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Captopril tablets

Product description
Approved date: January 29, 2007
 
Date of revision: October 1, 2010
 
         October 01, 2012
 
         November 30, 2015
 
Captopril sheet instructions
 
Please read the instructions carefully and use them under the guidance of a physician.
 
【Drug Name】
 
Generic name: Captopril tablets
 
English name: Captopril Tablets
 
Pinyin: Katuopuli Pian
 
[Ingredients] The main ingredient of this product is: captopril. Its chemical name is: 1-[(2S)-2-methyl-3-indolyl-propionyl]-L-proline.
 
Molecular formula: C9H15NO3S
 
Molecular weight: 217.29
 
【Properties】 This product is a sugar-coated tablet, which is white or off-white after removal of the coating.
 
[indications]
 
1. hypertension.
 
2. Heart failure.
 
[Specification] 25mg
 
[Usage and dosage] depends on the condition or individual differences. This product should be taken under the guidance or supervision of a physician. The dosage should be adjusted according to the individualization principle and adjusted according to the curative effect.
 
1. Adults commonly used:
 
(1) High blood pressure, oral administration of 12.5mg (1/2 tablet), 2~3 times a day, increased to 50mg (2 tablets) within 1~2 weeks as needed, 2~3 times a day, the effect is still not satisfactory Other antihypertensive drugs can be added.
 
(2) Heart failure, start oral administration of 12.5mg (1/2 tablet) 2~3 times a day, gradually increase to 50mg (2 tablets) if necessary, 2~3 times a day, if further dosage is needed, it should be observed After 2 weeks of treatment, consider taking it again; for patients who take a large amount of diuretics in the near future, who are in low sodium/low blood volume and have normal or low blood pressure, the initial dose should be 6.25mg 3 times a day, and then gradually increase to the usual amount through testing. .
 
2. The commonly used amount of children: blood pressure and treatment of heart failure, are starting from the weight of 0.3mg / kg, 3 times a day, if necessary, increase 0.3mg / kg every 8 to 24 hours, to obtain the lowest effective amount.
 
【Adverse reactions】
 
1. The more common ones are:
 
(1) rash, may be accompanied by itching and fever, often occurs within 4 weeks of treatment, with rash or urticaria, reduced, discontinued or disappeared after administration of antihistamines, 7% to 10% with eosinophils Increased or positive for antinuclear antibodies.
 
(2) palpitations, tachycardia, chest pain.
 
(3) Cough.
 
(4) The taste is slow.
 
2. Less common are:
 
(1) Proteinuria, which usually occurs within 8 months of the start of treatment, of which 1/4 of the nephrotic syndrome occurs, but proteinuria gradually decreases within 6 months, and the course of treatment is not affected.
 
(2) dizziness, headache, fainting. Caused by hypotension, especially in the absence of sodium or insufficient blood volume.
 
(3) Angioedema, found on the face, hands and feet.
 
(4) The heart rate is fast and uneven.
 
(5) Facial flushing or paleness.
 
3. Rarely: white blood cells and neutropenia, fever, chills, leukopenia and dose-related, 3 to 12 weeks after the start of treatment, the most significant 10 to 30 days, 2 weeks after withdrawal.
 
[Contraindications] It is forbidden to be allergic to this product or other angiotensin-converting enzyme inhibitors.
 
【Precautions】
 
1, the food in the stomach can reduce the absorption of this product by 30~40%, so it is advisable to take the medicine 1 hour before the meal.
 
2, this product can increase blood urea nitrogen, creatinine concentration, often temporary, in the presence of kidney disease or long-term severe hypertension and rapid decline in blood pressure, occasionally increased serum liver enzymes; may increase blood potassium, and potassium Special attention should be paid to the examination of serum potassium when diuretics are used.
 
3. Use this product with caution in the following situations:
 
(1) Autoimmune diseases such as severe systemic lupus erythematosus, where the chance of leukopenia or neutropenia is increased.
 
(2) Myelosuppression.
 
(3) Insufficient blood supply to the cerebral arteries or coronary arteries may increase ischemia due to lower blood pressure.
 
(4) Hyperkalemia is too high.
 
(5) Kidney dysfunction leads to increased blood potassium, decreased white blood cells and granulocytes, and retention of this product.
 
(6) Aortic stenosis, which may reduce coronary perfusion.
 
(7) Strict diet restrictions on sodium salt or dialysis, at this time the first dose of this product may occur suddenly and severe hypotension.
 
4. Follow-up inspection during the use of this product:
 
(1) White blood cell count and classification count, once every 2 weeks for the first 3 months, and then regularly checked, and immediately after signs of infection.
 
(2) Urine protein check once a month.
 
5, poor renal function should be used in small doses or reduced doses, slowly increasing; if you must use diuretics at the same time, it is recommended to use furosemide instead of thiazide, blood urea nitrogen and creatinine increased, the product will be reduced Or disable the diuretic at the same time.
 
6. If the proteinuria is gradually increased with this product, suspend the product or reduce the dosage.
 
7. If the white blood cell count is too low when using this product, suspend the use of this product, you can recover.
 
8, the use of this product when angioedema, should be discontinued, rapid subcutaneous injection of 1:1000 adrenaline 0.3 ~ 0.5ml.
 
9, this product can cause false positive urine test.
 
[Pregnant women and lactating women]
 
1, this product can pass the placenta, can harm the fetus, detect pregnancy should immediately stop this product.
 
2, this product can be discharged into the milk, the concentration is about 1% of the maternal blood drug concentration, so the application of lactating women must weigh the pros and cons.
 
3, pregnant women absorb ACE I can affect fetal development, and even cause fetal death, pregnant women are banned.
 
[Children's medication] It has been reported that this product can cause excessive blood pressure and long-term decrease in babies with oliguria and convulsions, so the application of this product is limited to other patients with ineffective antihypertensive treatment.
 
[Geriatric Use] The elderly are more sensitive to antihypertensive effects, and this product should be dose-reduced.
 
【medicine interactions】
 
1. Use with diuretics to enhance the antihypertensive effect, but should avoid causing severe hypotension, so the original diuretics should be discontinued or reduced. This product starts with a small dose and gradually adjusts the dose.
 
2. Use with other vasodilators may cause hypotension, such as fitting, should start with a small dose.
 
3. Use with bismuth potassium drugs such as spironolactone, triamterene, and amiloride may cause hyperkalemia.
 
4. In combination with endogenous prostaglandin synthesis inhibitors such as indomethacin, the antihypertensive effect of this product will be weakened.
 
5. In combination with other antihypertensive drugs, the antihypertensive effect is enhanced; combined with drugs that affect sympathetic nerve activity (nerve blockers or adrenergic nerve blockers) and beta blockers, the antihypertensive effect may be enhanced and should be guarded.
 
6. In combination with lithium, it may increase serum lithium levels and cause toxicity.
 
[Drug overdose] Overdose can cause hypotension, should be discontinued immediately, and expanded to correct, in adults can also be cleared by hemodialysis.
 
[Pharmacology and Toxicology] This product is a competitive angiotensin-converting enzyme inhibitor, which can not convert angiotensin I into angiotensin II, thereby reducing peripheral vascular resistance, and reducing sodium and water retention by inhibiting aldosterone secretion. This product can also expand peripheral blood vessels by interfering with the degradation of bradykinin. For patients with heart failure, this product can also reduce pulmonary capillary wedge pressure and pulmonary vascular resistance, increase cardiac output and exercise tolerance time.
 
[Pharmacokinetics] This product absorbs quickly after oral administration, and the absorption rate is above 75%. It takes effect 15 minutes after oral administration and reaches the peak concentration of blood for 1 to 1.5 hours. Lasts 6 to 12 hours. 25% to 30% of the product in the blood circulation binds to the protein. The half-life is shorter than 3 hours, and drug retention occurs when kidney function is impaired. The antihypertensive effect is progressive and reaches the maximum therapeutic effect in about several weeks. Metabolized into disulfide in the liver. This product is excreted by the kidneys, about 40% to 50% is discharged in the original form, and the rest are metabolites, which can be removed during hemodialysis. This product can not pass the blood-brain barrier. This product can be secreted through the milk and can pass through the placenta.
 
[Storage] shading, sealed (10 ~ 30 ° C) preservation.
 
[Package] medicinal plastic bottles, 100 tablets per bottle.
 
[Validity Period] 24 months
 
[Executive Standards] "Chinese Pharmacopoeia" 2015 Edition 2
 
[Approval No.] National Drug Standard H44021595
 
【manufacturer】
 
  Company Name: Guangdong Pi Di Pharmaceutical Co., Ltd.
 
  Production address: No. 66, Pidi Avenue, Yueshan Town, Kaiping City, Guangdong Province
 
  Postal code: 529331
 
  Phone number: (0750) 2789348
 
400-8899-328 (National Service Phone)
 
  Fax number: (0750) 2789348
 
  Website: http://www.pdpharm.com
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