Meratin
Producer: Mili Healthcare Ltd (Mili Helskere Ltd) Great Britain
Code of automatic telephone exchange: J01XD03
Release form: Liquid dosage forms. Solution for infusions.
General characteristics. Structure:
Active ingredient: 500 mg of an ornidazol in 100 ml of solution.
Excipients: sodium chloride, water for injections.
Antimicrobic drug of a broad spectrum of activity.
Pharmacological properties:
Pharmacodynamics. The mechanism of action of an ornidazol is connected with disturbance of structure of DNA of microorganisms, sensitive to it. Ornidazol is active concerning Trichomonas vaginalis, Entamoeba histolytica, Giardia lamblia (Giardia intestinalis), and also some anaerobic bacteria, such as Bacteroides, Fusobacterium spp., anaerobic gram-positive bacteria: Clostridium spp., sensitive strains of Eubacterium spp, anaerobic gram-positive cocci: Peptococcus spp., Peptostreptococcus spp.
Easily gets into a microbic cell and, contacting DNA, breaks replication process.
Pharmacokinetics. Ornidazol well gets through hematoencephalic and placental barriers, comes to cerebrospinal fluid, bile, gets into breast milk. At intravenous administration in a dose of 15 mg/kg and at further introduction in a dose of 7,5 mg on 1 kg of body weight each 6 h equilibrium concentration makes 18-26 mkg/ml. In an organism about 30-60% of drug by a hydroxylation, oxidations and a glikirovaniye are metabolized.
Conclusion. Ornidazol is excreted preferential with urine (60-80%) of nearly 20% – in not changed look), 6-15% – with a stake.
Indications to use:
Parenteral administration of drug is shown in cases of an acute and heavy infection or when oral administration is impossible at such diseases and states:
• the mephitic system gangrenes caused by microflora, sensitive to an ornidazol: septicaemia, meningitis, peritonitises, postoperative wound fevers, sepsis, septic abortion and endometritis;
• prevention of the infections caused by anaerobic bacteria at surgical interventions (especially at operations on colonic and a rectum), at gynecologic operations;
• amoebic dysentery with a heavy current, all abenteric forms of an amebiasis, a lambliasis, liver abscess.
Route of administration and doses:
The dosage and term of treatment defines the doctor depending on the nature of a disease, the scheme of treatment.
The drug should be administered intravenously within 15-30 min.
At mephitic system gangrenes to appoint intravenous administration in a dose of 500-1000 mg – an initial dose, then on 500 mg each 12 h or to 1000 mg are each 24 hours within 5-10 days (a step dose). After the condition of the patient was stabilized, it is necessary to pass to oral administration of an ornidazol (for example tablets on 500 mg, on 1 tablet each 12 hours).
To children aged up to 12 years with body weight a daily dose to appoint more than 6 kg at the rate of 20 mg/kg of body weight, distributed on 2 introductions within 5-10 days.
For prevention of the infections caused by anaerobic bacteria at surgical interventions to adults and children 12 years орнидазол are more senior to appoint in a dose 500-1000 mg in 30 minutes before an operative measure.
орнидазол it is necessary to apply to prevention of multi-infections together with aminoglycosides, penicillin or cephalosporins. It is necessary to administer the drugs separately.
Amoebic dysentery with a heavy current, all abenteric forms of an amebiasis, a lambliasis, liver abscess – for adults and children is more senior than 12 years the first introduction makes 500-1000 mg, further – to 500 mg there are each 12 hours within 3-6 days.
To children aged up to 12 years with body weight a daily dose to appoint more than 6 kg at the rate of 20-30 mg/kg of body weight, distributed on 2 introductions. The course of treatment is defined by the doctor depending on the nature of a disease.
At a renal failure to extend an interval between introductions or to reduce a single and daily dose of drug.
Features of use:
Use during pregnancy or feeding by a breast. Ornidazol is contraindicated in the I trimester of pregnancy. In ІІ and ІІІ pregnancy trimesters to accept drug only according to absolute indications. In case of need uses Meratin should stop feeding by a breast.
