Fosmicin 500 meiji medicine for infections (2 blisters x 10 tablets)

Dosage form Box of 2 blisters x 10 tablets
Specifications Fosfomycin calcium hydrate

Ingredient

Composition information	Content
Fosfomycin calcium hydrate	500mg

Uses

Indications

strains of bacteria sensitive to fosfomycin: Staphylococcus sp., Escherichia coli, shigella sp., Salmonella sp., Serratia sp. Campylobacter sp.

Fosmicin is used to treat infections caused by sensitive bacteria in the following diseases:

Deep bacterial infections.

cystitis. Learning

Antibacterial activity in vitro.

fosfomycin has bactericidal effects on gram -negative and gram -positive bacteria strains.

Mechanism of action

The mechanism of action of fosfomycin is very special. Fosfomycin penetrates bacterial cells through active transportation systems in the cytoplasm and inhibit the early stages of the biosynthesis of the peptidoglycan component of the bacterial cell wall (B-Lactam antibiotics inhibit the late stage of this process).

pharmacokinetics

blood concentration in blood

Poor absorption, bioavailability is about 26%. The concentration of blood drugs and pharmacokinetics parameters of fosfomycin on healthy volunteers (n = 20) use the only tablet or fosmicin capsule 1,000 mg presented in the table below. The pharmacokinetic parameters show a biological equivalent between tablets and fosmicin capsules.

Preparations Plasma concentration in plasma (PG/ML) Hoces parameters Hour 6 hours

10 hours

Tmax (hour) 5.36 2,68 1.54 2.63 5.86 4.35 Nang 5.19 2,32 1.42

2.43 5,64

4,55

The ratio of plasma proteins of fosfomycin is 2.16%.

Metabolism and elimination

fosfomycin is not metabolized in vivo and is eliminated via urine in the form of non -variable and active.

The percentage of drugs found in urine in healthy volunteers (n = 3) within 24 hours after taking the 1000mg -dose capsule is similar to when using the tablet form and are 28.4%.

Before taking Fosmicin 500 meiji medicine for infections (2 blisters x 10 tablets)

How to use

Fosmicin is used orally.

Dosage

The common dose for adults is 2 to 3 grams of fosfomycin per day, divided into 3 to 4 times.

Can adjust the dose depending on the age and clinical symptoms of the patient.

According to the general principle, fosfomycin should only be used for a minimum time to treat patients' infections after confirming the sensitivity of pathogenic bacteria to the drug to avoid the risk of drug resistance.

What to do when overdose? If overdose occurs, symptomatic and supportive treatment should be conducted.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

The adverse reaction includes symptoms in the gastrointestinal tract such as diarrhea, loose stools and abdominal or abdomen were recorded at 9 (10.11%) out of 89 patients in a clinical study.

The changes in subclinical test results have been recorded in 1 (11.11%) out of 9 patients participating in the research, namely a slight increase of AST (GOT)/Alt (GPT).

The adverse reactions have been recorded when using capsules.

Post -commercial surveys for capsules (concluded by biological equivalent to the tablet form) have been conducted on 28,238 patients at 1,958 treatment facilities.

There are 1,052 adverse reactions recorded in 947 (3.35%) out of 28,238 patients.

Main adverse adverse reactions include: Disorders of the digestive system (diarrhea, abdominal pain, nausea/vomiting, anorexia, indigestion, flatulence, stomatitis ...) are recorded in 822 patients, liver and bile disorders (increase AST (GOT), ALT (GPT) ..) are recorded in 66 cases, skin disorders and soft tissue (rash, itching, hypertime ...) and urinary system disorders (increase Bun) in 8 patients.

Clinically serious adverse adverse reactions

There may be a appearance of colitis and severe blood stools such as fake colitis (

Patients should be closely monitored and if the patient has abdominal pain or diarrhea, should stop the drug immediately and apply appropriate treatment measures.

Other adverse reactions

Symptoms

AST (GOT), ALT (GPT), Alkaline Phosphatase, LDH
kidney acid, platelet reduction Other hot, flushed, fever, chest drum, uncomfortable

Klebsiella oxytoca proliferation due to the use of fosfomycin Stop immediately.

Warnings

Contraindicated

Fosmicin is not for:

Patients with hypersensitivity to any ingredients of the drug.

Nephritis - Pyelonephritis or abscess around the kidneys.

Precautions when using

Be careful when using Fosmicin tablets for patients with liver dysfunction (the drug can worsen liver dysfunction).

Used for elderly patients

fosfomycin is excreted mainly through the kidneys. Because elderly patients often have renal function, should be noted when using the drug for this patient, may need to reduce the dose.

Used for pregnant women and nursing women

It is not recommended to use this drug for pregnant women, pregnant women or nursing women (the safety of the drug when used for pregnant women or breastfeeding women has not been proven).

The ability to drive and operate machinery

Caution when driving and operating machinery because the drug can cause headaches, tinnitus, dizziness, discomfort.

Pregnancy or lactation

Do not recommend the use of this drug for pregnant women, pregnant women or nursing women (the safety of the drug when used for pregnant women or breastfeeding women has not been proven).

Drug interaction

metoclopramide and drugs that increase the gastrointestinal motility when used simultaneously with fosfomycin will reduce fosfomycin levels in plasma and in urine.

fosfomycin has an increase in the same effect as P-Lactam antibiotics, aminoglycoside, macrolide, tetracycline, chloramphenicol, rifamycin, colistin, vancomycin and lincycin.

Storage

Store at temperatures below 25 ° C.

Expiry date: 36 months from the date of production.

This drug is only used by a doctor.

Read the instructions carefully before use. If you need more information, please consult your doctor or pharmacist.

Notify the doctor with unwanted effects when using the drug.

To be out of reach of children.

Do not use overdue drugs printed on the packaging.

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