Nixelaf-C 250mg /5 ml SUSP, Cefalexina
Each capsule contains 500 mg:
Cephalexin monohydrate equivalent to 500 mg
Excipient c.b.p. 1 capsule.
Each capsule contains 250 mg:
Cephalexin monohydrate equivalent to â € |.250 mg
Excipient c.b.p. 1 capsule.
Each vial with powder contains:
Cephalexin monohydrate equivalent to 125 mg
Vehicle c.b.p. 5 ml.
Each vial with powder contains:
Cephalexin monohydrate equivalent to 250 mg
Vehicle c.b.p. 5 ml.
INDICATIONS: Cephalexin is a semisynthetic cephalosporin lactam antibiotic-ÃŸ, first generation oral administration.
It is 7- monohydrate (D-amino-phenylacetamido) -3-methyl-3-cephem-4-carboxylic acid, with molecular formula ¢ € C16H17N3O4Sâ H2O.
The nucleus of cephalexin is similar to that of other cephalosporin antibiotic and acts similarly to penicillins.
In vitro studies demonstrate that the cephalosporins are bactericidal because they inhibit cell wall synthesis. Cephalexin shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections (Hedlun, 1970; Jones and Preston, 1983):
Gram-positive aerobes: Staphylococcus aureus (including penicillinase-producing strains), Staphylococcus epidermidis (penicillin-susceptible strains), Streptococcus pneumoniae, Streptococcus pyogenes.
Aerobic gram-negative Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Proteus mirabilis.
Most strains of enterococci (Enterococcus faecalis [formerly Streptococcus faecalis]) and methicillin-resistant staphylococci are resistant to cephalosporins, including cephalexin.
Cephalexin is activ | to against most strains of Enterobacter, Morganella morgagnii (formerly Proteus morgagnii) and Proteus vulgaris. It is not active against S. Mima and Herelleas species Acinetobacter calcoaceticus or Pseudomonas.
When susceptibility tests were performed by in vitro methods, staphylococci exhibit cross-resistance between antibiotics cephalexin and methicillin-type (Morrow, 1992).
There are other microorganisms which may be susceptible to high concentrations of cephalexin, but their clinical significance is unknown (Mandell et al. 1995).
Respiratory tract infections: Caused by S. pneumoniae and Streptococcus group A or ÃŸ-hemolytic S. pyogenes (Penicillin is usually the drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever; NIXELAF *-C is effective in the eradication of streptococci from the nasopharynx.
However, no information is available on the efficacy of cephalexin in the prophylaxis of rheumatic fever).
Ear infections: otitis media caused by S. pneumoniae, H. influenzae, staphylococci, streptococci and M. catarrhalis.
Genitourinary tract infections: Caused by E. coli, P. mirabilis, and Klebsiella sp or K. pneumoniae, and acute and chronic pyelonephritis, cystitis, acute prostatitis.
Dental infections: Caused by staphylococci and / or streptococci.
Infections of the skin and soft tissues: Caused by staphylococci and / or streptococci.
Infections of the bones and joints: Caused by staphylococci and / or P. mirabilis.
Hypersensitivity to penicillins and cephalosporins, infections caused by resistant organisms, interstitial nephritis, angioneurotic edema and in cases of patients with a history of hypersensitivity to penicillins. General Serious infections that require parenteral therapy with oral cephalosporins should not be treated in the acute phase.
PRECAUTIONS: The possibility exists that occur cross-allergic reactions to penicillins patients. Prolonged use of cephalexin superinfection may result because of nonsusceptible organisms, including Candida, Enterococcus, Clostridium difficile, etc., requiring discontinuation.
During prolonged therapy with these drugs, you should undertake a periodic renal function, liver and blood count.
One should keep in mind the possibility of fungal infections or bacterial added, known as super infections (generated by Pseudomonas or Candida).
If such an infection occurs, discontinue therapy and / or establish appropriate therapy.
Use in Pregnancy and Lactation: Cephalexin crosses the placental barrier and is excreted in breast milk. In fact, cephalosporins are considered drugs of class B according to the classification of the FDA (ie, no fetal risk, since they do not have evidence of teratogenic embryotoxic or mutagenic), so that its use in the second and third trimester of pregnancy is safe.
It has been shown that cephalexin is excreted in breast milk, therefore it is recommended that mothers who receive not breast-feed their children.
ADVERSE REACTIONS: A small percentage of patients receiving cephalexin may experience gastrointestinal disturbances such as nausea, vomiting and diarrhea.
As with other broad spectrum antibiotics, there are sporadic reports of pseudomembranous colitis; prolonged use can cause overgrowth of Candida, in the form of vulvovaginitis.
It has also been reported reversible neutropenia and occurs in some patients, skin erythema and maculopapular rash drugs. Cephalexin should be used with caution in cases of drug hypersensitivity reactions.
Occasionally headache, weakness, dizziness, lightheadedness, eosinophilia and neutropenia, stomatitis, vaginal moniliasis, anal itching occurs.
In isolated cases may manifest reversible renal dysfunction. In rare cases it can temporarily cause cholestatic hepatitis as with some penicillins and cephalosporins.
