Septilisin Duo

Cephalexin
Coated Tablets

Argentinian Industry
EXPENDITURE UNDER FILED PRESCRIPTION

Cephalosporin Antibiotic
FORMULA: each Coated Tablet of Septilisin Duo contains: Cephalexin (as Cephalexin Monohydrate) 1000 mg. Excipients: Es-
Magnesium carbonate, Colloidal silica, Brilliant Blue F.C.F., Lactose, Hypromellose, Titanium dioxide, Triacetin, Cellulose
Microcrystalline c.s.

Gluten-free from wheat, oats, barley, and rye (Without T.A.C.C.).

THERAPEUTIC ACTION
Bactericidal antibiotic by oral route. First-generation cephalosporin.

INDICATIONS
They stem from the antibacterial activity and pharmacokinetic characteristics of cephalexin. They are limited to infections.
treatable by oral route caused by sensitive germs, excluding meningeal locations, particularly:
Uncomplicated urinary infections, excluding acute prostatitis.
Skin and soft tissue infections.
Dental infections.
ENT infections: Strep A beta-hemolytic pharyngitis with documented etiology(*), sinusitis, otitis.
Lower respiratory tract infections: Superinfection of acute bronchitis, exacerbation of chronic bronchitis, community-acquired pneumonia
unity in individuals without risk factors, without signs of severe clinical picture and in the absence of data suggesting Streptococcus pneumoniae
penicillin-resistant pneumonia or atypical pneumonia.

Penicillin is the usual drug of choice for the treatment and prevention of streptococcal infections.

PHARMACOLOGICAL CHARACTERISTICS/PROPERTIES
Pharmacological Action
Septilisin Dúocontains cefalexin, an antibiotic belonging to the beta-lactam family, a group of cephalosporins called
first generation.
Cephalexin is used almost exclusively orally. It is bactericidal in vitro through the mechanism of inhibiting the synthesis of the
bacterial wall.
It has a broad spectrum of action, having demonstrated antibacterial activity, both in vitro and in clinical infections, against the
following microorganisms:
•Species usually sensitive:
Gram-positive aerobes: Corynebacterium diphtheriae, Propionibacterium acnes, methicillin-sensitive staphylococci, streptococci, Strep-
penicillin-sensitive pneumonia cocci.
Aerobios gram-negativos:Moraxella catarrhalis, Citrobacter koseri, Escherichia coli, Klebsiella spp, Neisseria gonorrhoeae,Pasteurella
spp.
Anaerobes: Fusobacterium spp, Prevotella spp.
Species usually with intermediate resistance:
Gram-positive aerobes: Haemophilus influenzae, Proteus mirabilis.
Anaerobios:Clostridium perfringens,Peptostreptococcus spp.
Species that are typically resistant:
Gram-positive aerobes: enterococci, Listeria monocytogenes, methicillin-resistant staphylococci (30-50% of the total staphylococci, so-
everything in a hospital setting.
Gram-negative aerobes: Acinetobacter spp, Citrobacter freundii, Enterobacter spp, Morganella morganii, Proteus vulgaris, Providencia
spp, Pseudomonas spp, Serratia spp.
Anaerobes: Bacteroides spp, Clostridium difficile.

Pharmacokinetics
Absorption: Administered orally, cephalexin is rapidly and almost completely absorbed at the level of the duodenum.
The process is delayed by the presence of food in the stomach, but the percentage of drug absorbed does not change.
Distribution: The maximum serum peak appears approximately one hour after ingestion, with average values of 9, 18, and 32.
mcg/ml for doses of 250, 500, and 1000 mg. The elimination half-life ranges from 50 to 70 minutes.
Due to being loosely bound to plasma proteins (6 to 10%), it shows good diffusion and wide tissue distribution.
Crosses the placenta. Poorly diffuses in CSF. Does not reach the lymphatic system.
Biotransformation: It is not metabolized in the organism.
Excretion: It is mostly eliminated by the kidney (through glomerular filtration and tubular secretion), in active form (80 to 100% in 24 hours)
ras).
Presents a very limited biliary excretion.
After a dose of 1 gram, the concentration in bile is 3 mcg/ml.
The values that determine the sensitivity or resistance of a bacterium to a certain antibiotic are defined based on the concentrations.
(mcg/ml) reached in serum. In the specific case of cephalexin, whose elimination is renal, the drug concentrations in the
urine greatly exceeds the resistance ranges of most uropathogens. Various studies have shown that more than
90% of cephalexin is eliminated unchanged within 8 hours after administration. During this period, the con-
Urinary peak concentrations following doses of 250 mg, 500 mg, and 1000 mg were 1000, 2200, and 5000 mcg/ml respectively. In others
studies, after a dose of 500 mg of cephalexin, the urinary concentrations were 2809 mcg/ml and 376 mcg/ml over the hours
0-2 and 2-4 for drug administration respectively. The mentioned values far exceed the inhibitory concentrations.
minimum inhibitory concentrations (MIC) that define resistance in Escherichia coli and Klebsiella pneumoniae.

DOSAGE/DOSAGE - METHOD OF ADMINISTRATION

The dosage will be adjusted, according to medical judgment, to the clinical picture of each patient. As an average dosage for guidance, for adults and children
For those over 12 years old, it is advised:
With normal kidney function:

1 tablet of Septilisin Dúocada every 12 hours.

Note: In severe infections, up to 4 g per day can be administered in divided doses; if higher doses are necessary, it should be
consider the parenteral route.

With renal insufficiency:

The dose should be reduced based on creatinine clearance.
Duration of treatment
It will depend on the evolution of the infectious process. Generally, it takes an average of 7-10 days, but it can extend to 14 days.
in lung diseases. In infections caused by beta-hemolytic streptococcus, a 10-day treatment is recommended.

