Quinizol - instructions for use, dose, side effects, contraindications

auxiliary substances (core): microcrystalline cellulose 35.0 mg, starch 45.0 mg, croscarmellose sodium 10.0 mg, talc 6.0 mg, magnesium stearate 3.0 mg; auxiliary substances (shell): hypromellose 10.12 mg, macrogol 1.0125 mg, talc 8.0 mg, titanium dioxide 2.0 mg.

Description:

round biconvex tablets coated with a film coat of white or almost white color.

On a cross-section of a tablet of white or almost white color.

Pharmacotherapeutic group:An antiprotozoal agent.

ATX: & nbsp

G.01.A.F.06 Ornidazole

Pharmacodynamics:

Antiprotozoal and antimicrobial drug, a derivative of 5-nitroimidazole. The mechanism of action is the biochemical reduction of the 5-intro group of ornidazole by intracellular transport proteins of anaerobic bacteria and protozoa. The recovered 5-nitro ornidazole interacts with DNA microbial cells by inhibiting synthesis of nucleic acids, which leads to the death of the bacteria. Active with respect to Trichomonas vaginalis, Giardia lamblia, Entamoeba histolytica, as well as anaerobes Bacteroides spp. (incl. Bacteroides fragilis, Bacteroidcs distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus), Fusobacterium spp., Clostridium spp.

Orniferous microorganisms are not sensitive to ornidazole.

Pharmacokinetics:

Suction

After oral administration ornidazole quickly absorbed in the gastrointestinal tract (GIT). Absorption is about 90%. The maximum concentration in the plasma is reached within 3 hours. Distribution

The association of ornidazole with proteins is about 13%. Penetrates into the cerebrospinal fluid, other body fluids and tissues.

Concentrations of ornidazole in plasma are in the range of 6-36 mg / l.

After multiple doses of 500 mg or 1000 mg every 12 hours, the cumulation factor was 1.5-2.5.

Metabolism

Ornidazole is metabolized in the liver with the formation of mainly 2-hydroxymethyl- and α-hydroxymethylmetabolites. Both metabolites are less active Trichomoinas vaginalis and anaerobic bacteria than unchanged ornidazole.

Excretion

The half-life is about 13 hours. After a single dose, 85% of the dose is excreted within the first 5 days, mainly in the form of metabolites. About 4% of the accepted dose is excreted through the kidneys in unchanged form, and 20-25% by the intestine.

Indications:

Trichomoniasis (urinary infections the women and men caused by(Trichomonas vaginalis); amoebiasis (all intestinal infections caused byEntamoeba histolylica, in t.ch. amoebic dysentery, extraintestinal forms of amoebiasis, especially amoebic liver abscess); giardiasis.

Prevention of anaerobic infections in operations on the colon and gynecological interventions.

Contraindications:

Hypersensitivity to the drug (including other derivatives of introimidazole). Children under 12 years (for this dosage form).

Carefully:

Diseases of the central nervous system (including epilepsy, multiple sclerosis), liver disease, alcoholism, pregnancy, lactation.

Pregnancy and lactation:

In the experiment Ornidazole did not have a teratogenic or embryotoxic effect. Since controlled studies in pregnant women were not administered Ornidazole during pregnancy (especially in the early stages) or lactating mothers can only be in absolute indications, when the possible benefits of its use for the mother exceed the potential risk to the fetus and the baby.

Dosing and Administration:

Ornidazole is taken orally after a meal, with a small amount of water.

With trichomoniasis

Treatment is carried out for 5 days, 500 mg orally 2 times a day (morning and evening).

In order to reduce the risk of re-infection at the same time, the course treatment of the sexual partner is carried out.

Children older than 12 years - inside 25 mg / kg for 5 days.

With intestinal amebiasis

Adults and children weighing more than 35 kg - 1.5 g once a 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. The course of treatment is 3 days.

With extraintestinal amebiasis

Adults and children over 12 years of age - 0.5 grams inside, morning and evening for 5-10 days. With giardiasis

Adults and children weighing more than 35 kg - 1.5 g / day; Children weighing less than 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:

Slightly drowsiness, headache and nausea. In some cases - violations of the central nervous system, such as: dizziness, tremor, rigidity of muscles, impaired coordination, convulsions, fatigue, temporary loss of consciousness, signs of sensory or mixed peripheral neuropathy.

There have been cases of distortion of taste sensations, changes in "liver" functional tests, skin reactions and hypersensitivity reactions.

Overdose:

Symptoms: increased dose-dependent side effects.

Treatment: symptomatic, specific antidote is unknown; with convulsions - diazepam.

Interaction:

Unlike other nitroimidazole derivatives, ornidazole does not inhibit aldehyde dehydrogenase and therefore is not incompatible with alcohol. Ornidazole enhances the effect of oral anticoagulants coumarinic series, which requires appropriate correction of their dose. Ornidazole prolongs the miorelaksiruyuschee action of vecuronium bromide.

Special instructions:Care should be taken in patients with diseases of the central nervous system (epilepsy, multiple sclerosis). There is a certain risk in patients with diseases of the liver, brain, alcohol abusers, pregnant and lactating mothers and children, especially when the dose is exceeded.

Effect on the ability to drive transp. cf. and fur:

Studies on the effect of the drug on the ability to drive and work with complex mechanisms have not been conducted, however, taking into account the possible development of side effects from the nervous system (including dizziness, impaired coordination of movements) during drug treatment should refrain from driving and from employment by other kinds of activity requiring an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Tablets, film-coated, 500 mg.

Packaging:

For 10 tablets in a foil blister of aluminum and PVC; 1 or 2 blisters with instructions for use in a cardboard box.

Storage conditions:

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 after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:PL-000208

Date of registration:14.02.2011

The owner of the registration certificate:VIMG Pharmaceuticals Pvt. Ltd. VIMG Pharmaceuticals Pvt. Ltd. India

Manufacturer: & nbsp

VMG Pharmaceuticals, Private Ltd. India

Information update date: & nbsp01.11.2011

Illustrated instructions

Instructions

Quinizole (Kvinizol)