OXIFAN [Ofloxacin] 400 mg Film-coated tablets

OXIFAN

instructions for medical use of the medicinal product

Tradename

Oxifan, Оксифан

International non-proprietary name

Ofloxacin, Офлоксацин

Composition

Oxifan 200 mg

Each film-coated tablet contains:

active ingredient: ofloxacin USP    200 mg

excipients: starch, hydroxypropylcellulose, magnesium stearate; film shell: hypromellose, polyvinylpyrrolidone, titanium dioxide.

Oxifan 400 mg

Each film-coated tablet contains:

active ingredient: ofloxacin USP    400 mg

excipients: starch, hydroxypropylcellulose, magnesium stearate; film shell: hypromellose, polyvinylpyrrolidone, titanium dioxide.

Dosage form

Tablets.

Pharmacotherapeutic group

The antimicrobial agent is a fluoroquinolone.

Pharmacological properties

Oksifan is an antimicrobial agent with a wide spectrum of antibacterial activity against gram-positive and gram-negative bacteria. The active substance is ofloxacin, a derivative of quinolone carboxylic acid.

Pharmacodynamics

Broad-spectrum antimicrobial drug
from the group of fluoroquinolones. The mechanism of action is due to the suppression of bacterial DNA replication by blocking DNA topoisomerase IV and DNA topoisomerase II (gyrase). It has a bactericidal effect.

The drug is active against microorganisms producing beta-lactamase and fast-growing atypical mycobacteria.

Drug sensitive: Staphylococcus aureus (including meticillin resistant staphylococci), Staphylococcus epidermidis, Neisseria species, Escherichia coli, Citrobacter, Klebsiella, Enterobacter, Hafnia, Proteus (indole-negative and indole-positive strains), Haemophilus influenzae, Chlamydiae, Legionella, Gardnerella.

Different sensitivity to the drug have: Streptococci, Serratia marcescens, Pseudomonas aeruginosa and Mycoplasmas.

Anaerobic bacteria (e.g. Fusobacterium species, Bacteroides species, Eubacterium species, Peptococci, Peptostreptococci) are resistant to the drug.

Ofloxacin is not active against Treponema pallidum.

Pharmacokinetics

After oral administration, it is rapidly and completely absorbed from the gastrointestinal tract. Eating slightly affects the degree of absorption, but may slow down its rate. Cmax in plasma is achieved after 2 hours. Protein binding is 25%. Ofloxacin is widely distributed in tissues and body fluids. It is excreted in the urine unchanged (about 80% in 24 hours).

Indications for use

Oksifan is indicated for the treatment of infections caused by susceptible microorganisms:
- infections of the upper and lower urinary tract;
- infections of the lower respiratory tract;
- uncomplicated urethral and cervical gonorrhea;
- non-gonococcal urethritis and cervicitis;
- infectious lesions of the skin and soft tissues;
- as part of the complex treatment of inflammatory diseases of the pelvic organs;
- prostatitis.

Oksifan tablets can be used in the sequential transition from parenteral to oral administration of the drug (step therapy).

Contraindications

- hypersensitivity to ofloxacin, other quinolones;

- epilepsy;

- pseudoparalytic myasthenia gravis;

- damage to the tendons when taking fluoroquinolones in history;

- children and adolescents up to 18 years;

- pregnancy;

- period of breastfeeding.

Dosage and administration

inside. The drug should be taken on an empty stomach with a small amount of liquid without chewing.

The dosage should be determined depending on the sensitivity of the pathogen and the severity of the infection. The following dosages are recommended:

Uncomplicated cystitis: 100 mg twice a day for 3-7 days.

Pyelonephritis: 200 mg 2 times a day for 5-7 days.

Lower respiratory infections: 400 mg twice a day for 7-10 days. The daily dose may be changed depending on the severity of the infection.

Uncomplicated urethral and cervical gonorrhea : 400 mg single dose.

Chlamydia trachomatis urethritis and cervicitis: 600 mg daily in divided doses for up to 7 days.

