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Tinidazole tablets

Product description
Approved date: January 29, 2007
 
Date of revision: September 30, 2010
 
         October 16, 2013
 
         November 30, 2015
 
Tinidazole sheet instructions
 
Please read the instructions carefully and use them under the guidance of a physician.
 
 
In order to reduce the formation of drug-resistant bacteria and ensure the effectiveness of tinidazole and other antibacterial drugs, tinidazole should be used only to treat or prevent infections caused by confirmed or suspected susceptible pathogens.
 
caveat:
 
This product has potential cancer risk.
 
In another long-term therapeutic trial of nitroimidazole, metronidazole, in rats and mice, it was found to be carcinogenic.
 
Although no similar data has been reported in the tinidazole test, the two drugs are structurally related and have similar biological effects.
 
This product should be used only for treatment approved indications.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
【Drug Name】
 
Common name: tinidazole tablets
 
English name: Tinidazole Tablets
 
Chinese Pinyin: Tixiaozuo Pian
 
[Ingredients] The main ingredient of this product is: tinidazole. Its chemical name is: 2-methyl-1-[2-(ethylsulfonyl)ethyl]-5-nitro-1H imidazole.
 
 
 
Molecular formula: C8H13N3O4S
 
Molecular weight: 247.28
 
【Properties】 This product is white to light yellow.
 
[indications]
 
In order to reduce the formation of drug-resistant bacteria and ensure the effectiveness of tinidazole and other antibacterial drugs, tinidazole should be used only to treat or prevent infections caused by confirmed or suspected susceptible pathogens.
 
If you have information about culture and sensitivity testing, you should refer to this information to select or modify an antimicrobial treatment plan. Without this information, experience with local epidemiological and bacterial sensitivity data may help to select treatment options.
 
1. This product is suitable for the treatment of the following diseases:
 
(1) Trichomoniasis
 
Tinidazole is indicated for the treatment of trichomoniasis caused by Trichomonas vaginalis. Pathogens should be verified by appropriate diagnostic procedures. Because trichomoniasis is a sexually transmitted disease with potentially serious sequelae, the sexual partner of the infected person should be treated at the same time to prevent repeated infections.
 
(2) Giardiasis
 
Tinidazole is indicated for the treatment of giardiasis caused by Giardia duodenum (also known as Giardia lamblia) and can be used in adults and children over 3 years of age.
 
(3) Amoebiasis
 
Tinidazole is indicated for the treatment of amoebic bowel disease and amoebic liver abscess caused by dysentery amoeba and can be used in adults and children over 3 years of age. But it does not apply to the treatment of asymptomatic cysts.
 
(4) Bacterial vaginitis
 
Tinidazole is indicated for the treatment of bacterial vaginosis in non-pregnant women (formerly known as Haemophilus vaginitis, Gardner vaginitis, non-specific vaginitis or anaerobic vaginitis).
 
Other pathogens associated with vulvovaginitis should be excluded, such as Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans, and herpes simplex virus.
 
(5) Combined with antibiotics and antacids for the treatment of Helicobacter pylori-associated duodenal ulcers
 
(6) Anaerobic infection
 
Intraperitoneal infection: peritonitis, abscess;
 
Gynecological infections: endometritis, endometritis, fallopian tube-ovarian abscess;
 
septicemia;
 
Postoperative wound infection;
 
Skin soft tissue infection;
 
Pneumonia, lung abscess, pleural empyema;
 
Acute ulcerative gingivitis.
 
2. This product is used to prevent post-operative infections caused by anaerobic bacteria, such as infections after colon, gastrointestinal and genitourinary surgery.
 
[Specification] 0.5g
 
【Dosage】
 
usage:
 
oral. It is recommended to take tinidazole after meals to minimize the incidence of gastrointestinal side effects such as upper abdominal discomfort. Food does not affect the oral bioavailability of tinidazole.
 
Dosage:
 
Treatment
 
(1) Trichomoniasis
 
Take a single dose of 2g and take it at mealtime. Sexual partners should be treated at the same dose.
 
(2) Giardiasis
 
Adult: Take a single dose of 2g and take it at mealtime.
 
Children over 3 years old: single dose 50mg/kg (not more than 2g), take it at mealtime.
 
(3) Amoebiasis
 
Amoebic bowel disease:
 
The recommended dose for adults is 2g per day, taken at meals and taken for 3 days.
 
The recommended dose for children over 3 years old is 50mg/kg/day (not more than 2g/day), taken at mealtime and taken for 3 days.
 
Amoebic liver abscess:
 
The recommended dose for adults is 2g per day, taken at meals, for 3 to 5 days.
 
Children over 3 years old: 50mg/kg/day (not more than 2g/day), take it at mealtime, take 3~5 days. Data on children's medications lasting more than 3 days were limited, but a small number of children continued to take medication for 5 days without any adverse reactions reported. Children over 3 days of treatment should be closely monitored.
 
(4) bacterial vaginitis
 
The recommended dose for non-pregnant adult women is 2g per day, taken at meals, taken for 2 days, or 1g per day, taken at meals, for 5 days.
 
Treatment of bacterial vaginosis with tinidazole has not been studied in pregnant patients.
 
