Nifedipine controlled-release tablets (30 mg*24 tablets)

Nifedipine is a 1,4-hydropyridine calcium ion antagonist. 1. Calcium ion antagonists can reduce the entry of calcium ions into cells through slow calcium channels. Nifedipine specifically acts on myocardial cells, coronary arteries, and smooth muscle cells of peripheral resistance vessels. 2. Nifedipine can dilate coronary arteries, especially large blood vessels, and can even dilate healthy blood vessels in incompletely blocked areas. 3. Nifedipine can also reduce the tension of coronary artery smooth muscle and prevent vasospasm. Ultimately, it increases blood flow and oxygen supply in narrowed blood vessels. At the same time, nifedipine reduces oxygen demand by reducing peripheral resistance (afterload). Long-term use of nifedipine can prevent the occurrence of new coronary atherosclerotic lesions. Nifedipine can reduce the increased peripheral resistance and blood pressure by reducing the tension of arterial smooth muscle. In the early stage of nifedipine treatment, a short-term reflex heart rate may occur, resulting in an increase in cardiac output. However, this increase is not enough to compensate for the expansion of blood vessels. 4. In addition, short-term or long-term use of nifedipine can increase the excretion of sodium and water. For patients with hypertension, the antihypertensive effect of nifedipine is particularly significant.

Active ingredient: Nifedipine

This product is a film-coated tablet. After removing the coating, the tablet core is a double-layer tablet of yellow and red.

1. Hypertension 2. Coronary heart disease 3. Chronic stable angina (exertional angina)

During treatment, medication should be taken as individualized as possible. Different basic dosages are given according to the patient's clinical condition. Patients with liver damage should be carefully monitored, and the dosage should be reduced in severe cases. Unless otherwise prescribed by a doctor, the following dosage is recommended for adults: one tablet (30 mg) once a day. Course of treatment: The duration of medication should be determined by the doctor. Dosage: Usually the whole tablet is swallowed with a small amount of liquid, and the medication time is not limited by mealtime. The tablet cannot be chewed or broken before taking!

The most common adverse reactions in clinical practice are as follows, with an incidence rate between 1% and 10%: Whole body: weakness (fatigue), edema, headache. Cardiovascular system: peripheral edema, palpitations, vasodilation (flushing, hot sensation). Digestive system: constipation. Nervous system: dizziness. The incidence rate of the following is between 0.1% and 1%: Whole body: abdominal pain, chest pain, leg pain, discomfort, pain. Cardiovascular system: hypotension, orthostatic hypotension, syncope, tachycardia. Digestive system: diarrhea, dry mouth, indigestion, flatulence, nausea. Musculoskeletal system: leg muscle cramps. Nervous system: insomnia, tension, paresthesia, drowsiness, dizziness. Respiratory system: dyspnea, rhinitis. Skin and its appendages: itching, rash. Urogenital system: nocturia, polyuria, impotence. The following conditions occur at an incidence rate between 0.01% and 0.1%: Whole body: allergic reactions. Substernal pain, chills, facial edema, fever, cellulitis, neck pain, pelvic pain, pain. Cardiovascular system: angina pectoris (except unstable type), cardiac discomfort, atrial fibrillation, bradycardia, cardiac arrest, extrasystoles, phlebitis, cutaneous vascular ectopy. Digestive system: anorexia, heating, gastrointestinal discomfort, gingivitis, gingival hyperplasia, increased GGT, abnormal liver function, vomiting, abdominal pain, esophagitis, gastrointestinal bleeding. Musculoskeletal system: arthralgia, joint discomfort, muscle pain. Nervous system: hypoesthesia, sleep abnormalities, tremor, anxiety, mental confusion, decreased libido, depression, hypertonia. Respiratory system: epistaxis, increased cough, rales, pharyngitis. Skin and its appendages: angioedema, polymorphic rash, pustular rash, sweating, urticaria, bullous rash. Special senses: visual disturbances, eye discomfort, eye pain, amblyopia, conjunctivitis, diplopia, tinnitus. Genitourinary system: dysuria, frequent urination, urinary stones, enuresis, breast congestion. Blood: lymphadenopathy Metabolism: gout. Skeletal muscles: arthralgia, arthritis, myalgia. The most common spontaneously reported adverse drug reactions are reported throughout the body: allergic reactions. Digestive system: fecal stones, dysphagia, esophagitis, gingival discomfort, intestinal obstruction, intestinal ulcer, jaundice, SGPT increased. Blood lymphatic system: leukopenia, purpura. Metabolic and nutritional disorders: hyperglycemia, weight loss. Musculoskeletal system: muscle spasms. Skin and its appendages: exfoliative dermatitis, gynecomastia, photosensitivity dermatitis. Special senses: blurred vision. In dialysis patients with malignant hypertension and hypovolemia, a significant drop in blood pressure may occur due to vasodilation.

