Warning

Laboratorios ERN, S.A. informs that some of the contents of this website are addressed exclusively to healthcare professionals, authorized for prescribing or dispensing of drugs. Specialized knowledge is required for proper interpretation.

_Fosfocina capsulas fm

Fosfocina cápsulas

Calcium fosfomycin.

500mg capsules.

Oral antibiotic for urinary tract.

-Urospecific: 90% of the drug is eliminated actively through the urine.

-Safe: Does not significantly affect the intestinal flora nor the oro-pharyngeal


    Package with 12 capsules.

    Financed by S.N.S.

    N.C. 656733.3


    Package with 24 capsules.

    Financed by S.N.S.

    N.C. 656734.0



    Packet with 500 capsules.

    N.C. 604728.6

Adults 500 mg-1g every 8 hours (1-2 capsules).

Capsules to be taken whole, with water, before or after meals.

Renal insufficiency within the recommended range, it is not necessary to modify the dosage.

FOSFOCINA

 

TECHNICAL SPECIFICS
FOSFOCINA 500mg Capsules
FOSFOCINA SUSPENSION

1. QUALITATIVE AND QUANTATIVE COMPOSITION

Fosfocina 500 mg Capsules
Calcium fosfomycin…………………500 mg per capsule
Excipients: polyethylenglycol 6000

Fosfocina Suspension
Calcium fosfomycin............................250 mg/5 ml reconstituted suspension.
Excipients: Saccharose palmitate, videocrem b guar gum, powdered banana essence, anhydrate of silicon colloid and fructose.

PHARMACEUTICAL FORM
Fosfocina 500 mg Capsules

Hard gelatine capsules

Fosfocina Suspension
Powder for oral suspension

2. THERAPEUTIC INDICATIONS

Fosfomycin, taken orally, is indicated in the treatment of non-complicated urinary tract infections, infections of the gastrointestinal tract and dermatological infections caused by micro-organisms sensitive to its action.

3. DOSAGE AND ADMINISTRATION

Adults 500 mg-1g every 8 hours (1-2 capsules or 2-4 5ml spoonfuls of suspension every 8 hours)
Children over 1 year 250-500 mg every 8 hours (1-2 5ml spoonfuls of suspension every 8 hours)
Premature babies and babies 150-300 mg every 8 hours (1-2 3ml spoonfuls every 8 hours)

Capsules to be taken whole, with water, before or after meals.

The suspension is suitable for treatment of children, premature babies, and babies, and for patients who have difficulty swallowing capsules.

Renal insufficiency Within the recommended range, it is not necessary to modify the dosage.

4. COUNTERINDICATIONS

Known hypersensitivity to fosfomycin or any of the components of this product.

Warnings and special precautions of use
Before administering this product the possible existence of previous manifestations of hypersensitivity to phosphomycin must be investigated. (See section 4.8 Adverse reactions)
Fosfocina suspension contains 2 grams of fructose per 5 ml dose, which must be taken into account in cases where patients show hereditary intolerance to this component.

Interactions with other medication and other forms of interaction
Phosphomycin can prove to be synergic with betalactamic antibiotics, aminoglucosides, vancomycine, colistin, chloramphenicol, tetracycline, erythromycin and trimethoprim.
Antagonism is not produced in associations with tetracycline, chloramphenicol and erythromycin despite the fact that those antibiotics can produce antagonism with betalactamics which, like fosfomycin, act by inhibiting the synthesis of the bacterial wall.

Pregnancy and breastfeeding
Studies conducted on animals have shown no evidence of teratogenic effects, but the possible effects of fosfomycin on pregnant women are not known. A small quantity of fosfomycin passes into breast milk.

Effects on capacity to drive or operate machinery
None have been observed.

5. ADVERSE REACTIONS

The following adverse reactions to fosfomycin have been observed:

Hypersensitive reactions:Cases of uricaria, cold sores, angioedema and severe hypersensitivity (anaphylaxis) have been observed.
Stomach upsets:Rarely vomiting, dyspeptic diarrhoea, nausea.
Alterations in hepatic function:Temporary increases in transaminase and alkaline phosphatase have been observed.
Haematological alterations:Rare cases of light increases in eosinophilis and platelets have been observed. Rarely, aplastic anaemia has been described.
Other adverse reactions:Cases of visual disturbance, dyspnea, loss of appetite, brochiospasm and headaches have been reported. On occasion reinfection by resistant bacteria has been described.

