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FOT-AMSA 1gr INJECTABLE SOL 4ml, Cefotaxime

INDICATIONS: The bactericidal activity of cefotaxime (FOT-AMSA ®) results from the inhibition of cell wall synthesis.

Cefotaxime (FOT-AMSA ®) has in vitro activity against a large number of gram positive and gram negative strains. It has been shown that cefotaxime (FOT-AMSA ®) is a potent inhibitor of beta-lactamases produced by certain types of Gram-negative bacteria. Cefotaxime (FOT-AMSA ®) is usually active against the following microorganisms, both in vitro and in clinical infections:

Gram-positive aerobes: Staphylococcus aureus (including strains producing and not producing penicillinase), Staphylococcus epidermidis, Enterococcus spp, Streptococcus pyogenes (beta-hemolytic streptococcus group A), Streptococcus agalactiae (group B streptococcus), Streptococcus pneumoniae (formerly Diplococcus pneumoniae ).

Gram-negative aerobes: Citrobacter spp, Enterobacter spp, Escherichia coli, Haemophilus influenzae (including ampicillin-resistant strains), Haemophilus parainfluenzae, Klebsiella spp (including Klebsiella pneumoniae), Neisseria meningitidis, Neisseria gonorrhoeae (including ß-lactamase strains negative and positive), Proteus mirabilis, Proteus vulgaris, Proteus inconstans group B, Morganella morganii, Providencia rettgeri, Providencia stuartii, Acinetobacter spp. Cefotaxime (FOT-AMSA ®) is active against certain strains of Pseudomonas aeruginosa.

Anaerobes Bacteroides spp, including strains of Bacteroides fragilis, Fusobacterium spp spp Peptococcus, Peptostreptococcus, Clostridium spp (many strains of Clostridium difficile are resistant).

Thus cefotaxime (FOT-AMSA ®) is indicated for: Treatment of patients with serious infections caused by susceptible strains in the lower respiratory tract.

Genitourinary tract infections.

Gynecological infections.

Infections of skin and skin structures.

Bacteremia and septicemia susceptible germs.

Intra-abdominal infections.

Bone and joint infections.

Central nervous system infections.

Human Pharmacokinetics: Cefotaxime (FOT-AMSA ®) is a semisynthetic cephalosporin antibiotic which inhibits the third generation synthesis of the bacterial cell wall, thus causing lysis thereof. After intravenous administration of a dose of 500 mg, 1 g and 2 is the average peak serum of 38.9, 101.7 and 214.4 ug / ml respectively.

If the same dose applied intramuscularly, peak concentrations are about the same but are achieved with about 30 minutes of difference from the IV

It binds to plasma albumin in 20 to 50%.

The volume of distribution is 0.3 ± 0.4 l / kg.

There is accumulating evidence that after repeated doses of 1 g every 6 hours administered intravenously for 14 days and there are no alterations of serum or renal clearance.

Approximately 60% of the administered dose was recovered in the urine over the next 6 hours after the start of the application in its deacetylated form, which has antibacterial activity.

CONTRAINDICATIONS: Cefotaxime (FOT-AMSA ®) is contraindicated in individuals with known hypersensitivity to cephalosporins.

PRECAUTIONS: It is recommended that the first administration of cefotaxime make the doctor or at least in his presence, to be vigilant and monitor the possible occurrence of hypersensitivity, in which case you should immediately cease its administration and institute therapeutic measures necessary.

Renal function should be carefully monitored, especially if aminoglycosides are administered simultaneously, and even more if used in high doses or for prolonged time required. In patients requiring sodium restriccón, should take into account the amount of it in the cefotaxime (FOT-AMSA ®) (2.09 mmol / g). In cases where matching hepatic and renal must perform a dose reduction. In long-term treatment with cefotaxime, you should practice on a regular blood count. Cross-reactions were observed between penicillins and cephalosporins in approximately 5-10%, making it necessary to monitor these patients.

When diarrhea occurs, especially if it is persistent and severe, and if used several antibiotics together, it should investigate the possibility that the application is presented pseudomembranous colitis due to Clostridium difficile overgrowth, which can be determined by colonoscopy and stool culture.

Each of the solutions should be applied only by the indicated route, ie the aqueous solution for intravenous use is (painful intramuscularly), and the lidocaine is an aqueous solution for intramuscular (or for any reason be applied by IV).

RESTRICTIONS OF USE DURING PREGNANCY AND LACTATION: There have been no controlled studies of cefotaxime (FOT-AMSA ®) in pregnant women.

There are no reported harmful effects on the fetus, but it is recommended not to use cefotaxime (FOT-AMSA ®) in pregnant women unless the doctor deems necessary.

Although cefotaxime (FOT-AMSA ®) is excreted in small amounts in breast milk, you should avoid breastfeeding during the application of this medication.

ADVERSE REACTIONS: The most frequent side effects are manifested as local type of inflammation, pain and redness at the application site IV Less frequent reactions are:

Hypersensitivity: Rash, pruritus, fever, eosinophilia and less frequently urticaria and anaphylaxis.

