipine. Hepatic enzyme inducers (such as phenytoin, carbamazepine, rifampicin, and barbiturates) may decrease the blood concentration of felodipine. 2. Felodipine does not affect the blood concentration of cyclosporine. 3. Although felodipine is highly bound to plasma proteins, it does not affect the binding of other highly protein-bound drugs (such as warfarin). 4. No significant changes in the pharmacokinetic behavior of digoxin were observed when this product was coadministered with digoxin in patients with heart failure. 5. This product has no significant interactions with other drugs, such as indomethacin or spironolactone.
[Pharmacological Action]
Pharmacological Action: This product is a dihydropyridine calcium channel antagonist (calcium channel blocker). It reversibly competes with nitrendipine and/or other calcium channel blockers for dihydropyridine binding sites, blocking voltage-dependent Ca2+ currents in vascular smooth muscle and cultured rabbit atrial cells, and K+-induced portal vein contracture in rats. In vitro studies have demonstrated that this product has a more selective inhibitory effect on vascular smooth muscle than on myocardium; negative inotropic effects were detected in vitro, but not in whole animals.
[Storage] Store below 25°C.
[Strength] 5 mg
[Packaging Size] 5 mg
[Expiry Date] 24 months.
[Approval Number] National Medicine Standard H20103396
[Manufacturer] Company Name: Nanjing Yiheng Pharmaceutical Co., Ltd.