Overdoses
No cases of overdose by fosfomycin administered orally have ever been described. If this should occur stomach upsets may occur, these should be treated symptomatically.

6. PHARMACOLOGICAL PROPERTIES

Pharmodynamic properties.
Phosphomycin acts to inhibit the synthesis of the bacterial wall. It penetrates the bacterial cell through two active transport systems: the alphaglycerophosphate path, constitutive in sensitive bacteria, and the hexose phosphate path, operative in some bacterial species through its induction, especially by the glucose-6-phosphate. Afterwards it selectively and irreversibly inhibits the UDP-N-acetyl-glucosamine: transferase phosphoenolpyruvate, the enzyme which catalyzes the first stage of synthesis in the bacterial wall.

Fosfomycin acts as a bactericide and works over a wide spectrum of gram-positive and gram-negative bacteria.

Gram-positive:Staphylococcus spp. (including methicillin resistant strains), Streptococcus pyogenes, Streptococcus pneumoniae, Streptococcus faecalis.
Gram-negative:Escherichia coli, Citrobacter spp., Enterobacter spp., Proteus mirabilis, Proteus vulgaris, Proteus rettgeri, Serratia marcescens, Haemophilus influenzae, Pseudomonas aeruginosa, Neisseria meningitidis, Neisseria gonorrhoeae, Salmonella spp., Shigella spp, Campylobacter spp, and Yersinia enterocolitica.
Klebsiella spp
and providencia are moderately sensitive.
Bacteroides, Brucella, Corynebacterium, Mycoplasma, Chlamydia, Treponema, Borrelia and Mycobacterium are resistant.

Pharmacokinetic properties
Calcium fosfomycin administered orally shows an incomplete absorption, with a biodisponibility of 30-40%, which allows it to reach maximum seric levels, 2-4 hours after administration, of 2.8mcg/ml, 3.8mcg/ml, 5.2mcg/ml and 7.1mcg/ml for doses of 0.25g, 0.5g, 1g, and 2g, respectively. The plasmatic concentrations are not influenced by food consumed. Repeated doses produce a light cumulative effect.

Pre-clinical safety data
The preclinical data shows no evidence of any special risk for humans, in accordance with conventional tests for safety, acute toxicity, chronic toxicity, mutagenicity, and reproductive toxicity.

7. PHARMACEUTICAL DATA

Incompatibilities
Capsules- None have been described.
Suspension- Must not be mixed with any other medication.

Period of validity
Capsules: 48 months
Suspension: 48 months

Special precautions for storage
Capsules and Extemporaneous Suspension: No special precautions necessary.
The suspension, once reconstituted, has a period of validity of 15 days.

Nature and content of  packaging
The capsules are presented in aluminium/PVC/PVDC blister packs.
The suspension is presented in glass bottles with a quantity sufficient to prepare 60ml or 120ml of extemporaneous solution. It is accompanied by a dosing spoon.

Instructions for use and handling
Capsules: Must be kept sealed in the original packet until the moment of use.
Suspension: Preparation: Invert the bottle to release any powder sealed to the bottom. Add a small amount of water and shake. Fill with water to the level marked with an arrow.
Note the preparation date in the appropriate box. Bear in mind that the solution is only usable for 15 days after reconstitution. Shake well before use. To achieve the correct dose, use the 3 and 5ml spoons which are included in the packaging.

TITULAR AUTHORIZED FOR COMMERCIALIZATION
Laboratorios ERN, S.A. Pedro IV, 499-08020 Barcelona, España

RESPONSIBLE FOR MANUFACTURING
Laboratorios ERN, S.A. Polígono Industrial Can Salvatella, c/ Gorcs i Lladó, 188 Barberá de Vallés. Barcelona. España
Laboratorios ERN, S.A. c/ Perú, 228 - 08020 Barcelona. España

Fosfocina suspensión

Fosfoc Suspens120 CUADR

Calcium fofomycin 250mg/5ml. Oral antibiotic for urinary tract. -Urospecific: 90%...

Fosfocina intravenosa

FOSFOCINA IV 308X292

Disodium fosfomycin. Powder for injectable solution 1 g 1 vial. Wide spectrum bactericidal...