(5) Combined with antibiotics and antacids for the treatment of Helicobacter pylori-associated duodenal ulcers
 
Adult: 2 times a day, 500mg each time, 7 days combined medication.
 
The combination is omeprazole and clarithromycin, and the dosage is as follows:
 
Omeprazole: 2 times a day, 20mg each time.
 
Clarithromycin: 2 times a day, 250mg each time.
 
Clinically, omeprazole has a similar rate of Helicobacter pylori eradication compared with the above prescription once a day, 20 mg each time. See the Omeprazole instructions for more information.
 
(6) Anaerobic infection
 
Adult: The starting dose on Day 1 is 2 g, 1 g per day thereafter, 1 g each time. Or 2 times a day, 500mg each time. The general course of treatment is 5 to 6 days, but the course of treatment needs to be determined according to clinical diagnosis, especially in some special parts, infection may be difficult to eradicate. Clinical trials suggest that continuous treatment for more than 7 days requires caution.
 
Children: No data available for children under 12 years of age.
 
2. Prevention of anaerobic infection after surgery:
 
Adult: 2 g of single dose 12 hours before surgery.
 
Children: No data available for children under 12 years of age.
 
Older people: There are no special instructions.
 
Kidney dysfunction medication:
 
Renal dysfunction usually does not require dose adjustment, but since tinidazole is easily cleared by hemodialysis, patients may need to increase the dose.
 
【Adverse reactions】
 
1. Clinical research experience
 
Since clinical trials are conducted under widely different conditions, the incidence of adverse effects of one drug observed in clinical trials cannot be directly compared to the incidence of adverse effects of another drug, and may not The incidence of adverse reactions in the reaction practice.
 
In a controlled and uncontrolled clinical trial of trichomoniasis and giardiasis, 3669 patients were given a single dose of 2 g of tinidazole, with an adverse reaction rate of 11.0%. In a controlled and uncontrolled clinical trial of amebiasis, 7165 patients were administered for multiple days with an adverse reaction rate of 13.8%. Common (adverse reaction rate ≥ 1%) adverse reactions of the body system are shown in the following table.
 
 
 
Table of publicly reported adverse reaction summary information
 
 
 
 
 
2g single dose
 
Multi-day administration
 
Gastrointestinal tract: metallic/bitter taste
 
3.7%
 
6.3%
 
nausea
 
3.2%
 
4.5%
 
Anorexia
 
1.5%
 
2.5%
 
Indigestion / sputum / upper abdominal discomfort
 
1.8%
 
1.4%
 
Vomiting
 
1.5%
 
0.9%
 
constipation
 
0.4%
 
1.4%
 
Central nervous system: weakness / fatigue / burnout
 
2.1%
 
1.1%
 
dizziness
 
1.1%
 
0.5%
 
Other: headache
 
1.3%
 
0.7%
 
Total adverse reactions
 
11.0%
 
(403/3669)
 
13.8%
 
(244/1765)
 
 
 
Other reported adverse effects of tinidazole include:
 
Central nervous system: Two serious adverse reactions include convulsions and transient peripheral neuropathy, the main symptoms of which are numbness and paresthesia. Other adverse reactions in the central nervous system include dizziness, ataxia, dizziness, insomnia, and burnout.
 
Gastrointestinal tract: discoloration of the tongue, stomatitis, diarrhea.
 
Allergies: urticaria, itching, rash, facial flushing, sweating, dry mouth, fever, burning sensation, thirst, salivation, angioedema.
 
Kidney: The urine is black.
 
Cardiovascular system: palpitations.
 
Blood system: transient white blood cells and neutropenia.
 
Others: Candida hyperplasia, increased vaginal secretions, oral candidiasis, abnormal liver function including increased levels of transaminase, joint pain, muscle pain and arthritis.
 
Rare adverse reactions include:
 
Bronchospasm, difficulty breathing, coma, confusion, depression, tongue coating, pharyngitis, and reversible thrombocytopenia.
 
Adverse reactions in children:
 
The nature and frequency of adverse reactions in clinical studies in children are similar to those in adults, including nausea, vomiting, diarrhea, altered taste, loss of appetite, and abdominal pain.
 
The most common adverse reactions (≥2% of adverse reactions) in patients with bacterial vaginosis include gastrointestinal reactions (such as decreased appetite and flatulence), urinary tract infections, dysuria, and abnormal urine, among others. Pelvic pain, vulvovaginal discomfort, vaginal odor, menorrhagia and upper respiratory tract infection. These adverse reactions were not found in studies of trichomoniasis, giardiasis, and amebiasis.
 
2. Post-marketing experience
 
The following adverse reactions were reported and determined after tinidazole was approved for use. Since the reports of these reactions are voluntary and the population size is uncertain, it is not possible to reliably estimate the incidence of adverse reactions from this data, nor to determine the inevitable causal relationship between them and the drugs.
 
In the early and late stages of tinidazole, there have been reports of severe acute allergic reactions. Allergic reactions include: urticaria, itching, angioedema, Stevens-Johnson syndrome, and erythema multiforme.
 
[taboo]
 
Those who are allergic to tinidazole or azole drugs, those who are allergic to other ingredients in this product, and those with organic central nervous system disease are prohibited.
 
