Erifoscin

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Erifoscin uses

Erifoscin consists of Erythromycin Estolate, Fosfomycin Calcium.

Erythromycin Estolate:


Pharmacological action

Erifoscin is a macrolide antibiotic. Has bacteriostatic action. However at higher doses against susceptible organisms has a bactericidal effect. erythromycin is reversibly bound to the ribosome of bacteria, thereby inhibiting protein synthesis. Erifoscin (Erythromycin Estolate) is active against gram-positive bacteria: Staphylococcus spp. (strains producing and not producing penicillinase), Streptococcus spp. (including Streptococcus pneumoniae); gram-negative bacteria: Neisseria gonorrhoeae, Haemophilus influenzae, Bordetella pertussis, Brucella spp., Legionella spp., Bacillus anthracis, Corynebacterium diphtheriae; anaerobic bacteria: Clostridium spp. erythromycin is also active against Mycoplasma spp., Chlamydia spp., Spirochaetaceae, Rickettsia spp. To erythromycin resistant gram-negative bacilli, including Escherichia coli, Pseudomonas aeruginosa, Shigella spp., Salmonella spp.

Pharmacokinetics

Erifoscin (Erythromycin Estolate) bioavailability is 30-65%. Distributed in most tissues and body fluids. Plasma protein binding is 70-90%. Metabolised in the liver, partly with the formation of inactive metabolites. T1/2 is 1.4-2 hours. It is derived from bile and urine.

Why is Erifoscin prescribed?

Infectious-inflammatory diseases caused by microorganisms sensitive to erythromycin, including diphtheria, pertussis, trachoma, brucellosis, a disease Legionnaires, sore throat, scarlet fever, otitis media, sinusitis, cholecystitis, pneumonia, gonorrhea, syphilis. Also Erifoscin (Erythromycin Estolate) used for the treatment of infectious-inflammatory diseases caused by pathogens (eg staphylococci) are resistant to penicillin, tetracycline, chloramphenicol, streptomycin.

For external use: acne vulgaris.

For local use: the infectious-inflammatory diseases of eyes.

Dosage and administration

Erifoscin prescribed individually depending on the location and severity of infection, the sensitivity of the parasite. In adults use a daily dose of 1-4 g. Children under the age of 3 months - 20-40 mg / kg / day, aged from 4 months to 18 years - 30-50 mg / kg / day. Multiplicity is 4 times / day. The treatment course - 5-14 days after the disappearance of symptoms treatment should be continued for a further 2 days. Accepts up to 1 hour before eating or 2-3 hours after eating.

Solution for external applications lubricate the affected skin.

The ointment is applied to the affected area and in diseases of the eye lay behind the lower eyelid. The dose, frequency and duration of application is determined individually.

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Erifoscin (Erythromycin Estolate) side effects, adverse reactions

Digestive system: nausea, vomiting, epigastric pain, cholestatic jaundice, tenesmus, diarrhea, dysbacteriosis; rarely - pseudomembranous enterocolitis, abnormal liver function, increase in liver transaminases, pancreatitis.

Allergic reactions: skin rash, urticaria, eosinophilia, rarely - anaphylactic shock.

Effects due to the influence of chemotherapy: oral candidiasis, vaginal candidiasis.

From the senses: the reversible ototoxicity - hearing loss and / or tinnitus (in the application of high doses - more than 4 g / day).

Since the cardiovascular system: rarely - tachycardia, prolongation of the QT interval on ECG, flickering and / or atrial flutter (patients with long QT interval on the ECG).

Local reactions: phlebitis at the site of / in the introduction.

Erifoscin contraindications

Jaundice in history, marked disturbances of liver function, hypersensitivity to macrolides.

Using during pregnancy and breastfeeding

Erythromycin crosses the placental barrier, excreted in breast milk.

In the application of erythromycin in pregnancy should assess the intended benefits to the mother and the potential risk to the fetus. If necessary, use during lactation should decide on the termination of breastfeeding.

Special instructions

With careful use Erifoscin when disorders of liver function and / or kidneys. Medications that increase the acidity of gastric juice and acidic drinks inactivate erythromycin. erythromycin can not drink milk and dairy products.

