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, and Gram-negative bacteria, including Neisseria gonorrhoeae; the effect on Gram-negative bacilli is generally weak; 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 were given this product for chronic treatment, resulting 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, and its 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 (node) inflammation, 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. Pyelonephritis, pyelitis, pyelitis, urethritis, cystitis, prostatitis, epididymitis, intrauterine infection, gonorrhea. 8. Otitis media, sinusitis, submandibular gland inflammation. 9. Syphilis.

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 likely to cause 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 enteritis may also occur. 2. Digestive tract 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 may occur occasionally, and severe cases may lead to coma and death. 4. Renal damage: It can aggravate renal damage in patients with renal insufficiency, leading to increased blood urea nitrogen and creatinine values. 5. Affecting tooth and bone development: This product can be deposited in teeth and bones, causing yellowing of teeth, and affecting the normal development of bones in fetuses, newborns and infants. 6. Allergic reactions: It is mainly manifested as rash, urticaria, drug fever, photosensitivity dermatitis and asthma. Systemic lupus erythematosus is rare. If it occurs, the drug should be discontinued immediately and appropriate treatment should be given. 7. Vestibular dysfunction such as dizziness, tinnitus, ataxia accompanied by nausea and vomiting may be seen (dose-dependent, more common in women than in men). It often occurs at the first few doses and can generally be recovered after 24 to 48 hours of discontinuation of the drug. 8. Blood system: Occasionally there may be hemolytic anemia, thrombocytopenia, neutropenia, eosinophilia, etc. 9. Vitamin deficiency: Occasionally there may be symptoms of vitamin K deficiency (hypoprothrombinemia, bleeding tendency, etc.), vitamin B deficiency symptoms (glossitis, stomatitis, loss of appetite, neuritis, etc.). 10. Increased intracranial pressure: Occasionally there may be symptoms of increased intracranial pressure such as vomiting, headache, diplopia, papilledema, and bulging anterior fontanelles. The drug should be discontinued immediately. 11. Shock: Shock may occur occasionally. Please pay attention to observation. If you find any discomfort, abnormal sensation in the mouth, asthma, urge to defecate, tinnitus and other symptoms, you should stop taking the drug immediately and take appropriate measures. 12. Skin: maculopapular rash, erythematous rash, etc.; occasionally exfoliative dermatitis, mixed drug eruption, erythema multiforme and Steven-Johnson syndrome. Long-term use of this product may occasionally cause pigmentation on the nails, skin and mucous membranes. 13. Others: Occasionally dizziness, fatigue, etc. Long-term use of this product may turn the thyroid gland brown-black, and thyroid dysfunction is rare. Hearing loss is rare.

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

Precautions for children: Since this product can cause permanent discoloration of teeth, enamel hypoplasia, and inhibit the development and growth of bones, it is contraindicated for children under 8 years old. Precautions for pregnancy and lactation: 1. This product can enter the fetus through the blood-placenta barrier and deposit in the calcium area of teeth and bones, causing fetal enamel hypoplasia and inhibiting fetal bone growth; it has teratogenic effects in animal experiments. Therefore, it is contraindicated for pregnant women and women who are preparing to become pregnant. 2. This product has a high concentration in breast milk. Although it can form an insoluble complex with calcium in breast milk and absorb very little, since this product can cause permanent discoloration of teeth, enamel hypoplasia, and inhibit the development and growth of infant bones, breastfeeding should be suspended during the medication period for lactating women. Precautions for the elderly: The clinical trials of this product did not include enough patients over 65 years old, so it is impossible to determine whether the reactions of the elderly after taking the drug are the same as those 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, insoluble complexes can be formed, 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, this product should be avoided in combination with penicillins. 8. The combined use of this product with strong diuretics (such as furosemide, etc.) can aggravate kidney damage. 9. The combined use of this product with other hepatotoxic drugs (such as anti-tumor chemotherapy drugs) can aggravate liver damage. 10. The combined use of this product with oral contraceptives can reduce the effectiveness of oral contraceptives.

Keep tightly closed in a cool, dry place.

50mg

36 months

Di'ao Group Chengdu Pharmaceutical Co., Ltd.

• Founded in:

  1997-07-31

• Address:

  No. 518, Herui Road, Chengdu Hi-tech Zone

• Tax NO.:

  91510100201913965Q

• Registered Funds:

  71.01 million yuan

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