Cefaclor sustained-release capsules

Pharmacological studies: This product is a broad-spectrum semi-synthetic cephalosporin antibiotic. Its activity against penicillinase-producing Staphylococcus aureus, group A hemolytic streptococci, grass-green streptococci and Staphylococcus epidermidis is the same as that of cefadroxil, and its antibacterial effect against non-enzyme-producing Staphylococcus aureus and pneumococci is 2 to 4 times stronger than that of cefadroxil. Its activity against Gram-negative bacilli, including Escherichia coli and Klebsiella pneumoniae, is stronger than that of cefadroxil, and is similar to that of cefadroxil. Its activity against Proteus mirabilis, Salmonella and Shigella is stronger than that of cefadroxil. 2.9 to 8 mg/L of this product can inhibit all Haemophilus influenzae, including strains resistant to ampicillin. Moraxella catarrhalis and Neisseria gonorrhoeae are very sensitive to this product. Indole-positive Proteus, Serratia, Acinetobacter and Pseudomonas aeruginosa are all resistant to this product. The mechanism of action of this product is to inhibit the synthesis of bacterial cell walls. Toxicological studies: There is no research data on the genetic toxicity, carcinogenicity and effect on fertility of this product. The results of reproductive toxicity tests on mice, rats and ferrets showed that no obvious toxic reactions occurred when the dosage reached 3 to 5 times the recommended maximum human dosage (calculated by body surface area). However, since animal experiments cannot fully predict the results of clinical medication, pregnant women can only take this product when they really need it.

The main component of this product is cefaclor monohydrate. Chemical name: (6R,7R)-7-[(R)-2-amino-2-phenylacetylamino]-3-chloro-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate. Chemical structure: Molecular formula: C15H14ClN3O4S·H2O Molecular weight: 385.82

This product is a capsule, and the contents are slightly yellow granules.

This product is suitable for the following mild and moderate infections caused by sensitive bacteria: 1. Acute exacerbation of chronic bronchitis caused by Haemophilus influenzae (only non-β-lactamase-producing bacteria), Moraxella (including β-lactamase-producing bacteria) and Pneumococcus; 2. Secondary infection of acute bronchitis caused by Haemophilus influenzae (only non-β-lactamase-producing bacteria), Moraxella (including β-lactamase-producing bacteria) and Pneumococcus; 3. Pharyngitis and tonsillitis caused by Streptococcus pyogenes; 4. Uncomplicated skin and skin soft tissue infections caused by Staphylococcus aureus (including methicillin-sensitive strains).

Oral. Common dosage for adults: acute exacerbation of chronic bronchitis, secondary infection of acute bronchitis, 0.5g each time, twice a day, for 7 consecutive days; pharyngitis, tonsillitis patients, 0.75g each time, twice a day, for 10 consecutive days; uncomplicated skin and skin and soft tissue infection, 0.75g each time, twice a day, for 7 to 10 consecutive days.

1. Serious adverse reactions 1. Shock, allergic reactions (dyspnea, flushing, edema, etc.): Observe carefully during administration, stop administration once discovered, and give appropriate treatment. 2. Severe renal damage such as acute renal insufficiency: Check regularly during treatment and observe carefully. Stop administration and treat once it occurs. 3. Pseudomembranous colitis with bloody stools: When abdominal pain and multiple diarrhea occur, stop administration and give appropriate treatment. 4. Stevens-Johnson syndrome, toxic epidermal necrosis: stop the drug immediately and treat. 5. Interstitial pneumonia, PIE syndrome: Interstitial pneumonia accompanied by fever, cough, dyspnea, abnormal chest X-ray, erythrocytosis, etc., PIE syndrome should stop administration and give adrenal cortex hormone treatment.

Patients with a history of allergy to this product and cephalosporin antibiotics are contraindicated.

Precautions for children: See [Usage and Dosage] for details. Precautions for pregnancy and lactation: Use with caution in pregnant women: This drug can be excreted through breast milk, so lactating women should use it with caution or stop breastfeeding. Precautions for the elderly: Patients with poor absorption, patients with non-oral nutrition, the elderly, and patients with poor general condition should use it with caution.

Not yet clear.

Keep away from light, tightly sealed, and stored in a cool, dark and dry place.

0.1875g (calculated as C15H14ClN3O4S)

24 months

Shanghai Shyndec Pharmaceutical Co., Ltd.

• Founded in:

  1996-11-27

• Address:

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

• Tax NO.:

  91310000630459924R

• Registered Funds:

  1,341,172,692 yuan

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