Precautionary measures

The use of erythromycin containing benzene for IV injection sometimes accompanied by the development of a fatal syndrome Gaspinga in children, as well as acute hepatitis drug in adults and children.

Erifoscin drug interactions

With simultaneous use of Erifoscin (Erythromycin Estolate) with theophylline, aminophylline, caffeine, there is an increase in their concentration in blood plasma and thus increases the risk of toxic effects.

Erythromycin increases the concentrations of cyclosporine in the blood plasma and may increase the risk of nephrotoxicity.

Drugs that block tubular secretion prolongs T1/2 of erythromycin.

Incompatible with lincomycin, clindamycin and chloramphenicol (antagonism).

Erifoscin (Erythromycin Estolate) reduces the bactericidal action of beta-lactam antibiotics (penicillins, cephalosporins, carbapenems).

With simultaneous use of erythromycin increases the concentration of theophylline.

At the same time receiving chemotherapy, which is carried metabolism in the liver (carbamazepine, valproic acid, hexobarbital, phenytoin, alfentanil, dizopiramid, lovastatin, bromocriptine), may increase the concentration of these drugs in plasma (an inhibitor of microsomal liver enzymes).

IV injection of erythromycin increases the effects of ethanol (accelerating gastric emptying and decrease the duration of alcohol dehydrogenase in the gastric mucosa).

Erythromycin reduces the clearance of triazolam and midazolam and therefore may increase the pharmacological effects of benzodiazepines.

At the same time taking with terfenadine or astemizole may develop arrhythmias (fibrillation and ventricular flutter, ventricular tachycardia, until death); with dihydroergotamine or non hydrated ergot alkaloids may vasoconstriction to spasm, dysesthesia.

With simultaneous application Erifoscin (Erythromycin Estolate) slows elimination (increases the effect) of methylprednisolone, felodipine and anticoagulants of cumarine series.

In a joint appointment with lovastatin increased rhabdomyolysis.

Erythromycin increases the bioavailability of digoxin.

Erythromycin reduces the effectiveness of hormonal contraceptives.

Erifoscin in case of emergency / overdose

Symptoms: disruption of the liver until the acute liver failure, and hearing loss.

Treatment: gastric lavage, forced diuresis, hemo-and peritoneal dialysis. Produced a constant monitoring of vital functions (ECG, electrolyte composition of blood).

Fosfomycin Calcium:


INDICATIONS AND USAGE

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

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

CONTRAINDICATIONS

Erifoscin (Fosfomycin Calcium) 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 Erifoscin (Fosfomycin Calcium), 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.

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PRECAUTIONS

General

Do not use more than one single dose of Erifoscin to treat a single episode of acute cystitis. Repeated daily doses of Erifoscin (Fosfomycin Calcium) 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 Erifoscin (Fosfomycin Calcium) can be taken with or without food.
  • That their symptoms should improve in two to three days after taking Erifoscin (Fosfomycin Calcium); 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 (with or without stomach cramps and fever) 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 Erifoscin, metoclopramide, a drug which increases gastrointestinal motility, lowers the serum concentration and urinary excretion of Erifoscin (Fosfomycin Calcium). Other drugs that increase gastrointestinal motility may produce similar effects.

Cimetidine:Cimetidine does not affect the pharmacokinetics of Erifoscin (Fosfomycin Calcium) when coadministered with Erifoscin (Fosfomycin Calcium).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long term carcinogenicity studies in rodents have not been conducted because Erifoscin (Fosfomycin Calcium) is intended for single dose treatment in humans. Erifoscin (Fosfomycin Calcium) 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. Erifoscin (Fosfomycin Calcium) 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, Erifoscin crosses the placental barrier. Erifoscin (Fosfomycin Calcium) crosses the placental barrier of rats; it does not produce teratogenic effects in pregnant rats at dosages as high as 1000 mg/kg/day (approximately 9 and 1.4 times the human dose based on body weight and mg/m2, respectively). 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 Erifoscin (Fosfomycin Calcium) tromethamine 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 Erifoscin (Fosfomycin Calcium), 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 Erifoscin (Fosfomycin Calcium) 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.