1. Contraindicated for patients with known allergy to nifedipine. 2. Contraindicated for cardiogenic shock. 3. Due to enzyme induction, nifedipine cannot reach effective blood concentration when used in combination with rifampicin. Therefore, it should not be used in combination with rifampicin. 4. Contraindicated for pregnant and lactating women.

Precautions for children: Forbidden. Precautions for pregnancy and lactation: Forbidden for pregnant and lactating women. Precautions for the elderly: After taking this product, its half-life is prolonged, Cmax and AUC are increased. Be careful to start taking it from the lowest dose to reduce the incidence of adverse reactions.

Combination with other antihypertensive drugs will enhance the antihypertensive effect of nifedipine. When nifedipine is used simultaneously with beta-blockers, patients must be strictly monitored because severe hypotension may occur. Individual cases of worsening heart failure are known. Nifedipine is metabolized by the cytochrome P4503A4 system located in the intestinal mucosa and liver. Drugs that are known to inhibit or promote this enzyme will affect the first-pass effect (after oral administration) or clearance of nifedipine. Phenytoin: It can induce the cytochrome P4503A4 system. When combined with phenytoin, the bioavailability of nifedipine is reduced, resulting in a decrease in efficacy. When the two drugs are used in combination, the clinical efficacy of nifedipine needs to be monitored and the dose of nifedipine needs to be increased if necessary. If the dose of nifedipine has been increased when the two drugs are used in combination, the dose of nifedipine should be reduced after phenytoin is discontinued. Digoxin: When used simultaneously with nifedipine, digoxin clearance is reduced, thereby increasing digoxin plasma concentrations. Therefore, patients should be examined to prevent digoxin overdose, and if necessary, the digoxin dose can be reduced according to the plasma digoxin concentration. Quinidine: When nifedipine and quinidine are taken simultaneously, quinidine concentrations decrease, or after nifedipine is discontinued, quinidine plasma concentrations increase significantly in individual cases. Therefore, patients taking quinidine should monitor plasma quinidine concentrations when adding or discontinuing nifedipine, and adjust the dose as necessary according to the doctor's advice. Some authors have reported that nifedipine plasma concentrations increase when nifedipine and quinidine are taken together, while other authors have reported that no changes in the pharmacokinetics of nifedipine are found. Therefore, if patients who are already taking nifedipine take quinidine, blood pressure should be closely monitored, and the nifedipine dose can be reduced if necessary. Quinopristin/dalfopristin: The combined use of nifedipine and quinopristin/dalfopristin may increase the plasma concentration of nifedipine. If the above drugs are used in combination, blood pressure should be closely monitored. If necessary, the dose of nifedipine should be reduced. Cimetidine: This drug can inhibit the cytochrome P4503A4 system, so it can increase the plasma concentration of nifedipine and enhance the antihypertensive effect. Rifampicin: It has a strong effect of inducing the cytochrome P4503A4 system. If it is used in combination with quinopristin/dalfopristin, the bioavailability of nifedipine will be reduced, thereby reducing its efficacy. Therefore, nifedipine is prohibited from being used in combination with rifampicin. Diltiazem: It can reduce the clearance of nifedipine. When the two are used in combination, caution should be exercised. If necessary, the dose of nifedipine should be considered to be reduced. Grapefruit juice: It can inhibit the cytochrome P4503A4 system. If it is used in combination with nifedipine, the blood concentration of nifedipine can be increased due to the reduced first-pass effect. The effect of lowering blood pressure is enhanced. For those who regularly take grapefruit juice, this effect can last for at least 3 days after the last dose. Cisapride: Cisapride combined with nifedipine can increase the plasma concentration of nifedipine. Therefore, if the two are used together, blood pressure should be closely monitored and the dose of nifedipine should be reduced if necessary. Coumarin anticoagulants: There are very few reports of increased clotting time in patients taking nifedipine using coumarin anticoagulants. However, the relationship with nifedipine treatment is not clear. Theoretical potential interactions Erythromycin: No studies have been conducted on the interaction between nifedipine and erythromycin. It is well known that erythromycin can inhibit the metabolism of other drugs mediated by cytochrome P4503A4. Therefore, the potential effect of increasing the plasma concentration of nifedipine after combined use with nifedipine cannot be ruled out. Fluoxetine: No clinical studies have been conducted on the possible drug interaction between nifedipine and fluoxetine. Fluoxetine inhibits the metabolism of nifedipine mediated by cytochrome P4503A4 in vitro. Therefore, the possibility of an increase in nifedipine blood concentration when these two drugs are used simultaneously cannot be ruled out. When fluoxetine and nifedipine are used simultaneously, the patient's blood pressure should be monitored, and if necessary, a reduction in the nifedipine dose may be considered. Amprenavir, indinavir, nelfinavir, ritonavir, saquinavir: No clinical studies have been conducted on the possible drug interactions between nifedipine and amprenavir, indinavir, nelfinavir, ritonavir, and saquinavir. These drugs are known to inhibit the cytochrome P4503A4 system. In addition, indinavir and ritonavir inhibit the cytochrome P4503A4-mediated metabolism of nifedipine in vitro. Therefore, the possibility of an increase in nifedipine blood concentration due to a decrease in the first-pass effect and a decrease in the amount of excretion when these drugs are used simultaneously with nifedipine cannot be ruled out. When administered simultaneously, the patient's blood pressure should be monitored, and if necessary, a reduction in the nifedipine dose may be considered. Nefazodone: Clinical studies on possible drug interactions between nifedipine and nefazodone have not been conducted. Nefazodone is known to inhibit the metabolism of other drugs mediated by cytochrome P4503A4. Therefore, the possibility of increased nifedipine blood concentrations when these two drugs are used simultaneously cannot be ruled out. When nefazodone and nifedipine are used simultaneously, the patient's blood pressure should be monitored, and if necessary, the dose of nifedipine may be reduced. Ketoconazole, itraconazole, fluconazole: Clinical studies on the interaction between nifedipine and ketoconazole, itraconazole, and fluconazole have not been conducted. These drugs are known to inhibit the cytochrome P4503A4 system. Therefore, when taken orally with nifedipine simultaneously, the effect of increased nifedipine bioavailability due to reduced first-pass effect cannot be ruled out. If the drugs are used together, blood pressure should be closely monitored. If necessary, the dose of nifedipine may be reduced. Tacrolimus: It is metabolized by the cytochrome P4503A4 system. Published data indicate that when used in combination with nifedipine, the dose of tacrolimus needs to be reduced in some cases. When the two drugs are used in combination, the blood concentration of tacrolimus should be monitored and the dose of tacrolimus should be reduced if necessary. Carbamazepine: There have been no studies on whether nifedipine and carbamazepine have a potential interaction. However, because carbamazepine can induce enzyme activity, which leads to a decrease in the blood concentration of nimodipine, a calcium channel blocker with a similar structure to nifedipine, it cannot be ruled out that the combination of the two can reduce the blood concentration of nifedipine, thereby reducing the efficacy. Phenobarbital: There have been no studies on whether nifedipine and phenobarbital have a potential interaction. However, because phenobarbital can induce enzyme activity, which leads to a decrease in the blood concentration of nimodipine, a calcium channel blocker with a similar structure to nifedipine, it cannot be ruled out that the combination of the two can reduce the blood concentration of nifedipine, thereby reducing the efficacy. Valproic acid: No studies have been conducted on the potential interaction between nifedipine and valproic acid. However, because valproic acid can inhibit enzyme activity, leading to an increase in the plasma concentration of nimodipine, a calcium channel blocker with a similar structure to nifedipine, it cannot be ruled out that the combination of the two can increase the plasma concentration of nifedipine, thereby improving the efficacy. No interaction exists. The combination of nifedipine with ajmaline, benazepril, isoquinol, doxazosin, irbesartan, omeprazole, orlistat, pantoprazole, ranitidine, rosiglitazone, talinolol, triamterene, and hydrochlorothiazide has no effect on the pharmacokinetics of nifedipine. Candesartan: The combination of nifedipine and candesartan has no effect on the pharmacokinetics of either. Aspirin: The combination of nifedipine and 100 mg aspirin has no effect on the pharmacokinetics of nifedipine. At the same time, the combination of the two does not affect the effect of 100 mg aspirin on platelet aggregation and bleeding time. Other forms of interaction Nifedipine can cause a false increase in the spectrophotometric value of urinary vanillylmandelic acid, but HPLC determination is not affected.

Keep in a dark, cool and dry place (not exceeding 20℃).

30 mg

24 months.

Shanghai Shyndec Pharmaceutical Co., Ltd.

• Founded in:

  1996-11-27

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  No. 378, Jianlu Road, Pudong New Area, Shanghai

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  91310000630459924R

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