As with other structurally similar drugs, patients with a history of blood irregularities or cachexia are contraindicated. Although no examples of leading to long-term blood diseases have been found in current animal and clinical studies.
 
Pregnant women in early pregnancy (3 months before pregnancy) are banned.
 
Lactating women are banned. Breastfeeding was suspended unless during the treatment of tinidazole and within 3 days of discontinuation of the drug.
 
【Precautions】
 
1. Patient notice
 
Patients should be told that this product should be taken with food to minimize upper abdominal discomfort and gastrointestinal side effects. Food does not affect the oral bioavailability of tinidazole.
 
Patients should be advised not to drink alcoholic beverages and alcohol or propylene glycol-containing preparations during the treatment period and within 3 days to avoid possible disulfiram-like reactions such as facial flushing, abdominal cramps, nausea, vomiting, headache, Heartbeat acceleration, etc.
 
Patients should be prescribed this product. Leaking or not completing the entire course of treatment can directly reduce the treatment effect, which may lead to bacterial resistance.
 
2. Antimicrobial drugs including tinidazole are only used for bacterial infectious diseases. This product is not used for viral infection.
 
3. Drugs with similar chemical structures, including tinidazole, are thought to be associated with various neurological symptoms such as dizziness, dizziness, ataxia, peripheral neuropathy, and less common convulsions. If any mental symptoms appear during the application of this product, stop taking the medicine immediately.
 
4. It has been reported that some patients treated with tinidazole have adverse reactions to spastic seizures and peripheral neuropathy, the latter being characterized by numbness or paresthesia of the extremities.
 
5. Use of tinidazole may cause candida vaginitis. In clinical studies, 235 women were treated with tinidazole for bacterial vaginosis, and 11 of them (4.7%) developed vaginal mold infection.
 
6. Impact on motor vehicle driving and mechanical operation
 
No special attention is required. However, as mentioned above, a class of drugs with similar chemical structures, including tinidazole, are thought to be associated with a range of neurological symptoms such as dizziness, dizziness, ataxia, peripheral neurological symptoms (sensory abnormalities, sensory disturbances, hypoesthesia) ), less horror. If any neurological symptoms occur during the application of this product, stop the drug immediately.
 
[Pregnant women and lactating women]
 
There are no data on the safety and efficacy of tinidazole in pregnant women. Because this product can pass through the placenta and quickly enter the fetal circulation, it should be banned within 3 months of pregnancy.
 
Animal experiments found that the maximum dose of 2500 mg / kg (converted by body surface area, about 6.3 times the maximum human therapeutic dose) was administered to the fetus, without placental toxicity and teratogenic effects. One study showed that maternal administration of 500 mg/kg (by body surface area conversion, about 2.5 times the maximum human therapeutic dose) in pregnant mice has a higher fetal mortality rate. Maternal administration of 600 mg/kg (converted by body surface area, approximately 3 times the maximum human therapeutic dose) was not biologically related to the development of neonatal rats. Although the potential mutagenicity and affecting animal regeneration in animal experiments does not necessarily predict human drug response, the use of tinidazole in the first trimester of pregnancy is potentially dangerous for both the mother and the fetus.
 
This product is excreted in the milk after 72 hours of administration. The concentration in the milk is similar to the blood concentration, so lactating women should be banned. If medication is necessary, breastfeeding should be suspended and breastfeeding should be given after 3 days of withdrawal.
 
[Children's medication]
 
For the treatment of protozoa, giardiasis and amoebiasis are limited to children over 3 years of age. The safety and efficacy of this product for the treatment of giardiasis and amoebiasis in children under 3 years of age is unclear.
 
For the treatment of anaerobic infections and prevention of post-operative anaerobic infections, there are no data available for children under 12 years of age.
 
[Geriatric Use]
 
Clinical studies have not provided enough data for tinidazole in elderly patients over the age of 65, so it is not certain whether they are different from younger patients. In general, the dose of elderly patients needs to be carefully determined, considering minimizing liver, kidney, and heart damage, and some complications and interactions with other therapeutic agents.
 
【medicine interactions】
 
The following is a report on the drug interactions of metronidazole, a nitroimidazole that is chemically related to tinidazole, so the following reports may also occur in tinidazole.
 
1. The potential impact of tinidazole on other drugs
 
Warfarin and other oral coumarin anticoagulants: In view of the reports of metronidazole, tinidazole can enhance the efficacy of warfarin and other coumarin anticoagulants, resulting in prolonged prothrombin time . The amount of anticoagulant may need to be adjusted during the treatment of tinidazole and within 8 days after discontinuation.
 
Alcohol, Sodium Disulfide: Avoid drinking alcoholic beverages and any alcohol or propylene glycol during the treatment of tinidazole and within 3 days after stopping the drug.
Approved date: January 29, 2007
 
Date of revision: September 30, 2010
 
         October 16, 2013
 
         November 30, 2015
 
Tinidazole sheet instructions
 
Please read the instructions carefully and use them under the guidance of a physician.
 
 
In order to reduce the formation of drug-resistant bacteria and ensure the effectiveness of tinidazole and other antibacterial drugs, tinidazole should be used only to treat or prevent infections caused by confirmed or suspected susceptible pathogens.
 
caveat:
 
This product has potential cancer risk.
 