CONTRAINDICATIONS
History of allergy to cephalosporins, penicillins, and/or any of the components of the formulation. Pregnancy and lactation: see
PRECAUTIONS

WARNINGS
Before starting treatment with cephalosporins, a thorough patient interview should be conducted to look for any history of
allergy to cephalosporins and/or penicillins, to prevent any allergic reaction, including anaphylaxis, since there is hypersensitivity
dad crusade between both groups of antibiotics. Patients with a history of allergy should be strictly monitored (such
such as asthma, eczema, and hay fever). In doubtful cases, it is advisable to carry out the first administration under medical supervision. In the presence of
the appearance of allergic symptoms of any kind should interrupt the treatment.
If bacteriological information (cultures, sensitivity) is available, it should be taken into account to select or modify the an-
antibiotic therapy; in its absence, an empirical selection will be made based on the available local epidemiological information.
Due to the possible alteration of the normal colonic flora (proliferation of Clostridium species, mainly C. difficile), it has been described
with almost all antibacterial agents, including cephalexin, cases of colitis, including pseudomembranous colitis. For this reason,
this diagnosis should be taken into account in cases of diarrhea associated with the administration of antibiotics.

PRECAUTIONS
In order to reduce the development of bacterial resistance and preserve the effectiveness of antibiotics, they should only be used
to treat or prevent infections of proven or strongly suspected bacterial etiology.
In case of renal insufficiency, the dosage should be adjusted (see 'DOSAGE/DOSAGE - METHOD OF ADMINISTRATION').
Renal function should be monitored when associating a cephalosporin with potentially nephrotoxic antibiotics (especially aminoglycosides).
glycosides) or with a diuretic (such as furosemide, ethacrynic acid).
When using Fehling or Benedict reagents to detect glucose in urine, the medication may cause positive reactions.
false. This does not occur when using glucose oxidase as a reagent.
Under treatment with cephalosporins, a false positive result may appear in the Coombs test.
Pregnancy: Although cephalexin has not demonstrated teratogenic capability in animal studies, it is recommended to establish clear...
It alters the benefit/risk ratio before its use during pregnancy. Nevertheless, cephalexin is one of the treatments.
of choice in urinary tract infection in pregnancy.
Breastfeeding: The passage of cephalexin into breast milk is minimal and it is generally considered compatible with breastfeeding. However, the
the only way to avoid potential problems in the infant (alteration of the intestinal flora, direct effects, interference with exams
The use of teriologicals in cases of fever should be avoided during that period or breastfeeding should be suppressed during administration.
Use in elderly patients: No differences in safety or efficacy have been observed compared to individuals.
Under 65 years of age.
Use in children: This dosage form is not suitable for use in children under 12 years of age.
Interactions
Metformin: The concomitant administration of cephalexin may cause an increase in the maximum plasma concentration (by 34%,
average) and of the area under the curve (24%, average), and decrease in renal clearance (14%, average) of metformin.
Probenecid: Like other beta-lactams, it can inhibit the renal excretion of cephalexin.

ADVERSE REACTIONS:
The medication is generally well tolerated.
The following adverse events have been reported:
Gastrointestinal: Diarrhea was the most frequent; in most cases, it does not require discontinuation of treatment. They may present-
you may experience symptoms of pseudomembranous colitis during or after treatment with cephalexin. Nausea and vomiting have been reported with
low frequency. Dyspepsia and abdominal pain have also been reported. As with some penicillins and some other cephalosporins, in
Rare cases of hepatitis and transient cholestatic jaundice have been reported.
Hypersensitivity: Allergic reactions have been observed (in the form of skin rash, urticaria, angioedema, and rarely, erythema)
polymorphic theme, Stevens-Johnson syndrome or toxic epidermal necrolysis; generally, such reactions subside after...
stop the treatment, although some may require supportive therapeutic measures. Isolated cases of ana have also been reported.
filaxia.
Others: Genital and anal itching, genital candidiasis, vaginitis and vaginal discharge, dizziness, fatigue, headache, agitation, confusion, hallucinations, arthralgia.
gia, arthritis and joint disorders. Rarely, reversible interstitial nephritis has been reported. Cases have been reported
of eosinophilia, neutropenia, hypoprothrombinemia and elevation of serum transaminases glutamic-oxaloacetic and glutamic-pyruvic.

OVERDOSAGE
To date, no cases of untreated overdose have been reported.
In the event of an overdose, go to the nearest hospital or contact a Poison Control Center, especially:
Dr. Ricardo Gutiérrez Children's Hospital. Phone: (011) 4962-6666/2247.
Dr. Alejandro Posadas Hospital
Children's Hospital Dr. Pedro de Elizalde.

PRESENTATION: Container containing 14 Coated Tablets.

Keep away from heat (not exceeding 30ºC) and excessive humidity.

LIKE ALL MEDICATION, SEPTILISIN DÚO MUST BE KEPT OUT OF REACH OF CHILDREN.

This medication should be used exclusively under medical prescription and supervision and cannot be refilled without a new prescription.
doctor.

Medicinal specialty authorized by the Ministry of Health and Environment. Certificate No. 34,354.
Date of last review: April/2006.

BagóLaboratoriesS.A.
Argentina Research and Technology
Prepared in La Rioja Industrial Park.
Bernardo de Irigoyen No. 248 (C1072AAF)
Technical Director: Julio C. Marangoni. Pharmacist.
Street 4 No. 1429 (B1904CIA). Tel.: (0221) 425-9550/54. La Plata. Buenos Aires.