Date of approval.
Date of revision.
Ornidazole Tablets Instructions
Please read the instructions carefully and use under the guidance of a physician
Drug Name]
Generic name: Ornidazole Tablets
Trade name: Henbolay
English name: Ornidazole Tablets
Hanyu Pinyin: Aoxiaozuo Pian
Ingredients
The active ingredient of this product is Ornidazole.
Chemical name: 1-(3-chloro-2-hydroxypropyl)-2-methyl-5-nitroimidazole
Chemical structure formula.
Molecular formula: C7H10ClN3O3
Molecular weight: 219.63
Properties
This product is white or off-white film-coated tablets, which appear white or off-white after removing the coating.
Indications
In order to reduce the production of drug-resistant bacteria and to ensure the effectiveness of Ornidazole and other antibacterial drugs, Ornidazole should only be used for the treatment or prevention of infections that have been proven or highly suspected to be caused by sensitive bacteria. The results of bacterial culture and drug sensitivity tests should be considered when selecting or modifying an antibacterial drug regimen. If data from these tests are not available for reference, empirical treatment should be based on local epidemiology and pathogen susceptibility.
Bacterial culture and drug sensitivity testing should be performed prior to treatment to isolate and identify the infecting pathogen and determine its susceptibility to the antimicrobial agent. Treatment with the antimicrobial drug can be initiated until the above sensitivity results are obtained, and then treatment against the pathogenic organism can be selected after the sensitivity results are obtained.
Bacterial culture and drug sensitivity test should be conducted regularly during the treatment period to know whether the pathogenic bacteria are continuously susceptible to the antibacterial drug and to detect drug resistance when it appears.
The indications of this product are.
1.This product is suitable for the treatment of amebiasis, genitourinary trichomoniasis and Giardia lamblia.
2.This product is suitable for the treatment of infections caused by anaerobic bacteria that are sensitive to this product.
3.This product is suitable for the prevention of surgical procedures may cause sensitive anaerobic bacterial infections.
4.This product can also be used for sequential treatment after treatment with Ornidazole injection.
During the use of this product, other adjuvant therapeutic measures should also be taken according to clinical needs.
Specification
0.25g
Dosage
1.Amoebiasis
Adults: 1.0~1.5g daily, orally.
Children: 30mg/kg daily, orally.
For hepatic amebiasis, in the abscess stage, ornidazole treatment needs to be combined with abscess expulsion treatment.
2.Trichomoniasis
1）5-day therapy
Adults: 0.5g each time, twice a day (once in the morning and once in the evening), for 5 days.
2）Monotherapy.
Adults: 1.5g in a single dose after dinner.
3.Giardia lamblia flagellosis
Adults: 1.0g daily, orally.
Children: 30mg/kg daily, orally.
4.Treatment of anaerobic bacterial infection
Adults: 1.0~1.5g daily, orally.
Children: 20～30mg/kg per day, orally.
5.Prevent anaerobic bacterial infection
Adults: 0.5g 12 hours before surgery, 0.5g every 12 hours for three days after surgery, orally.
Children: The treatment regimen is the same as adults, the dose is 20-30mg/kg per day, orally.
[Adverse Reactions].
Digestive system.
Common: nausea, vomiting, metallic taste.
Rare: stomach pain.
Very rare: hepatitis.
Skin and mucous membranes.
Rare: rash.
Nervous system.
Rare: dizziness, headache, drowsiness, ataxia, confusion.
Rare: tremor, rigidity, seizures, anxiety, impaired consciousness, symptoms of sensory or mixed peripheral nerve disease.
Immune system.
Rare: allergic reactions.
Hematologic and lymphatic system.
Rare: bone marrow suppression, neutropenia.
Occurrence frequency is unclear: leukopenia caused by high dose or long-term drug use.
Contraindications]
This product is contraindicated in patients with hypersensitivity to nitroimidazoles or ornidazole.
This product is contraindicated in patients who are hypersensitive to any of the excipient components of this product.
Precautions】
1.If symptoms such as ataxia, vertigo and confusion occur during use, the drug should be discontinued immediately.
2. Patients with central nervous system diseases or peripheral nervous system diseases should closely observe the neurological function status during use and stop using immediately if the condition is found to be aggravated.
3.In the case of patients with hematological system diseases, the doctor must monitor closely before and after treatment.
4. In cases where high doses or more than 10 days of ornidazole use are required, patients should undergo regular laboratory and clinical examinations, especially hematological examinations. In case of leukopenia, please follow medical advice whether to continue treatment.
5.No alcoholic beverages or drugs should be taken during the course of medication, which may cause fever, redness, vomiting, tachycardia and other symptoms.
6.During the course of treatment with Ornidazole, if you already have candidiasis, deterioration may occur. If necessary, appropriate measures should be taken to intervene.
7, A shortened drug half-life has been observed in hemodialysis patients, so an increased dose may be required before or after dialysis.
