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Dazolic tablet 500 mg cor x10

Trade name: Dazolic International name: Ornidazole Pharmacological group: antiprotozoal drug Pharmacological group according to ATC: P01AB03. Ornidazole Pharmacological action: antiprotozoal Pharmacodynamics: 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 in microbial cells, inhibiting the synthesis of their nucleic acids, which leads to the death of bacteria. Active against Trichomonas vaginalis, Gardnerella vaginalis, Giardia intestinalis, Entamoeba histolytica, Lamblia spp., as well as obligate anaerobes Bacteroides spp. (including 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). Aerobic microorganisms are not sensitive to ornidazole. Pharmacokinetics: Absorption from the gastrointestinal tract is high. Bioavailability - 90%. Communication with plasma proteins is less than 15%. Metabolized in the liver by hydroxylation, oxidation and glucuronidation. T1/2 - 12-14 hours. Penetrates into breast milk and most tissues, passes through the blood-brain barrier and the placenta. It is excreted in the form of metabolites by the kidneys (60-70%) and with feces (20-25%), about 5% of the dose is excreted unchanged. Indications for use: Trichomoniasis, amebiasis: amoebic dysentery, extraintestinal amebiasis (including amoebic liver abscess), giardiasis, prevention of infections caused by anaerobic bacteria during operations on the colon and gynecology. Contraindications: Hypersensitivity. With caution: Central nervous system diseases (including epilepsy, multiple sclerosis), liver disease, alcoholism,

pregnancy, lactation period. Dosage regimen: For trichomoniasis: orally - 1.5 g once or 1 g in combination with intravaginal administration of 500 mg (vaginal tablets) at night. Treatment can be carried out for 5 days, prescribing 500 mg orally 2 times a day (morning and evening), also prescribing 1 vaginal tablet of 500 mg at night. After hygienic treatment of the external genitalia, the vaginal tablet should be inserted deep into the vagina. Children - orally, once, at the rate of 25 mg/kg. For amoebic dysentery, adults and children with body weight over 35 kg - 1.5 g once a day, with body weight over 60 kg - 2 g / day. Children weighing less than 35 kg - 40 mg/kg/day. Course - 3 days. For the treatment of other forms of amebiasis: adults and children over 12 years old - 0.5 g orally, morning and evening 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, frequency of administration - 2 times a day (morning and evening), duration of treatment - 5-10 days . For giardiasis: adults and children weighing over 35 kg - orally, 1.5 g once a day, children weighing up to 35 kg - 40 mg/kg/day. Duration of treatment is 1-2 days. Prevention of infections caused by anaerobic bacteria - 0.5-1 g before surgery, after surgery - 0.5 g 2 times a day for 3-5 days. Side effects: Drowsiness, headache, dysfunction of the gastrointestinal tract (including nausea), dizziness, tremor, muscle rigidity, incoordination, convulsions, fatigue, temporary loss of consciousness, sensory or mixed peripheral neuropathy, perversion of taste, changes liver enzyme activity, allergic reactions.

Overdose: Symptoms: epileptiform seizures, depression, peripheral neuritis. Treatment: symptomatic (diazepam - for seizures). Interaction: Enhances the effect of coumarin anticoagulants, prolongs the muscle relaxant effect of vecuronium bromide. Compatible with ethanol (does not inhibit acetaldehyde dehydrogenase) unlike other imidazole derivatives (metronidazole). Special instructions: When treating trichomoniasis, sexual partners should be treated simultaneously.

Manufacturer: Sun Pharmaceutical Industries Ltd, India Registration certificate holder: Sun Pharmaceutical Industries Ltd, India Release form: film-coated tablets 500 mg (strips), film-coated tablets 0.5 g (strips) Ingredients: ornidazole 500 mg Shelf life: 3 years Data on registration: P No. 015785/01 dated 05/25/2009, 06/25/2004 Registration certificate status: valid HS codes: 3004 90 190 9

Dazolic

Release form, composition and packaging

White or almost white, film-coated tablets, round, biconvex, scored on one side. 1 tab. ornidazole 500 mg. Excipients: starch, microcrystalline cellulose, sodium lauryl sulfate, polyvinyl pyrrolidone K90, purified talc, magnesium stearate, colloidal silicon dioxide, sodium starch glycolate (type A), eudrazite E-100, titanium dioxide, polyethylene glycol 6000, isopropyl alcohol, acetone, purified water.

Clinical and pharmacological group: Antiprotozoal drug with antibacterial activity.

pharmachologic effect

Antiprotozoal drug. The mechanism of action is associated with disruption of the DNA structure of sensitive microorganisms. Active against Trichomonas vaginalis, Giardia lamblia, Entamoeba histolytica, as well as against some anaerobic bacteria (including Bacteroides spp., Clostridium spp., Fusobacterium spp. and anaerobic cocci).

