Audited Supplier
NO.
Internal Medicine
For oral administration
Elderly, Children, Adult
Solid
Tablet
Biological Products
Chemical Synthesis
Available
Available
24 Months
Available
USP.
OEM
Box/Carton
500mg
China
293299909
Product Description
Product information:
Pharmacology:
This product is a macrolide antibiotic. It has inhibitory effect on Gram positive bacteria such as Staphylococcus aureus, Streptococcus, pneumococcus, etc. it also has inhibitory effect on some gram negative bacteria such as Haemophilus influenzae, pertussis, Neisseria gonorrhoeae, Legionella pneumophila and some anaerobic bacteria such as Bacteroides fragilis, Streptococcus digestion, Propionibacterium acnes, etc. in addition, it also has inhibitory effect on mycoplasma inhibition. The antibacterial activity of this product is similar to erythromycin in vitro, but its antibacterial activity against some bacteria such as Staphylococcus aureus, Streptococcus and Haemophilus influenzae is stronger than erythromycin in vivo. There was cross resistance between this product and erythromycin. The mechanism of action of this product is to inhibit the binding of nuclear protein 50S subunit and inhibit protein synthesis.
Pharmacokinetics:
The bioavailability (f) was 55%. Food can delay absorption slightly, but does not affect bioavailability. 2 mg / L after a single oral dose of 400 mg / L and 250 mg / L of 250 mg / l every 12 hours. The metabolite (14 hydroxyclarithromycin) was 0.6 mg / L and 500 mg / l every 12 hours. The average plasma concentration of the drug in the stable peak state was 2.7-2.9 mg / L, and its metabolite was 0.83-0.88 mg / L. The drug concentration in nasal mucosa, tonsil and lung tissue was higher than that in blood. In the plasma, the protein binding rate was 65% - 75%. Its main metabolite is 14 hydroxyclarithromycin with macrolide activity. The blood elimination half-life (T1 / 2 β) after single dose administration was 4.4 hours; the blood elimination half-life (T1 / 2 β) was 3-4 hours after oral administration of 250mg every 12 hours, and its metabolites were 5-6 hours; the blood elimination half-life (T1 / 2 β) of the prototype drug after oral administration of 500 mg every 12 hours was 4.5-4.8 hours, and its metabolites were 6.9-8.7 hours. After oral or intravenous administration of 14C clarithromycin, 36% of the dose was excreted from urine and 52% from stool within 5 days. The excretion of low-dose drug through fecal and urinary routes was similar, but the urine excretion was more when the dose was increased.
Indication:
This product is suitable for the following infections caused by clarithromycin sensitive bacteria:
1. Nasopharynx infection: tonsillitis, pharyngitis, paranasal sinusitis;
2. Lower respiratory tract infection: including bronchitis, bacterial pneumonia and atypical pneumonia;
3. Skin infection, pustulosis, erysipelas, folliculitis, furuncle and wound infection.
Taboo:
1. It is forbidden to be allergic to this product or macrolide drugs.
2. Forbidden for pregnant and lactating women.
3. Patients with severe liver function damage, water and electrolyte disorders, and patients taking terfenadine are forbidden.
4. Some heart diseases (including arrhythmia, bradycardia, prolonged Q-T interval, ischemic heart disease, congestive heart failure, etc.) are prohibited.
Matters needing attention:
1. The patients with liver function damage and moderate to severe renal function damage should be used with caution.
2. If the renal function is seriously damaged (creatinine clearance rate is less than 30ml / min), the dosage should be adjusted. The commonly used dose was 0.25g once a day, and 0.5g for the first dose and 0.25g for the later one, twice a day for the patients with severe infection.
3. There is cross allergy and cross resistance between this product and erythromycin and other macrolide drugs.
4. As with other antibiotics, serious infection caused by fungi or resistant bacteria may occur. At this time, it is necessary to discontinue the use of this product and take appropriate treatment.
5. This product can be taken orally on an empty stomach, or with food or milk. Taking with food does not affect its absorption.
6. Hemodialysis or peritoneal dialysis can not reduce the blood concentration of the drug.
7. Clarithromycin has toxic effects on embryos and fetuses in experimental animals. Clarithromycin and its metabolites can enter breast milk. Pregnant women and lactating women should weigh the advantages and disadvantages before deciding whether to use it. If there are indications for the use of this product for breast-feeding women should be suspended.
