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

cellulose microcrystalline, lactose, silicon colloidal dioxide, povidone (K-30), water *, sodium lauryl sulfate, talc, magnesium stearate, croscarmellose sodium.

Shell composition:

Opapray II (85G51314) **, water *.

* - Removed during production.

** - The composition of opedrai II (85G51314): hypromellose (HPMC 2910), titanium dioxide, macrogol-400, an aluminum lacquer based on a dye quinoline yellow, an aluminum lacquer based on a dye, a brilliant blue.

Description:

Oblong biconvex tablets are green, film-coated, with a risk on one side and smooth on the other. On the fracture, two layers are visible: a green shell and a tablet mass of almost white color.

Pharmacotherapeutic group: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-nitro group of ornidazole by intracellular transport proteins of anaerobic microorganisms 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, Gardnerella vaginalis, Giardia intestinalis, Entamoeba histolytica, Lamblia spp., as well as obligate anaerobes Bacteroides spp. (incl. Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicrori, 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:

Absorption of gastrointestinal tract - high. Bioavailability is 90%. The maximum plasma concentration of about 30 μg / ml is achieved within 2 hours after taking a single dose of 1.5 g, which decreases to 9 μg / ml after 24 hours and 2.5 μg / ml after 48 hours.

Half-life (T_1/2) - 12 - 14 hours. Connection with plasma proteins - not less than 15%. Penetrates through the blood-brain barrier.

Derive in the form of metabolites by the kidneys (60-70%) and through the intestine (20 - 25%), about 5% of the dose is excreted unchanged. 85% of a single dose is withdrawn within 5 days.

Indications:

- Trichomoniasis;

- all forms of amoebiasis (diseases of intestinal and extraintestinal localization, including amoebic liver abscess, amoebic dysentery, and asymptomatic amoebiasis);

- giardiasis;

- anaerobic bacterial infections (gynecological and abdominal infections caused by Bacteroides spp., Clostridium spp., Eubacterium spp., Peptococcus spp., Peptostreptococcus spp. and other anaerobes, sensitive to ornidazole.

- Treatment of infections Helicobacter pylori with peptic ulcer of the duodenum or stomach in combination with bismuth preparations and antibiotic.

- Prophylactic appointment before surgical intervention on the gastrointestinal tract and reproductive organs.

Contraindications:

Hypersensitivity to ornidazole and other nitroimidazole derivatives, as well as to other components of the drug.

- Leukopenia (including anamnesis).

- Organic damage to the central nervous system (including epilepsy).

- Pregnancy ( I trimester), the period of lactation.

- Children under 3 years (for this dosage form).

- Rare hereditary diseases, such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption.

Carefully:

Pregnancy (II-III trimesters), renal / hepatic insufficiency.

Pregnancy and lactation:

Carefully: Pregnancy (II-III trimesters).

contraindicated: Pregnancy ( I trimester), the period of lactation.

Dosing and Administration:

Ornidazole should be taken orally after eating with a small amount of water.

Trichomoniasis

Adults:

1 tablet 2 times a day (morning and evening) for 5 days.

Women need to be additionally appointed ornidazole in the form of vaginal tablets. If necessary, you can repeat the course of treatment. Between the courses should be a break in 3-4 weeks with the conduct of repeated control laboratory tests.

An alternative scheme of therapy is the appointment of 2 g once to the patient and his sexual partner.

Treatment is carried out at the same time for both sexual partners.

Children:

Daily dose for children is 25 mg / kg body weight and is assigned in one session.

Amebiasis

Possible treatment regimens:

Duration treatment	Daily dose
Duration treatment	Adults and children weighing more than 35 kg	Children with body weight up to 35 kg
a) 3 days	3 tablets in one evening. At a body weight of more than 60 kg - 4 tablets (2 tablets in the morning and in the evening).	40 mg / kg body weight in one session
b) 5-10 days	2 tablets (1 tablet in the morning and in the evening)	25 mg / kg body weight in one session

Adults:

With asymptomatic amoebiasis 500 mg (1 tablet) 2-3 times a day for 5-7 days.

For chronic amoebiasis 500 mg (1 tablet) 3 times a day for 5-10 days.

In acute amoebic dysentery, 1.5 g (3 tablets) once a day.

With liver abscess, the maximum daily dose of 2.5 g in 1 or 2-3 doses, for 3-5 days, in combination with antibiotics (tetracyclines) and other methods of treatment.

Lambliasis

Adults and children weighing more than 35 kg: 3 tablets once in the evening.

Children weighing less than 35 kg: 40 mg / kg once a day.

Duration of treatment is 1-2 days.

Infections caused by anaerobic bacteria

Adults:

For 500 mg (1-2 tablets) 3 times a day during or after meals.

Ornidazole can be used in monotherapy or in combination with other antibacterial drugs.

Children:

Daily dose for children is 10 mg / kg body weight and is prescribed 2 times a day. The average treatment period should not exceed 7 days.

Prevention of infections, caused by anaerobic bacteria (before surgical operations on the abdominal cavity, in gynecology and obstetrics)

First 1 g (2 tablets of 500 mg) in a single dose, then 1 tablet 500 mg 2 times a day for 3-5 days.

Eradication Helicobacter pylori

500 mg 3 times a day for 7 days (as part of combination therapy, for example, with amoxicillin 2.25 g / day.).

Side effects:

From the side of the central nervous system: headache, dizziness, tremor, rigidity of muscles, impaired coordination of movements, convulsions, sensory or mixed peripheral neuropathy, vertigo, sleep disturbance, weakness, increased excitability, irritability, temporary loss of consciousness.

From the digestive tract: epigastric pain, nausea, vomiting, diarrhea, constipation, intestinal colic, decreased appetite, there were cases of perversion of taste sensations, changes in liver functional tests.

From the hematopoietic system: leukopenia.

From the musculoskeletal system: arthralgia.

Allergic reactions: skin rash, itching, hives.

Overdose:

High doses can cause increased side effects, mainly nausea, vomiting and dizziness; in more severe cases, there may be ataxia, paresthesia and convulsions, depression.

In case of poisoning apply symptomatic and supportive treatment, there is no specific antidote.

Interaction:

Strengthens the effect of anticoagulants coumarinic series, prolongs the miorelaksiruyuschee effect of vecuronium bromide. Compatible with ethanol (does not inhibit acetaldehyde dehydrogenase), unlike other imidazole derivatives (metronidazole).

Special instructions:

Patients with severe hepatic insufficiency ornidazole should be administered with caution, because as a result of slowing metabolism, the concentration of ornidazole and its metabolites in plasma increases.

Because of the slowing down of excretion, care should be taken when choosing a dose of ornidazole in patients with renal insufficiency. In such patients, the dose should be reduced by half.

Ornidazole should be used with extreme caution in patients with bone marrow and central nervous system depression, as well as in elderly patients. The appearance of ataxia, dizziness and any other deterioration in the neurological status of patients requires discontinuation of treatment.

With prolonged therapy (more than 10 days), monitor the picture of peripheral blood and liver function.

With leukopenia, the possibility of continuing treatment depends on the risk of developing an infectious process.

When treating trichomonadal vaginitis in women and trichomoniasis in men, it is necessary to abstain from sexual activity. It is necessary to simultaneously treat sexual partners. After trichomoniasis therapy, control tests should be performed for three consecutive cycles before and after menstruation.

After treatment of giardiasis, if symptoms persist, 3 feces analysis should be performed at intervals of several days in 3-4 weeks (in some successfully treated patients lactose intolerance caused by invasion,can persist for several weeks or months, recalling the symptoms of giardiasis).

Form release / dosage:Tablets, film-coated 500 mg.

Packaging:

3 or 10 tablets in a blister of PVC / aluminum foil.

By 1, 4, 5, 7 or 10 blisters for 3 tablets in a cardboard box, along with instructions for medical use.

For 1 or 2 blisters of 10 tablets per cardboard pack, along with instructions for medical use.

Storage conditions:

At a temperature of no higher than 30 ° C, in a dry and dark place.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N015084 / 01

Date of registration:16.10.2009 / 04.02.2014

Expiration Date:Unlimited

The owner of the registration certificate:Panacea Biotech Co., Ltd.Panacea Biotech Co., Ltd. India

Manufacturer: & nbsp

PANACEA BIOTEC, Ltd. India

Representation: & nbspPANACEA BIOTEC Co., Ltd. PANACEA BIOTEC Co., Ltd. India

Information update date: & nbsp11.03.2017

Illustrated instructions

Instructions

Gairo (Giro)