Pharmacokinetics

Suction and distribution

After taking the drug orally, ornidazole is well absorbed from the gastrointestinal tract. Bioavailability – 90%. Cmax is achieved within 1-2 hours. Plasma protein binding is at least 15%. Penetrates through the BBB.

Metabolism and excretion

T1/2 - about 13 hours. Excreted in the form of metabolites by the kidneys (60-70%) and with feces (20-25%), about 5% - unchanged.

Indications

trichomoniasis;
amebiasis, amoebic dysentery, extraintestinal amebiasis (including amoebic liver abscess);
giardiasis;
prevention of infections caused by anaerobic bacteria during operations on the colon and gynecology.

Dosage regimen

For trichomoniasis, adults are prescribed 500 mg 2 times a day for 5 days. For children, the dose is set at the rate of 25 mg/kg body weight 1 time/day once. For amoebic dysentery, adults and children with a body weight of more than 35 kg, 1.5 g 1 time / day, with a body weight of more than 60 kg - 2 g / day.

For children weighing less than 35 kg, the daily dose is set at the rate of 40 mg/kg body weight. The course of treatment is 3 days. For other forms of amebiasis, adults and children over 12 years old - 500 mg, children aged 7 to 12 years - 375 mg, children aged 1 to 6 years - 250 mg, up to 1 year - 125 mg. Frequency of administration: 2 times/day (morning and evening); Duration of therapy is 5-10 days. For giardiasis, adults and children weighing more than 35 kg – 1.5 g 1 time/day, children weighing less than 35 kg – 40 mg/kg/day. The duration of therapy is 1-2 days. To prevent infections caused by anaerobic bacteria, prescribe 0.5-1 g before surgery and 0.5 g 2 times a day after surgery for 3-5 days.

Side effect

From the central nervous system and peripheral nervous system: headache, dizziness, disturbances of consciousness, tremor, rigidity, incoordination, convulsions, sensory or mixed peripheral neuropathy.
From the digestive system: nausea, vomiting, diarrhea.

Contraindications

organic diseases of the central nervous system;
I trimester of pregnancy;
lactation;
hypersensitivity to the components of the drug.

Pregnancy and lactation

The drug is contraindicated for use in the first trimester of pregnancy and during lactation (breastfeeding).

special instructions

When treating trichomoniasis, sexual partners should be treated. When drinking alcohol while using the drug, no disulfiram-like reactions are observed (ornidazole does not inhibit acetaldehydrogenase).

Overdose

Symptoms: epileptiform convulsions, depression, neuritis of peripheral nerves.

Treatment: symptomatic therapy is carried out, for convulsions - diazepam.

Drug interactions

When used together, ornidazole enhances the effects of indirect anticoagulants (coumarin derivatives) and prolongs the muscle relaxant effect of vecuronium bromide.

Storage conditions and periods

List B. The drug should be stored in a dry place, protected from light and out of reach of children, at a temperature not exceeding 25°C. Shelf life – 3 years.

The effectiveness of the drug Dazolic (ornidazole) in the treatment of bacterial vaginosis

Bacterial vaginosis is one of the most common vulvovaginal infections, especially among women of reproductive age. Numerous studies have established that the vaginal ecosystem is very complex, multicomponent, hormone-dependent and easily vulnerable. Many factors in the life of a modern woman can upset this balance: the use of antibiotics, contraceptives, casual sex, and more.

Table 1. Duration of the disease

Table 2. Frequency of detection of typical laboratory signs of bacterial vaginosis

Assessing the significance of this problem in women's health, in the 80s of the last century, which is relatively recent, bacterial vaginosis was identified as an independent nosological form, which is defined as an infectious non-inflammatory syndrome associated with vaginal dysbiosis, and is characterized by massive proliferation of strictly anaerobic gram-negative bacteria. The frequency of this type of biocenosis disturbance increases from year to year. In the 90s of the last century, it was diagnosed in 19-33.0% of women, at the beginning of the 21st century it was detected in 38-44.6% of women, and in 2005 - in almost 70% of “conditionally healthy” women. Bacterial vaginosis is a polymicrobial vaginal syndrome, the most common pathogens of which are obligate anaerobic bacteria of the genus Prevotella (Bacteroides), Fusobacterium, Peptostreptococcus, Mobiluncus

, as well as microaerophiles -
Gardnerella vaginalis
and
Mycoplasma hominis
. Considering the multicomponent etiological factor of the disease, the objective of our study was to prove that the drug Dazolic (ornidazole) is optimal for the treatment of bacterial vaginosis. It is known that ornidazole does not have resistance to pathogenic and opportunistic microflora; in addition, it does not inhibit lactobacilli. Also, the advantages in choosing the drug Dazolic (ornidazole) should be considered optimal compliance: tolerability of ornidazole with alcohol (does not inhibit aldehyde dehydrogenase). In addition, since ornidazole does not produce active metabolites, fewer cases of intoxication (nausea, metallic taste in the mouth) were observed when taking it.

Purpose of clinical trials

– to evaluate the clinical effectiveness and tolerability of oral administration of the drug Dazolic in the treatment of bacterial vaginosis in women of reproductive age.

Inclusion criteria.

Patients 18-45 years old with bacterial vaginosis, the diagnosis should be confirmed by clinical and laboratory signs proposed by Amsel R et al. In (1983).

Exclusion criteria

age under 18 and over 45 years;
ascending process of genital pathology, somatic burden, including endocrine pathology, obesity, heart failure, serious liver or kidney pathology;
asocial status of the patient, which makes clinical and serological control impossible;
systemic and/or local therapy within 1 month before this study;
women during pregnancy and breastfeeding;
patients with STIs (syphilis, gonorrhea, etc.);
patients with a history of ornidazole intolerance.

Performance evaluation criteria:

dynamics of complaints and clinical manifestations;
laboratory effectiveness:
normalization of smears for microflora and lack of growth of anaerobic microflora in bacteriological culture.

Good effect:

complete regression of clinical symptoms;
complete elimination of the pathogen.

Satisfactory effect:

complete regression of clinical symptoms;
detection of pathogenic microorganisms by one of the methods after completion of therapy.

Bad effect:

no regression of clinical symptoms;
clinical relapse;
detection of pathogenic microorganisms after completion of therapy.

Criteria for assessing adverse reactions (tolerability) from the treatment:

I (mild) degree – the presence of adverse reactions that do not affect the patient’s daily activity;
II (moderate) degree - the presence of side effects that cause discomfort with some impact on daily activity;
III (severe) degree - the presence of side effects leading to loss of performance and the inability to perform normal daily activities.

Research methods

In all patients, the microflora of the genitourinary organs was examined with determination of the number and types of microorganisms and a general smear before and 7-10 days after treatment.

General clinical examinations were carried out in all patients and included a general blood test and a general urinalysis.

The study was conducted on the basis of the Federal State Institution “UrNIIDVII Rosmedtekhnologii”. The study included 26 women aged 22 to 45 years (mean age 29.5 ± 2.7) diagnosed with bacterial vaginosis. Complaints of copious creamy discharge with an unpleasant odor, which intensified before menstruation, were made by 19 patients, itching of the external genitalia was noted by 3 women, and discomfort in the urethra was noted by 2 patients.

The duration of the disease in most patients was less than four weeks. And only one patient had symptoms that persisted for more than 6 months before going to a specialized institution.

During an objective examination, vulvar hyperemia was detected in only one patient; heavy or moderate vaginal discharge, which was located in the posterior fornix and/or evenly distributed along the vaginal walls, was detected in all patients. In 19 women (86.3%) with a disease duration of less than one month, they had a liquid consistency of white or grayish tint. In three patients (13.6%), the discharge in the posterior vaginal fornix had a thick consistency, gray color and had the property of stretching. All women had no signs of inflammation in the mucous membrane of the vagina and cervix. The distribution of typical laboratory signs of bacterial vaginosis in patients is presented in Table 2.

In the majority of the examined patients, the pH of the vaginal discharge shifted to the alkaline side. An unpleasant “fishy” smell of discharge, which intensifies when mixed with a 10% KOH solution, was detected in all but two patients. The presence of “key cells” in vaginal smears was also detected in the majority of patients (92.3%). The number of leukocytes varied from 8 to 40 per field of view, but in the majority of patients (73.1%) did not exceed 15. In all patients (26 people), the causative agent of bacterial vaginosis was Gardnerella vaginalis

, against which 5-NIMZ is active and ornidazole is also active.
Microscopy of the vaginal smear did not reveal known pathogenic pathogens - Trichomonas vaginalis, Neisseria gonorrhoeae, Candida albicans
, therefore all patients under our supervision received monotherapy with Dazolic 500 mg twice a day for five days
per os .
All 26 women completed the study. During the therapy, normalization of the clinical picture and laboratory parameters was achieved in the majority of patients. Clinical symptoms disappeared on days 3-4 of treatment in 23 patients, 1 patient still had complaints of discomfort in the urethra, and two patients had complaints of discharge.

When monitoring the cure 7-10 days after the end of therapy with Dazolic, all 26 patients noted an improvement in their condition; complaints of discharge persisted in only one patient. In smears for microflora in 3 women, single “key cells” were found; during bacteriological examination, an increase in G . vaginalis

a titer of less than 103 CFU/ml was also detected in 2 patients. In addition, in 12 patients (46.2%) an insufficient amount or absence of lactoflora remained. In all patients receiving therapy with Dazolic, the pH of the vaginal discharge shifted to the acidic side. The amino test was also negative in all those examined.

In the clinical study conducted, the drug Dazolic was well tolerated: no side effects or complications were noted in any patient.

Thus, studies conducted at the Federal State Institution UrNIIDVII Rosmedtekhnologii have shown that Dazolic is highly effective in the treatment of women with bacterial vaginosis and is well tolerated by patients.