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MONUROL is a brand name for Fosfomycin, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: MONUROL® (fosfomycin tromethamine) is indicated for the treatment of acute uncomplicated lower urinary tract infections (acute cystitis) in women of 18 years of age and older caused by the following susceptible pathogens: Escherichia coli, Enterococcus faecalis. MONUROL is not indicated for the treatment of…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • A single dose only should be used to treat an episode of acute cystitis. • Repeated daily doses of MONUROL (fosfomycin tromethamine) did not improve the clinical success or microbiological eradication rates compared to single dose therapy, but did increase the incidence of adverse events.
• MONUROL contains sucrose. Its use is not recommended in patients with hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. 3 Pharmacokinetics). 2 Recommended Dose and Dosage Adjustment The recommended dosage for women over 18 years with acute uncomplicated urinary tract infections (acute cystitis) is one sachet containing the equivalent of 3 grams of fosfomycin.
3 Reconstitution). No dosage adjustment is required in patients with hepatic impairment. No dosage adjustment is required in geriatric patients. 3 Pharmacokinetics). 1 Pediatrics). 3 Reconstitution Oral Solutions: The contents of the single dose sachet should be added to about 125 mL (½ cup) of cold water, stirred to dissolve and immediately taken orally.
4 Administration It is recommended that MONUROL be taken on an empty stomach or at least 2-3 hours after a meal. As for other medications, MONUROL should not be co-administered, if possible, with other drugs. 5 Missed Dose MONUROL treatment consists of a single dose.
In the event of a missed dose, MONUROL should be taken on an empty stomach or at least 2-3 hours after the next meal.
). Exercise caution when driving or operating a vehicle or potentially dangerous machinery. Gastrointestinal Clostridium difficile-associated disease Clostridium difficile-associated disease (CDAD) has been reported with the use of many antibacterial agents, including fosfomycin tromethamine.
CDAD may range in severity from mild diarrhea to fatal colitis. It is important to consider this diagnosis in patients who present with diarrhea or symptoms of colitis, pseudomembranous colitis, toxic megacolon, or perforation of the colon subsequent to the administration of any antibacterial agent.
CDAD has been reported to occur over 2 months after the administration of antibacterial agents. Treatment with antibacterial agents may alter the normal flora of the colon and many permit overgrowth of Clostridium difficile. C. difficile produces toxins A and B, which contribute to the development of CDAD.
CDAD may cause significant morbidity and mortality. CDAD can be refractory to antimicrobial therapy. If the diagnosis of CDAD is suspected or confirmed, appropriate therapeutic measures should be initiated. Mild cases of CDAD usually respond to discontinuation of antibacterial agents not directed against C.
difficile. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Powder for solution 3g per sachet Mandarin and orange flavorings (contain sulphites), saccharin, sucrose MONUROL (fosfomycin powder for solution) Page 7 of 27 antibacterial agent clinically effective against C.
difficile. Drugs that inhibit peristalsis may delay clearance of C. difficile and its toxins, and therefore should not be used in the treatment of CDAD. Surgical evaluation should be instituted as clinically indicated since surgical intervention may be required in certain severe cases (see _ADVERSE_REACTIONS8 ADVERSE REACTIONS).
3 Pharmacokinetics). 2 Recommended Dose and Dosage Adjustment The recommended dosage for women over 18 years with acute uncomplicated urinary tract infections (acute cystitis) is one sachet containing the equivalent of 3 grams of fosfomycin.
3 Reconstitution). No dosage adjustment is required in patients with hepatic impairment. No dosage adjustment is required in geriatric patients. 3 Pharmacokinetics). 1 Pediatrics). 3 Reconstitution Oral Solutions: The contents of the single dose sachet should be added to about 125 mL (½ cup) of cold water, stirred to dissolve and immediately taken orally.
4 Administration It is recommended that MONUROL be taken on an empty stomach or at least 2-3 hours after a meal. As for other medications, MONUROL should not be co-administered, if possible, with other drugs. 5 Missed Dose MONUROL treatment consists of a single dose.
