Vitaprost plus rektal suppositories. 10 pieces

Description

Composition
Active substance:
Prostate Extract – 100 mg (relative to water soluble peptides – 20 mg), lomefloxacin hydrochloride – 400 mg ;.
Excipients:
The basis for suppositories – hard fat (Witepsol) – sufficient quantity to obtain a suppository weighing 2.25 g
Description:
Torpedo-shaped suppositories from white or nearly white to pale grayish cream color. It allowed the appearance of white deposits on the surface of the suppository and the presence of air at the exit of the rod and the funnel-shaped recess.
Product form:
Rectal suppositories 400mg + 20 mg.
5 suppositories in blisters of PVC film laminated polyethylene One or two blisters with instruction for medical use the drug in a pile of cardboard
Contraindications
Increased sensitivity to the drug. Age 18 years (during the formation and growth of the skeleton).
Indications
Acute and chronic bacterial prostatitis caused by susceptible microorganisms, including those accompanied by inflammatory diseases of the urinary tract. The state before and after surgery on the prostate gland.
Interaction with other drugs
It increases the activity of oral anticoagulants and increases the toxicity of NSAIDs. Drugs that block tubular secretion, slow down the excretion of lomefloxacin. The combined use of antiarrhythmic drugs of class I A (quinidine, procainamide) and Class III (amiodarone, sotalol) may cause lengthening of the interval Q-T. No cross-resistance with penicillins, cephalosporins, aminoglycosides, co-trimoxazole, metronidazole. The drug can be used in combination therapy.
Overdose
About the cases of drug overdose Vitaprost® Plus it has not been reported. Information about lomefloxacin overdose is very limited. Symptomatic therapy. Hemo and peritoneal dialysis in overdose ineffective.
pharmachologic effect
Pharmacological group:
The antimicrobial agent – fluoroquinolone.
Pharmacological properties:
Combined preparation Vitaprost® Plus has antimicrobial and anti-inflammatory properties.
Pharmacodynamics:
Lomefloksatsin – antimicrobial bactericidal broad spectrum of action of the fluoroquinolones. It affects the bacterial enzyme DNA gyrase, which provides supercoiling forms a complex with its tetramer (A2B2 subunit of gyrase) and gives transcription and DNA replication, leads to the death of the microbial cells. Beta-lactamase produced by pathogens, have no effect on the activity of lomefloxacin. Active against gram-negative aerobic microorganisms: Citrobacter diversus, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Proteus mirabilis, Pseudomonas aeruginosa (for urinary tract infections only); Gram positive aerobic microorganisms: Staphylococcus saprophyticus, other micro-organisms: Chlamydia trachomatis. Since the minimum inhibitory concentration of 2 .mu.g / ml active against the following microorganisms (however, clinical efficacy in infections caused by these microorganisms under strictly controlled studies have not studied): Gram positive aerobic bacteria: Staphylococcus aureus (including methicillin-resistant strains), Staphylococcus epidermidis ( including methicillin-resistant strains); Gram-negative aerobic microorganisms: Aeromonas hydrophila, Citrobacter freundii, Enterobacter aerogenes, Enterobacter agglomerans, Haemophilus parainfluenzae, Hafnia alvei, Klebsiella oxytoca, Klebsiella ozaenae, Morganella morganii, Proteus vulgaris, Providencia alcalifaciens, Providencia rettgeri, Serratia liquefaciens, Serratia marcescens; other organisms: Legionella pneumophila. By lomefloxacin resistant: Streptococcus spp. Groups A, B, D and G, Streptococcus pneumoniae, Pseudomonas cepacia, Ureaplasma urealyticum, Mycoplasma hominis and anaerobic bacteria. It acts as extra- and intracellularly located on Mycobacterium tuberculosis, reduces the time of their separation from the body, provides faster absorption infiltrates. In most microorganisms operates at low concentrations (concentration required to inhibit the growth of 90% of strains, typically less than 1 ug / ml). Resistance is rare. Prostate extract has Organotropona action on the prostate. Reduces the degree of swelling, leukocytic infiltration prostate, normalizes the secretory function of epithelial cells, increases the number of lecithin granules secret acini, stimulates the muscle tone of the bladder. Improves microcirculation in the prostate by reducing thrombus formation, antiplatelet activity, prevents the development of thrombosis in the prostate gland venules. Vitaprost® Plus normalizes parameters of prostate and semen. It reduces pain and discomfort, eliminates dysuria, improves the copulatory function.
Pharmacokinetics:
lomefloksatsin
Absorption – 95-98%; meals reduces the absorption of 12%. maximum concentration time (TSmah), -. 0.8-1.5 h Maximum concentration (Cmax) after intake of 0.8 mg 100 ug / ml, 200 mg – 1.4 g / ml, 400 mg – 3- 5.2 .mu.g / ml. Ingestion decreases Cmax by 18% and increases to 2 hours TSmah stationary concentration (Css) in plasma is determined after 48 hours Connection to plasma proteins -.. 10%. Well into the organs and tissues (the respiratory tract, ENT organs, soft tissues, bones, joints, abdominal organs, pelvis, genitals), where the concentration of lomefloxacin in 2-7 times higher than in plasma. A minor part of the drug is metabolized to form metabolites. The half-life (T1 / 2) – 8-9 hours; mean renal clearance of 145 ml / min.
In elderly patients, the plasma clearance is reduced by 25%. By reducing creatinine clearance up to 10-40 ml / min / 1.73 m T1 / 2 is increased. Kidney by tubular secretion displayed 70-80% (preferably in an unmodified form, 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.
