Zolemet

Zolemet

metronidazole

Manufacturer:

Shandong Qidu

Distributor:

Endure Medical
Full Prescribing Info
Contents
Metronidazole.
Description
Each mL contains: Metronidazole 5 mg.
Action
Pharmacology: Metronidazole is a derivative of nitroimidazole and has a strong antibacterial effect on most anaerobe, but it has no effect on aerobe or facultative anaerobe. The antibacterial spectrum includes Bacteroides fragilis and other Bacteroides, Fusiform bacillus, Clostridium perfringens, Eubacterium, Veillonella, Peptococcus and Peptostreptococcus, etc. Actinomycete, Cillobacterium and Propionibacterium are resistant to the product. The product can inhibit the redox reaction of amoeba, leading to a fracture in the nitrogen chain of protozoon. According to in vitro tests, when the drug concentration is l-2 mg/L, Amoeba histolytica will change its form at 6-20 hours and be killed completely within 24 hours. When the concentration is 0.2mg/L, Amoeba histolytica can be killed within 72 hours. The product has strong effect of killing trichomonad, while the mechanism is not clear yet. The product has carcinogenic effect on some animals.
Pharmacokinetics: It reaches peak value 20 minutes after intravenous administration and the effective concentration lasts for 12 hours. The protein-binding rate is lower than 5%. The drug distributes extensively in all tissues and body fluid after it is absorbed. It can pass through blood brain barrier and reach its effective concentration in saliva, placenta, bile, breast milk, amniotic fluid, semen, urine, pus and cerebrospinal fluid. It is reported that the drug concentration in placenta, breast milk and bile is similar to the plasma concentration. The plasma concentration in human cerebrospinal fluid of a healthy person is 43% of plasma concentration. 60%-80% of the product is excreted through kidney and about 20% of the original drug is excreted through urine, while the remaining is excreted through urine in the form of metabolite (25% is glucuronic acid combination and 14% is other metabolic combination). 10% is excreted through feces and 14% is excreted through skin.
Indications/Uses
It is used in the prevention of postoperative inspections due to anaerobic bacteria, particularly species of Bacteroides and anaerobic Streptococci. It is also indicated in the treatment of septicaemia, bacteraemia, peritonitis, brain abscess, necrotizing pneumonia, osteomyelitis, puerperal sepsis, pelvic abscess, pelvic cellulitis, and postoperative wound infections from which pathogenic anaerobes have been isolated.
Dosage/Direction for Use
Metronidazole injection should be infused intravenously at an approximate rate of 5 mL/min. Oral medication should be substituted as soon as feasible.
Anaerobic Infections: Treatment for seven days should be satisfactory for most patients but, depending upon clinical and bacteriological assessments, the physician might decide to prolong treatment e.g. for the eradication of infection from sites which cannot be drained or are liable to endogenous recontamination by anaerobic pathogens from the gut, oropharynx or genital tract.
Prophylaxis against anaerobic infections: Chiefly in the context of abdominal (especially colorectal) and gynaecological surgery.
Adults: 500 mg shortly before operation, repeated every 8 hours. Oral doses of 200 mg or 400 mg every 8 hours to be started as soon as feasible.
Children: 7.5 mg/kg every 8 hours.
Treatment of established anaerobic infections: Intravenous route is to be used initially if patient's symptoms preclude oral therapy.
Adults: 500 mg every 8 hours.
Children: 7.5 mg/kg every 8 hours; Initial loading dose, 15 mg/kg IV infused over 60 minutes; Term infants, (1-4 weeks of age).
Contraindications
It is forbidden to use the product in patients with active central nervous system disease, blood disease and allergy.
Warnings
Examine the product in detail before use and it cannot be used if any of the following cases is observed: solution turbidity, foreign matter, loosened sealing, solution leakage, cracks in the body or opening of the bottle.
Once the product is used, it should be used up in one time. It is strictly forbidden to use the product in food and feed processing.
Special Precautions
Interference with diagnosis: metabolite of the product can make urine turn dark red.
For patients with liver disease, the dosage should be reduced. When ataxia or other symptoms in central nervous Metronidazole system are observed, the administration should be stopped. Leukocyte count should be carried out before repeating a treatment course. For patients with anaerobic infections accompanied by renal failure, the administration interval should be extended from 8 hours to 12 hours.
The product can inhibit the metabolism of alcohol, so drinking should be abandoned during drug administration as symptoms (including abdominal pain, vomiting and headache, etc.) may occur after drinking.
The osmotic pressure mole concentration of the product is 260-340 mOsmol/kg.
Use in Pregnancy & Lactation: Mutagenic effect is observed in animal test, so it is forbidden to use the product in women in pregnancy and lactation.
Use in Elderly: Due to hypohepatia in the elder, pharmacokinetics will be changed if the product is used, which requires a close monitoring of plasma concentration.
Use In Pregnancy & Lactation
Mutagenic effect is observed in animal test, so it is forbidden to use the product in women in pregnancy and lactation.
Adverse Reactions
Adverse reactions are observed in 15%-30% of the cases. Reactions in digestive tract are most frequently observed, including nausea, vomiting, inappetence, diarrhea, abdominal colic, which have no influence on treatment. Symptoms in nervous system include headache, vertigo, occasional paresthesia, numbness of the limbs, ataxia and polyneuritis, etc. A large dosage can cause hyperspasmia. Reactions (such as urticaria, flush, pruritus, cystitis, dysuria, melanuria, a metallic taste in the mouth and leukopenia, etc.) are observed in rare cases. Those reactions are reversible and spontaneous recovery is attainable after the drug administration is stopped.
Drug Interactions
The product can inhibit the metabolism of warfarin and other oral anticoagulants and strengthen their effects, leading to prolonged prothrombin time.
When the product is co-administered with drugs (such as phenytoin sodium and Phenobarbital, etc.) which induce liver microsomal enzymes, the metabolism of the product can be strengthened and the plasma concentration can be reduced, while the excretion of phenytoin sodium is slowed down.
When the product is co-administered with drugs (such as cimetidine, etc.) which is inhibit the activity of liver microsomal enzymes, the metabolism of the product in liver and its excretion can be slowed down and the serum half-life of the product is prolonged, so the dosage should be adjusted according to the result of plasma concentration test.
The product can interfere with the metabolism of disulfiram. When the two drugs are co-administrated or after the patients drink alcohol, mental symptoms may occur, so it is inadvisable to use the product within two weeks after disulfiram is used.
The product can interfere with amino transferase and LDH testing result, which can lower the level of cholesterol and triglyceride.
Storage
Store at temperatures not exceeding 30°C
MIMS Class
ATC Classification
J01XD01 - metronidazole ; Belongs to the class of imidazole derivative antibacterials. Used in the systemic treatment of infections.
Presentation/Packing
Soln for infusion 5 mg/mL x 100 mL.
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