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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:

Adverse Events Erifoscin

N=1233

Nitrofurantoin

N=374

Trimethoprim/ sulfamethoxazole

N=428

Ciprofloxacin

N=455

Diarrhea 9.0 6.4 2.3 3.1
Vaginitis 5.5 5.3 4.7 6.3
Nausea 4.1 7.2 8.6 3.4
Headache 3.9 5.9 5.4 3.4
Dizziness 1.3 1.9 2.3 2.2
Asthenia 1.1 0.3 0.5 0.0
Dyspepsia 1.1 2.1 0.7 1.1

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 Erifoscin (Fosfomycin Calcium) therapy.

Post-marketing Experience:

Serious adverse events from the marketing experience with Erifoscin (Fosfomycin Calcium) outside of the United States have been rarely reported and include: angioedema, aplastic anemia, asthma (exacerbation), 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 Erifoscin (Fosfomycin Calcium): anaphylaxis and hearing loss.

Laboratory Changes:

Significant laboratory changes reported in U.S. clinical trials of Erifoscin (Fosfomycin Calcium) 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.

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OVERDOSAGE

In acute toxicology studies, oral administration of high doses of Erifoscin (Fosfomycin Calcium) 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 Erifoscin (Fosfomycin Calcium) 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 Erifoscin (Fosfomycin Calcium). Erifoscin (Fosfomycin Calcium) may be taken with or without food.

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

PREPARATION

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

HOW SUPPLIED

Erifoscin (Fosfomycin Calcium) is available as a single-dose sachet containing the equivalent of 3 grams of Erifoscin (Fosfomycin Calcium).

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 Erifoscin (Fosfomycin Calcium) 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

Treatment Arm Treatment Duration (days) Microbiologic Eradication Rate Clinical Success Rate Outcome (based on difference in microbiologic eradication rates 5-11 days post therapy)
5-11 days post therapy Study day 12-21
Erifoscin (Fosfomycin Calcium) 1 630/771 (82%) 591/771 (77%) 542/771 (70%)
Ciprofloxacin 7 219/222(98%) 219/222 (98%) 213/222 (96%) Erifoscin (Fosfomycin Calcium) inferior to ciprofloxacin
Trimethoprim/

sulfamethoxazole

10 194/197(98%) 194/197(98%) 186/197(94%) Erifoscin (Fosfomycin Calcium) inferior to trimethoprim/ sulfamethoxazole
Nitrofurantoin 7 180/238(76%) 180/238(76%) 183/238(77%) Erifoscin (Fosfomycin Calcium) equivalent to nitrofurantoin
Pathogen Erifoscin (Fosfomycin Calcium) 3 gm single dose Ciprofloxacin 250 mg bid x 7d Trimethoprim/sulfamethoxazole 160 mg/ 800 mg bid x 10 d Nitrofurantoin 100mg bid x 7d
E. coli 509/644 (79%) 184/187 (98%) 171/174 (98%) 146/187 (78%)
E. faecalis 10/10 (100%) 0/0 4/4 (100%) 1/2 (50%)

Rev. September 2014

NDC 0456-4300-01

Erifoscin (Fosfomycin Calcium) ®

(fosfomycin tromethamine)

(equivalent to 3 grams of Erifoscin (Fosfomycin Calcium))

CONTENTS: 1 SATCHET OF Erifoscin (Fosfomycin Calcium)

GOOD FOR 1 COMPLETE COURSE OF THERAPY

Please see full prescribing information and patient insert enclosed.

Erifoscin pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Erifoscin available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Erifoscin destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Erifoscin Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Erifoscin pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. "FOSFOMYCIN". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  2. "FOSFOMYCIN". http://www.drugbank.ca/drugs/DB0082... (accessed August 28, 2018).
  3. "2N81MY12TE: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Dat... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Erifoscin?

Depending on the reaction of the Erifoscin after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Erifoscin 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.

Is Erifoscin addictive or habit forming?

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.

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Review

sdrugs.com conducted a study on Erifoscin, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Erifoscin consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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