Phosphoral Rhompharm - instructions for use, dose, side effects, contraindications

Phosphomycin is a broad-spectrum antibiotic of phosphonic acid. The bactericidal effect of phosphomycin is based on the fact that phosphomycin is a structural analogue of phosphoenol pyruvate.Inactivates N-acetyl-glucosamino-3-o-enolpyruvyl transferase, irreversibly blocks the condensation of uridine diphosphate-N-acetyl-glucosamine with phosphoenol pyruvate, suppresses the synthesis of UDF-N-acetylmuramic acid, thus inhibiting the initial stage of peptidoglycan formation of the bacterial cell wall. In vitro phosphomycin reduces the adhesion of a number of bacteria to the epithelium of the urinary tract.

In vitro phosphomycin is sensitive to Gram-positive (Staphylococcus saprophyticus, Enterococcus faecalis) and gram-negative (Escherichia coli, Klebsiella pneumoniae, Citrobacter spp., Enterobacter spp., Proteus mirabilis) microorganisms.

Inactivation of the enzyme N-acetyl-glucosamino-3-o-enolpyruvyl-transferase reduces the likelihood of cross-resistance to antibiotics with a similar mechanism of action and creates the conditions for synergism (in experiments in vitro Synergetic effect with amoxicillin, cephalexin, pipemidinic acid was revealed).

Pharmacokinetics:

Suction

When taken orally, fosofomycin trometamol quickly absorbed from the gastrointestinal tract. In the body dissociates into phosphomycin and trometamol (trometamol does not have antibacterial properties).Bioavailability with a single oral intake is 32-54%, compared with intravenous administration. The maximum plasma concentration of phosphomycin is reached in 2-3 hours, from the moment of admission and is 30 mg / l.

Distribution

After oral administration of phosphomycin trometamol distributed in a moderate manner. Does not bind to plasma proteins, it is not metabolized. The half-life of the drug from the plasma is from 3 to 4 hours. Maximum concentrations of more than 2000 mg / l in urine are achieved after 2-4 hours, from the time of admission.

The concentration above the minimum inhibitory concentration of the pathogenic agent that causes urinary tract infection is 128 mg / L and is maintained for at least 36 hours.

Excretion

Fosofomycin is 90% excreted by the kidneys unchanged, by glomerular filtration, about 10% in unchanged form is excreted through the intestine. In the case of renal dysfunction (CC <80 ml / min), including physiological decline in the elderly, excretion of the active substance by the kidneys is dependent, depending on the level of renal dysfunction, but the concentration in the urine remains at the therapeutic level.

Indications:

Bacterial infections of the urinary tract of various locations caused by microorganisms susceptible to phosphomycin: acute uncomplicated urinary tract infections; asymptomatic bacteriuria; prevention of urinary tract infections after surgery and transurethral diagnostic studies.

Contraindications:

- Hypersensitivity to phosphomycin or other components of the drug;

- patients on dialysis;

- severe renal failure (CC <10 mL / min);

- children's age till 12 years;

- deficiency of sugar / isomaltase;

- fructose intolerance, glucose-galactose malabsorption.

Pregnancy and lactation:

When pregnancy is used only if the intended benefit for the mother exceeds the potential risk to the fetus.

When prescribing the drug during lactation it is necessary to stop breastfeeding for the duration of therapy.

Dosing and Administration:

PHOSPHORAL ROMFARM is applied once, on an empty stomach, 2-3 hours before or after a meal, preferably before going to bed, previously emptying the bladder: adults and children over 12 years in a daily dose of 3 g. The contents of the package are dissolved in 1/2 a glass of water.

For the prevention of urinary tract infections during surgery, diagnostic procedures, the above dose is taken 2 times - 3 hours before the intervention and 24 hours after it.

Side effects:

Disorders from the gastrointestinal tract (nausea, heartburn, diarrhea), skin rash, allergic reactions, headache, dizziness, asthenia, paresthesia (sensation of numbness of the skin, "crawling crawling"), optic neuritis, tachycardia, lowering of blood pressure , itchy skin, bronchial asthma, agionvrotic edema, urticaria, anaphylactic shock, vomiting, dyspepsia, pseudomembranous colitis, abdominal pain, increased activity of "liver" transaminases, vulvovaginitis, thrombocytosis, and leukopenia.

Overdose:Symptoms of overdose: diarrhea (with persistent diarrhea prescribed symptomatic treatment), vestibular syndrome, hearing impairment, "metallic" taste and general taste disorders.

In case of an overdose, it is recommended to increase the diuresis by taking the liquid inside. There is no specific antidote.

Interaction:

You should avoid simultaneous use with metoclopramide, antacids or drugs,containing calcium salts, as this can lead to a decrease in the concentration of phosphomycin in serum and urine.

Simultaneous reception with other drugs that increase the motility of the gastrointestinal tract, can also lead to a decrease in the concentration of phosphomycin in serum and urine.

Special instructions:

The use of broad-spectrum antibiotics, including phosphomycin trometamol, can lead to the development of antibiotic-associated colitis (including pseudomembranous colitis). Therefore, it is necessary to take into account the probability of this diagnosis in patients with severe diarrhea during or after taking fosfomycin trometamol. If the diagnosis is confirmed, the appropriate treatment should be started immediately, in this case the preparations inhibiting peristalsis are contraindicated.

Simultaneous food intake slows the absorption of phosphomycin. Therefore, it is desirable to apply the drug on an empty stomach or 2-3 hours after eating.

PHOSPHORAL ROMFARM contains sucrose.

Patients with diabetes mellitus and those who need to follow a diet, it should be borne in mind that in 1 package FOSFORAL ROMFARM contains up to 1.86 g of sugar.PHOSPHORAL RHOMPHARM should not be used in patients with fructose intolerance, glucose-galactose malabsorption syndrome or isomaltase deficiency.

Effect on the ability to drive transp. cf. and fur:

Patients should be warned about the possibility of developing dizziness, and when dizziness occurs, one should refrain from performing these activities.

Form release / dosage:

Granules for solution for oral administration, 3 g.

Packaging:

By 8.0 g of the drug in multilayered laminated bags.

For 1 or 2 bags together with the instructions for use are placed in a cardboard box.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-003494

Date of registration:10.03.2016

Expiration Date:10.03.2021

The owner of the registration certificate:K.O. Ромфарм Компани С.Р.Л.K.O. Ромфарм Компани С.Р.Л. Romania

Manufacturer: & nbsp

S.C. ROMPHARM Company, S.R.L. Romania

Representation: & nbspРомфарма ОООРомфарма ООО

Information update date: & nbsp09.08.2016

Illustrated instructions

Instructions

Phosphorhal Rhompharm (Fosforal Rompharm)