Monurol

What do you feel about the cost of the medicine? Is it expensive?  No   Yes

Monurol uses

• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• Preparation
• How supplied
• References
• Clinical studies
• Monurol reviews

INDICATIONS AND USAGE

Monurol is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains ofEscherichia coli and Enterococcus faecalis.Monurol is not indicated for the treatment of pyelonephritis or perinephric abscess.

If persistence or reappearance of bacteriuria occurs after treatment with Monurol, other therapeutic agents should be selected. (See PRECAUTIONS and CLINICAL STUDIES section)

CONTRAINDICATIONS

Monurol is contraindicated in patients with known hypersensitivity to the drug.

WARNINGS

Clostridium difficileassociated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Monurol, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth ofC. difficile.

C. difficileproduces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains ofC. difficilecause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed againstC. difficilemay need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment ofC. difficile, and surgical evaluation should be instituted as clinically indicated.

PRECAUTIONS

General

Do not use more than one single dose of Monurol to treat a single episode of acute cystitis. Repeated daily doses of Monurol 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.

Information for Patients

Patients should be informed:

• That Monurol can be taken with or without food.
• That their symptoms should improve in two to three days after taking Monurol; if not improved, the patient should contact her health care provider.
• Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

Drug Interactions

Metoclopramide:When coadministered with Monurol, metoclopramide, a drug which increases gastrointestinal motility, lowers the serum concentration and urinary excretion of fosfomycin. Other drugs that increase gastrointestinal motility may produce similar effects.

Cimetidine:Cimetidine does not affect the pharmacokinetics of fosfomycin when coadministered with Monurol.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long term carcinogenicity studies in rodents have not been conducted because Monurol is intended for single dose treatment in humans. Monurol was not mutagenic or genotoxic in thein vitroAmes' bacterial reversion test, in cultured human lymphocytes, in Chinese hamster V79 cells, and thein vivomouse micronucleus assay. Monurol did not affect fertility or reproductive performance in male and female rats.

Pregnancy: Teratogenic Effects

Pregnancy Category B

When administered intramuscularly as the sodium salt at a dose of 1 gm to pregnant women, fosfomycin crosses the placental barrier. Monurol crosses the placental barrier of rats; it does not produce teratogenic effects in pregnant rats at dosages as high as 1000 mg/kg/day. When administered to pregnant female rabbits at dosages as high as 1000 mg/kg/day (approximately 9 and 2.7 times the human dose based on body weight and mg/m², respectively), fetotoxicities were observed. However, these toxicities were seen at maternally toxic doses and were considered to be due to the sensitivity of the rabbit to changes in the intestinal microflora resulting from the antibiotic administration. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether Monurol is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Monurol, a decision should be made whether to discontinue nursing or to not administer the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in children age 12 years and under have not been established in adequate and well-controlled studies.

Geriatric Use

Clinical studies of Monurol did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

ADVERSE REACTIONS

Clinical Trials:

In clinical studies, drug related adverse events which were reported in greater than 1% of the fosfomycin-treated study population are listed below:

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 3.0%, dysmenorrheal 2.6%, pharyngitis 2.5%, dizziness 2.3%, abdominal pain 2.2%, 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 less than 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, SGPT increased, skin disorder, somnolence, and vomiting.

One patient developed unilateral optic neuritis, an event considered possibly related to Monurol therapy.

Post-marketing Experience:

Serious adverse events from the marketing experience with Monurol outside of the United States have been rarely reported and include: angioedema, aplastic anemia, asthma, cholestatic jaundice, hepatic necrosis, and toxic megacolon.

Although causality has not been established, during post marketing surveillance, the following events have occurred in patients prescribed Monurol: anaphylaxis and hearing loss.

Laboratory Changes:

Significant laboratory changes reported in U.S. clinical trials of Monurol without regard to drug relationship include: increased eosinophil count, increased or decreased WBC count, increased bilirubin, increased SGPT, increased SGOT, increased alkaline phosphatase, decreased hematocrit, decreased hemoglobin, increased and decreased platelet count. The changes were generally transient and were not clinically significant.

OVERDOSAGE

In acute toxicology studies, oral administration of high doses of Monurol up to 5 gm/kg were well-tolerated in mice and rats, produced transient and minor incidences of watery stools in rabbits, and produced diarrhea with anorexia in dogs occurring 2-3 days after single dose administration. These doses represent 50-125 times the human therapeutic dose.

