The instruction for medical use
of Dazolik Torgovoye medicine a name
Mezhdunarodnoye the unlicensed
name Ornidazol Lekarstvennaya
the Tablet form, film coated 500 mg
One tablet contains
active agent of an ornidazol of 500 mg,
excipients: starch, cellulose microcrystalline, sodium the lauryl sulfate, K 90 povidone, talc purified of magnesium stearate, silicon dioxide colloidal anhydrous, sodium glikollit starch (type A),
a cover: copolymer of the main butylmethacrylate, titanium dioxide (E171), polyethyleneglycol 6000, isopropyl alcohol, acetone, the water purified.
of the Tablet of white color, film coated, round biconvex shape, with risky on one party.
Other antibacterial drugs. Imidazole derivatives. Ornidazol.
The ATX J01XD03 code
Pharmacokinetics Later properties of intake, active ingredient of the drug Dazolik – ornidazol
almost all is soaked up from a digestive tract. After reception of an oral dose of 1.5 g the maximum concentration in blood plasma, equal 30 mkg/ml, are reached within 3 hours after reception and decreases to 9 mkg/ml and 2.5 mkg/ml within 24 and 48 hours, respectively. After reception of an oral dose of 750 mg the maximum concentration in blood plasma, equal 11 mkg/ml, was reached during from 2 to 3 hours after reception. After reception of an oral dose of 500 mg the maximum concentration in blood plasma, equal 7, 8 and 7 mkg/ml, was reached during the periods at 1, 2 and 4 hours, respectively.
Linking of an ornidazol with proteins of blood plasma makes about 15% and less. Ornidazol well gets into cerebrospinal fluid and other liquids and body tissues. Concentration of an ornidazol in vaginal liquid approximately same, as in blood plasma, is also reached 24 hours later after reception of a single oral dose. The volume of distribution is equal to about 0.9 l/kg.
Ornidazol is metabolized mainly in a liver, generally by hydrolysis and an oksidation. 5 metabolites of an ornidazol, two of which have antibacterial activity, are established, but are less active concerning Trichomonas vaginalis and anaerobic bacteria, than not changed ornidazol.
The most part of an ornidazol is excreted in urine in the form of metabolites, and about 4% of a dose are allocated in not changed look. The clearance of an ornidazol is from 45 to 50 ml/min. of blood plasma.
Through digestive tract about 22% of an oral dose are removed.
Biliary excretion of an ornidazol and its metabolites is sometimes observed.
Elimination half-life of an ornidazol – from 11 to 14 hours. Elimination half-life of an ornidazol and its main metabolites of M1 and M2 is extended at patients with abnormal liver functions.
Dazolik possesses antibacterial and antiprotozoan action.
Active agent of the drug Dazolik – ornidazol interacting with deoxyribonucleic acid (DNA) of a microbic cell, causes disturbance of its helical structure, a rupture of threads, suppresses synthesis of nucleic acids and causes death of microbic cells and cells of protozoa.
Dazolik is effective at treatment of the protozoan infections caused by Trichomonas vaginalis, Gardenella vaginalis, Giardia lamblia and Entamoeba histolytica and also concerning some causative agents of mephitic gangrenes – Peptostrepococcus, Peptococcus, Bacteroides, Clostridium and Fusobacterium (the minimum inhibiting concentration & lt, 4 mkg/ml).
– an intestinal amebiasis and an amebiasis of a liver
– a giardiasis
– trichomoniasis of urinogenital ways
– a bacterial vaginitis
– the mephitic gangrenes caused by sensitive microorganisms
the Route of administration and doses
of Adult 500 mg twice a day, orally, within 5 days.
To children 6 years of 10-25 mg/kg of body weight in two steps within 5 days are more senior.
Adult 1.5 g, once, within 3 days.
To children 6 years of 40 mg/kg of body weight once, within 3 days are more senior.
of Adult 1.5 g, once, within 1 – 2 days
to Children is more senior than 6 years of 40 mg/kg of body weight within 2 days.
of 1.5 g once, orally or 500 mg twice a day within 5 days. Partners in sex also have to undergo the same treatment.
A bacterial vaginitis
Three tablets at one time or 1 tablet Dazolika once within
5 7 days.
– nausea, vomiting, dyspepsia, pains in epigastric area, dryness in a mouth, loss of appetite, a perversion of flavoring feelings
– allergic reactions (skin rash, an itching)
it is rare
– a polyuria (as angiotensin can partially block II receptors)
– drowsiness, a headache, dizziness, fatigue, a temporary loss of consciousness, damages of central nervous system (ataxy, a dysarthtia, a tremor, spasms) and peripheral nerves (burning sensation, numbness of extremities, paresthesias)
– oppression of a leukopoiesis, a leukopenia
– change of activity of liver enzymes
of the Contraindication
– hypersensitivity to an ornidazol and other derivatives of an imidazole
– dysfunctions of the central nervous system (CNS): epilepsy or peripheral neuropathy
– liver diseases
– a hemodialysis
– alcohol intake
– pregnancy and the period of a lactation
– children’s age up to 6 years
Unlike other derivatives of a nitroimidazole, Dazolik does not inhibit an aldegiddegidrogenaza therefore does not cause side effects, like a disulfiram. However Dazolik exponentiates effect of oral anticoagulants of a coumarinic row that demands the corresponding dose adjustment. Ornidazol extends myorelaxation action a bromide vekoruniya. It was reported that ornidazol increases clearance of a 5-ftoruratsil.
Concentration of drug decreases at simultaneous use with inductors of microsomal enzymes (phenobarbital, rifampicin) and increases at simultaneous use with inhibitors of microsomal systems of a liver, in particular, with blockers of H2 receptors (Cimetidinum).
It is required to appoint special instructions with care ornidazol to patients with an ataxy, dizziness and disturbance of a mental state as it was reported about cases when drug worsens a mental condition of patients with disturbances of the central and peripheral nervous systems. With care it is necessary to appoint Dazolik sick with insufficiency of function of a liver (it is necessary to reduce a dosage), the patient with hemopoiesis disturbance (big risk of development of a leukopenia, neutropenia).
In trichomoniasis the simultaneous treatment of sexual partners is recommended.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Considering side effects of medicine it is necessary to be careful when driving or potentially dangerous mechanisms.
Symptoms: strengthening of side effects.
Treatment: symptomatic, specific antidote is unknown, in spasms diazepam is appointed.
A form of release and packing
On 10 tablets in planimetric bezjyacheykovy packing from aluminum foil.
On 1 and 5 planimetric bezjyacheykovy packs together with the instruction for medical use in the state and Russian languages place in a cardboard pack.
To Store storage conditions in the dry, protected from light place, at a temperature not over 25C.
To store out of children’s reach!
A period of storage
not to use after an expiration date
According to the prescription
the Name and the country
of the Sun Pharmaceutical Industries Ltd manufacturing organization, India
the Legal address:
Acme Plaza, Andheri – Kurla Road,
Andheri (E), Mumbai 400,059, India
the Address of location of production:
Survey No. 214, Government Industrial Estate, Phase II, Silvassa 396,230, U.T of D & NH, India
the Name and the country of the owner of the registration certificate
of Sun Pharmaceutical Industries Ltd, India
the Name and the country of the organization of the packer
of Sun Pharmaceutical Industries Ltd, India
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) 050004, Almaty, Tulebayev St., 38, 5 the floor Ph. (727) 250-92-35, fax (727) 250-33-64 firstname.lastname@example.org, email@example.com