In another long-term therapeutic trial of nitroimidazole, metronidazole, in rats and mice, it was found to be carcinogenic.
 
Although no similar data has been reported in the tinidazole test, the two drugs are structurally related and have similar biological effects.
 
This product should be used only for treatment approved indications.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
【Drug Name】
 
Common name: tinidazole tablets
 
English name: Tinidazole Tablets
 
Chinese Pinyin: Tixiaozuo Pian
 
[Ingredients] The main ingredient of this product is: tinidazole. Its chemical name is: 2-methyl-1-[2-(ethylsulfonyl)ethyl]-5-nitro-1H imidazole.
 
 
 
Molecular formula: C8H13N3O4S
 
Molecular weight: 247.28
 
【Properties】 This product is white to light yellow.
 
[indications]
 
In order to reduce the formation of drug-resistant bacteria and ensure the effectiveness of tinidazole and other antibacterial drugs, tinidazole should be used only to treat or prevent infections caused by confirmed or suspected susceptible pathogens.
 
If you have information about culture and sensitivity testing, you should refer to this information to select or modify an antimicrobial treatment plan. Without this information, experience with local epidemiological and bacterial sensitivity data may help to select treatment options.
 
1. This product is suitable for the treatment of the following diseases:
 
(1) Trichomoniasis
 
Tinidazole is indicated for the treatment of trichomoniasis caused by Trichomonas vaginalis. Pathogens should be verified by appropriate diagnostic procedures. Because trichomoniasis is a sexually transmitted disease with potentially serious sequelae, the sexual partner of the infected person should be treated at the same time to prevent repeated infections.
 
(2) Giardiasis
 
Tinidazole is indicated for the treatment of giardiasis caused by Giardia duodenum (also known as Giardia lamblia) and can be used in adults and children over 3 years of age.
 
(3) Amoebiasis
 
Tinidazole is indicated for the treatment of amoebic bowel disease and amoebic liver abscess caused by dysentery amoeba and can be used in adults and children over 3 years of age. But it does not apply to the treatment of asymptomatic cysts.
 
(4) Bacterial vaginitis
 
Tinidazole is indicated for the treatment of bacterial vaginosis in non-pregnant women (formerly known as Haemophilus vaginitis, Gardner vaginitis, non-specific vaginitis or anaerobic vaginitis).
 
Other pathogens associated with vulvovaginitis should be excluded, such as Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans, and herpes simplex virus.
 
(5) Combined with antibiotics and antacids for the treatment of Helicobacter pylori-associated duodenal ulcers
 
(6) Anaerobic infection
 
Intraperitoneal infection: peritonitis, abscess;
 
Gynecological infections: endometritis, endometritis, fallopian tube-ovarian abscess;
 
septicemia;
 
Postoperative wound infection;
 
Skin soft tissue infection;
 
Pneumonia, lung abscess, pleural empyema;
 
Acute ulcerative gingivitis.
 
2. This product is used to prevent post-operative infections caused by anaerobic bacteria, such as infections after colon, gastrointestinal and genitourinary surgery.
 
[Specification] 0.5g
 
【Dosage】
 
usage:
 
oral. It is recommended to take tinidazole after meals to minimize the incidence of gastrointestinal side effects such as upper abdominal discomfort. Food does not affect the oral bioavailability of tinidazole.
 
Dosage:
 
Treatment
 
(1) Trichomoniasis
 
Take a single dose of 2g and take it at mealtime. Sexual partners should be treated at the same dose.
 
(2) Giardiasis
 
Adult: Take a single dose of 2g and take it at mealtime.
 
Children over 3 years old: single dose 50mg/kg (not more than 2g), take it at mealtime.
 
(3) Amoebiasis
 
Amoebic bowel disease:
 
The recommended dose for adults is 2g per day, taken at meals and taken for 3 days.
 
The recommended dose for children over 3 years old is 50mg/kg/day (not more than 2g/day), taken at mealtime and taken for 3 days.
 
Amoebic liver abscess:
 
The recommended dose for adults is 2g per day, taken at meals, for 3 to 5 days.
 
Children over 3 years old: 50mg/kg/day (not more than 2g/day), take it at mealtime, take 3~5 days. Data on children's medications lasting more than 3 days were limited, but a small number of children continued to take medication for 5 days without any adverse reactions reported. Children over 3 days of treatment should be closely monitored.
 
(4) bacterial vaginitis
 
The recommended dose for non-pregnant adult women is 2g per day, taken at meals, taken for 2 days, or 1g per day, taken at meals, for 5 days.
 
Treatment of bacterial vaginosis with tinidazole has not been studied in pregnant patients.
 
(5) Combined with antibiotics and antacids for the treatment of Helicobacter pylori-associated duodenal ulcers
 
Adult: 2 times a day, 500mg each time, 7 days combined medication.
 
The combination is omeprazole and clarithromycin, and the dosage is as follows:
 
Omeprazole: 2 times a day, 20mg each time.
 
Clarithromycin: 2 times a day, 250mg each time.
 
Clinically, omeprazole has a similar rate of Helicobacter pylori eradication compared with the above prescription once a day, 20 mg each time. See the Omeprazole instructions for more information.
 
