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Clarithromycin Lactobionate Capsules

Function and Efficacy

Clarithromycin belongs to the class of semisynthetic macrolide antibiotics. Clarithromycin binds to the 50S subunit of bacterial ribosomes, thereby inhibiting its protein synthesis and producing an antibacterial effect. In vitro, it has good antibacterial activity against both standard strains and clinical isolates, and has a strong antibacterial effect against a variety of aerobic and anaerobic Gram-positive or Gram-negative bacteria. Generally, the minimum inhibitory concentration (MIC) of clarithromycin is the logarithmic dilution concentration of the minimum inhibitory concentration of erythromycin. The results of in vitro pharmacodynamic studies have shown that clarithromycin can inhibit Legionella pneumophila and Mycoplasma pneumoniae, and kill Helicobacter pylori, and its activity under neutral conditions is stronger than that under acidic conditions. In vitro and in vivo data show that objective existence has a significant clinical effect on mycobacteria. In vivo data show that Enterobacter, Pseudomonas and other non-lactose metabolizing Gram-negative bacteria are not sensitive to clarithromycin.

Ingredients

Chemical name: 6-0-methylerythromycin lactobionate Molecular weight: C38H69NO13·C12H22O12

Name Description Content CAS NO. Manufacturer
ClarithromycinIngredients

Clarithromycin belongs to the class of semisynthetic macrolide antibiotics. Clarithromycin binds to the 50S subunit of bacterial ribosomes, thereby inhibiting its protein synthesis and producing an antibacterial effect. In vitro, it has good antibacterial activity against both standard strains and clinical isolates, and has significant antibacterial effects against a variety of aerobic and anaerobic Gram-positive or Gram-negative bacteria. Generally, the minimum inhibitory concentration (MIC) of clarithromycin is the logarithmic dilution concentration of the minimum inhibitory concentration of erythromycin. The results of in vitro pharmacodynamic studies have shown that clarithromycin can inhibit Legionella pneumophila and Mycoplasma pneumoniae, and kill Helicobacter pylori, and its activity under neutral conditions is stronger than that under acidic conditions. In vitro and in vivo data show that objective existence has a significant clinical effect on mycobacteria. In vivo data show that Enterobacter, Pseudomonas and other non-lactose metabolizing Gram-negative bacteria are insensitive to clarithromycin.

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81103-11-9 46

Appearance

This product is a capsule, and the contents are white or off-white powder or granules.

Indication

Clarithromycin is suitable for the following infections caused by pathogens that are sensitive to it, including: 1. Lower respiratory tract infections: such as bronchitis, pneumonia, etc.; 2. Upper respiratory tract infections: such as pharyngitis, sinusitis, etc.; 3. Skin and soft tissue infections: such as folliculitis, cellulitis, erysipelas; 4. Local or disseminated infections caused by avian mycobacterium or intracellular mycobacterium, local and total infections caused by mycobacterium avium, mycobacterium accidentum or mycobacterium kansasii; 5. Clarithromycin is suitable for HIV-infected patients with CD4 lymphocyte counts less than or equal to 100mm3 to prevent mixed infections caused by disseminated avian mycobacterium. 6. When there is a gastric acid inhibitor, clarithromycin is also suitable for eradicating Helicobacter pylori, thereby reducing the recurrence of duodenal ulcers. 7. Treatment of odontogenic infections.

Usage and Dosage

1. For oral administration, the commonly recommended dose for adults is two tablets (0.25g) twice a day. In case of severe infection, the dose is increased to four tablets (0.5g) each time, twice a day. The course of treatment is 5-14 days, and the course of treatment for acquired pneumonia and sinusitis is 6-14 days. 2. For patients with renal damage and creatinine clearance less than 30ml/min, the dose is halved, that is, two tablets (0.25g) each time, once a day: for severe infection, two tablets (0.25g) each time, twice a day, and continuous treatment should not exceed 14 days. 3. For mycobacterial infection, the recommended dose for adults is four tablets (0.5g) each time, twice a day. The treatment of disseminated MAC infection in AIDS patients should continue until clinical efficacy is apparent, and clarithromycin should be used in combination with other anti-mycobacterial drugs. 4. Treatment of non-tuberculous mycobacteria

Adverse Reactions

The most common adverse reactions in adults are gastrointestinal discomfort, such as nausea, indigestion, abdominal pain, vomiting and diarrhea. Other adverse reactions include headache, abnormal taste and transient increase in liver transaminases.

Precautions

1. It is contraindicated for patients who are allergic to macrolide antibiotics. 2. Clarithromycin is contraindicated for use with the following drugs: astemizole, cisapride, pimozide, and terfenadine.

Special Population Medication

Precautions for children: Not yet clear. Precautions for pregnancy and lactation: The safety of clarithromycin for pregnant and lactating women has not been confirmed. Clarithromycin can be excreted in breast milk. Precautions for the elderly: Not yet clear.

Drug Interactions

Interaction with antiretroviral drugs: When HIV-infected adults take clarithromycin and zidovudine orally at the same time, the steady-state blood concentration of zidovudine will decrease. This is mainly because clarithromycin interferes with the absorption of zidovudine, so staggering the time of administration can avoid this effect. However, the above-mentioned interaction did not occur when HIV-infected pediatric patients took clarithromycin suspension and zidovudine or dideoxyinosine at the same time. Pharmacokinetic studies have shown that when ritonavir (200 mg, three times a day) and clarithromycin (500 mg, twice a day) are used in combination, clarithromycin metabolism will be significantly inhibited, and the Cmax, Cmin and AUC of clarithromycin will increase by 31%, 182% and 77%, respectively. The therapeutic window of 14-OH clarithromycin is large. When

Storage

seal.

Packaging Specification

0.125g (calculated as C38H69NO13, 125,000 units)

Validity Period

24 months

Manufacturer

Sichuan Deyuan Pharmaceutical Group Co., Ltd.

  • Founded in:

    2001-02-19
  • Address:

    No. 518, Haozikou Road, Central District, Neijiang City
  • Tax NO.:

    915110007232358235
  • Registered Funds:

    30.28 million yuan
  • Website:

  • Email:

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