Vitaprost Plus, rectal 400 mg+20 mg 10 pcs.

Vitaprost® Plus combination drug has antimicrobial and anti-inflammatory properties.

Indications

Acute and chronic bacterial prostatitis caused by sensitive microorganisms, including those accompanied by inflammatory diseases of the genitourinary tract. Conditions before and after surgery on the prostate gland.

Pharmacological effect

The combined drug Vitaprost® Plus has antimicrobial and anti-inflammatory properties.

Special instructions

Special instructions when using the drug Vitaprost® Plus are associated with the presence in its composition of the antibiotic lomefloxacin, which belongs to the group of fluoroquinolones. During treatment with Vitaprost® Plus, the simultaneous use of antimicrobial agents – fluoroquinolones should be limited in order to avoid the development of overdose and an increase in the frequency of side effects. In case of cirrhosis of the liver, no adjustment of the dosage regimen is required (provided that renal function is normal). During the treatment period, prolonged exposure to sunlight and the use of artificial ultraviolet lighting should be avoided. At the first signs of photosensitivity (increased skin sensitivity, burns, hyperemia, swelling, the appearance of blisters, rashes, itching, dermatitis), hypersensitivity, manifestations of neurotoxicity (excitement, convulsions, tremors, photophobia, confusion, toxic psychoses, hallucinations), therapy should be stopped. Used only for the treatment of adult men; not used in women and children. Treatment of chronic prostatitis should be comprehensive, involving, along with the prescription of the drug Vitaprost® Plus, the use of other groups of drugs and non-drug treatment methods. Before starting treatment for chronic prostatitis and, if necessary, during treatment, it is recommended to analyze prostate secretions. During treatment with Vitaprost® Plus, there is a potential risk of developing hypoglycemia, including the development of hypoglycemic coma, which is more common in elderly people and patients with diabetes mellitus who take oral hypoglycemic drugs or insulin. Therefore, plasma glucose concentrations should be carefully monitored in these patients. At the first signs of hypoglycemia (confusion, dizziness, ravenous appetite, headache, nervousness, palpitations or increased pulse rate, pale skin, perspiration, trembling, weakness), therapy should be stopped. During treatment with Vitaprost® Plus, there is a risk of developing mental adverse reactions that may appear even after a single dose. Treatment with Vitaprost® Plus should be stopped immediately if the patient reports any central nervous system side effects, including mental disturbances, or decreased glucose concentrations, and treatment with an antibiotic other than a fluoroquinolone should be immediately initiated if possible. Epidemiological studies have reported an increased risk of aortic aneurysm and dissection after use of fluoroquinolones, especially in elderly patients. In patients with a history of aneurysm, or who have aortic aneurysm and/or dissection, and other risk factors or conditions predisposing to the development of aortic aneurysm and dissection (eg, Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behçet’s disease, hypertension, atherosclerosis), fluoroquinolones should only be used after careful assessment of the benefit-risk ratio and consideration of other possible treatment options. If patients experience sudden pain in the abdomen, chest, or back, they should contact their doctor immediately at the emergency room.

Active ingredient

Lomefloxacin, Prostate extract

Active components

Prostate extract+Lomefloxacin

Composition

One suppository contains: active ingredients: prostate extract – 100 mg (in terms of water-soluble peptides – 20 mg); lomefloxacin hydrochloride – 400 mg; excipients: solid fat (Vitepsol, brands H 15, W 35, Supposir, brands NA 15, NAS 50) – until a suppository weighing 2.25 g is obtained.

Contraindications

Hypersensitivity to the components of the drug. Age up to 18 years (period of formation and growth of the skeleton).

Side Effects

Side effects of the drug Vitaprost® Plus, with the exception of 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, dysbiosis, dryness of the oral mucosa, diarrhea or constipation, flatulence, discoloration of the tongue, decreased appetite or bulimia, perversion of taste, increased activity of “liver” transaminases.

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

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

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

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, hypersecretion of sputum, flu-like symptoms.

From the senses: blurred vision, pain and noise in the ears, pain in the eyes.

Other: increased sweating, chills, thirst, superinfection.

Specifications

Suppositories are torpedo-shaped from white or almost white to light cream with a grayish tint. 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.

Prescribing

Antiprostatic drugs

Complete set of goods

Rectal suppositories 400 mg + 20 mg. 5 suppositories in a blister pack made of polyvinyl chloride film laminated with polyethylene One or two blister packs along with instructions for medical use of the drug in a cardboard pack

Functional features

Lomefloxacin Absorption – 95-98%; food intake reduces absorption by 12%. The time to reach the maximum concentration (TCmax) is 0.8-1.5 hours. The maximum concentration (Cmax) after oral administration of 100 mg is 0.8 µg/ml, 200 mg – 1.4 µg/ml, 400 mg – 3-5.2 µg/ml. Eating reduces Cmax by 18% and increases TCmax up to 2 hours. The steady-state concentration (Css) in plasma is determined after 48 hours. Communication with plasma proteins is 10%. Penetrates well into organs and tissues (respiratory tract, ENT organs, soft tissues, bones, joints, abdominal organs, pelvic organs, genitals), where the concentration of lomefloxacin is 2-7 times higher than in plasma. A small part of the drug is metabolized to form metabolites. Half-life (T1/2) – 8-9 hours; average renal clearance −145 ml/min. In elderly patients, plasma clearance decreases by 25%. When creatinine clearance decreases to 10-40 ml/min/1.73 sq.m, T1/2 increases. 70-80% is excreted by the kidneys through tubular secretion (mainly unchanged, 9% in the form of glucuronides, 0.5% in the form of other metabolites); through the intestines – 20-30%. Prostate extract – pharmacokinetic parameters have not been studied.

Storage conditions

At a temperature not higher than 25°C. Keep out of the reach of children.

Shelf life

2 years. Do not use the drug after the expiration date.

Manufacturer

Nizhpharm JSC, Russia