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

Ornidazole is effective against Trichomonas vaginalis, Entamoeba histolytica, Giardia lamblia (Giardia intestinalis), as well as some anaerobic bacteria such as Bacteroides spp., Clostridium spp., Fusobacterium spp., And anaerobic cocci: Peptostreptococcus spp.

Orniferous microorganisms are not sensitive to ornidazole.

Pharmacokinetics:

The binding of ornidazole to proteins is about 15%. Penetrates into breast milk and most tissues, cerebrospinal fluid, other body fluids, passes through the blood-brain barrier and the placenta. Ornidazole is metabolized in the liver with the formation of mainly 2-hydroxymethyl- and α-hydroxymethylmetabolites. Both metabolites are less active in relation to Trichomonas vaginalis and anaerobic bacteria than unchanged ornidazole. The half-life is about 13 hours. It is excreted as metabolites through the intestine and kidneys. About 5% of the dose is excreted unchanged.

Indications:

Quinizole is indicated for the treatment of infections caused by ornidazole-sensitive microorganisms and protozoa:

- infections caused by anaerobic microorganisms (septicemia, peritonitis, meningitis, osteomyelitis,infection of the pelvic organs, skin and soft tissue infection, postoperative wound infections), including as part of combination therapy;

- a severe form of intestinal and hepatic amoebiasis.

Prevention of anaerobic infections during surgical interventions on the abdominal organs, pelvic organs.

Contraindications:

Hypersensitivity to ornidazole, excipients and other derivatives of nitroimidazole, I trimester of pregnancy, the period of breastfeeding, organic diseases of the central nervous system, pathological changes in blood and abnormalities of blood cells.

Carefully:

Dysfunction of the liver, alcoholism, elderly patients, pregnancy II and III trimester.

Pregnancy and lactation:

Ornidazole is contraindicated for use in the first trimester of pregnancy and during breastfeeding. In the experiment ornidazole does not have a teratogenic or toxic effect on the fetus. Since controlled studies in pregnant women have not been performed, ornidazole in the II and III trimesters of pregnancy is possible only on absolute indications, when the possible benefits of its use for the mother exceed the potential risk to the fetus.

If you need to use the drug during breastfeeding, you should stop breastfeeding. Renewal of breastfeeding is possible no earlier than 48 hours after the last dose of the drug.

Dosing and Administration:

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

The rate of intravenous drip infusion is 5 ml per minute.

Interval between administrations - 12 hours.

The duration of the course of treatment is determined individually, depending on the clinical condition. According to the indications, depending on the nature of the infection, as early as possible the transition to maintenance therapy with oral forms of ornidazole.

With intestinal amebiasis and amoebic liver abscess: adults - the initial dose of 500 mg - 1 g, followed by a transition to the administration of a dose of 500 mg every 12 hours. Children: 2-30 mg / kg / day. The course of treatment is 3-6 days.

Anaerobic bacterial infections: adults - an initial dose of 500 mg - 1 g, followed by a transition to the administration of 500 mg every 12 hours. Children: 10 mg / kg every 12 hours. The course of treatment is 5-10 days.

Prevention of infection caused by anaerobic bacteria: 500 mg - 1 g for 30 minutes before the operation.

Side effects:

Side effects are systematized using the following classification: very often (> 1/10), often (> 1/100 - <1/10), infrequently (> 1/1000 - <1/100), rarely (> 1/10000 - <1/1000), very rarely (<1/10000).

Disturbances from the nervous system: often - headache, drowsiness, fatigue, dizziness; rarely - temporary loss of consciousness, tremor, rigidity of muscles, impaired coordination of motion, convulsions, sensory or mixed peripheral neuropathy; very rarely - a change in taste.

Violation of the blood and lymphatic system: infrequently - oppression of bone marrow hematopoiesis, neuropathy.

Disorders from the digestive system: very often - nausea, vomiting, metallic taste in the mouth; rarely - diarrhea, a change in the activity of "liver" enzymes, loss of appetite.

Impaired immune system: infrequently - hypersensitivity reactions, skin rash, itching, urticaria, angioedema.

General disorders and disorders at the site of administration: pain in the injection site.

Overdose:

Dose-dependent symptoms, mentioned in the section "Side effect", but in a more pronounced form.

Treatment: symptomatic therapy; with convulsions appointed diazepam.

Interaction:

Ornidazole enhances the effect of indirect anticoagulants of the coumarin series, which requires appropriate correction of their dose.

Lengthens the miorelaxing effect of vecuronium bromide.

Joint reception with phenobarbital or other inducers of liver enzymes reduces the half-life of ornidazole from the blood plasma.

When combined use of ornidazole with inhibitors of microsomal liver enzymes (for example, cimetidine) there is an increase in the concentration of ornidazole.

Do not mix with other drugs in one bottle.

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.

In the course of treatment, there may be a worsening of the course of diseases of the peripheral nervous system. When symptoms of peripheral neuropathy, ataxia, dizziness or confusion arise, treatment should be suspended.

In patients on hemodialysis, a reduced half-life is observed.You may need to adjust the dose of the drug.

Patients receiving therapy and lithium preparations should monitor the concentration of lithium, electrolytes and creatinine in the blood plasma during treatment with ornidazole.

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

During the period of treatment, it is not recommended to drive vehicles and engage in other potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Solution for infusion, 5 mg / ml.

Packaging:

100 ml per bottle of low density polyethylene, with a lid of low density polyethylene.

One bottle together with the instruction for use is placed in a cardboard box.

Storage conditions:

In a dry, the dark 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:LP-000479

Date of registration:01.03.2011 / 09.06.2016

Expiration Date:Unlimited

The owner of the registration certificate:ARS, LLC ARS, LLC Russia

Manufacturer: & nbsp

VMG Pharmaceuticals, Private Ltd. India

Representation: & nbspARS, LLCARS, LLC

Information update date: & nbsp28.12.2017

Illustrated instructions

Instructions

Quinizole (Kvinizol)