Trade name of the drug: Welflox

Active ingredients (INN): ofloxacin, ornidazole

Dosage form: film-coated tablets.

Composition:

To ach coated tablet contains:

active substance: ofloxacin 200 mg, ornidazole 500 mg;

excipients: corn starch, sodium starch glycolate, povidone, crospovidone, microcrystalline cellulose 101, aerosil, magnesium stearate, isopropyl alcohol, coating for Instacoat Orange tablets

Description: Tablet in the form of a capsule, covered with an orange biconvex film shell, with a break line on one side and smooth on the other side.

Pharmacotherapeutic group: Antibacterial synthetic agent.

ATX code: J01RA09

 

Pharmacological properties

Pharmacodynamics

Ofloxacin belongs to the group of fluoroquinolones. Has a wide range of effects.

The bactericidal effect of ofloxacin, like other fluoroquinolones, is due to its ability to block the bacterial enzyme DNA gyrase (without which microorganisms cannot exist).

Ofloxacin has a wide spectrum of action against microorganisms resistant to penicillins, aminoglycosides, cephalosporins, as well as microorganisms with multiple resistance. Viruses and fungi are not sensitive to the drug.

Ornidazole is highly effective in the treatment of protozoal and mixed infections. Ornidazole is effective against Trichomonas vaginalis , Entamoeba histolytica , Giardia lamblia ( Giardia intestinalis), as well as some anaerobic bacteria such as Gardnerella vaginalis , Bacteroides and Clostridium spp., Fusobacterium , and anaerobic cocci.

 

Pharmacokinetics

Suction:

Ornidazole is rapidly absorbed. The average  absorption  is  90 %. The peak plasma concentration is  reached after 3 hours. Ofloxacin is almost completely absorbed when administered orally.

Distribution:

The degree of connection of ornidazole with plasma proteins is 13%. Ornidazole penetrates well into the cerebrospinal fluid and tissues. Plasma concentration is in the optimal range for various indications for the use of the drug (6-36  mg / l ). The binding of ofloxacin to plasma proteins in vitro is about 32%. Ofloxacin is widely distributed in body tissues .

Metabolism:

Ornidazole is mainly metabolized in the liver to form 2-hydroxymethyl and α-hydroxymethyl metabolites. Both metabolites are less active against Trichomonas vaginalis and anaerobic bacteria than unchanged ornidazole. The maximum concentration of ofloxacin in the blood is observed 1-3 hours after administration.

Derivation:

The half-life of ornidazole is about 13 hours. After a single dose, 85% of the dose is excreted within 5 days, mainly in the form of metabolites. About 4% of the dose taken is excreted unchanged through the kidneys. The half-life of ofloxacin is 4-6 hours. Ofloxacin is excreted mainly unchanged in the urine.

 

Indications for use

The drug is indicated for the treatment of mixed infections that are caused by pathogens (microorganisms and protozoa) that are sensitive to the components of the drug:

• diseases of the genitourinary system: acute and chronic pyelonephritis, prostatitis, cystitis, epididymitis, surgical infections, complicated or recurrent infections of the urinary tract, gynecological diseases;
• sexually transmitted diseases caused by penicillin-resistant gonococci, chlamydia, Trichomonas and other microorganisms;
• infections of the abdominal cavity and biliary tract, as well as amebiasis – amoebic dysentery, extraintestinal forms, especially amoebic liver abscess, giardiasis and other infectious diseases such as typhoid fever, salmonellosis, shigellosis;
• oral infections, acute necrotizing ulcerative gingivitis;
• prevention of infectious complications in patients with immunodeficiency or in patients with neutropenia; preoperative preparation or postoperative treatment of surgical infections, especially in gastroenterology.

 

Method of administration and dosage

The drug should be taken orally without chewing with water. It is allowed to take the drug both before and after meals. It is not recommended to take for more than 2 months. The dose of the drug and the duration of treatment are determined by the doctor. The average dose for adults is 1 tablet 2 times a day with a duration of treatment of 7-10 days; treatment should be continued for at least 3 days after the disappearance of the clinical symptoms of the disease.

 

Side effects

Gastrointestinal: abdominal pain; nausea; vomiting; anorexia, enterocolitis, hypoglycemia in patients with diabetes mellitus who receive hypoglycemic drugs.

Nervous system: agitation; dizziness; headache; sleep disorders (insomnia or drowsiness); peripheral sensitivity disorders; lack of coordination.

Hematopoiesis : anemia; leukopenia, eosinophilia, thrombocytopenia, pancytopenia.

Kidney: increases plasma creatinine.

Liver : increased activity of liver enzymes and bilirubin.

Cardiovascular system: arterial hypotension, tachycardia.

Musculoskeletal system: tendinitis, especially in elderly patients, it can also be arthralgia, myalgia.

Allergic reactions: skin fever, itching, photosensitivity, angioedema.

 

Contraindications

Hypersensitivity (allergy) to the components of the drug, epilepsy, damage to the central nervous system with a tendency to seizures (after traumatic brain injury, stroke, inflammatory processes of the brain and meninges); age under 16; pregnancy, lactation period.

 

Drug interactions

If you are taking antacids or drugs that contain iron, the effectiveness of the Drug decreases, and therefore the drug is taken 2 hours before or 2 hours after using these drugs.

With simultaneous use with non-steroidal anti-inflammatory drugs, the risk of a stimulating effect on the central nervous system and the development of seizures increases.

With simultaneous use with probenecid, cimetidine, furosemide and methotrexate, the excretion of the drug decreases, and with urine, the half-life increases and the risk of its toxic effect increases. Strengthens the effect of coumarone anticoagulants, increases the muscle relaxant effect of vecuronium bromide.

 

special instructions

When treating with the drug, one should not be unnecessarily exposed to direct sunlight; exposure to ultraviolet rays (mercury-quartz lamps, solarium) should be avoided.

Patients with diabetes mellitus who are taking sugar-reducing drugs, the drug should be used with caution.

Patients with impaired renal function or severe liver damage (cirrhosis) should not exceed the average daily dosage (2 tablets).

Prolonged use of the drug, but can cause a secondary infection associated with the growth of microorganisms resistant to the drug.

During treatment with the drug, you should refrain from drinking alcoholic beverages.

P USAGE during pregnancy and lactation

The use of the drug during pregnancy and lactation is contraindicated.

Influence on the ability to drive a car and complex mechanisms

Patients who drive vehicles, work with machines and mechanisms should be aware of possible undesirable effects on the part of the nervous system.

The drug should not be used after the expiration date and should be kept out of the reach of children.

 

Overdose

The most important symptoms of an overdose are symptoms from the central nervous system: dizziness, confusion, convulsions, reactions from the digestive tract – nausea and vomiting. In case of overdose, consult a doctor immediately.

 

Release form

10 tablets in a blister, 3 or 5 blisters in a carton box, along with instructions for medical use.

 

Storage conditions

Store in a dry, dark place at a temperature

not higher than 25 ° С.

 

Shelf life

2 years.

 

Conditions of dispensing from pharmacies

On prescription.