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Product name: Tinidazole injection
Molecular formula: C8H13N3O4S
Molecular weight: 247.28
Character: The product is a colorless or almost colorless clear liquid.
Pharmacology and toxicity: The product has higher activity for protozoa and anaerobic bacteria, and has antibiosis activity for bacterides, clostridia, peptococcus, clostridium, peptostreptococcus, other bacillus, etc. The concentration of 2~4ml/l can restrain the majority anaerobic bacteria, microaerobe and helicobacter pylori are sensitive to this product; the MIC of trichomonas vaginalis is similar to metronidazole. Mechanism of action is not completely clarity. Nitroreductase of anaerobic bacteria has important effect in energy metabolism of sensitive strain, the nitro ic decomposed cytotoxic, thus affect metabolic of DNA, kill the anaerobic bacteria, drug-resistance bacteria have drug fast for this product. Because they are usually lack of nitroreductase, the function of this product through restaining the oxidation deoxidizing reaction of protozoa, it can rupture the azote bond of protozoa and kill it.
Pharmacokinetics: After administrated by intravenous drip 0.8g and 1.6g, the Cmax were 14-21mg/l and 32mg/l, administrated 1g by intravenous each day, Cmax can maintain 8mg/l above, tinidazole can widely scatter in every tissue organ in the body, it can achieve higher concentration in generative organ, intestinal tract, hind body, muscle , milk, lower concentration in liver , fat. The similar Cmax in bile, saliva to the corresponding time period, the penetrability is higer than metronidazole for blood-cerebrospinal fluid barrier. The concentration of cerebrospinal fluid is 80% of the corresponding time period when meninges has not inflammation. It has relationship with higher fatty of tinidazole. Tinidazole can achieve higher concentration in fetus, and placenta trough in liver, about 25%discharde from urine, the blood elimination beta was 11.6-13.3hour, average is 12.6hour.
Indications: Various anaerobic organisms infection: septicemia, osteomyelitis, pelvic inflammation, peritoneum inflammation, lung infection, sinusitis, oral cavity inflammation, prevent infection after operation: infection after colon and recta operation; various anaerobic organisms infection etc after intestines operation and department of gynecology operation.
Usage and Dosage:
1. Cure various anaerobic organisms infection : drip-infusion slowly , 1 time per day, 0.8g every time, in successive 5-6 days.
2. Prevent anaerobic organisms infection after operation: total dosage 1.6g, drip-infusion slowly in one or two times, the first time is 2 to 4 hours before operation, the second time is during the operation or 12 to 24 hours after the operation.
Adverse reaction: TINIDAZOLE has very little adverse reaction, it is mainly nausea, vomiting, upper abdominal pain, appetite decrease and metallic taste. May be headache, vertigo, tetter itch, constipation and general malaise. In additional may be acute circumscribed edema, neutrocytopenia, disulfiram-like reaction and black urine, drip position appears gently phlebitis. High dosage can cause epileptic seizure and peripheral neuropathy.
Contraindications: The usage is contraindicated in individuals with an allergic reaction to this medicine, or patients who suffer blood disease, neuropath.
1. Drip-infusion of this product should be slowly when the concentration is 2mg/ml, the drip time is not less than 2mg/ml the speed should be decreased by 1-2 times. The drug should not be contact with pinhead including aluminium and bloster, avoid driping together with other drugs.
2. carcinogenesis and mutagenesis: animal test or in virto assay detect this product can lead to carcinogenesis and mutagenesis. but lack of document in human body.
3. if happened adverse reactions of central nervous system, should drug withdrawal in time.
4. it can interact the analysis result of amino acid, lactate dehydrogenase, triacylglycerol, hexokinase, the mV decreased by zero.
5. drinking wine is forbidden if taking this medicine, it can cause acetaldehyde accumulation in the body, interfere oxidative process of alcohol, leading to disulfiram-like reaction, patients may appears abdominal part spasm, nausea, vomiting, headache, prosopo-flush.
6. metabolism of the drug step down in hypohepatia patients, the drug and metabolin accumulated in the body. The dosage should be reduce, also monitoring blood drug level
7. this product can keep on cleaning from gastric juice, place some into gastric canal as suction reduced pressure, it can cause blood drug level decreased. When hematodialysis, the drug and metabolin can be cleared immediately, so it is not need to reduce the dosage
8. The patients monilia infection should use this drug, symptom will become more serious. Using anti-fungus treat simultaneously.
Pediatric use: It is forbidden to use for children who is younger than 12 years.
Geratology: Because pharmacokinetics and hypohepatia are changed, when the old man administrated, they should monitor blood concentration.
Pregnancy and lactation: The product can penetrate placenta , circulate immediately in fetus. Abdominal administration has toxicity for fetus in animal experiment, it has not enough and strictly contrast observation to the affection for fetus of human. The use is forbidden in lactation during 3 months, pregnant woman above 3 months are suggested to use the drug only appears significant symptom.
The concentration in milk is similar to in blood, it appears carcinogenesis to young rat. Women must avoid using it in lactation. If the drug must be used , lactation should be stopped a few days, and continue.
1. the drug can restrain metabolism of warfrin and other oral anticoagulant drug, strengthening their affection, causing time longer of thrombozyme,
2. when together use with induce hepatic microsomal enzyme such as phenytion and Phenobarbital, it can strengthen metabolism of the drug, descend the blood concentration, slow phenytion excrete.
3. when together use with inhibit hepatic microsomal enzyme such as cimetidine, it can slow metabolism and excretion of this drug in the liver, prolong blood elimination t1/2, if should be adjust the dosage according to blood concentration.
4. the drug interact metabolism of Disulfiram, both together use, the patients may appears psychiatric symptom, so the patients must not use the drug when administrated Disulfiram during 2 weeks.
5. this drug can interact the test result of blood serum aminopherase and lactic acid dehydrogenase, descend the level of cholesterol and triacylglycerol. .
Specification: 100ml : 0.4g
Storage: store in the closed container.
Package: glass injection bottle
Expiry date: two years