(6) Anaerobic infection
 
Adult: The starting dose on Day 1 is 2 g, 1 g per day thereafter, 1 g each time. Or 2 times a day, 500mg each time. The general course of treatment is 5 to 6 days, but the course of treatment needs to be determined according to clinical diagnosis, especially in some special parts, infection may be difficult to eradicate. Clinical trials suggest that continuous treatment for more than 7 days requires caution.
 
Children: No data available for children under 12 years of age.
 
2. Prevention of anaerobic infection after surgery:
 
Adult: 2 g of single dose 12 hours before surgery.
 
Children: No data available for children under 12 years of age.
 
Older people: There are no special instructions.
 
Kidney dysfunction medication:
 
Renal dysfunction usually does not require dose adjustment, but since tinidazole is easily cleared by hemodialysis, patients may need to increase the dose.
 
【Adverse reactions】
 
1. Clinical research experience
 
Since clinical trials are conducted under widely different conditions, the incidence of adverse effects of one drug observed in clinical trials cannot be directly compared to the incidence of adverse effects of another drug, and may not The incidence of adverse reactions in the reaction practice.
 
In a controlled and uncontrolled clinical trial of trichomoniasis and giardiasis, 3669 patients were given a single dose of 2 g of tinidazole, with an adverse reaction rate of 11.0%. In a controlled and uncontrolled clinical trial of amebiasis, 7165 patients were administered for multiple days with an adverse reaction rate of 13.8%. Common (adverse reaction rate ≥ 1%) adverse reactions of the body system are shown in the following table.
 
 
 
Table of publicly reported adverse reaction summary information
 
 
 
 
 
2g single dose
 
Multi-day administration
 
Gastrointestinal tract: metallic/bitter taste
 
3.7%
 
6.3%
 
nausea
 
3.2%
 
4.5%
 
Anorexia
 
1.5%
 
2.5%
 
Indigestion / sputum / upper abdominal discomfort
 
1.8%
 
1.4%
 
Vomiting
 
1.5%
 
0.9%
 
constipation
 
0.4%
 
1.4%
 
Central nervous system: weakness / fatigue / burnout
 
2.1%
 
1.1%
 
dizziness
 
1.1%
 
0.5%
 
Other: headache
 
1.3%
 
0.7%
 
Total adverse reactions
 
11.0%
 
(403/3669)
 
13.8%
 
(244/1765)
 
 
 
Other reported adverse effects of tinidazole include:
 
Central nervous system: Two serious adverse reactions include convulsions and transient peripheral neuropathy, the main symptoms of which are numbness and paresthesia. Other adverse reactions in the central nervous system include dizziness, ataxia, dizziness, insomnia, and burnout.
 
Gastrointestinal tract: discoloration of the tongue, stomatitis, diarrhea.
 
Allergies: urticaria, itching, rash, facial flushing, sweating, dry mouth, fever, burning sensation, thirst, salivation, angioedema.
 
Kidney: The urine is black.
 
Cardiovascular system: palpitations.
 
Blood system: transient white blood cells and neutropenia.
 
Others: Candida hyperplasia, increased vaginal secretions, oral candidiasis, abnormal liver function including increased levels of transaminase, joint pain, muscle pain and arthritis.
 
Rare adverse reactions include:
 
Bronchospasm, difficulty breathing, coma, confusion, depression, tongue coating, pharyngitis, and reversible thrombocytopenia.
 
Adverse reactions in children:
 
The nature and frequency of adverse reactions in clinical studies in children are similar to those in adults, including nausea, vomiting, diarrhea, altered taste, loss of appetite, and abdominal pain.
 
The most common adverse reactions (≥2% of adverse reactions) in patients with bacterial vaginosis include gastrointestinal reactions (such as decreased appetite and flatulence), urinary tract infections, dysuria, and abnormal urine, among others. Pelvic pain, vulvovaginal discomfort, vaginal odor, menorrhagia and upper respiratory tract infection. These adverse reactions were not found in studies of trichomoniasis, giardiasis, and amebiasis.
 
2. Post-marketing experience
 
The following adverse reactions were reported and determined after tinidazole was approved for use. Since the reports of these reactions are voluntary and the population size is uncertain, it is not possible to reliably estimate the incidence of adverse reactions from this data, nor to determine the inevitable causal relationship between them and the drugs.
 
In the early and late stages of tinidazole, there have been reports of severe acute allergic reactions. Allergic reactions include: urticaria, itching, angioedema, Stevens-Johnson syndrome, and erythema multiforme.
 
[taboo]
 
Those who are allergic to tinidazole or azole drugs, those who are allergic to other ingredients in this product, and those with organic central nervous system disease are prohibited.
 
As with other structurally similar drugs, patients with a history of blood irregularities or cachexia are contraindicated. Although no examples of leading to long-term blood diseases have been found in current animal and clinical studies.
 
Pregnant women in early pregnancy (3 months before pregnancy) are banned.
 
Lactating women are banned. Breastfeeding was suspended unless during the treatment of tinidazole and within 3 days of discontinuation of the drug.
 
