Ornidazol (ornidazol) coated tablets 500 mg. №10

Description

Ornidazol composition
active substance: ornidazole;
1 tablet contains ornidazole in terms of 100% substance, 500 mg;
excipients: microcrystalline cellulose; povidone; talc; sodium starch glycolate (type A); lactose, monohydrate; calcium stearate, “Opadry ΙΙ White” coating mixture (contains: hypromellose; lactose, monohydrate; titanium dioxide (E 171); triacetin; polyethylene glycol / macrogol).

Dosage form
Film-coated tablets.

Pharmacological properties
Ornidazol is an antiprotozoal and antibacterial agent derived from 5-nitromidazole. Active against Trichomonas vaginalis, Entamoeba histolytica, Giardia lamblia (Giardia intestinalis), as well as against some anaerobic bacteria such as Bacteroides, Clostridium spp., Fusobacterium spp., And anaerobic cocci.
According to the mechanism of action, ornidazole is a DNA-tropic drug with selective activity against microorganisms that have enzyme systems capable of reducing the nitro group and catalyzing the interaction of proteins of the pheredoxin group with nitro compounds. After the penetration of the drug into the microbial cell, the mechanism of its action is due to the restoration of the nitro group under the influence of nitroreductases of the microorganism and the activity of the already reduced nitroimidazole. Recovery products form complexes with DNA, causing its degradation, disrupt the processes of DNA replication and transcription. In addition, the metabolic products of the drug have cytotoxic properties and disrupt the processes of cellular respiration.

Indications:

• Trichomoniasis (genitourinary infections in women and men caused by Trichomonas vaginalis).
• Amoebiasis (all intestinal infections caused by Entamoeba histolytica, including amoebic dysentery, all extraintestinal forms of amebiasis, especially amoebic liver abscess).
• Giardiasis.

Contraindications
Hypersensitivity to the drug or to other nitroimidazole derivatives. Patients with CNS damage (epilepsy, brain damage, multiple sclerosis). Pathological blood lesions or other hematological abnormalities.

Children
Ornidazol is used in pediatrics.

Application during pregnancy or lactation
Ornidazole has no teratogenic or toxic effects on the fetus. Since controlled studies of pregnant women have not been conducted, it is possible to prescribe the drug in early pregnancy or during lactation only if there are absolute indications, if the possible advantage when using the drug for the mother outweighs the potential risk to the fetus / child.

Method of administration and dosage
Ornidazol should always be taken orally after meals.
Patients with hepatic impairment: the dosing interval should be doubled for patients with severe hepatic impairment.

• Trichomoniasis:                                                                                                                                                              500 mg tablets are used in single or 5-day therapy regimens.
  Since taking ornidazole can lead to reactions such as redness, numbness, fever, nausea and vomiting, as well as possible hypotension and tinnitus, therefore, alcohol should not be consumed for at least 3 days after taking the drug.
  A single therapeutic dose – 3 tablets are taken in the evening, the next 5 days – 1 tablet in the morning, 1 tablet in the evening.
  To eliminate the possibility of re-infection, the sexual partner must undergo the same course of treatment.
  The single daily dose for children is 25 mg / kg.
• Amoebiasis:
  Possible treatment regimens                                                                                                                                          3-day course of treatment for patients with amoebic dysentery                                                                                With a body weight of more than 35 kg – 3 tablets at one time in the evening. With a body weight of more than 60 kg, 4 tablets (2 tablets in the morning and 2 tablets in the evening).                                                        Children weighing up to 35 kg – 40 mg / kg of body weight – a single dose.                                                            5-10-day course of treatment for all forms of amebiasis                                                                                      Adults and children weighing more than 35 kg – treatment 2 tablets (1 tablet in the morning and 1 tablet in the evening).                                                                                                                                                              Children weighing up to 35 kg – 25 mg / kg of body weight – a single dose.

Overdose
Manifested by an increase in the symptoms of adverse reactions.
Treatment: the specific antidote is unknown, in case of seizures, diazepam should be used. Therapy is symptomatic.

Side effects:

• From the lymphatic system and the hematopoietic system: manifestations of the effect on the bone marrow, leukopenia, neutropenia.
• From the nervous system: drowsiness, headache, dizziness, tremors, rigidity, lack of coordination, ataxia, seizures, fatigue, spatial disorientation, temporary loss of consciousness, confusion, agitation and peripheral neuropathy.
• General disorders: fever, chills, general weakness, shortness of breath.
• From the gastrointestinal tract: taste disturbance, metallic taste in the mouth, coated tongue, nausea, vomiting, diarrhea, pain in the epigastric region, dry mouth, loss of appetite.
• From the hepatobiliary system: unknown – jaundice, violation of the biochemical indicator of liver function, increased levels of liver enzymes; hepatotoxicity.
• From the immune system: hypersensitivity reactions, including anaphylactic shock, angioedema.
• On the part of the skin and subcutaneous tissue: skin rashes, urticaria, flushing of the skin, itching.
• Infections and invasions: exacerbation of candidomycosis.
• Others: darkening of the color of urine, cardiovascular disorders, incl. lowering blood pressure.

Shelf life
4 years.

Storage conditions
Store in its original packaging at a temperature not exceeding 25 ° C.
Keep out of the reach of children.