In the event of a missed dose, MONUROL should be taken on an empty stomach or at least 2-3 hours after the next meal. 5 OVERDOSAGE Experience regarding the overdose of oral fosfomycin is limited. Hypotonia, somnolence, electrolytes disturbances, thrombocytopenia and hypoprothrombinemia have been reported in cases of overdose with parenteral use of fosfomycin.
In the event of overdosage, treatment should be symptomatic and supportive. The patient must be monitored, in particular for plasma/serum electrolyte levels. Urinary elimination of fosfomycin should be encouraged by adequate administration of oral fluids.
Fosfomycin is effectively cleared from the body by haemodialysis with a mean elimination half-life of approximately 4 hours. For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada's toll-free number, 1-844 POISON-X (1- 844-764-7669).
631 g of fosfomycin tromethamine (equivalent to 3 g of fosfomycin) along with the non-medicinal ingredients listed above. MONUROL is available as a single-dose sachet. 7 WARNINGS AND PRECAUTIONS Carcinogenesis and Mutagenesis See 16 NON-CLINICAL TOXICOLOGY.
MONUROL (fosfomycin tromethamine) is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient (such as the mandarin and orange flavourings, which contain sulphites), or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Genitourinary Persistent infections In the case of persistent infections, a thorough examination and a re-evaluation of the diagnosis are recommended as this is often due to complicated urinary tract infections or the prevalence of resistant pathogens (see Susceptibility/Resistance).
Immune Hypersensitivity reactions, including anaphylaxis and anaphylactic shock, which can be life- threatening, have been reported during MONUROL treatment. MONUROL also contains sulphites, which may, in rare cases, cause severe hypersensitivity and bronchospasm.
If any such reactions occur, adequate medical treatment is required and MONUROL should never be re-administrated (see 2 CONTRAINDICATIONS and 8 ADVERSE REACTIONS). 3 mL/min), the half-life of fosfomycin has been shown to increase. Therefore, the physician should evaluate if the potential benefits of the drug outweigh the potential risks for patients with severe renal impairment or patients undergoing haemodialysis.
3 Pharmacokinetics).
Reproductive Health:
Female and Male Potential Fertility Study in animals has shown that fosfomycin tromethamine treatment did not adversely affect spermatogenesis or the reproductive capacity of the male rats nor adversely affect oogenesis, the regularity of the estrus cycle, or fertility and gestation in the female rats (see _NON- CLINICAL_TOXICOLOGY16 NON-CLINICAL TOXICOLOGY).
Teratogenic Risk Fosfomycin crosses the placental barrier. 1 Pregnant Women and 16 NON-CLINICAL TOXICOLOGY). Susceptibility/Resistance Development of Drug Resistant Bacteria Prescribing MONUROL in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and risks the development of drug-resistant bacteria.
1 Pregnant Women Fosfomycin crosses the placental barrier and its safety in the treatment of infections during pregnancy has not been established. MONUROL should not be used during pregnancy unless clearly needed and after taking into account the benefits to the mother and potential risks to the fetus (see 16 NON-CLINICAL TOXICOLOGY).
2 Breast-feeding As MONUROL may be excreted in human milk, a decision should be made whether to discontinue nursing or to not administer MONUROL, taking into account the benefits to the mother and potential risks to the neonate (see 16 NON-CLINICAL TOXICOLOGY).
3 Pediatrics Pediatrics (<18 years old): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 4 Geriatrics Evidence from clinical studies and experience suggests that use in the geriatric population is not associated with differences in drug efficacy or tolerance.
3 Pharmacokinetics). 1 Adverse Reaction Overview In three US trials, 1233 patients were treated with MONUROL (fosfomycin tromethamine). 1 %). The most frequently observed symptom, diarrhea, was considered mild and self-limiting. A single case of unilateral optic neuritis was reported and considered possibly related to MONUROL therapy (see 7 WARNINGS AND PRECAUTIONS).
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates […]
Driving and Operating Machinery Although no studies have been conducted on the effects on the ability to drive and use machines, dizziness has been reported from patients taking MONUROL (fosfomycin tromethamine). This may influence some patients’ ability to drive and operate machinery (see