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

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

Indications

Prostatitis, Prostate HyperplasiaAcute and chronic bacterial prostatitis caused by susceptible microorganisms, including those accompanied by inflammatory diseases of the urogenital tract. Conditions before and after surgical intervention on the prostate gland.

Active ingredient

Lomefloxacin, Prostate extract

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, mark H 15, W 35, Supposir, mark NA 15, NAS 50) – to obtain suppository mass of 2.25 g.

How to take, the dosage

Rectally. 1 suppository once a day after an enema or self-emptying of the bowels. The suppository should be taken out of the contour cell pack before use. After insertion of Vitaprost® Plus it is advisable to stay in bed for 30-40 minutes. The course of treatment continues until the disappearance of the pathogen in the prostate secretion and is from 10 to 30 days (the duration of treatment is determined by the doctor individually for each patient). If necessary, repeat courses may be conducted. If after treatment there is no improvement or the symptoms worsen, or new symptoms appear, you should consult your doctor.

Special Instructions

Particular instructions for use of Vitaprost® Plus are related to the presence of the antibiotic lomefloxacin belonging to the group of fluoroquinolones in its composition. During Vitaprost® Plus treatment, concomitant use of antimicrobial agents-fluoroquinolones should be limited in order to avoid overdose and increased frequency of side effects. No dosing regimen adjustment is required in case of liver cirrhosis (provided that renal function is normal). During the treatment period, prolonged exposure to sunlight and use of artificial ultraviolet light should be avoided. At the first signs of photosensitization (increased skin sensitivity, burns, hyperemia, edema, blisters, rash, itching, dermatitis), hypersensitivity, signs of neurotoxicity (agitation, convulsions, tremors, photophobia, confusion, toxic psychosis, hallucinations) the therapy should be stopped. It is used only to treat adult men; it is not used in women and children. Treatment of chronic prostatitis must be complex including, along with prescription of Vitaprost® Plus, application of other groups of medicines and non-medicinal methods of treatment. Before initiation of treatment of chronic prostatitis and, if necessary, during treatment it is recommended to analyze prostate gland secretion. During treatment with Vitaprost® Plus there is a potential risk of hypoglycemia, up to and including hypoglycemic coma, which is more common in elderly people and patients with diabetes who take oral hypoglycemic drugs or insulin. In this regard, the plasma glucose concentration in these patients should be carefully monitored. At the first signs of hypoglycemia (confusion of consciousness, dizziness, “wolfish” appetite, headache, nervousness, palpitations or increased pulse rate, pale skin, sweating, trembling, weakness) the therapy should be stopped. During the treatment with Vitaprost® Plus there is a risk of psychic adverse reactions which may occur even after a single dose. Vitaprost® Plus should be immediately discontinued if a patient reports any adverse effects on the central nervous system, including mental disturbances, or a decrease in glucose concentration, and therapy with another antibiotic other than fluoroquinolones should be started immediately, if possible. Epidemiologic studies have reported an increased risk of aneurysm and aortic dissection after fluoroquinolones, especially in elderly patients. In patients with a history of aneurysm, or who have aneurysm and/or aortic dissection, as well as other risk factors or conditions predisposing to the development of aneurysm and aortic dissection (e.g., Marfan syndrome, Ehlers-Danloh vascular syndrome, Takayasu arteritis, gigantocellular arteritis, Behcet’s disease, arterial hypertension, atherosclerosis), fluoroquinolones should be used only after careful evaluation of the benefit-risk ratio and consideration of other possible therapy options. In the event of sudden pain in the abdomen, chest, or back, patients should immediately consult a physician in the emergency department.

Synopsis

The suppositories are torpedo-shaped, from white or almost white to light creamy with a grayish tint. It is allowed to have a white coating on the surface of the suppository and the presence of an air rod and a funnel-shaped depression on the slice.

Features

Lomefloxacin Absorption is 95-98%; ingestion reduces absorption by 12%. Time to maximum concentration (TCmax) is 0.8-1.5 hours. Maximal 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. Food intake decreases Cmax by 18% and increases TCmax up to 2 h. The steady-state plasma concentration (Css) is determined after 48 h. Binding with plasma proteins is 10%. It penetrates well into organs and tissues (respiratory tract, ENT organs, soft tissues, bones, joints, abdominal organs, pelvis, genitals), where lomefloxacin concentration is 2-7 times higher than in plasma. A small part of the drug undergoes metabolism with the formation of metabolites. The elimination half-life (T1/2) is 8-9 h; average renal clearance is -145 ml/min. Plasma clearance decreases by 25% in elderly patients. When creatinine clearance decreases to 10-40 ml/min/1.73 sq.m, the T1/2 increases. The kidneys excrete 70-80% (mainly unchanged, 9% – as glucuronides, 0.5% – as other metabolites) by tubular secretion, and 20-30% – through the intestines. Prostate extract – pharmacokinetic parameters have not been studied.

Contraindications

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

Side effects

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

Nervous system disorders: asthenia, dizziness, nervousness, anxiety, fatigue, malaise, headache, fainting states, insomnia, hallucinations, seizures, hyperkinesias, tremors, paresthesia, depression, agitation.

Digestive system: pseudomembranous enterocolitis, dysbacteriosis, dry mouth, diarrhea or constipation, flatulence, discolored tongue, decreased appetite or bulimia, perversion of taste, increased activity of liver transaminases.

Blood forming organs and hemostasis system: bleeding from the gastrointestinal tract, thrombocytopenia, increased fibrinolysis, lymphadenopathy, purpura, nasal bleeding.

Cardio-vascular system: decreased arterial pressure, tachycardia, bradycardia, extrasystoles, arrhythmias, progression of heart failure and angina pectoris, pulmonary embolism, cardiomyopathy, phlebitis.

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

Metabolism: hypoglycemia, gout.

Musculoskeletal system: arthralgia, vasculitis, cramps of the calves, back and chest pain

Respiratory system: shortness of breath, bronchospasm, cough, sputum hypersecretion, flu-like symptoms.

Senses: visual impairment, pain and noise in the ears, pain in the eyes.

Other: increased sweating, chills, thirst, superinfection.