Conditions of supply of pharmacies
Without recipe.
side effects
Side effects of the drug Vitaprost® Plus, with the exception of allergic reactions due to the presence in its composition of antibiotic lomefloxacin.
From the digestive system: nausea, vomiting, dryness of the oral mucosa, gastralgia, abdominal pain, diarrhea or constipation, flatulence, pseudomembranous colitis, dysphagia, changing the language of color, loss of appetite or bulimia, dysgeusia, goiter, increased activity of “hepatic “transaminases.
From the nervous system: fatigue, malaise, asthenia, headache, dizziness, insomnia, hallucinations, convulsions, hyperkinesia, tremor, paresthesia, nervousness, anxiety, depression, agitation, fainting.
On the part of the psyche: Violations of attention, disorientation, agitation, nervousness, memory impairment, delirium.
From the urogenital system: glomerulonephritis, dysuria, polyuria, anuria, albuminuria, urethral bleeding, crystalluria, hematuria, urinary retention, edema; orchitis, epididymitis.
From the Metabolic: hypoglycemia, hyperglycemia, dysglycemia, gout.
Severe hypoglycemia, until the development of hypoglycemic coma, particularly in elderly patients, diabetic patients taking oral hypoglycemic drugs or insulin.
On the part of the musculoskeletal system: arthralgia, vasculitis, leg cramps, back pain and chest, tendon rupture.
From the side of hematopoiesis and hemostasis system: bleeding from the gastrointestinal tract, thrombocytopenia, purpura, increased fibrinolysis, epistaxis, lymphadenopathy.
The respiratory system: dyspnea, bronchospasm, cough, hypersecretion of mucus, flu-like symptoms.
From the senses: blurred vision, pain and tinnitus, eye pain.
Cardio-vascular system: decrease in blood pressure, tachycardia, bradycardia, extrasystoles, arrhythmia, the progression of heart failure and angina, pulmonary embolism, cardiomyopathy, phlebitis, lengthening the interval QT, ventricular arrhythmia type “pirouette”. Allergic reactions: itching, rash, photosensitivity, malignant erythema multiforme (Stevens-Johnson syndrome).
Other: increased sweating, chills, thirst, superinfection.
If any of the above side effects are compounded or you notice any other side effects not mentioned in the instructions, tell your doctor.
special instructions
Cautions when using the drug Vitaprost® Plus linked to the presence in its composition lomefloksatsin antibiotic related to fluoroquinolones group. During treatment with Vitaprost® Plus should be limited to the simultaneous use of antimicrobials – fluoroquinolones in order to avoid the development of an overdose, and increase the frequency of side effects. In liver cirrhosis is not required dosing regime correction (assuming normal renal function). During treatment should avoid prolonged exposure to sunlight and the use of artificial ultraviolet light. At the first sign of photosensitivity (increased sensitivity of the skin, burns, redness, swelling, blisters, rashes, itching, dermatitis), hypersensitivity manifestations neurotoxicity (agitation, convulsions, tremor, photophobia, confusion, toxic psychoses, hallucinations) therapy should be discontinued. Used only for the treatment of adult men; not used in women and children. Treatment of chronic prostatitis must be integrated, along with the assignment presupposes preparation Vitaprost® Plus use of other groups of drugs and non-drug therapies. Prior to the treatment of chronic prostatitis and, if necessary, in the course of treatment is recommended to carry out the analysis of prostate secretion. During drug treatment Vitaprost® Plus there is a potential risk of hypoglycemia, until the development of hypoglycemic coma, which is more common in the elderly and patients with diabetes mellitus who are taking oral hypoglycemic agents or insulin. In this connection it should closely monitor the concentration of plasma glucose in these patients. At the first signs of hypoglycemia (confusion, dizziness, “wolf” appetite, headache, nervousness, palpitations or increased heart rate, pale skin, sweating, trembling, weakness) therapy should be discontinued. During drug treatment Vitaprost® Plus there is the risk of psychiatric side effects, which can appear even after a single dose. drug treatment should be discontinued immediately Vitaprost® Plus, if the patient reports any side effects on the central nervous system, including mental disorders, or reducing the concentration of glucose, and immediately begin antibiotic therapy with other, different from fluoroquinolones, if possible. Epidemiological studies have reported an increased risk of aneurysm and aortic dissection after the use of fluoroquinolones, especially in elderly patients. In patients with an aneurysm in history, or having an aneurysm and / or dissection, as well as other risk factors or conditions that predispose to the development of aneurysm and aortic dissection (eg, Marfan syndrome, Ehlers-Danlos vascular type syndrome, Takayasu’s arteritis, giant cell arteritis, Behcet’s disease, hypertension, atherosclerosis), fluoroquinolones should only be used after careful assessment of the benefit-risk consideration and other possible treatment options. In case of sudden pain in the abdomen, chest or back, patients should immediately consult a doctor in the emergency room.
During the period of treatment must be careful when driving and occupation of other potentially hazardous activities that require high concentration and psychomotor speed reactions.
Storage conditions
At temperatures above 25 ° C. Keep out of the reach of children.
Dosing and Administration
Rectally. 1 suppository 1 time a day after the enema or independent stool. Before applying the suppository should be removed from the blisters. After administration Vitaprost® Plus preferably within 30-40 minutes stay in bed. The course of treatment is continued until the disappearance of pathogen in prostate secret, and is from 10 to 30 days (duration of treatment is determined by a doctor for each patient individually). If necessary, may repeat courses. If after treatment there is no improvement or symptoms are aggravated, or there are new symptoms, you should consult with your doctor.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist