Vitaprost^® Plus (Suppositories) Instructions for Use

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Contact Information

NIZHPHARM group of companies (Russia)

ATC Code

J01MA (Fluoroquinolones)

Dosage Form

Vitaprost® Plus

Rectal suppositories 400 mg+20 mg: 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Rectal suppositories from white or almost white to light cream with a grayish tint, torpedo-shaped; the appearance of a white coating on the surface of the suppository and the presence of an air rod and a funnel-shaped depression on the cut are allowed.

Excipients: hard fat – to obtain a suppository weighing 2.25 g.

5 pcs. – contour cell packs (1) – cardboard packs.
5 pcs. – contour cell packs (2) – cardboard packs.

Clinical-Pharmacological Group

A drug with antibacterial and anti-inflammatory action used for prostate diseases

Pharmacotherapeutic Group

Systemic antibacterial agents; quinolone derivatives; fluoroquinolones

Pharmacological Action

A combined drug with antibacterial and anti-inflammatory action used for prostate diseases.

Lomefloxacin is a broad-spectrum bactericidal agent from the fluoroquinolone group. It acts on the bacterial enzyme DNA gyrase, which provides supercoiling of DNA, forms a complex with its tetramer (gyrase subunits A2B2) and disrupts DNA transcription and replication, leading to the death of the microbial cell.

Highly active against gram-negative aerobic microorganisms Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Citrobacter diversus, Klebsiella pneumoniae, Enterobacter cloacae, Proteus vulgaris, Salmonella spp., Shigella spp., Moraxella morganii, Haemophilus influenzae, Haemophilus parainfluenzae, Pseudomonas aeruginosa, Legionella pneumophila.

Moderately sensitive to the drug are Staphylococcus aureus, Staphylococcus epidermidis, Serratia liquefaciens, Serratia marcescens, Mycobacterium tuberculosis, Chlamydia trachomatis, Hafnia alvei, Citrobacter freundii, Aeromonas hydrophila, Proteus mirabilis, Proteus stuartii, Providencia rettgeri, Providencia alcalifaciens, Klebsiella oxytoca, Klebsiella ozaenae, Enterobacter aerogenes, Enterobacter agglomerans.

Resistant to the drug are Streptococcus spp., Pseudomonas cepacia, Ureaplasma urealyticum, Treponema pallidum, Mycoplasma hominis and anaerobic bacteria.

Lomefloxacin acts on most microorganisms at low concentrations (the concentration required to inhibit the growth of 90% of strains is usually not more than 1 µg/ml). Resistance rarely develops.

Prostate extract has an organotropic effect on the prostate. It reduces the degree of edema, leukocyte infiltration of the prostate gland, normalizes the secretory function of epithelial cells, increases the number of lecithin grains in the secretion of acini, and stimulates the muscle tone of the bladder. It reduces thrombus formation, has antiplatelet activity, and prevents the development of venule thrombosis in the prostate gland. It normalizes prostate and ejaculate parameters. It reduces pain and discomfort, improves copulatory function.

Pharmacokinetics

Data on the pharmacokinetics of Vitaprost^® Plus are not provided.

Indications

• Acute and chronic bacterial prostatitis caused by susceptible microorganisms, (including those accompanied by inflammatory diseases of the genitourinary tract);
• Conditions before and after surgical intervention on the prostate gland.

ICD codes

Dosage Regimen

The drug should be applied rectally, 1 suppository once a day after an enema or spontaneous bowel movement.

Before use, the suppository should be removed from the contour cell packaging. After administration of the drug, the patient should remain in bed for 30-40 minutes.

The course of treatment continues until the pathogen disappears in the prostate secretion and ranges from 10 to 30 days (individually for each patient).

Adverse Reactions

Adverse effects of Vitaprost^® Plus, except for allergic reactions, are associated with the presence of the antibiotic Lomefloxacin in its composition.

Allergic reactions: skin itching, urticaria, photosensitivity, malignant exudative erythema (Stevens-Johnson syndrome).

From the nervous system: asthenia, dizziness, nervousness, anxiety, fatigue, malaise, headache, fainting, insomnia, hallucinations, convulsions, hyperkinesis, tremor, paresthesia, depression, agitation.

From the digestive system: pseudomembranous enterocolitis, dysbacteriosis, dryness of the oral mucosa, diarrhea or constipation, flatulence, change in tongue color, decreased appetite or bulimia, taste perversion, increased activity of liver transaminases.

From the hematopoietic organs and hemostasis system: bleeding from the gastrointestinal tract organs, thrombocytopenia, increased fibrinolysis, lymphadenopathy, purpura, nosebleed.

From the cardiovascular system: decreased blood pressure, tachycardia, bradycardia, extrasystole, arrhythmias, progression of heart failure and angina pectoris, pulmonary embolism, cardiomyopathy, phlebitis.

From the urinary system: glomerulonephritis, dysuria, polyuria, anuria, albuminuria, urethral bleeding, crystalluria, hematuria, urinary retention, edema.

From the reproductive system: orchitis, epididymitis.

From metabolism: hypoglycemia, gout.

From the musculoskeletal system: arthralgia, vasculitis, calf muscle cramps, back and chest pain.

From the respiratory system: shortness of breath, bronchospasm, cough, increased sputum secretion, flu-like symptoms.

From the sensory organs: visual impairment, pain and noise in the ears, eye pain.

Other: increased sweating, chills, thirst, superinfection.

Contraindications

• Childhood and adolescence under 18 years (period of skeletal formation and growth);
• Hypersensitivity to the components of the drug.

With caution, the drug should be used in cerebral atherosclerosis, epilepsy and other CNS diseases with epileptic syndrome.

Use in Pregnancy and Lactation

The drug is not used in women.

Use in Hepatic Impairment

In liver cirrhosis, no dose adjustment is required (provided normal renal function).

Pediatric Use

Contraindication: childhood and adolescence under 18 years (period of skeletal formation and growth).

Special Precautions

During treatment with Vitaprost^® Plus, the simultaneous use of antimicrobial agents – fluoroquinolones should be limited to avoid the development of overdose and an increase in the frequency of adverse effects.

In liver cirrhosis, no dose adjustment is required (provided normal renal function).

During treatment, prolonged exposure to sunlight and the use of artificial UV illumination should be avoided. At the first signs of photosensitivity (including increased skin sensitivity, burn, hyperemia, swelling, blistering, rash, itching, dermatitis), hypersensitivity, manifestations of neurotoxicity (including agitation, convulsions, tremor, photophobia, confusion, toxic psychoses, hallucinations), therapy should be discontinued.

Influence on the ability to drive vehicles and mechanisms

During treatment, patients must be cautious when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

Data on drug overdose are not provided.

Drug Interactions

With simultaneous use, the activity of oral anticoagulants increases and the toxicity of NSAIDs increases.

Drugs that block tubular secretion slow down the excretion of the drug.

There is no cross-resistance with penicillins, cephalosporins, aminoglycosides, co-trimoxazole, metronidazole.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.