8. The use of Ornidazole may cause dizziness and confusion. Do not drive or operate machinery after using this drug.
Pregnant women and nursing mothers
No trials have been conducted and no references are available.
Avoid the use of this product during pregnancy and lactation.
Use in Children
Use according to the weight of the child.
For elderly patients
No studies have been conducted and no references are available.
Drug Interactions
1.Compared with other nitroimidazoles, this product has no inhibitory effect on acetaldehyde dehydrogenase.
2, Ornidazole can enhance the anticoagulant effect of coumarins, attention should be paid to monitoring and adjusting the dose of anticoagulants.
3.Barbiturates can reduce the plasma half-life of Ornidazole.
4.Cimetidine can prolong the plasma half-life of Ornidazole.
5.Onidazole can prolong the muscle relaxation effect of vecuronium bromide.
6. Ornidazole can reduce the clearance of fluorouracil to increase its toxicity.
7.When lithium and imidazole are used simultaneously, plasma lithium concentration, creatinine and electrolytes should be monitored.
[Drug overdose].
The dosage should be used strictly in accordance with the doctor’s prescription. Overdose of this drug can aggravate the adverse reactions or even be dangerous. There is no specific antidote for Ornidazole. In case of serious adverse reactions, stop using the drug immediately and
Seek medical attention promptly. Ornidazole can be removed by gastric lavage or hemodialysis. In case of cramps, intravenous diazepam is recommended.
Pharmacology and Toxicology
Pharmacological effects
Ornidazole is a third-generation nitroimidazole derivative. The mechanism by which it exerts antibacterial and antiprotozoal effects may be that it causes the death of microorganisms through the reduction of nitro in its molecule to amino in an anaerobic environment or through the formation of free radicals that interact with cellular components.
The susceptible bacteria of Ornidazole are: 1) Bacteroides fragilis (Bacteroides fragilis); 2) Bilophila (Bilophila); 3) Clostridium (Clostridium); 4) Clostridium difficile (Clostridium difficile); 5) Clostridium perfringens (Clostridium perfringens); 6) Clostridium spp. (Fusobacterium); 7) Streptococcus digestiveis (Peptostreptococcus); 8) Porphyromonas (Porphyromonas); 9)
Prevotella (Prevotella); and 10) Veillonella (Veillonella).
The sensitive protozoa for Ornidazole are: Amoeba, Trichomonas, and Giardia lamblia, respectively. The remaining protozoa should not be treated with ornidazole.
Toxicological studies
Repeated dosing toxicity: rats given ornidazole at a dose of 400 mg/kg/day for 2 consecutive years did not show any effect on animal longevity or cause serious functional or morphological changes. Dogs administered for 1 year at doses up to 250 mg/kg/day developed central nervous system signs that were seen in rat tests with nitroimidazole derivatives.
Genotoxicity: Similar to other nitroimidazoles, ornidazole is mutagenic in a variety of strains, but human lymphocyte and mouse dominant lethality assays showed no effect of ornidazole on mammalian cell chromosomes.
Reproductive toxicity: In the high-dose studies conducted in rats, mice and rabbits, no significant effects of ornidazole on fetuses and perinatal period were observed. No teratogenic effects were observed in rats and mice at doses up to 400 mg/kg/day and in rabbits at doses up to 100 mg/kg/day. Oral administration of ornidazole inhibited fertility in male rats, but unlike other 5-nitroimidazole compounds, ornidazole did not inhibit spermatogenesis.
Carcinogenicity: Ornidazole was not found to be carcinogenic in rats administered at a dose of 400 mg/kg/day for 2 years.
Pharmacokinetics
Absorption
Ornidazole is absorbed very rapidly. Maximum blood concentration is reached 2-3 hours after oral administration.
Distribution
After oral administration of 750 mg of Ornidazole, the maximum blood concentration is about 11 μg/ml; drug half-life is 12-14 hours; Ornidazole is absorbed and spreads throughout the body, and can enter the cerebrospinal fluid and placenta; plasma protein binding rate is <15%.
Metabolism
95% of Ornidazole is metabolized by the liver.
Elimination
Ornidazole is mainly eliminated through the kidneys (65%) and bile as inactive metabolites.
Storage
Store under 30℃ under shade and sealed.
Package
Package
PVC solid pharmaceutical tablet/aluminum foil for pharmaceutical packaging, 12 tablets/plate×1 plate/box, 16 tablets/plate×1 plate/box, 12 tablets/plate×2 plates/box.
[Available
Validity
Period]
24 months
【Execution standard
Approval Number
State Drug Authentication H20030148
Manufacturer
Enterprise name: Sichuan Keren Pharmaceutical Co.
Production Address: Ziyang Economic and Technological Development Zone, Anyue Industrial Park (Shiqiaopu Town, Anyue County)
Postal Code: 642350
Telephone number: 028-86130259
After-sales consultation: 028-82860553
Pharmacovigilance：028-67825853
Fax number：028-86139152
Website: http://www.kelun.com