【Precautions】
 
1. Patient notice
 
Patients should be told that this product should be taken with food to minimize upper abdominal discomfort and gastrointestinal side effects. Food does not affect the oral bioavailability of tinidazole.
 
Patients should be advised not to drink alcoholic beverages and alcohol or propylene glycol-containing preparations during the treatment period and within 3 days to avoid possible disulfiram-like reactions such as facial flushing, abdominal cramps, nausea, vomiting, headache, Heartbeat acceleration, etc.
 
Patients should be prescribed this product. Leaking or not completing the entire course of treatment can directly reduce the treatment effect, which may lead to bacterial resistance.
 
2. Antimicrobial drugs including tinidazole are only used for bacterial infectious diseases. This product is not used for viral infection.
 
3. Drugs with similar chemical structures, including tinidazole, are thought to be associated with various neurological symptoms such as dizziness, dizziness, ataxia, peripheral neuropathy, and less common convulsions. If any mental symptoms appear during the application of this product, stop taking the medicine immediately.
 
4. It has been reported that some patients treated with tinidazole have adverse reactions to spastic seizures and peripheral neuropathy, the latter being characterized by numbness or paresthesia of the extremities.
 
5. Use of tinidazole may cause candida vaginitis. In clinical studies, 235 women were treated with tinidazole for bacterial vaginosis, and 11 of them (4.7%) developed vaginal mold infection.
 
6. Impact on motor vehicle driving and mechanical operation
 
No special attention is required. However, as mentioned above, a class of drugs with similar chemical structures, including tinidazole, are thought to be associated with a range of neurological symptoms such as dizziness, dizziness, ataxia, peripheral neurological symptoms (sensory abnormalities, sensory disturbances, hypoesthesia) ), less horror. If any neurological symptoms occur during the application of this product, stop the drug immediately.
 
[Pregnant women and lactating women]
 
There are no data on the safety and efficacy of tinidazole in pregnant women. Because this product can pass through the placenta and quickly enter the fetal circulation, it should be banned within 3 months of pregnancy.
 
Animal experiments found that the maximum dose of 2500 mg / kg (converted by body surface area, about 6.3 times the maximum human therapeutic dose) was administered to the fetus, without placental toxicity and teratogenic effects. One study showed that maternal administration of 500 mg/kg (by body surface area conversion, about 2.5 times the maximum human therapeutic dose) in pregnant mice has a higher fetal mortality rate. Maternal administration of 600 mg/kg (converted by body surface area, approximately 3 times the maximum human therapeutic dose) was not biologically related to the development of neonatal rats. Although the potential mutagenicity and affecting animal regeneration in animal experiments does not necessarily predict human drug response, the use of tinidazole in the first trimester of pregnancy is potentially dangerous for both the mother and the fetus.
 
This product is excreted in the milk after 72 hours of administration. The concentration in the milk is similar to the blood concentration, so lactating women should be banned. If medication is necessary, breastfeeding should be suspended and breastfeeding should be given after 3 days of withdrawal.
 
[Children's medication]
 
For the treatment of protozoa, giardiasis and amoebiasis are limited to children over 3 years of age. The safety and efficacy of this product for the treatment of giardiasis and amoebiasis in children under 3 years of age is unclear.
 
For the treatment of anaerobic infections and prevention of post-operative anaerobic infections, there are no data available for children under 12 years of age.
 
[Geriatric Use]
 
Clinical studies have not provided enough data for tinidazole in elderly patients over the age of 65, so it is not certain whether they are different from younger patients. In general, the dose of elderly patients needs to be carefully determined, considering minimizing liver, kidney, and heart damage, and some complications and interactions with other therapeutic agents.
 
【medicine interactions】
 
The following is a report on the drug interactions of metronidazole, a nitroimidazole that is chemically related to tinidazole, so the following reports may also occur in tinidazole.
 
1. The potential impact of tinidazole on other drugs
 
Warfarin and other oral coumarin anticoagulants: In view of the reports of metronidazole, tinidazole can enhance the efficacy of warfarin and other coumarin anticoagulants, resulting in prolonged prothrombin time . The amount of anticoagulant may need to be adjusted during the treatment of tinidazole and within 8 days after discontinuation.
 
Alcohol, Sodium Disulfide: Avoid drinking alcoholic beverages and any alcohol or propylene glycol during the treatment of tinidazole and within 3 days after stopping the drug....Preparation, otherwise there may be abdominal cramps, nausea, vomiting, headache, flushing reaction. It has been reported that people who drink alcohol while taking metronidazole and disulfide wake up will have a psychotic reaction. Although tinidazole has not been reported similarly, tinidazole should not be used in patients who have taken disulfide in the past two weeks.
 
Lithium: Metronidazole has been reported to increase serum lithium levels. It is not known whether tinidazole has the same properties, but it is recommended that patients with both lithium and tinidazole should be tested for serum lithium and creatinine after a few days of treatment to monitor the potential risk of lithium poisoning.
 
Phenytoin, phenytoin: It has been reported that intravenous injection of phenytoin with oral metronidazole will result in a prolongation of phenytoin half-life and a reduction in clearance. Metronidazole did not significantly affect the pharmacokinetics of oral administration of phenytoin.
 
