Cefaclor sustained-release tablets

This product is a second-generation cephalosporin, an oral semi-synthetic antibiotic, with a broad-spectrum anti-Gram-positive and Gram-negative bacteria effect. Its mechanism of action is the same as other cephalosporins, mainly by inhibiting the synthesis of cell walls to achieve bactericidal effects. This product is stable to the beta-lactamase of some bacteria, so some beta-lactamase-producing microorganisms may be sensitive to this product. In vitro and clinical studies have confirmed that this product has antibacterial activity against most of the following microorganisms: Gram-positive bacteria: Staphylococcus aureus, Streptococcus pyogenes, Streptococcus pneumoniae, this product is ineffective against methicillin sodium-resistant Staphylococci. Gram-negative bacteria: Haemophilus influenzae (only for strains that do not produce beta-lactamase), Moraxella catarrhalis (including strains that produce beta-lactamase).

The main ingredient of this product is cefaclor.

This product is a film-coated tablet, which appears light yellow after removing the coating.

This product is suitable for mild and moderate infections in the following parts caused by sensitive strains of Staphylococcus aureus, hemolytic streptococci, pneumococcus, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, Shigella dysenteriae, etc.: 1. Tonsillitis, peritonsillitis, pharyngitis, bronchitis, pneumonia, bronchopneumonia, asthma and bronchiectasis infection and post-operative infection; 2. Acute and chronic pyelonephritis, cystitis, prostatitis and genitourinary system infection; 3. Otitis media, otitis externa, sinusitis; 4. Maxillary periostitis, maxillary periostitis, maxillary osteomyelitis, acute palatitis, alveolar abscess, apical periodontitis, peri-wisdom tooth inflammation, post-tooth extraction infection; 5. Blepharitis, blepharitis, acute dacryocystitis; 6. Folliculitis, furuncle, erysipelas, cellulitis, impetigo, carbuncle, acne infection, subcutaneous abscess, trauma infection, mastitis, lymphangitis, etc.

Oral administration: the usual dose for adults is 375 mg (1 tablet at a time), twice a day. The dose should be doubled for critically ill patients.

1. Serious adverse reactions (1) Shock, allergic reactions (dyspnea, flushing, edema, etc.): Careful observation should be made during administration. Once discovered, administration should be stopped and appropriate treatment should be given. (2) Severe renal damage such as acute renal insufficiency should be observed carefully. Once it occurs, administration should be stopped and appropriate treatment should be given. (3) Pseudomembranous colitis with bloody stools: When abdominal pain and repeated diarrhea occur, administration should be stopped and appropriate treatment should be given. (4) Skin, mucous membrane, inflammation, eye syndrome (sterens-Johnson syndrome), toxic epidermal necrosis (Lyell syndrome): The drug should be stopped immediately and treatment should be given. (5) Interstitial pneumonia, PIE syndrome: Interstitial pneumonia and PIE syndrome accompanied by fever, cough, dyspnea, abnormal chest X-ray, and erythrocytosis.

Patients who are allergic to this product or other cephalosporins are contraindicated.

Precautions for children: Not clear. Precautions for pregnancy and lactation: 1. Use with caution in pregnant women. 2. This product can be excreted through breast milk, so lactating women should use it with caution or stop breastfeeding. Precautions for the elderly: Elderly patients should adjust the dosage or medication interval according to their renal function under the guidance of a physician.

This experiment has not been conducted and there are no reliable references.

Seal tightly and store in a cool, dark (avoid light and not exceeding 20°C) dry place.

0.375g (calculated as C15H14ClN3O4S)

Tentatively 24 months.

Shandong Zibo Xinda Pharmaceutical Co., Ltd.

• Founded in:

  1993-03-11

• Address:

  No. 1, Lutai Avenue, Zibo High-tech Zone

• Tax NO.:

  9137030361328152XT

• Registered Funds:

  84.93 million yuan

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