Medicinal Products

ALFATIL 250 mg / 5 mL

Generic drug of the therapeutic class: Infectiology - Parasitology
active ingredients: Cefaclor
laboratory: Ethypharm

Powder for oral suspension
Bottle of 60 ml
All forms

Indication

They arise from the antibacterial activity and pharmacokinetic characteristics of cefaclor. They take into account both the clinical studies that the drug has given and its place in the range of antibacterial products currently available.
They are limited to infections caused by sensitive germs when these infections allow oral antibiotic therapy and excluding meningeal locations, including:
- ENT infections: documented angina at beta-hemolytic streptococcus A, sinusitis, otitis,
- lower respiratory infections:
. superinfections of acute bronchitis,
. exacerbations of chronic bronchitis,
. Community-acquired pneumonia in subjects
. without a risk factor,
. without signs of clinical severity,
. in the absence of any evidence of resistance of S. pneumoniae to penicillin,
. in the absence of any argument suggestive of atypical pneumonia.
- uncomplicated urinary infections, except prostatitis and pyelonephritis.
Official recommendations concerning the appropriate use of antibacterials should be taken into account.

Dosage ALFATIL 250 mg / 5 mL Powder for oral suspension 60 ml bottle

Oral way.
Dosage:
- In the subject with normal renal functions:
. In adults, the usual daily dose is 250 mg every eight hours, or 750 mg / day.
For more severe infections or those due to intermediate sensitivity bacteria, the doses can be doubled (500 mg every eight hours, 1.5 g / day).
. In children, the usual daily recommended dose is 20 mg / kg / day, one dose every eight hours. For more severe infections, particularly otitis media, and those due to intermediate sensitivity bacteria, doses of 40 mg / kg / day, divided into three doses, are recommended with a maximum dose of 1 g / day.
- In patients with renal insufficiency:
In case of renal insufficiency, the dosage is adapted according to the clearance of creatinine or serum creatinine (see Table):
Clearance of creatinine: Daily dosage .
. <Clr <40 ml / min / 1.73 m²: 500 mg every 12 hours.
. Clcr <20 ml / min / 1.73 m²: reduced to one-third of the normal dosage or half.
Duration of treatment :
The duration of treatment is 7 to 10 days on average for all therapeutic indications, up to 14 days for pneumopathies.
The treatment duration of angina is 10 days.
Administration mode :
- The administration is done either with a measuring scale (graduated in mg of active principle), particularly adapted to the small child, or with a measuring spoon (5 ml) adapted to the child.
- When administered with the graduated measuring cup, the dose per dose is read directly on the graduations of the measuring piston. Thus, the dose indicated corresponds to the dose for one dose.
- Three shots per 24 hours are required.
- For example, if a dose of 250 mg is prescribed for a dose, the plunger of the scoop will be pulled until the graduation marked 250 mg (= 5 ml) is at reading level (collar of the scoop), three times in 24 hours.
- In case of administration with the measuring spoon: a measurement of 5 ml = 250 mg of active ingredient.

Against indications

This medication should never be used in case of allergy to cephalosporin antibiotics.
Due to the presence of sucrose, this drug is contraindicated in case of fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency.

Alfatil side effects

- Allergic manifestations:
. Febrile reactions.
. Rashes, morbilliform rash, pruritus.
. Urticaria, Quincke's edema, and rarely anaphylactic shock. Anaphylactic reactions are more common in patients already sensitized to penicillin.
. Severe allergic reactions such as Stevens-Johnson syndrome and epidermal necrolysis have been reported in rare cases.
. Rare cases of serum sickness reactions have been reported. These are rashes most often urticarial, exceptionally erythema multiforme type, associated with arthralgia / arthritis, with or without fever, usually occurring during or after a second administration (or more) of drug. These symptoms, which have been described more frequently in young children, regress without sequelae a few days after stopping treatment. The effectiveness of antihistamines and corticosteroids has not been demonstrated. Short hospitalizations have sometimes been deemed necessary.
This symptomatology, which could be related to a hypersensitivity reaction, differs from the typical picture of serum sickness in that it is rarely related to lymphadenopathy and proteinuria and circulating immune complexes have not been found. in the rare cases where they were searched.
- Digestive manifestations:
. Diarrhea, nausea, vomiting, candidiasis.
. As with other antibiotics of this class, cases of pseudomembranous colitis have been reported with cefaclor.
- Liver manifestations:
Transient elevation of transaminases (ALT and ASAT) and alkaline phosphatases.
- Hematological manifestations:
Rare cases of neutropenia and agranulocytosis.
- Genital manifestations:
Vaginal pruritus or vaginitis, with or without candidiasis.
- Nephrotoxicity:
. Alterations in renal function have been observed with antibiotics in the same group, especially when combined with aminoglycosides and diuretics.
. Rare cases of reversible interstitial nephropathy have been reported. - As with any antibiotic, prolonged use of the drug may lead to a phenomenon of resistance of the germs involved.

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