Rarely, severe reactions are observed in the skin, including toxic epidermal necrolysis (exanthematic necrolysis), the Stevens-Johnson syndrome, hypersensitivity reactions, including angioedema and anaphylaxis. As with other cephalosporins, there are some reports of reversible interstitial nephritis. There is the possibility of anaphylactic reactions, however, occur only in extremely rare cases. Allergic symptoms usually go away once treatment stopped.
DRUG INTERACTIONS: Because cephalosporins only act on microorganisms growing in the proliferative phase, should not be combined with bacteriostatic antibiotics.
Simultaneous administration of cephalexin and probenecid causes more high and prolonged serum concentrations of the first, because the clearance rate by the kidney is reduced.
Concomitant treatment of cephalosporins, especially at high doses with nephrotoxic drugs such as aminoglycosides or potent diuretics, may have adverse effects on renal function.
Combine cephalosporins and oral anticoagulants may prolong prothrombin time. No incompatibilities with oral cephalosporins are known.
CHANGES IN RESULTS OF LABORATORY TESTS: There is interference in urine testing (false positives) using copper reducing agents (Benedict and Fehling solutions). There is also interference with alkaline picrate method for creatinine determination.
It has been reported positive direct Coombs test during treatment with cephalosporins.
In Coombs tests in newborns whose mothers have received cephalosporin antibiotics before parturition, it should be aware that a positive Coombs test may be due to the drug. There may also be changes in hematological studies or blood compatibility testing.
Cephalosporins may interfere with the determination of ketone bodies in urine.
PRECAUTIONS IN RELATION TO EFFECTS Carcinogenesis, Mutagenesis, Impairment of Fertility: There are no reports to date of carcinogenicity, mutagenicity, teratogenicity or impaired fertility.
DOSAGE AND ADMINISTRATION:
Adults and children> 12 years: Most infections respond to a dose of 1-2 g, divided into 2-3 doses (500 mg every 8 hours). You should consider the following additional information.
When it comes to severe infections or deep tissue when participating insensitive organisms, the dose should be increased from 1 to 1.5 g every 6 hours.
In the prophylaxis of urinary tract infections in adults, the dose of 125 mg every night is recommended and may be continued for several months (the suspension of 125 mg / 5 mL is indicated for this use).
Children <12 years: Ideally, the dose should be calculated based on the weight, especially in infants. Subsequent doses for children derive the dose range of 25-60 mg / kg / day. For chronic diseases, severe infections or deep tissues, this dose can be raised to 100 mg / kg / day, up to 4 g per day.
0-1 years: 25-60 mg / kg / day.
1-2 years: 62.5-125 mg / day four times a day to 125 or 250 mg every 12 hours.
3-6 years: 125-250 mg / day four times a day to 250 or 500 mg every 12 hours.
7-12 years: 250-500 mg / day four times a day to 500 or 1,000 mg every 12 hours.
Other Indications: For the treatment of most acute infections, treatment should continue for at least two days after clinical signs have normalized and the symptoms have disappeared, but in chronic cases, such as recurrent urinary tract diseases is recommended treatment with 500 mg four times a day for two weeks. For gonorrhea, a single dose of 3 g with 1 g of probenecid is sufficient in the case of men.
For women 2 g of cephalexin recommended with 0.5 g probenecid. The concurrent administration of probenecid delays cephalexin excretion and serum rises between 50 and 100%.
In Streptococcus beta-hemolytic is necessary to observe a minimum 10-day therapy to prevent damage.
Cephalexin is not nephrotoxic, but, like other antibiotics renal excretion, there unnecessary accumulation when renal function is below 50% of normal. It is generally recommended to reduce the dose only when creatinine clearance is below 10 ml / min The maximum recommended dose in adults (6 g) and children (4 g) must be reduced to 50% in mild renal failure, 75% in moderate and 87.5% for severe.
(ml / min)
In elderly patients should be considered especially renal function. Adults undergoing hemodialysis should receive an additional dose of 500 mg of NIXELAF-C * post-dialysis, with a maximum of 1 g daily. Children with renal failure should receive 8 mg / kg / day.
MANIFESTATIONS AND MANAGEMENT OF OVERDOSE OR ACCIDENTAL INGESTION: In case of accidental overdose after ingesting 4 g, some patients experience nausea, epigastric pain and dizziness. The recommended treatment of overdosage management is to eliminate the drug by administration of activated charcoal, if necessary, the application of symptomatic treatment. It has been reported that hemodialysis or peritoneal dialysis removes significant amounts of cephalexin body.
NIXELAF-C * Capsules:
Box of 20 and 24 capsules of 250 mg.
Box of 10, 15 and 20 capsules of 500 mg.
NIXELAF-C * Suspension:
Vial powder for reconstitution with 100, 90 and 75 ml of suspension (250 mg / 5 ml).
Bottle with powder for reconstitution 100 and 90 ml suspension (125 mg / 5 ml), all presentations with a measuring cup.
Capsules: Store at room temperature not more than 30 ° C.
Suspension: Keep the bottle tightly closed at room temperature to no more than 30 ° C and dry.
Drug Name: NIXELAF-C
Comparative Brand: KEFLEX
Active Ingredient: Cephalexin
Concentration: 250 MG / 5 ML
Response time: No
Laboratory BRULUAGSA S. A. de CV