Minocycline Hydrochloride Capsules

Pharmacology: This product is a semi-synthetic tetracycline-type broad-spectrum antibiotic with high efficiency and long-lasting 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. 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. Its chemical name is: 4,7-bis(dimethylamino)-1,4,4?,5,5??,6,11,12?-octahydro-3,10,12,12?-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide hydrochloride. Molecular formula: C23H27N3O7HCl Molecular weight: 493.94

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 and bacteremia. (2) Superficial suppurative infections: folliculitis, pyoderma, tonsillitis, frozen shoulder, dacryocystitis, gingivitis, vulvitis, traumatic infection, postoperative infection, etc. (3) Deep suppurative diseases: mastitis, lymphangitis (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) 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 enterocolitis 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 elevated blood urea nitrogen and creatinine values. 5. Affects 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 (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: 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 this product 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 from being taken at the same time. (3) When this product is used in combination with drugs containing aluminum, calcium, magnesium, and iron ions, an insoluble complex 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 cause a decrease in the blood concentration of this product, the dose of this product must be adjusted when used in combination. (6) The combination of the 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 from being used in combination with penicillins. (8) The combined use of this product with strong diuretics (such as furosemide, etc.) may aggravate renal damage. (9) The combined use of this product with other hepatotoxic drugs (such as anti-tumor chemotherapy drugs) may 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.

Calculated as C23H27N3O7 100mg

36 months

North China Pharmaceutical Company.Ltd

• Founded in:

  1992-12-20

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  No. 388, Heping East Road, Shijiazhuang City

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  91130100104397700P

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