For patients with impaired renal function and elderly patients, the dosage of Oksifan tablets should be adjusted depending on the degree of impairment.

The duration of treatment, as a rule, does not exceed ten days.

Special instructions and precautions

Use with caution in patients with impaired renal and hepatic function. During the period of treatment, it is required to monitor the level of glucose in the blood. With long-term therapy, it is necessary to periodically monitor the function of the kidneys, liver, peripheral blood picture. When using Oksifan, sufficient hydration of the body should be ensured, the patient should not be exposed to ultraviolet radiation. Children are prescribed only when life is threatened, taking into account the intended benefits and the potential risk of side effects, when it is impossible to use other, less toxic drugs. Alcohol should be avoided during treatment with the drug.

Influence on the ability to drive vehicles and mechanisms

Use with caution in patients whose activities are associated with the need for a high concentration of attention and speed of psychomotor reactions.

Use during pregnancy and during breastfeeding

Use during pregnancy and during breastfeeding is contraindicated.

Interaction with other drugs

Sustained theophylline levels may increase with the simultaneous use of ofloxacin and theophylline. Co-administration of ofloxacin with theophylline may prolong the half-life of theophylline, increase serum theophylline levels, and may increase the risk of theophylline-related adverse reactions.

Drugs that suppress peristalsis are contraindicated.

Antacids containing magnesium, aluminum sucralfate, zinc or iron reduce the absorption of ofloxacin. Therefore, ofloxacin should be taken 2 hours before the use of antacids.

Patients receiving concomitant treatment with coumarin derivatives should be closely monitored by a specialist.

Ofloxacin may cause hypoglycemia or hyperglycemia in patients receiving hypoglycemic agents. It is recommended to control the level of glucose with simultaneous use. Ofloxacin may cause some increase in serum concentrations of glibenclamide when co-administered; the condition of patients taking this combination should be monitored.

When high doses of quinolones are used concomitantly with the use of drugs that undergo renal tubular secretion, their excretion may be impaired and serum levels may increase (for example, probenecid, cimetidine, furosemide and methotrexate).

Side effect

·    nausea, vomiting, flatulence, diarrhea, anorexia, cholestatic jaundice, abdominal pain (including gastralgia), hyperbilirubinemia, increased activity of hepatic transaminases, pseudomembranous enterocolitis;

·    dizziness, headache, unsteady movements, convulsions, tremors, numbness and paresthesia of the extremities, nightmares, intense dreams, psychotic reactions, irritability, anxiety, phobias, confusion, depression, hallucinations, impaired color perception, increased intracranial pressure, diplopia, disorders taste, hearing, smell and balance;

·    arthralgia, tendinitis, tendosynovitis, myalgia, tendon rupture;

·    collapse, vasculitis, tachycardia;

·    petechiae (pinpoint hemorrhages), bullous hemorrhagic dermatitis, vasculitis, papular rash;

·    agranulocytosis, leukopenia, anemia, pancytopenia, thrombocytopenia, aplastic and hemolytic anemia;

·    hypercreatininemia, impaired renal function, acute interstitial nephritis, increased urea content;

·    itching, skin rash, urticaria, allergic nephritis, allergic pneumonitis, eosinophilia, angioedema, fever, bronchospasm, Lyell's syndrome, Stevens-Johnson syndrome, photosensitivity, erythema multiforme;

·    vaginitis, superinfection, dysbacteriosis, hypoglycemia (in patients with diabetes mellitus).

Overdose

Symptoms:   nausea, vomiting, dizziness, confusion.

Treatment: it is necessary to carry out a gastric lavage, to ensure sufficient fluid intake.

Storage conditions

Store in a cool and dry place, at a temperature not exceeding 30ºC.

Keep out of the reach of children!

Best before date

3 years. Do not use after the expiry date stated on the packaging.

Holiday conditions

Released by prescription.

Release form

Oksifan 200 mg

10 tablets in an aluminum foil blister. 1 blister with instructions for use in a cardboard box.

Oksifan 400 mg

10 tablets in an aluminum foil blister. 1 blister with instructions for use in a cardboard box.