Monuril

Monuril

fosfomycin

Manufacturer:

Zambon
Full Prescribing Info
Contents
Fosfomycin trometamol.
Description
Each sachet contains fosfomycin trometamol 5.631 g equivalent to fosfomycin 3 g. It also contains the following excipients: Mandarin flavor, orange flavor, saccharin and sucrose.
Each sachet contains granules which when dissolved in water make an orange-flavored suspension for oral administration.
Action
Pharmacology: Pharmacodynamics: Fosfomycin is a bactericidal antibiotic with a rather broad spectrum. It is bactericidal by inhibiting the enzyme enolpyruviltransferase, which is involved in the synthesis of the bacterial cell wall. The use of a single dose of fosfomycin reduces the risk of resistance. Monuril has no negative influence on the intestinal flora.
Microbiology: Fosfomycin is active against gram-positive (S. faecalis) and gram-negative microorganisms (E. coli, Proteus). Resistance is observed for Klebsiella, Enterobacter, Serratia and Pseudomonas. Cross-resistance with other antibiotics is not reported. For the breakpoint, MIC 128 mg/L is usually taken. (See table.)


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Pharmacokinetics: Fosfomycin is moderately absorbed after oral administration of Monuril. The absolute bioavailability is 30-55%. The peak serum concentration is attained after 2-3 hrs and amounts to 30-45 mcg/mL after administration of 50 mg/kg. After administration of a single dose of fosfomycin 50 mg/kg body weight, therapeutically active concentration in urine is maintained for 36 hrs.
Fosfomycin is not bound to plasma protein. Tissue penetration is good. The apparent volume of distribution is about 22 L.
The elimination half-life is 2.5-7 hrs. Fosfomycin is excreted in the urine by glomerular filtration. In patients with renal insufficiency, excretion is reduced and serum elimination half-life is prolonged. After oral administration, 35-50% is excreted in the urine. Urinary excretion decreases along with the decrease in renal function. Fosfomycin is not metabolized.
Indications/Uses
Treatment of acute lower uncomplicated urinary tract infections. Prophylaxis of lower urinary tract infections in transurethral diagnostic maneuvers.
Dosage/Direction for Use
Treatment of Acute Uncomplicated Lower Urinary Tract Infections: Adult ≥18 years: Recommended Dosage: 3 g as a single dose.
Prophylaxis of Lower Urinary Tract Infections in Transurethral Diagnostic Maneuvers: Two Monuril doses. The 1st dose is administered 3 hrs before the intervention and the 2nd dose, 24 hrs after the first one.
Administration: Monuril must only be administered orally on an empty stomach, preferably at bedtime after emptying the bladder. The dose must be dissolved in a glass of water (50-75 mL) or in other non-alcoholic drinks and administered soon after dissolving.
Meals can retard the absorption of fosfomycin trometamol with consequent slight decrease in blood and urinary levels. Therefore, Monuril should be taken on an empty stomach, 2-3 hrs apart from meals.
Overdosage
No case of overdose is known. If an overdose occurs, favoring the renal elimination of fosfomycin with a proper oral administration of liquid is enough.
Contraindications
Patients with impaired renal function (creatinine clearance <80 mL/min). History of hypersensitivity to fosfomycin or to any of the ingredients of Monuril.
Special Precautions
Do not use >1 single dose of Monuril to treat a single episode of acute cystitis. Repeated daily doses of Monuril did not improve the clinical success or microbiological eradication rates compared to single-dose therapy, but did increase the incidence of adverse events. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy.
Use in pregnancy & lactation: Clinical experience in human pregnancy with fosfomycin trometamol is limited; however, fosfomycin, in 3 different forms, has been in wide use in other countries for many years without apparent ill consequences. Animal studies with fosfomycin trometamol (the form used in Monuril) have shown no hazard to the fetus. Previous animal studies with the calcium and sodium salt of fosfomycin in rats showed signs of fetal toxicity at the highest doses tested (approximately 25 times the therapeutic dose), but studies at lower doses and in rabbits showed no hazard. Although animal studies with fosfomycin trometamol have shown no hazard, it should only be used in pregnancy when the expected benefit outweighs the risk.
Fosfomycin has been shown to cross into breast milk. Therefore, Monuril should not be given to lactating women except when absolutely necessary.
Use in children: Safety and effectiveness in children ≤12 years have not been established in adequate and well-controlled studies.
Use In Pregnancy & Lactation
Clinical experience in human pregnancy with fosfomycin trometamol is limited; however, fosfomycin, in 3 different forms, has been in wide use in other countries for many years without apparent ill consequences. Animal studies with fosfomycin trometamol (the form used in Monuril) have shown no hazard to the fetus. Previous animal studies with the calcium and sodium salt of fosfomycin in rats showed signs of fetal toxicity at the highest doses tested (approximately 25 times the therapeutic dose), but studies at lower doses and in rabbits showed no hazard. Although animal studies with fosfomycin trometamol have shown no hazard, it should only be used in pregnancy when the expected benefit outweighs the risk.
Fosfomycin has been shown to cross into breast milk. Therefore, Monuril should not be given to lactating women except when absolutely necessary.
Adverse Reactions
In clinical trials, the most frequently reported adverse events occurring in >1% of the study population regardless of drug relationship were: Diarrhea 10.4%, headache 10.3%, vaginitis 7.6%, nausea 5.2%, rhinitis 4.5%, back pain 3%, dysmenorrhea 2.6%, pharyngitis 2.5%, dizziness 2.3%, abdominal pain 2.2%, dyspepsia 1.8%, asthenia 1.7% and rash 1.4%.
The following adverse events occurred in clinical trials at a rate of <1% regardless of drug relationship: Abnormal stools, anorexia, constipation, dry mouth, dysuria, ear disorder, fever, flatulence, flu syndrome, hematuria, infection, insomnia, lymphadenopathy, menstrual disorder, migraine, myalgia, nervousness, paresthesia, pruritus, increased SGPT, skin disorder, somnolence and vomiting.
Drug Interactions
Fosfomycin trometamol did not adversely influence the pharmacologic effectiveness of commonly prescribed class of drugs: Analgesic (morphine), anticonvulsant (diazepam), bronchodilator (aminophylline), antipyretic (acetaminophen), diuretic (hydrochlorothiazide) and spasmolytic (butylscopolamine).
Concomitant administration of metoclopramide has been shown to lower serum and urinary concentration and should be avoided.
Storage
Do not store above 30°C.
Shelf-Life: 3 years.
MIMS Class
ATC Classification
J01XX01 - fosfomycin ; Belongs to the class of other antibacterials. Used in the systemic treatment of infections.
Presentation/Packing
Granules for oral soln (sachet) 3 g x 1's.
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