Doxycycline Hydrochloride for Injection

Pharmacological action: Tetracycline antibiotics. This product is a broad-spectrum antibacterial agent with bactericidal effect at high concentrations. Rickettsia, Mycoplasma, Chlamydia, atypical mycobacteria, and spirochetes are also sensitive to this product. This product is more effective against Gram-positive bacteria than Gram-negative bacteria, but Enterococcus is resistant to it. Others such as Actinomycetes, Bacillus anthracis, Listeria monocytogenes, Clostridium, Nocardia, Vibrio, Brucella, Campylobacter, and Yersinia are sensitive to this product. This product has certain antibacterial activity against Neisseria gonorrhoeae, but penicillin-resistant Neisseria gonorrhoeae is also resistant to doxycycline. Due to the widespread use of tetracyclines over the years, common clinical pathogens have become seriously resistant to this product, including Gram-positive bacteria such as Staphylococcus and most Gram-negative bacilli. This product is different from tetracycline

Chemical name: 6-methyl-4-(dimethylamino)-3,5,10,12,12α,-pentahydroxy-1,11-dioxo-1,4,4α,5,5α,6,11,12α-octahydro-2-naphthacenecarboxamide hydrochloride hemiethanol hemihydrate.

This product is light yellow loose mass or powder.

1. Doxycycline is used for infections caused by the following bacteria: Rickettsia (Lasanky spotted fever, typhus fever, typhus, Q fever, Rickettsial pox, splenic fever, etc.), Mycoplasma pneumonia (pleuropneumonia-like bacteria, EatonAgent), psittacosis and ornithosis, lymphogranuloma venereum and granuloma inguinale, relapsing fever spirochetes (Borrelia burgdorferi). 2. The following Gram-positive bacteria: (1) Haemophilus ducreyi (chancroid), Pasteurella pestis and Pasteurella tularensis, rod-shaped Bartonella, Bacteroides, Vibrio comma and Vibrio embryonius, Brucella (used in combination with streptomycin). Since most of the following bacteria are resistant to tetracycline, sensitivity testing is recommended. If the bacterial sensitivity test shows a certain degree of sensitivity to the drug, doxycycline can be used for infections caused by the following Gram-negative bacteria: (2) Escherichia coli, Enterobacter aerogenes, Shigella, Mima and Hercetella, Haemophilus influenzae (respiratory tract infections), Klebsiella (respiratory and urinary tract infections). 3. Infections caused by the following Gram-positive bacteria: (1) Streptococci: 44% of Streptococcus pyogenes and 74% of Streptococcus faecalis are resistant to tetracyclines. Therefore, tetracyclines are not suitable for infections caused by streptococci unless they are highly sensitive. Penicillin is the first choice for the prevention of upper respiratory tract infections and rheumatic fever caused by type A β-hemolytic streptococci. (2) Pneumococcus, Staphylococcus aureus: respiratory tract, skin and soft tissue infections. Tetracyclines are not the first choice for staphylococcal infections. 4. When penicillin is contraindicated, doxycycline can be used as an alternative drug for infections caused by the following bacteria: (1) Neisseria gonorrhoeae and Neisseria meningitidis, Treponema pallidum and Treponema pygiene (syphilis and yaws), Listeria monocytogenes. (2) Clostridium, Bacillus anthracis, Fusobacterium fusoni, Actinomyces. 5. Doxycycline can be used as an adjunctive drug for acute intestinal amebiasis. 6. Doxycycline is still used to treat trachoma even though the infectious agent has not been eliminated as confirmed by fluorescent immunoassay.

Adults: The usual dosage is: On the first day, 200 mg is administered once or twice by intravenous drip; thereafter, 100-200 mg is administered daily, divided into one or two intravenous drips, depending on the severity of the infection. For the treatment of primary and secondary syphilis, 300 mg is recommended daily for 10 days. Children over 8 years old: Children weighing 45 kg or less: On the first day, 4 mg/kg is administered, divided into one or two intravenous drips; thereafter, 2-4 mg/kg is administered daily, depending on the severity of the infection. Children weighing more than 45 kg are given the adult dose. The infusion time is determined by the dose (100-200 mg/day), generally 1-2 hours. 100 mg of the drug is injected at a concentration of 0.5 mg/ml.

Gastrointestinal: Anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions of the anus and genitals (Candida overgrowth). Oral or parenteral tetracyclines can cause this type of reaction. Skin: Maculopapular rash, erythema. Occasionally, exfoliative dermatitis. Photosensitive dermatitis. Renal toxicity: Increased BUN has been reported and is clearly dose-dependent. Hypersensitivity reactions: Urticaria, angioedema, anaphylaxis, allergic purpura, exacerbation of pericarditis and lupus erythematosus symptoms. Protruding fontanelles in infants and benign intracranial hypertension in adults have been reported. This reaction disappears quickly after discontinuation of the drug. Blood: Hemolytic anemia, thrombocytopenia, neutropenia

It is contraindicated in patients with a history of hypersensitivity to any tetracycline.

Precautions for children: Doxycycline should be avoided in children under 8 years of age because its safety has not been proven. Like other tetracyclines, doxycycline binds tightly to calcium in osteoblastic tissue. It has been found that oral administration of 25 mg/kg (once every six hours) reduces the growth rate of the fibula in young children, which can be restored after stopping the drug. Precautions for pregnancy and lactation: Studies on intravenous administration of doxycycline in pregnant women have not been conducted. It should not be used in pregnant women without medical advice. Animal experiments have shown that tetracyclines can pass through the placenta and are found in fetal tissues, which are toxic to fetal development (hindering bone growth). Embryotoxicity caused by the use of drugs in early pregnancy in animals has been documented. Drugs have been found in breast milk after lactating women take this type of drug. Precautions for the elderly: Long-term use of this product can damage the liver and should be used with caution.

1. The simultaneous use of doxycycline with hepatic enzyme inducers such as phenobarbital and phenytoin sodium can shorten its half-life and reduce blood drug concentration, thus affecting efficacy. Therefore, the dose of doxycycline should be adjusted. 2. It can interfere with the bactericidal effect of penicillin and should be avoided in combination with penicillin. 3. This product can inhibit the activity of plasma prothrombin, so patients receiving anticoagulant therapy need to adjust the dose of anticoagulants. 4. This product cannot be used in combination with metal ion drugs such as aluminum, calcium, magnesium, and iron.

Store in a sealed container in a cool place (no higher than 20°C). Validity period: 24 months

0.1g (as doxycycline)

24 months

Guangdong Jianxin Pharmaceutical Co., Ltd.

• Founded in:

  2006-11-02

• Address:

  Jianxin Pharmaceutical Industrial Park, Zhupu District, Sanlian Industrial Zone, Haojiang District, Shantou City

• Tax NO.:

  91440512794663657G

• Registered Funds:

  60 million yuan

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