Universal reference book for medicines
Name of the drug: ORNIDAZOL (ORNIDAZOL)

Active substance: metronidazole

Type: Antiprotozoal preparation with antibacterial activity

Manufacturer: АРС (Russia) manufactured by VMG Pharmaceuticals (India)
Composition, form of production and packaging
Solution for infusion
1 ml 1 fl.

Metronidazole 5 mg 500 mg

100 ml - polyethylene bottles (1) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2011.

PHARMACHOLOGIC EFFECT

Antiprotozoal and antimicrobial drug, a derivative of 5-nitroimidazole.
The mechanism of action is the biochemical reduction of the 5-nitro group of ornidazole by intracellular transport proteins of anaerobic microorganisms and protozoa. The reduced 5-nitro group of ornidazole interacts with DNA by microorganism cells, inhibiting the synthesis of their nucleic acids, which leads to the death of bacteria. It is active against Trichomonas vaginalis, Gardnerella vaginalis, Giardia intestinalis, Entamoeba histolytica, Lamblia spp., And obligate anaerobes Bacteroides spp. (eg, Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus), Fusobacterium spp., Veillonela spp., Prevotella (P.bivia, P. buccae, P.disiens), and some gram-positive microorganisms (Eubacterium spp., Clostridium). Orniferous microorganisms are not sensitive to ornidazole.
PHARMACOKINETICS

The binding of ornidazole to proteins is about 15%.
The active substance penetrates into the cerebrospinal fluid, breast milk and most tissues, passes through the blood-brain barrier and the placenta. Metabolized in the liver by hydroxylation, oxidation and glucuronation. Basic 2-hydroxymethyl- and? -hydroxymethyl metabolites are less active against Trichomonas vaginalis and anaerobic bacteria than unchanged ornidazole. T 1/2 - about 13 hours. It is excreted in the form of metabolites by the kidneys (60-70%) and with the calves (20-25%), about 5% of the dose is excreted unchanged, other body fluids and tissues.
INDICATIONS

Trichomoniasis, amebiasis, amoebic dysentery, extraintestinal amoebiasis (including amoebic liver abscess);
giardiasis; prevention of postoperative infectious complications caused by anaerobic bacteria, with surgery on the colon and gynecological operations.
DOSING MODE

In / in the administration of ornidazole is indicated in severe infections, as well as in the absence of the possibility of taking the drug inside.

Usually a single dose for adults and children over 12 years is 500 mg, I / O speed of continuous (inkjet) or dropwise administration is 5 ml per min.
The interval between the administrations is 8 hours. The duration of treatment is determined individually. The maximum daily dose is no more than 2 g. According to the indications, depending on the nature of the infection, the transition to maintenance therapy with oral forms of metronidazole is carried out.
For trichomoniasis: adults - 0.5 g 3 times a day for 5 days or 1 g in combination with intravaginal injection of 500 mg (vaginal tablets) overnight.
Children - in a single dose, at a rate of 25 mg / kg of body weight per day.
With amoebic dysentery adults and children weighing over 35 kg - 1.5 grams per day with a body weight of more than 60 kg 2 g / day.
Children with a body weight of less than 35 kg 40 mg / kg / day. Duration of treatment - 3 days.
For the treatment of other forms of amoebiasis: adults and children weighing more than 35 kg - 0.5 grams orally 2 times a day, with a weight of 35 kg - 25 mg / kg once for 5-10 days.
Single doses for children: aged 7-12 years - 0.375 g; 1-6 years - 0.25 g; up to 1 year - 0.125 g; multiplicity of appointment -2 times a day (morning and evening); the duration of treatment is 5-10 days.
With giardiasis: adults and children weighing over 35 kg - 1.5 g / day;
Children with body weight up to 35 kg - 40 mg / kg / day. Duration of treatment is 1-2 days.
Prevention of postoperative infectious complications caused by anaerobic bacteria - 0.5 g before surgery, then every 12 hours for 0.5 g, for 3-5 days.

SIDE EFFECT

Drowsiness, headache, abnormal gastrointestinal function (including nausea), dizziness, tremor, muscle rigidity, impaired coordination of motion, convulsions, fatigue, temporary loss of consciousness, sensory or mixed peripheral neuropathy, perversion of taste sensations, alteration of activity of "hepatic "enzymes, allergic reactions.

If any of the side effects indicated in the manual are aggravated, or any other side effects not indicated in the instructions are noted, you should inform the doctor immediately.

CONTRAINDICATIONS

Hypersensitivity, pregnancy (I trimester), lactation period, organic diseases of the central nervous system.

SPECIAL INSTRUCTIONS

Intravenous administration of a solution for infusion is indicated to patients who are unable to receive oral medication.
In mixed infections, the infusion solution of ornidazole can be used in combination with oral antibiotics. When i / v drip introduction can not be mixed with other drugs.
In the treatment of trichomoniasis, simultaneous treatment of both partners should be carried out.

Effect on the ability to drive and potentially dangerous machinery.
During the treatment period, care must be taken when driving and potentially dangerous mechanisms due to possible dizziness, drowsiness, stiffness and visual disturbances, which can lead to a slowing of the speed of psychomotor reactions and a decrease in the ability to concentrate.
OVERDOSE

Symptoms: epileptiform cramps, depression, peripheral neuritis.

Treatment: symptomatic.

DRUG INTERACTION

Strengthens the effect of anticoagulants coumarinic series, prolongs the miorelaksiruyuschee effect of vecuronium bromide.
Lengthens the miorelaxing effect of vecuronium bromide. Unlike other imidazole derivatives (metronidazole), it is compatible with alcohol (does not inhibit acetaldehyde dehydrogenase).
TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

In a dry, protected from light place at a temperature of no higher than 25 ° C.
Keep out of the reach of children.
Shelf life - 3 years.
Do not use the product after the date shown on the package.
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