Monural^® (Granules) Instructions for Use

Instructions
Dosage forms

ATC Code

J01XX01 (Fosfomycin)

Active Substance

Fosfomycin (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antibiotic of the phosphonic acid derivative group. Urinary antiseptic

Pharmacotherapeutic Group

Antibiotic

Pharmacological Action

A broad-spectrum antibiotic, a derivative of phosphonic acid, exerts a bactericidal effect, the mechanism of which is associated with the suppression of the first stage of bacterial cell wall synthesis.

It is a structural analog of phosphoenol pyruvate and enters into competitive interaction with the enzyme N-acetyl-glucosamine-3-o-enolpyruvyl-transferase.

As a result, specific, selective, and irreversible inhibition of this enzyme occurs, which ensures the absence of cross-resistance with other classes of antibiotics and the possibility of synergism with other antibiotics (in vitro, synergism with amoxicillin, cefalexin, and pipemidic acid is noted).

Active in vitro against most gram-positive microorganisms: Enterococcus spp., Enterococcus faecalis, Staphylococcus aureus, Staphylococcus saprophyticus, Staphylococcus spp.; gram-negative microorganisms: Escherichia coli, Citrobacter spp., Enterobacter spp., Klebsiella spp., Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Pseudomonas spp., Serratia spp.

In vitro, Fosfomycin reduces the adhesion of a number of bacteria to the epithelium of the urinary tract.

Pharmacokinetics

Absorption

After oral administration, it is rapidly absorbed from the gastrointestinal tract. The bioavailability after a single oral dose of 3 g is 34-65%. C_max is reached after 2-2.5 hours and is 22-32 µg/ml.

Distribution and Metabolism

Fosfomycin trometamol does not bind to plasma proteins, dissociates in the body into Fosfomycin and trometamol (which does not have antibacterial properties) and is not further metabolized, accumulating primarily in the urine. After a single 3 g dose, a high concentration is achieved in the urine (from 1053 to 4415 mg/l), which is 99% bactericidal for most common urinary tract infection pathogens. The MIC (is 128 mg/l) is maintained in the urine for 24-48 hours (which suggests a single-dose course of treatment).

Excretion

T_1/2 from plasma is 4 hours. It is excreted unchanged by the kidneys (up to 95%), creating high concentrations in the urine; about 5% is excreted with bile.

Pharmacokinetics in Special Clinical Cases

In patients with moderate renal impairment (CrCl>80 ml/min), including its physiological decrease in the elderly, the T_1/2 of fosfomycin is slightly prolonged, but the concentration in the urine remains at a therapeutic level.

Indications

Acute bacterial cystitis;
Acute episodes of recurrent bacterial cystitis;
Bacterial nonspecific urethritis;
Asymptomatic massive bacteriuria in pregnant women;
Postoperative urinary tract infections;
Prevention of urinary tract infection during surgical intervention and transurethral diagnostic examinations.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
N30	Cystitis
N34	Urethritis and urethral syndrome
N39.0	Infection of urinary tract, site not specified
O23	Infections of genitourinary tract in pregnancy
Z29.2	Other prophylactic chemotherapy (administration of antibiotics for prophylactic purposes)

ICD-11 code	Indication
GC00.Z	Cystitis, unspecified
GC02.Z	Urethritis and urethral syndrome, unspecified
GC08.Z	Urinary tract infection, site and agent not specified
JA62.Z	Infections of genitourinary tract in pregnancy, unspecified
QC05.Y	Other specified prophylactic measures

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Granules

Adults are prescribed 3 g once a day. The course of treatment is 1 day. If necessary (in severe or recurrent infections, in the elderly), a repeated dose of 3 g after 24 hours is possible.

For the prevention of urinary tract infection during surgical intervention and transurethral diagnostic procedures, take a dose of 3 g 3 hours before the intervention and 3 g 24 hours after the first dose.

Children over 5 years of age are prescribed a dose of 2 g only once.

When prescribing to patients with renal impairment, the dose should be reduced and the interval between doses should be increased.

Adverse Reactions

From the digestive system nausea, heartburn, diarrhea.

Other skin rash, allergic reactions.

Contraindications

Severe renal failure (CrCl<10 ml/min);
Children under 5 years of age;
Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

The use of the drug during pregnancy and lactation is possible only if the intended therapeutic benefit for the mother outweighs the potential risk of teratogenic effects.

Use in Renal Impairment

When prescribing to patients with renal impairment, the dose should be reduced and the interval between doses should be increased.

Contraindicated in severe renal failure (CrCl<10 ml/min).

Pediatric Use

Contraindicated in children under 5 years of age.

Drug Interactions

With simultaneous use with metoclopramide, a decrease in the concentration of fosfomycin in blood serum and urine is possible (this combination is not recommended).

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer