Dasolik, 500 mg 10 pcs

An antiprotozoal and antimicrobial drug, a derivative of 5-nitroimidazole. Mechanism of action consists in biochemical reduction of 5-nitrogroup of ornidazole by intracellular transport proteins of anaerobic bacteria and protozoa. The reduced 5-nitrogroup of ornidazole interacts with the DNA of the cells of microorganisms, inhibiting the synthesis of their nucleic acids, which leads to the death of the bacteria.

It is active against Trichomonas vaginalis, Giardia lamblia, Entamoeba histolytica as well as anaerobes Bacteroides spp. (including Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus), Fusobacterium spp. Aerobic microorganisms are not sensitive to ornidazole.

Absorption from the gastrointestinal tract is high. Bioavailability – 90%. Time to reach maximum concentration (TCmax) – 1-2 hours. Binding to plasma proteins – less than 15%. Metabolized in the liver by hydroxylation, oxidation and glucuronidation. T1/2 is 12-14 hours. It penetrates into breast milk and most tissues, passes through the blood-brain barrier and the placenta.

The elimination half-life (T1/2) is about 13 hours. It is excreted as metabolites by kidneys (60-70%) and with feces (20-25%), about 5% of dose is excreted unchanged.

Indications

Trichomoniasis, amebiasis, amoebic dysentery, extraintestinal amebiasis (including amoebic liver abscess); giardiasis; prevention of infections caused by anaerobic bacteria during operations on the colon and gynecology.

Pharmacological effect

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 bacteria and protozoa. The reduced 5-nitro group of ornidazole interacts with DNA in microbial cells, inhibiting the synthesis of their nucleic acids, which leads to the death of bacteria.

Active against Trichomonas vaginalis, Giardia lamblia, Entamoeba histolytica, as well as anaerobes Bacteroides spp. (including Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus), Fusobacterium spp., Clostridium spp. Aerobic microorganisms are not sensitive to ornidazole.

Absorption from the gastrointestinal tract is high. Bioavailability – 90%. Time to reach maximum concentration (TCmax) – 1-2 hours. Communication with plasma proteins – less than 15%. Metabolized in the liver by hydroxylation, oxidation and glucuronidation. T1/2 – 12-14 hours. Penetrates into breast milk and most tissues, passes through the blood-brain barrier and placenta.

The half-life (T1/2) is about 13 hours. It is excreted in the form of metabolites by the kidneys (60-70%) and with feces (20-25%), about 5% of the dose is excreted unchanged.

Special instructions

When treating trichomoniasis, both sexual partners should be treated simultaneously.

Influence on the ability to drive vehicles and operate machinery.

Active ingredient

Ornidazole

Composition

Each tablet contains:

Active substances:

Ornidazole – 500.0 mg

Excipients:

starch,

microcrystalline cellulose,

sodium lauryl sulfate,

povidone-K90,

purified talc,

magnesium stearate,

colloidal silicon dioxide,

sodium carboxymethyl starch (type A),

butyl methacrylate,

dimethylaminoethyl methacrylate and methyl methacrylate copolymer [1:2:1] (Eudragit E 100),

titanium dioxide,

macrogol-6000.

Pregnancy

The drug is contraindicated for use in the first trimester of pregnancy and during lactation (breastfeeding).

Contraindications

Hypersensitivity. Children up to 3 years of age (for this dosage form).

With caution

Side Effects

Drowsiness, headache, dysfunction of the gastrointestinal tract (including nausea), dizziness, tremor, muscle rigidity, impaired coordination of movements, convulsions, fatigue, temporary loss of consciousness, sensory or mixed peripheral neuropathy, perversion of taste, increased activity of liver enzymes, allergic reactions.

Interaction

Enhances the effect of indirect coumarin anticoagulants and prolongs the muscle relaxant effect of vecuronium bromide.

Compatible with ethanol (does not inhibit acetaldehyde dehydrogenase) unlike other imidazole derivatives (metronidazole).

Overdose

Symptoms: seizures, depression, peripheral neuritis.

Treatment: symptomatic (diazepam – for seizures).

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25°C.

Shelf life

3 years.

Manufacturer

Sun Pharmaceutical Industries Ltd, India