8. Drugs should not be placed in children's reach.
9. Discarded drug packaging should not be discarded at will.
| Product name | Clarithromycin Tablets |
| Shelf Life | 24 Months |
| Specification | 500mg 10tablets/Blister, 10blisters/Box |
| Storage | Store in a cool and dry place (no more than 20 ºC). |
Pharmacology:
This product is a macrolide antibiotic. It has inhibitory effect on Gram positive bacteria such as Staphylococcus aureus, Streptococcus, pneumococcus, etc. it also has inhibitory effect on some gram negative bacteria such as Haemophilus influenzae, pertussis, Neisseria gonorrhoeae, Legionella pneumophila and some anaerobic bacteria such as Bacteroides fragilis, Streptococcus digestion, Propionibacterium acnes, etc. in addition, it also has inhibitory effect on mycoplasma inhibition. The antibacterial activity of this product is similar to erythromycin in vitro, but its antibacterial activity against some bacteria such as Staphylococcus aureus, Streptococcus and Haemophilus influenzae is stronger than erythromycin in vivo. There was cross resistance between this product and erythromycin. The mechanism of action of this product is to inhibit the binding of nuclear protein 50S subunit and inhibit protein synthesis.
Pharmacokinetics:
The bioavailability (f) was 55%. Food can delay absorption slightly, but does not affect bioavailability. 2 mg / L after a single oral dose of 400 mg / L and 250 mg / L of 250 mg / l every 12 hours. The metabolite (14 hydroxyclarithromycin) was 0.6 mg / L and 500 mg / l every 12 hours. The average plasma concentration of the drug in the stable peak state was 2.7-2.9 mg / L, and its metabolite was 0.83-0.88 mg / L. The drug concentration in nasal mucosa, tonsil and lung tissue was higher than that in blood. In the plasma, the protein binding rate was 65% - 75%. Its main metabolite is 14 hydroxyclarithromycin with macrolide activity. The blood elimination half-life (T1 / 2 β) after single dose administration was 4.4 hours; the blood elimination half-life (T1 / 2 β) was 3-4 hours after oral administration of 250mg every 12 hours, and its metabolites were 5-6 hours; the blood elimination half-life (T1 / 2 β) of the prototype drug after oral administration of 500 mg every 12 hours was 4.5-4.8 hours, and its metabolites were 6.9-8.7 hours. After oral or intravenous administration of 14C clarithromycin, 36% of the dose was excreted from urine and 52% from stool within 5 days. The excretion of low-dose drug through fecal and urinary routes was similar, but the urine excretion was more when the dose was increased.
Indication:
This product is suitable for the following infections caused by clarithromycin sensitive bacteria:
1. Nasopharynx infection: tonsillitis, pharyngitis, paranasal sinusitis;
2. Lower respiratory tract infection: including bronchitis, bacterial pneumonia and atypical pneumonia;
3. Skin infection, pustulosis, erysipelas, folliculitis, furuncle and wound infection.
Taboo:
1. It is forbidden to be allergic to this product or macrolide drugs.
2. Forbidden for pregnant and lactating women.
3. Patients with severe liver function damage, water and electrolyte disorders, and patients taking terfenadine are forbidden.
4. Some heart diseases (including arrhythmia, bradycardia, prolonged Q-T interval, ischemic heart disease, congestive heart failure, etc.) are prohibited.
Matters needing attention:
1. The patients with liver function damage and moderate to severe renal function damage should be used with caution.
2. If the renal function is seriously damaged (creatinine clearance rate is less than 30ml / min), the dosage should be adjusted. The commonly used dose was 0.25g once a day, and 0.5g for the first dose and 0.25g for the later one, twice a day for the patients with severe infection.
3. There is cross allergy and cross resistance between this product and erythromycin and other macrolide drugs.
4. As with other antibiotics, serious infection caused by fungi or resistant bacteria may occur. At this time, it is necessary to discontinue the use of this product and take appropriate treatment.
5. This product can be taken orally on an empty stomach, or with food or milk. Taking with food does not affect its absorption.
6. Hemodialysis or peritoneal dialysis can not reduce the blood concentration of the drug.
7. Clarithromycin has toxic effects on embryos and fetuses in experimental animals. Clarithromycin and its metabolites can enter breast milk. Pregnant women and lactating women should weigh the advantages and disadvantages before deciding whether to use it. If there are indications for the use of this product for breast-feeding women should be suspended.
8. Drugs should not be placed in children's reach.
9. Discarded drug packaging should not be discarded at will.
