Description: Tinidazole and Sodium Chloride Injection is a sterile water solution of tinidazole and sodium chloride. It is a colorless or almost colorless clear liquid. It is mainly indicated for the infections caused by confirmed or possible sensitive anaerobia such as bacteroides spp., bacteroides fragilis, other bacteroides, clostridium, peptococcus, eubacterium, streptococcus oligofermentans and veillonella as follows: severe oral infections (like severe pericoronitis and severe oral space infection), septicemia, sinusitis, pneumonia, pulmonary bronchitis infection, skin cellulitis, osteomyelitis, peritonitis, postsurgical wound infection, gastrointestinal tract infection, and female reproductive infection.

Pharmacological effects: It has a strong antibacterial effect on most anaerobic bacteria. Its antibacterial spectra include bacteroides fragilis and other bacteroides, fusobacterium, peptococcus, peptostreptococcus, veillonella, gardnerella, etc. The concentration of 2-4mg/L can inhibit most anaerobia. Microaerophilic bacteria and helicobacter pylori are sensitive to it. The MIC of trichomonas vaginalis is similar to that of metronidazole. The activity of its metabolites to gardnerella is higher than that of metronidazole.Its bactericidal mechanism has not been fully elucidated yet. Nitroreductase in anaerobes plays an important role in the energy metabolism of sensitive strains. Nitro in this product is reduced to a cell toxicant, which acts on the bacterial DNA metabolic processes, and promotes bacterial death. Resistant bacteria often are short of nitroreductase and resistant to this product. Its anti-amoeba mechanism is the inhibition of its oxidation-reduction reaction, and result in the breakage of protozoa nitrogen chain, thereby killing the protozoa.

Pharmacokinetics: After intravenous infusion of 0.8g and 1.6g, the plasma concentration peak is 14-21 mg/L and 32 mg/L respectively. If 1g is intravenously infused each day, the plasma concentration can maintain at more than 8mg/L. Tinidazole widely distributed in the body can reach high concentration in the reproductive organs, intestines, abdominal muscles and milk, but low concentration in the liver and fat. Its concentration in the bile and saliva is similar as its plasma concentration in the same period. Its penetration into the blood-brain barrier is higher than that of metronidazole. When there is no meningitis, its concentration in the cerebrospinal fluid is 80% of its plasma concentration in the same period, which is correlated with liposolubility of tinidazole. Tinidazole can reach high concentration in the fetus and placenta through the blood-brain barrier. The protein binding rate of tinidazole is 12%. Tinidazole is excreted by the livers, about 20%-25% is excreted in the form of prototypes from the urine after intravenous administration, and 12% is excreted in the form of metabolites from the urine. T1/2 of clearance is 11.6-13.3 hours, and the mean T1/2 of clearance is 12.6 hours. For patients with kidney dysfunction, pharmacokinetic indicators remain unchanged, but hemodialysis can rapidly clear tinidazole. Thus, it should be administered once after hemodialysis.


Indications: It is mainly indicated for the infections caused by confirmed or possible sensitive anaerobia such as bacteroides spp., bacteroides fragilis, other bacteroides, clostridium, peptococcus, eubacterium, streptococcus oligofermentans and veillonella as follows: severe oral infections (like severe pericoronitis and severe oral space infection), septicemia, sinusitis, pneumonia, pulmonary bronchitis infection, skin cellulitis, osteomyelitis, peritonitis, postsurgical wound infection, gastrointestinal tract infection, and female reproductive infection. It is indicated for intraintestinal and extraintestinal amebiasis, vaginal trichomoniasis, giardiasis, gardnerella vaginitis, etc. It is indicated for helicobacter pylori-induced gastric inflammation and peptic ulcer as the substitute for metronidazole.

Precautions: This product should be infused at a slow rate, and the infusion time should not be less than 2 hours each bottle. Drugs should not be in contact with aluminum-containing needles and needle tubes, and not be infused with other drugs.If the adverse reactions from the central nervous system occur during the course of treatment, the drug should be withdrawn in time.This product may interfere with the test results of alanine aminotransferase, lactate dehydrogenase, triglycerides, hexokinase, etc., and result in the decrease of measured value to zero.During medication, alcohol beverage should not be consumed because it can induce acetaldehyde accumulation in the body, interfere with alcohol oxidization, produce disulfiram-like reaction, abdominal convulsion, nausea, vomiting, headache, flushing, etc.For patients with liver dysfunction, the dose should be reduced and the plasma concentration should be monitored due to its slow metabolism as well as easy accumulation of the drug and its metabolites in the body.It can be cleared continuously from the gastric fluid. For some patients with placement of gastric tube for suctioning and pressure reduction, it can cause the decrease in plasma concentration. During hemodialysis, this product and its metabolites are quickly cleared. The dose should not be reduced in application.For patients with candida infection, their symptoms may be aggravated after application, and they should be given antifungal drug therapy at the same time. In treatment of vaginal trichomoniasis, the sex partner should receive treatment meanwhile.It can quickly enter into the fetal circulation system through the placenta. It was found in animal studies that intraperitoneal administration is toxic to the fetus while oral administration is non-toxic. The effect of this product on the fetus has not been sufficiently and closely controlled and observed. Therefore, the pregnant women can choose this drug only when there are clear indications, but should withdraw it within 3 months of pregnancy. Patients with more than 3 months of pregnancy should use with great caution after full consideration or upon medical instructions. Its concentration in the milk is similar to its plasma concentration. Animal studies indicated that this product has a carcinogenic effect on rats. Thus, it is not recommended for the lactating women. If it must be used, the lactating women should discontinue breastfeeding, and resume breastfeeding 3 days after the end of the treatment.

Adverse reaction: Adverse reactions are rare and slight. Common adverse reactions include nausea, vomiting, anorexia and oral odor. Dizziness, headache, vertigo, itching, rash, constipation and general malaise are also reported. Angioneurotic edema, neutropenia, disulfiram-like reaction and melanuria may also occur. Slight phlebitis is occasionally seen at the infusion site. High dose may also induce seizures and peripheral neuropathy.