The following events have been observed in patients who have taken Monurol in overdose: vestibular loss, impaired hearing, metallic taste, and general decline in taste perception. In the event of overdosage, treatment should be symptomatic and supportive.

DOSAGE AND ADMINISTRATION

The recommended dosage for women 18 years of age and older for uncomplicated urinary tract infection (acute cystitis) is one sachet of Monurol. Monurol may be taken with or without food.

Monurol should not be taken in its dry form. Always mix Monurol with water before ingesting. (See PREPARATION section)

PREPARATION

Monurol should be taken orally. Pour the entire contents of a single-dose sachet of Monurol into 3 to 4 ounces of water (1/2 cup) and stir to dissolve. Do not use hot water. Monurol should be taken immediately after dissolving in water.

HOW SUPPLIED

Monurol is available as a single-dose sachet containing the equivalent of 3 grams of fosfomycin.

NDC

Single-dose sachet 0456-4300-08

One unit carton 0456-4300-01

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).

Keep this and all drugs out of the reach of children.

Manufactured by:

Zambon Switzerland Ltd.

Division of Zambon Group, SpA

Via Industria 13

6814 Cadempino, Switzerland

Made in Switzerland

Distributed by:

Forest Pharmaceuticals, Inc.

Subsidiary of Forest Laboratories LLC

St. Louis, MO 63045

REFERENCES

• National Committee for Clinical Laboratory Standards, Methods for Dilution. Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically - Third Edition; Approved Standard NCCLS Document M7-A3, Vol. 13, No. 25 NCCLS, Villanova, PA, December, 1993.
• National Committee for Clinical Laboratory Standards, Performance Standard for Antimicrobial Disk Susceptibility Tests - Fifth Edition; Approved Standard NCCLS Document M2-A5, Vol. 13, No. 24 NCCLS, Villanova, PA, December, 1993.

CLINICAL STUDIES

In controlled, double-blind studies of acute cystitis performed in the United States, a single-dose of Monurol was compared to three other oral antibiotics. The study population consisted of patients with symptoms and signs of acute cystitis of less than 4 days duration, no manifestations of upper tract infection (e.g., flank pain, chills, fever), no history of recurrent urinary tract infections (20% of patients in the clinical studies had a prior episode of acute cystitis within the preceding year), no known structural abnormalities, no clinical or laboratory evidence of hepatic dysfunction, and no known or suspected CNS disorders, such as epilepsy, or other factors which would predispose to seizures. In these studies, the following clinical success (resolution of symptoms) and microbiologic eradication rates were obtained

Rev. September 2014

NDC 0456-4300-01

Monurol ^®

(fosfomycin tromethamine)

(equivalent to 3 grams of fosfomycin)

CONTENTS: 1 SATCHET OF Monurol

GOOD FOR 1 COMPLETE COURSE OF THERAPY

Please see full prescribing information and patient insert enclosed.

Monurol pharmaceutical active ingredients containing related brand and generic drugs:

• Fosfomycin Tromethamine

Monurol available forms, composition, doses:

• Powder for Suspension; Oral; Fosfomycin Tromethamine 2 g
• Powder for Suspension; Oral; Fosfomycin Tromethamine 3 g

Monurol destination | category:

• Human:
• Antibiotics
• Urinary anti-infectives

Monurol Anatomical Therapeutic Chemical codes:

• J01XX01 - Fosfomycin

Monurol pharmaceutical companies:

• Axxess Pharma
• Cathay Drug
• Emerging Pharma
• Firma Popular
• Forest Laboratories
• Gerolymatos
• Labomed Instituto Farmaceutico
• Orion Pharma
• Purdue Pharma
• Rafa Laboratories
• Sanofi-Aventis
• United Italian Trading
• Zambon
• Zenfields HK
• Zuellig Pharma

References

1. Dailymed."MONUROL (FOSFOMYCIN TROMETHAMINE) POWDER [FOREST LABORATORIES]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
2. "FOSFOMYCIN". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
3. "FOSFOMYCIN". http://www.drugbank.ca/drugs/DB0082... (accessed August 28, 2018).

Frequently asked Questions

Depending on the reaction of the Monurol after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Monurol not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

Review

Visitor reports

Visitor reviews

The information was verified by Dr. Rachana Salvi, MD Pharmacology