Minocycline Hydrochloride Capsules

1 Pharmacology: This product is a semi-synthetic tetracycline broad-spectrum antibiotic with high efficiency and long-term effect. Among tetracycline antibiotics, this product has the strongest antibacterial effect. The antibacterial spectrum is similar to that of tetracycline. It has a strong effect on Gram-positive bacteria including tetracycline-resistant Staphylococcus aureus, Streptococcus, etc. and Gram-negative bacteria such as Neisseria gonorrhoeae; the effect on Gram-negative bacilli is generally weaker; this product also has a good inhibitory effect on Chlamydia trachomatis and Ureaplasma urealyticum. In recent years, due to the abuse of tetracycline antibiotics, most common Gram-positive and Gram-negative bacteria are now resistant to this product. The mechanism of action of this product is to bind to the A position of the 30S subunit of the ribosome, prevent the extension of the peptide chain, and thus inhibit the protein synthesis of bacteria or other pathogenic microorganisms. This product is an antibacterial drug, but at high concentrations, it also has a bactericidal effect. 2 Toxicology: This product can cause the thyroid gland of experimental animals (rats, dogs and monkeys) to turn black. Rats given this product for chronic treatment resulted in goiter and even thyroid tumors. This product can also cause thyroid hyperplasia in rats and dogs.

The main ingredient of this product is minocycline hydrochloride, whose chemical name is 4,7-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide hydrochloride

This product is in the form of capsules.

This product is suitable for the following infections caused by pathogens sensitive to this product, such as Staphylococcus, Streptococcus, Pneumococcus, Neisseria gonorrhoeae, Shigella dysenteriae, Escherichia coli, Klebsiella, Proteus, Pseudomonas aeruginosa, Treponema pallidum and Chlamydia: 1. Sepsis, bacteremia. 2. Superficial suppurative infections: folliculitis, pyoderma, tonsillitis, frozen shoulder, dacryocystitis, gingivitis, vulvitis, traumatic infection, postoperative infection, etc. 3. Deep suppurative diseases: mastitis, lymphangiitis (adenitis), submandibular gland inflammation, osteomyelitis, osteitis. 4. Acute and chronic bronchitis, asthmatic bronchitis, bronchiectasis, bronchopneumonia, bacterial pneumonia, atypical pneumonia, pulmonary suppuration. 5. Dysentery, enteritis, infectious food poisoning, cholangitis, cholecystitis. 6. Peritonitis. 7.

Oral administration. The first dose for adults is 0.2g, followed by 0.1g every 12 hours, or 50mg every 6 hours.

1. Dysbacteriosis: This product is more common in causing dysbacteriosis. In mild cases, it causes vitamin deficiency, and secondary infection caused by Candida albicans and other drug-resistant bacteria is also common. Clostridium difficile pseudomembranous enterocolitis may also occur. 2. Gastrointestinal reactions: loss of appetite, nausea, vomiting, abdominal pain, diarrhea, stomatitis, glossitis, perianal inflammation, etc.; esophageal ulcers may occur occasionally. 3. Liver damage: nausea, vomiting, jaundice, fatty liver, elevated serum aminotransferase, hematemesis and bloody stools, etc. may occur occasionally. In severe cases, coma and death may occur. 4. Renal damage: It can aggravate renal damage in patients with renal insufficiency, leading to elevated blood urea nitrogen and creatinine levels. 5. Impact on tooth and bone development: This product can be deposited in teeth and bones, causing yellowing of teeth, and affecting the normal bones of fetuses, newborns and infants.

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

Precautions for children: Because this product can cause permanent discoloration of teeth, enamel hypoplasia, and inhibit bone development and growth, it is not recommended for children under 8 years old unless the expected benefits outweigh the possible risks. Precautions for pregnancy and lactation: 1. Animal research results show that tetracyclines can pass through the placenta and can be found in fetal tissues, causing toxic effects on fetal development (usually associated with delayed bone development). Treatment in early pregnancy in animals can show signs of embryotoxicity. 2. Minocycline hydrochloride, like other tetracycline antibiotics, can pass through the placenta and cause fetal damage when taken by pregnant women. If minocycline hydrochloride is taken during pregnancy or if a woman becomes pregnant while taking the drug, the patient should be informed of the potential risks of the drug to the fetus. 3. The use of tetracyclines during tooth development (late pregnancy) can cause permanent discoloration of teeth. Incomplete development of enamel has also been reported. 4. Taking tetracyclines in the last three months of pregnancy can form stable calcium complexes in fetal bones. A decrease in fibula growth rate can be observed in immature infants and young children taking tetracycline drugs (25 mg/kg every 6 hours). Changes in fibula growth rate can be restored after discontinuation of the drug. 5. Congenital malformations, including limb reduction, have been reported in post-marketing clinical experience. 6. Minocycline hydrochloride can be secreted in human milk; therefore, a decision should be made whether to stop breastfeeding or stop taking the drug. Precautions for the elderly: Clinical trials of this product did not include enough patients over 65 years old, so it is impossible to determine whether the response of the elderly after taking the drug is the same as that of young people. The dose selection for elderly patients should be cautious, usually starting with the minimum dose, because the elderly are more likely to have reduced liver, kidney or heart function, and may also suffer from other diseases or be taking other drugs.

1 Since this product can reduce the activity of prothrombin, the dose of anticoagulants should be reduced when it is used in combination with anticoagulants. 2 Since antacids (such as sodium bicarbonate) can reduce the absorption and activity of this product, this product and antacids should be avoided to be taken at the same time. 3 When this product is used in combination with drugs containing aluminum, calcium, magnesium, and iron ions, it can form insoluble complexes, which reduces the absorption of this product. 4 When lipid-lowering drugs cholestyramine or colestipol are used in combination with this product, the absorption of this product may be affected. 5 Since barbiturates, phenytoin or carbamazepine can induce the activity of microsomal enzymes and reduce the blood concentration of this product, the dose of this product must be adjusted when used in combination. 6 The combination of general anesthetic methoxyflurane and this product can lead to fatal nephrotoxicity. 7 Since this product can interfere with the bactericidal activity of penicillin, it should be avoided to use this product in combination with penicillins. 8. The combination of this product with strong diuretics (such as furosemide, etc.) can aggravate kidney damage. 9. The combination of this product with other hepatotoxic drugs (such as anti-tumor chemotherapy drugs) can aggravate liver damage. 10. The combination of this product with oral contraceptives can reduce the effectiveness of oral contraceptives.

Keep tightly closed in a cool, dry place.

Calculated as C23H27N3O7 50mg

36 months

Chongqing KERUI Pharmaceutical (GROUP) Co., Ltd.

• Founded in:

  1999-03-03

• Address:

  No. 2 Dashizhi Road, Nan'an Economic and Technological Development Zone, Chongqing

• Tax NO.:

  915001082031636780

• Registered Funds:

  110.6375 million yuan

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