Children. Ornidazol it is contraindicated to children to apply less than 6 kg with body weight.
At exceeding of the recommended doses children have a certain risk of emergence of side effects, at patients with damages of a liver, patients who abuse alcohol. At use of high doses of an ornidazol and in case of treatment clinical and laboratory monitoring is recommended to spend over 10 days.
At persons in the presence in the anamnesis of disturbances from blood control of leukocytes is recommended, especially when carrying out repeated courses of treatment.
Strengthening of disturbances from the central or peripheral nervous system can be observed during performing treatment ornidazoly. In case of peripheral neuropathy, lacks of coordination of movements (ataxy), dizziness or opacification of consciousness treatment should be stopped.
The candidiasis aggravation demanding the corresponding treatment can be observed.
In case of carrying out a hemodialysis it is necessary to consider reduction of an elimination half-life and to appoint additional doses of drug to or after a hemodialysis.
Concentration of salts of lithium, creatinine and concentration of electrolytes need to be controlled during therapy use by lithium.
The effect of other medicines can be strengthened or weakened during treatment ornidazoly.
Ability to influence speed of response at control of motor transport or work with other mechanisms. At use of an ornidazol such manifestations as drowsiness, muscle tension, dizziness, a tremor, spasms, weakening of coordination, a temporary loss of consciousness are possible. The possibility of such manifestations needs to be considered for the patients managing motor transport or working with other mechanisms.
Side effects:
From blood and lymphatic system: manifestations of influence on marrow, moderate leukopenia, neutropenia.
From immune system: hypersensitivity reactions, including an acute anaphylaxis, a Quincke's disease.
From skin and hypodermic cellulose: skin rashes, urticaria, dermahemia, itch.
From a nervous system: dizziness, drowsiness, a headache, a tremor, muscle tension, a lack of coordination, an ataxy, spasms, a temporary loss of consciousness, confusion of consciousness, symptoms of the touch or mixed peripheral neuropathy, excitement.
From digestive tract: taste disturbance, metal smack in a mouth, dryness in a mouth, a language oblozhennost, nausea, vomiting, dyspepsia, feeling of weight and morbidity in epigastric area.
From a liver and biliary tract: hepatotoxic, changes of hepatic functional trials.
General frustration and changes in an injection site: fervescence, a fever, the general weakness, fatigue, an asthma, changes of y an injection site, including pain, reddening, y burning sensation an injection site.
Others: darkening of color of urine, cardiovascular frustration, in a t.ch.snizheniye of arterial pressure.
Interaction with other medicines:
Unlike other derivatives of a nitroimidazole, орнидазол does not inhibit an aldegiddegidrogenaza and therefore it is compatible to alcohol. However орнидазол strengthens effect of peroral anticoagulants of a coumarinic row (warfarin) that demands the corresponding correction of their dosing.
Ornidazol prolongs myorelaxation action a bromide vekuroniya.
Combined use of phenobarbital and other inductors of enzymes reduces the period of circulation of an ornidazol in blood serum while inhibitors of enzymes (for example Cimetidinum) raise.
Contraindications:
Hypersensitivity to components of drug or to other derivatives of a nitroimidazole. Patients with defeat TsNS, epilepsy, multiple sclerosis, an alcoholism. Blood circulation disturbances, pathological defeats of blood or other hematologic anomalies.
Overdose:
Symptoms: nausea, vomiting, anorexia, strengthening of symptoms of other side reactions is possible.
Treatment: the specific antidote is unknown, in case of developing of spasms it is necessary to apply diazepam. Therapy is symptomatic.
Storage conditions:
To store at a temperature not over 25 ºС in original packaging in the place, unavailable to children. Period of validity 2 years.
Issue conditions:
According to the recipe
Packaging:
On 100 ml of solution in a bottle with the rubber bung closed by an aluminum cap and in the sealed plastic cover. 1 bottle in a cardboard box.