Ovea granules for solution inside 3g 1 pc package 8g

Description

Composition
Active substance:
fosfomycin trometamol 5.631 g, calculated as fosfomycin – 3.0 g;
Excipients:
sucrose – 2,107 g, saccharin – 0.012 g Orange flavoring – 0,15 g, tangerine flavor 0.1 g
Description:
almost white granules.
Product form:
Granules for preparation for receiving the solution into 3 g
8 g of product in the package of composite material (polyethylene – aluminum foil – polyethylene film). Each packet is placed in a cardboard box with instructions for use.
Contraindications
Hypersensitivity to fosfomycin and other components of the formulation; severe renal failure (creatinine clearance (CC)
Precautions: diabetes, old age, renal dysfunction (creatinine clearance greater than 10 mL / min).
Dosage
3 g
Indications
Infectious-inflammatory diseases caused by microorganisms sensitive to fosfomycin:
– acute bacterial cystitis, acute episodes of recurrent bacterial cystitis;
– bacterial nonspecific urethritis;
– massive asymptomatic bacteriuria in pregnant women;
– postoperative urinary tract infection;
Prevention of infection during surgery on the urinary tract and transurethral diagnostic tests.
Interaction with other drugs
In a joint application with fosfomycin metoclopramide reduces the concentration of fosfomycin in serum and urine.
The simultaneous use of antacids or calcium salts reduces the fosfomycin concentration in plasma and urine.
Other drugs that increase the motor activity of the gastrointestinal tract, can cause a similar effect.
There are particular problems associated with the change in the international normalized ratio (INR). In patients receiving antibiotics, were recorded numerous cases of increased activity antagonists antivitamin K. Risk factors include severe infection or inflammation, age and poor general health. In these circumstances, it is difficult to determine whether the change in INR result of an infectious disease or its treatment. However, certain classes of antibiotics most often mentioned in this context, namely: fluoroquinolones, macrolides, cyclins, cotrimoxazole and some cephalosporins.
Overdose
Data in respect of fosfomycin oral overdose is limited. In patients who have taken an overdose of the drug Ovea observed the following reactions: dysfunction of the vestibular apparatus, hearing impairment, “metallic” taste in the mouth, as well as a general decline in the perception of flavor.
Treatment of an overdose – is symptomatic and supportive.
liquid reception is recommended in case of overdose inwardly to increase diuresis.
pharmachologic effect
Pharmacological group:
antibiotic.
Pharmacodynamics:
Preparation Ovea comprises fosfomycin [mono (2-amino-2-hydroxymethyl-1,3-propanediol) (2R-cis) – (3-methyloxirane) phosphonate] – antibacterial agent broad spectrum phosphonic acid derivative, for the treatment of urinary infections ways.
The mechanism of action is associated with the suppression of the first stage of bacterial cell wall synthesis. As a structural analog of phosphoenolpyruvate competitively irreversibly inhibits the enzyme UDP-N-atsetilglyukozaminolpiruviltransferazu that catalyzes the reaction for the formation of UDP-N-acetyl-3-O- (1-carboxyvinyl) -Dglyukozamina from phosphoenolpyruvate and UDP-N-acetyl-D-glucosamine. Also, the drug is capable of reducing adhesion of bacteria to the mucous membranes of the bladder, which can act as a predisposing factor for a recurrent infections.
The mechanism of action of the drug explains the lack of cross-resistance with other antibiotics and synergism with antibiotics of other classes, such as beta-lactam antibiotics.
Fosfomycin is active against a broad spectrum of gram-positive and gram-negative microorganisms, typically allocated in infections of the urinary tract, such as Escherichia coli, Citrobacter spp., Klebsiella spp., Proteus spp., Serratia spp., Pseudomonas aeruginosa, Enterococcus faecalis.
The emergence of resistance in vitro mutation of genes is explained gIpT and uhp, which control the transport L-alpha-glycerophosphates, and glucose phosphate, respectively.
Pharmacokinetics:
Suction
When administered fosfomycin well absorbed from the intestine and reaches about 50% bioavailability. Maximum plasma concentration is observed after 2-2.5 hours after oral administration and is 22-32 mg / l. The half-life of blood plasma is 4 hours.
