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Nitrofurantoin Enteric-coated Capsules

Function and Efficacy

This product has antibacterial effects on Gram-positive bacteria such as Enterococcus. The antibacterial activity of this product is not affected by pus and tissue decomposition products, and its activity is stronger in acidic urine. The antibacterial mechanism is to interfere with the oxidoreductase system in bacteria, thereby blocking its metabolic process. Escherichia coli is mostly sensitive to this product, and some strains of Enterobacteriaceae such as Enterobacter aerogenes, Enterobacter cloacae, Proteus, and Klebsiella are sensitive to this product. Pseudomonas aeruginosa is usually resistant to this product.

Ingredients

This product contains nitrofurantoin (C8H6N4O5) which should be 93.0% to 107.0% of the labeled amount. Chemical name: 1-[[(5-nitro-2-furanyl)methylene]amino]-2,4-imidazoledione Molecular weight: C8H6N4O5

Name Description Content CAS NO. Manufacturer
NitrofurantoinIngredients

It has antibacterial effect on Gram-positive bacteria such as Enterococcus, interferes with the oxidoreductase system in bacteria, and thus blocks their metabolic process. It is more active in acidic urine. Most Escherichia coli are sensitive, and some strains of Enterobacteriaceae such as Enterobacter aerogenes, Enterobacter cloacae, Proteus, and Klebsiella are sensitive to this product, while Pseudomonas aeruginosa is usually resistant.

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Appearance

This product is an enteric-coated capsule, and the contents are yellow powder.

Indication

Anti-infective drug. It is suitable for acute simple lower urinary tract infection caused by sensitive bacteria, and can also be used for the prevention of urinary tract infection.

Usage and Dosage

Take orally 50-100 mg once, 200-400 mg per day.

Adverse Reactions

1. Gastrointestinal reactions such as nausea, vomiting, anorexia and diarrhea are common. 2. Allergic reactions such as rash, drug fever, granulocytopenia and hepatitis may also occur. Hemolytic anemia may occur in patients with glucose-6-phosphate dehydrogenase deficiency. 3. Neurological adverse reactions such as headache, dizziness, drowsiness, myalgia and nystagmus may occasionally occur, which are mostly reversible. In severe cases, peripheral neuritis may occur. Patients with existing renal impairment or long-term use of this product are more likely to develop this disease. 4. Nitrofurantoin may occasionally cause acute pneumonia symptoms such as fever, cough, chest pain, lung infiltration and eosinophilia, which may disappear quickly after discontinuation of the drug. Corticosteroids may alleviate symptoms in severe patients. Patients who take the drug for more than 6 months may occasionally develop interstitial pneumonia or pulmonary fibrosis. The drug should be discontinued as soon as possible and appropriate treatment measures should be taken.

Precautions

1. It is contraindicated for newborns and full-term pregnant women. 2. It is contraindicated for patients with impaired renal function. 3. It is contraindicated for patients who are allergic to furan drugs.

Special Population Medication

Precautions for children: It is contraindicated for newborns under 1 month old. Precautions for pregnancy and lactation: 1. Because nitrofurantoin can pass through the placental barrier and the fetal enzyme system is not fully developed, it is not suitable for pregnant women in the late pregnancy and is contraindicated for pregnant women at full term to avoid the possibility of hemolytic anemia in the fetus. 2. A small amount of nitrofurantoin can enter breast milk and induce hemolytic anemia in infants, especially those with glucose-6-phosphate dehydrogenase deficiency. Breastfeeding should be stopped when taking this product. Precautions for the elderly: Elderly patients should use it with caution and the dosage should be adjusted according to renal function.

Drug Interactions

1. When drugs that can cause hemolysis are used in combination with nitrofurantoin, the hemolytic reaction may be increased. 2. When used in combination with hepatotoxic drugs, the hepatotoxic reaction may be increased; when used in combination with neurotoxic drugs, the neurotoxicity may be increased. 3. Both probenecid and sulfinpyrazone can inhibit the renal tubular secretion of nitrofurantoin, resulting in an increase in the latter's blood concentration and (or) a prolonged serum half-life, while the urine concentration is reduced and the efficacy is also weakened. The dosage of probenecid and the like should be adjusted.

Storage

Keep away from light and store in sealed container.

Packaging Specification

50 mg

Validity Period

24 months

Manufacturer

China Resources Zizhu Pharmaceutical Co., Ltd.

  • Founded in:

    1980-11-26
  • Address:

    Building 18, No. 27 Chaoyang North Road, Chaoyang District, Beijing
  • Tax NO.:

    91110000101939631P
  • Registered Funds:

    660.6396 million yuan
  • Website:

  • Email:

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