Digestive: diarrhea, pseudomembranous colitis, nausea and vomiting have been reported rarely. In rare cases have been observed with ultrasound images suggestive of biliary sludge, but this effect disappears after discontinuation of treatment with cefotaxime, why management is recommended preserved, even when associated with a painful.

Hepatic: Increased transient and generally mild SGOT and SGPT and / or alkaline phosphatase.

Hematologic: Neutropenia, agranulocytosis, particularly in prolonged treatment. Occasionally been reported eosinophilia, thrombocytopenia, and in rare cases, hemolytic anemia.

When kidney failure and large doses of beta-lactams may occur encephalopathy manifested by altered consciousness, abnormal movements and seizures.

Kidney function can be altered when associated with large doses of aminoglycosides.

DRUG INTERACTIONS AND OTHER GENDER: Cefotaxime (FOT-AMSA ®) should not be physically mixed with other medicines, or you may inconsistency, especially with: allopurinol, aminoglycosides (amikacin, streptomycin, gentamicin, kanamycin, neomycin, tobramycin), aminophylline, calcium, cotrimoxazole, erythromycin, filgrastrim, fluconazole, norepinephrine or noradrenaline, since tetracycline has proved physicochemical incompatibility.

Cefotaxime (FOT-AMSA ®) administered concurrently with aminoglycosides, diuretics or other cephalosporins can potentially cause abnormalities of renal function.

CHANGES IN RESULTS OF LABORATORY TESTS Coombs reaction may be reported as a false-positive during treatment with cefotaxime (FOT-AMSA ®).

It can produce a false-positive reaction in the determination of glucose in urine when used reducing substances, as when using copper sulphate. This can be avoided, if employed as a specific method of the glucose oxidase.

Cefotaxime (FOT-AMSA ®) may cause intermittent and slight elevation of SGPT and SGOT and / or alkaline phosphatase.

PRECAUTIONS IN RELATION TO EFFECTS Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies with cefotaxime (FOT-AMSA ®) have shown no effects of carcinogenicity mutagenicity, teratogenicity or impaired fertility.

DOSAGE AND ADMINISTRATION: The dosage should be determined by susceptibility of the causative organisms, the severity of the infection and the patient's condition.

The usual dosage is:

Normal renal function:

Adults and children over 12 years: Intravenous or intramuscular: the usual dose is 1-3 g per day, which can be increased to a maximum of 12 g per day, divided into 3 applications.

Newborns, infants and young children: The recommended dose is 50-75 mg / kg / day, once-daily, or divided into 2 every 12 hours or 4 applications (one every 6 hours).

In infants older than 4 weeks the dose may be increased to 200 mg / kg / day according to the severity of the infection.

Children weighing more than 50 kg should receive the recommended adult dose.

Impaired renal function: If creatinine clearance is equal or less than 10 ml / min using half dose.

If creatinine clearance is less than or equal to 5 ml / min, 1 g administered every 12 hours.

Recommendations for reconstitution of the intravenous solution: Shake well to dissolve the powder in the diluent.

The normal color of cefotaxime (FOT-AMSA ®) varies from pale yellow to amber, depending on the concentration, the diluent used and storage time.

For intravenous use note that the diluent (water for injection) corresponds to this application.

To administer by intravenous infusion diluted cefotaxime (FOT-AMSA ®) in 50 ml (or 100 ml if the dose is greater) of glucose 5% solution of sodium chloride 0.9% or dextrose 5%, to pass on 30 minutes. In children must be diluted to 20-60 mg / ml and administered for 30-60 minutes.

Recommendations for reconstitution of the solution for intramuscular injection (lidocaine): Reconstitute the vial with the solvent in the vial, injected deeply into the gluteal region. It is recommended not to inject more than 1 g per side. The accompanying bulb included, containing lidocaine to increase local tolerance intramuscular administration.

Consequently not be used intravenously or in patients with a history of hypersensitivity to lidocaine.

MANIFESTATIONS AND MANAGEMENT OF OVERDOSE OR ACCIDENTAL INGESTION

As with other antibiotics, prolonged use of cefotaxime (FOT-AMSA ®) may result in overgrowth of non-susceptible organisms and superinfection occur during therapy.

High doses tend to increase the chances of colitis and renal disorders.

In each case must be taken care necessary to assess the patient's condition and treat existing complications discontinuing the drug.

PRESENTATIONS:

Intravenous Solution:

For retail and generics market: Box with vial 1 g powder for injection vial with 4 ml water.

For the Health Sector:

Container with vial with 1 g powder for injection vial 4 ml water. Key No. 1935.

Intramuscular Solution Box with powder vial with 1 g vial with diluent (water for injection and lidocaine 1%) in a volume of 4.0 ml.

RECOMMENDED STORAGE: Store at room temperature not exceeding 30 ° C. Protect from light.
Drug Name: Fot-Amsa
Comparable patent medicine:
Active Ingredients: Cefotaxime
Presentation: Solution injectable
Concentration: 1g/4ml
Laboratory: Laboratory AMSA
Box with vial with powder and diluent vial with 4ml
Made in Mexico