Product Overview
[Drug Name]
Generic Name: Nifedipine Controlled-Release Tablets
Trade Name: Lifang Nifedipine Controlled-Release Tablets 30mg x 12 Tablets
Pinyin Full Code: LiFang XiaoBenDiPingKongShiPian 30mg x 12 Tablets
[Main Ingredient]
The main ingredient of this product is nifedipine. Chemical Name: 2,6-Dimethyl-4-(2-nitrophenyl)-1,4-dihydro-3,5-pyridinedicarboxylic acid dimethyl ester. Molecular Formula: C₁ₐH₁₈N₂O₆. Molecular Weight: 346.34
[Properties]
This product is a pink film-coated tablet. After removal of the coating, a reddish-brown and light yellow double-layer tablet core is revealed.
[Indications/Main Functions]
1. Hypertension 2. Chronic stable angina pectoris (exertional angina) due to coronary artery disease
[Specifications]
30mg x 12 tablets
[Dosage and Administration]
Treatment should be tailored to individual needs whenever possible. A different basic dose should be administered based on the patient's clinical condition. Unless otherwise directed by a physician, the following dosages are recommended for adults: 1. Hypertension: The recommended dosage is 30 mg (1 tablet) once daily. If necessary, the dosage can be increased to 60 mg (2 tablets) once daily based on individual needs. 2. Coronary Artery Disease: The usual initial dosage for chronic stable angina (exertional angina) is 30 mg (1 tablet) once daily. If necessary, the dosage can be increased to 60 mg (2 tablets) once daily based on individual needs. Nifedipine dosage adjustments or omission may be necessary when used with CYP3A4 inhibitors or inducers (see [Drug Interactions]). Duration of treatment: The duration of medication should be determined by the physician. Dosage: The tablet is usually swallowed whole with a small amount of liquid, regardless of mealtimes. Grapefruit juice should be avoided (see [Drug Interactions]). Special Populations: Patients with mild, moderate, or severe hepatic impairment based on Child-Pugh scores should be carefully monitored and may require a dose reduction. The pharmacokinetics of nifedipine have not been studied in patients with severe hepatic impairment (see [Precautions] and [Pharmacokinetics]).
[Adverse Reactions]
See the package insert for details.
[Contraindications]
· This product is contraindicated in patients with known hypersensitivity to nifedipine or any of its ingredients. · Nifedipine is contraindicated in patients with cardiogenic shock. · Nifedipine is contraindicated in patients with a KOCK pouch (ileostomy after proctocolectomy). · Due to enzyme induction, nifedipine does not achieve effective plasma concentrations when used with rifampicin. Therefore, it should not be used in combination with rifampicin. · Nifedipine is contraindicated in women under 20 weeks of pregnancy and during lactation.
[Precautions]
1. Patients with heart failure and severe aortic stenosis should exercise extreme caution when taking this product when their blood pressure is very low (severe hypotension with systolic blood pressure <90 mmHg). 2. This product contains non-deformable substances. Therefore, patients with severe gastrointestinal stenosis should use this product with caution due to the possibility of obstructive symptoms. Gastric stones are very rare, but if they occur, surgical treatment may be required. 3. Case reports have reported cases of obstructive symptoms in patients without gastrointestinal disorders. 4. This drug may cause false-positive results during barium meal X-rays (misinterpretation of polyps due to filling defects). 5. Patients with mild, moderate, or severe hepatic impairment based on the Child-Pugh score should be carefully monitored and may require a dose reduction. The pharmacokinetics of nifedipine have not been studied in patients with severe hepatic impairment (see [Dosage and Administration] and [Pharmacokinetics]). Therefore, nifedipine should be used with caution in patients with severe hepatic impairment. 6. Nifedipine is eliminated through the cytochrome P450 3A4 system. Therefore, drugs that inhibit or induce the cytochrome P450 3A4 system may alter the first-pass effect or clearance of nifedipine (see [Drug Interactions] for details). Therefore, weak to moderate inhibitors of the cytochrome P450 3A4 system may increase nifedipine plasma concentrations, such as: - Macrolide antibiotics (e.g., erythromycin) - Anti-HIV protease inhibitors (e.g., ritonavir) - Azole antifungals (e.g., ketoconazole) - Antidepressants: Nefazodone and fluoxetine - Quinupristin/dalfopristin - Valproic acid - Cimetidine. When nifedipine is coadministered with the above-mentioned drugs, blood pressure should be monitored and, if necessary, a reduction in the nifedipine dose should be considered. 7. Effects on Ability to Drive and Use Machines: Individual responses to medications vary, and therefore may affect the ability to drive and use machines. This effect is particularly pronounced at the beginning of treatment, during medication changes, and when consuming alcohol. 8. This product has a non-absorbable outer shell that allows the drug to be slowly released into the body for absorption. Upon completion of this process, the intact, empty tablets may be found in the feces. 9. Nifedipine controlled-release tablets contain a photosensitive active ingredient; therefore, this product should be stored away from light. The tablets should be kept away from moisture and taken immediately after being taken out of the aluminum-plastic plate.