Cyclosporin, tacrolimus: According to some reports, metronidazole has the potential to increase the levels of cyclosporin and tacrolimus. In the case of tinidazole in combination with any of these, the toxicity of these immunosuppressive drugs should be monitored.
 
Fluorouracil: Studies have shown that metronidazole reduces the clearance of fluorouracil, which leads to no benefit to the treatment effect and increases its side effects. If it is unavoidable to use tinidazole in combination with fluorouracil, the patient's fluorouracil-related toxicity should be monitored.
 
2. Potential effects of other drugs on tinidazole
 
CYP3A4 inducer/inhibitor: Tinidazole is administered in combination with a drug that induces liver microsomal enzymes, ie, CYP3A4 inducers such as phenobarbital, rifampicin, phenytoin, phenytoin (a prodrug of phenytoin) It may accelerate the elimination of tinidazole and reduce the level of tinidazole in plasma. Administration of tinidazole with drugs that inhibit liver microsomal enzyme activity, ie CYP3A4 inhibitors such as cimetidine and ketoconazole, may prolong the half-life of tinidazole and reduce its plasma clearance, thereby increasing tinidazole Concentration in plasma.
 
Cholestyramine: It has been reported that cholestyramine can reduce the oral bioavailability of metronidazole by 21%. It is therefore recommended that cholestyramine and tinidazole be administered separately to reduce the potential impact on oral bioavailability of tinidazole.
 
Oxytetracycline: It is reported that oxytetracycline can antagonize the therapeutic effect of metronidazole.
 
3. Laboratory drug interactions
 
Similar to metronidazole, tinidazole may also interfere with the determination of certain serum biochemical indicators such as glutamate aminotransferase (AST), alanine aminotransferase (ALT), lactate dehydrogenase (LDH), Triglycerides and glucohexose kinases. A value of zero may be observed. All assays with interference reported are involved in the coupling of the NAD + NADH enzyme during the redox reaction of nicotinamide adenine dinucleotide. The potential interference is due to the similarity of the absorption peaks of NADH and tinidazole.
 
Similar to metronidazole, tinidazole may also produce transient leukopenia and neutropenia, however, no persistent hematological abnormalities caused by tinidazole have been observed in clinical trials. If it is necessary to repeat the treatment, it is recommended to count the total number of white blood cells and the classification.
 
【Drug overdose】
 
There were no reports of drug overdose in human tinidazole.
 
Treatment of drug overdose: There is no specific antidote to tinidazole, so the treatment should be the right medicine. The gastric lavage method may be effective. Hemodialysis can also be considered because approximately 43% of in vivo drugs can be eliminated within 6 hours of hemodialysis.
 
【Pharmacology and Toxicology】
 
Pharmacological action
 
Mechanism of action: Tinidazole is an anti-protozoal and antibacterial agent. The nitro group of tinidazole can be reduced by the cell extract of Trichomonas, and the free nitro group produced by the reduction has antigenic insect activity. In an in vitro test, chemically reduced tinidazole releases nitrite and causes damage to purified bacterial DNA. In addition, the drug causes DNA base changes in bacterial cells and DNA strand breaks in mammalian cells. The mechanism of action of tinidazole against Giardia and amoeba is not clear.
 
Antibacterial activity: Bacterial culture and drug susceptibility testing are not yet available as routine diagnostic methods for bacterial vaginosis. Standard methods for potential bacterial pathogens, Gardnerella vaginalis, Campylobacter or Mycoplasma susceptibility testing have not been established. The following in vitro data have been obtained, but its clinical significance is not yet clear. Tinidazole has in vitro activity against most of the following pathogens associated with bacterial vaginosis: Bacteroides, Gardnerella vaginalis, Prevobacter. Tinidazole showed no antibacterial activity against most vaginal lactic acid bacteria.
 
Antiprotozoal activity: Tinidazole was confirmed to be active against the following protozoa in vitro and in clinical infections: Trichomonas vaginalis, Giardia (also known as Piriflagellate) and Amoeba protozoa. There are no standard susceptibility test methods for protozoal parasites that can be used in clinical microbiology laboratories.
 
Drug resistance: The resistance of tinidazole to Giardia, amoeba or bacteria associated with bacterial vaginitis has not been investigated.
 
Cross-resistance: In vitro, approximately 38% of Trichomonas vaginalis, which is less sensitive to metronidazole, also showed reduced sensitivity to tinidazole. Its clinical significance is still unclear.
 
Toxicological research
 
Repeated dosing toxicity: Beagle dogs were orally administered with tinidazole 100, 300 and 1000 mg/kg/day for 28 consecutive days. On day 18, the high dose was reduced to 600 mg/kg/day due to severe clinical symptoms. The response associated with dosing was characterized by thymus atrophy in male and female animals in the middle and high dose groups and prostate atrophy in males in all dose groups. The noobetic toxicity dose (NOAEL) of female animals was 100 mg/kg/day; male animals developed mild prostate atrophy at a dose of 100 mg/kg/day (about 0.9 times the human highest therapeutic dose in terms of body surface area). Failed to determine NOAEL.
 
Genotoxicity: In the Ames test, tinidazole was mutagenic to Salmonella typhimurium TA100 strain, TA98 strain was negative, TA1535, 1537 and 1538 strains were positive and negative, and Klebsiella pneumoniae was positive. The results of tinidazole CHL/CHO chromosome aberration test were negative, and the mouse micronucleus test results were positive.
 
Reproductive toxicity: In a 60-day fertility toxicity test, tinidazole can reduce fertility in male rats at a dose of 600 mg/kg/day (about 3 times the human body surface area, the highest therapeutic dose) And cause testicular tissue damage. 300 and 600 mg/kg/day doses can affect sperm formation. 100 mg/kg/day (about 0.5 times the human body's highest therapeutic dose in terms of body surface area) has no significant effect on testicular and sperm formation. The above effects are characteristic of 5-nitroimidazole drugs.
 
The embryonic-fetal developmental toxicity test results of pregnant mice showed that tinidazole had no embryonic-fetal toxicity or teratogenicity at the highest dose of 2500 mg/kg (about 6.3 times the human body surface area, the highest therapeutic dose). Pregnancy rats showed a slight increase in fetal mortality at a dose of 500 mg/kg (about 2.5 times the body's highest therapeutic dose in terms of body surface area).
 
Tinidazole can enter the fetal circulation through the placental barrier. Tinidazole can be excreted in milk at concentrations similar to serum drug concentrations.
 
Carcinogenicity: Metronidazole (nitroimidazoles with related chemical structures) has been reported to be carcinogenic to mice and rats, and no carcinogenicity to hamsters. Several trials of metronidazole have shown evidence of breast and liver carcinogenicity in mouse lung, liver, lymphoid, and female rats. There are no reports of tinidazole in carcinogenicity tests in rats, mice or hamsters.
 
【Pharmacokinetics】
 
absorb:
 
This product is absorbed quickly and completely after oral administration. A bioavailability study of tinidazole tablets in healthy adult volunteers showed that subjects were given 2 g of tinidazole on an empty stomach with a peak plasma concentration (Tmax) of 1.6 ± 0.7 hours and maximum plasma concentration. (Cmax) was 47.7 (±7.5 μg/ml, the area under the curve (AUC) (AUC, 0-∞) within 72 hours was 901.6 ± 126.5 μg/hr/ml, and the half-life (T1/2) was 13.2 ± 1.4h. The in vivo concentration was 14.3 μg/ml in 24 hours, 3.8 μg/ml in 48 hours, and 0.8 μg/ml in 72 hours. The concentration reached steady state in 2.5 to 3 days.
 
When the product was taken at the same time as the food, the Tmax was delayed by 2 hours, and the Cmax was reduced by about 10%, but had no effect on AUC and T1/2.
 
distributed:
 
After absorption, this product can quickly enter people's tissues and body fluids, and spread through the blood-brain barrier. The distribution volume is approximately 50 liters and 12% tinidazole binds to plasma proteins. Tinidazole penetrates the placental barrier and is excreted through the milk.
 
metabolism:
 
Most of the tinidazole is metabolized in the body, the main way is oxidation, hydrolysis, conjugate binding. Most of the plasma is present in its original form and a small amount is metabolized to a 2-hydroxymethyl metabolite. Tinidazole completes biotransformation through CYP3A4. In vitro metabolism studies show that tinidazole concentration above 75μg/ml does not inhibit the activities of CYP1A2, CYP2B6, CYP2C9, CYP2D6, CYP2E1 and CYP3A4.
 
The metabolic interaction between tinidazole and other drugs is not clear.
 
eliminate:
 
The plasma half-life of tinidazole is about 12 to 14 hours. The drug is excreted through the liver and kidney. Tinidazole is excreted in the urine as a prototype (about 20% to 25% of the administered dose), and about 12% of the drug is excreted in the feces.
 
Patients with renal insufficiency:
 
There was no significant difference in the pharmacokinetics of tinidazole between healthy subjects and patients with impaired renal function (CrCL ≤ 22 ml/min). However, by hemodialysis, the elimination rate of tinidazole in the kidney was significantly enhanced; the half-life was reduced from 12.0 hours to 4.9 hours.
 
Approximately 43% of the body's tinidazole was eliminated during 6 hours of hemodialysis.
 
There are no data on pharmacokinetic studies in patients with conventional peritoneal dialysis.
 
Patients with liver dysfunction:
 
There is no data showing tinidazole pharmacokinetics in patients with impaired liver function. Metronidazole, a similar drug that also contains a nitroimidazole structure, has been reported in several reports that the rate of metabolic elimination is reduced in patients with impaired liver function.
 
[Storage] shading, sealed (10 ~ 30 ° C) preservation.
 
[Packing] aluminum plastic packaging, 8 pieces per box.
 
[Validity Period] 36 months
 
[Executive Standards] "Chinese Pharmacopoeia" 2015 Edition 2
 
[Approval No.] National Drug Standard H44021585
 
【manufacturer】
 
  Company Name: Guangdong Pi Di Pharmaceutical Co., Ltd.
 
  Production address: No. 66, Pidi Avenue, Yueshan Town, Kaiping City, Guangdong Province
 
  Postal code: 529331
 
  Phone number: (0750) 2789348
 
400-8899-328 (National Service Phone)
 
  Fax number: (0750) 2789348
 
  Website: http://www.pdpharm.com
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