Ingestion slows absorption without affecting the concentration in urine.
Distribution
Fosfomiin distributed in the kidney, bladder wall, prostate and seminal glands. Permanent fosfomycin concentrations in urine above the minimum
Bacteriostatic concentration (UKMO) is achieved in 24-48 hours after oral administration.
Fosfomycin is not bound to plasma proteins and overcomes the placental barrier.
After a single injection fosfomycin released into breast milk in small quantities.
breeding
Fosfomycin excreted unchanged, primarily by the kidneys by glomerular filtration rate (40-50% of the dose is found in the urine), the half-life is about 4 hours, and to a lesser extent – in the feces (18-23% of the dose).
The appearance of the second peak serum concentration after 6 and 10 hours after dosing suggesting that the drug is exposed enterohepatic recirculation.
The pharmacokinetic properties of fosfomycin do not depend on the age and pregnancy.
Cumulated drug in patients with renal insufficiency; pharmacokinetic parameters between fosfomycin and glomerular filtration rate established linear relationship.
Pregnancy and breast-feeding
When pregnancy is used only if the intended benefits to the mother outweighs the potential risk to the fetus.
Fosfomycin in very low concentrations into breast milk.
If necessary, the appointment Ovea during lactation should stop breastfeeding.
Conditions of supply of pharmacies
Prescription.
side effects
The most common adverse reactions at the single dose of fosfomycin are disorders of the gastrointestinal tract, most commonly diarrhea. These reactions are transient and disappear spontaneously.
Below are adverse drug reactions that have been reported when using fosfomycin, in clinical trials or post-registration observations.
Frequency responses indicated as follows: very often (> 1/10), often (> 1/100 to
special instructions
During treatment fosfomycin may occur hypersensitivity reactions, including anaphylaxis and anaphylactic shock, a danger to life.
If such a reaction occurs, it is necessary to eliminate the repeated reception of fosfomycin and proper treatment.
Antibiotic-associated diarrhea was noted in the application of nearly all antibacterial agents, including fosfomycin. Its severity can range from mild diarrhea to fatal colitis. Diarrhea, particularly heavy, recurring and / or blood, during or after treatment with Ovea (including, for several weeks after treatment), may be a symptom of a disease caused by Clostridium difficile (pseudomembranous colitis). This diagnosis is important to consider in the treatment of patients during or after receiving Ovea drug. When perceived or confirmed diagnosis of pseudomembranous colitis appropriate treatment should be initiated immediately. Drugs that inhibit intestinal motility in a given clinical situation contraindicated.
Renal insufficiency: fosfomycin concentration in urine is maintained for 48 hours after taking the usual dose if creatinine clearance greater than 10 mL / min.
The drug is contraindicated in patients undergoing hemodialysis.
Patients with diabetes must take into account that in the package 1 Ovea drug at a dosage of 3 g contained 2,107 grams of sucrose.
Patients with a rare hereditary diseases such as fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency, this preparation is contraindicated.
The effect on the ability to operate vehicles, machinery
Special studies have been conducted, but patients should be advised that use of the drug may cause dizziness. If dizziness should refrain from carrying out these activities.
Storage conditions
Store at a temperature not higher than 25 ° C, in the original package.
Keep out of the reach of children.
Dosing and Administration
Inside.
The granules dissolved in 1/2 glass of water (50-75 ml) or another beverage is stirred until complete dissolution, taken immediately after dissolution. Preparation Ovea take 1 time per day on an empty stomach inside 1 hour before or 2-3 hours after a meal, preferably at bedtime, after emptying the bladder.
Adults and children over 12 years: 1 package (3 g), 1 time a day once.
In order to prevent urinary tract infection during surgery, transurethral diagnostic procedures take medication 2 x 3 g: for 3 hours before surgery and 24 hours after the intervention.
In more severe cases (elderly patients, recurrent infections) accept more packet 1 (3 g) after 24 hours.
Patients with mild or moderate renal insufficiency dose adjustment is required. In patients with severe renal insufficiency or the use of hemodialysis is contraindicated drug.
Patients with hepatic impairment dose adjustment is required.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist