Bula do remedy Claforan

the package insert of the medicine Claforan. Therapeutic class of the Antibiotics. Active principles Cefotaxime sodium.

what For?

Claforan is indicated in the treatment of infections of the respiratory tract, ent, renal, urinary tract, skin, soft tissue, bone, joints, genital organs, and the region’s intra-abdominal. It is also indicated in cases of gonorrhoea, endocarditis, meningitis (except that caused by Listeria) and other infections of the Central Nervous System, sepsis, prophylaxis pre-operative infections, post-surgical and infections in patients with low resistance.

Use the adult and paediatric – Use injectable

Dosage

How to use?

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  • Adults and adolescents above 12 years of age

The dosage and the route of administration should be determined by susceptibility of the organism and the causal severity of the infection and condition of the patient.

unless prescribed otherwise, adults and children over 12 years should receive 1 to 2 g of Claforan every 12 hours.

In cases of infections with pathogens of lower susceptibility, it may be necessary to increase the daily dose (see table below).

it Is recommended that intravenous administration if daily doses exceeding 2 g.

However, in cases where the daily dose exceeds 4 g, and must include a route of administration should be intravenous.

The following dosing schedule serves as a guide:

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Type of infection single dose interval dose daily dose
Infection typical in which a pathogen is susceptible is known or suspected 1 g 12 hours 2 g
the Infection of several pathogens with high to medium susceptibility are known or suspected 1-2 g 12 hours 2-4 g
Infection is not identified that can not be located, in which there is a risk of life 2-3 g 8-6 hours 6-12 g

For the treatment of gonorrhoea it is recommended a single dose of 0.5 g intramuscularly (treatment of gonorrhoea caused by micro-organisms less sensitive, requires dose escalation).

patients should be examined for syphilis prior to starting the treatment with Claforan.

For the prophylaxis of infections in post-surgical it is recommended to administer a dose of 1 to 2 g 30 to 60 minutes before the start of surgery.

Depending on the risk of infection, this same dose can be repeated.

Dosing for special cases

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  • newborns, babies and children

Babies and children up to 12 years (< 50 kg) should receive Claforan daily dose of 50 to 100 mg/Kg body weight at intervals of 6 to 12 h

In cases where occurring infections with life-threatening can if you use the daily dose of 150 to 200 mg/Kg of body weight.

Children with a weight equal to or above 50 kg must follow the dosage of the adults.

In the case of use of Claforan in premature infants and neonates up to 1 week, the daily dosage intravenously should be 50 – 100 mg/Kg of body weight, in the range of 12 hours, while for premature infants and newborns 1 to 4 weeks should be 75 – 150 mg/kg at intervals of 8 hours.

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  • Dosage in patients with renal failure and in dialysis

If the creatinine clearance is less than 10 mL/min, the maintenance dose should be reduced to half of normal.

The initial dose depends on the susceptibility of the pathogen and severity of infection.

In patients on hemodialysis, administer 1 to 2 g daily, depending on the severity of the infection. On the day of hemodialysis, cefotaxime should be administered after the session of dialysis.

As in the antibiotic therapy in general, administration of Claforan should be extended for a minimum of 48 to 72 hours after lowering the temperature of the patient, or after the observation of eradication of bacterial.

Side Effects

What are the evils that can cause me?

anaphylactic Reactions: may occur rarely angioedema, bronchospasm, malaise possibly culminating in shock.

Can occur rash, pruritus and less frequently urticaria.

as Well as for other cephalosporins, isolated cases of bullous eruptions (erythema multiforme, syndrome of Stevens-Johnsons and necrosis, toxic epidermal) were observed.

Effects on the gastrointestinal tract: signs of commitment to the gastrointestinal such as nausea, vomiting, abdominal pain, or diarrhea, can occur.

as Well as other broad-spectrum antibiotics, may occur diarrhea accompanied by blood in the stool can be a symptom of colitis.

Even though the presence of pseudomembranous colitis is only suspected (and in many cases caused by Clostridium difficile), treatment with Claforan should be immediately suspended.

This type of colitis requires immediate medical treatment and appropriate.

Drugs that inhibit intestinal motility (peristalsis) must not be so administered.

Effects on liver: although rare, may occur effects on the liver function, such as, for example, increases in blood levels of bilirubin and/or liver enzymes AST (SGOT), ALT (SGPT), gamma GT, alkaline phosphatase, and DHL.

Effects on the blood crasis: as well as to other antibiotics beta-lactamic agents, can occur neutropenia and more rarely agranulocytosis during treatment with cefotaxime, particularly if given over long periods.

there have Been reported some cases of eosinophilia and thrombocytopenia, rapidly reversible with treatment interruption.

Were also reported rare cases of haemolytic anaemia.

Effects on the function of the kidneys: there may be a transitory increase in serum creatinine, especially when co-administered with aminoglycosides and may rarely occur interstitial nephritis.

The administration of high doses of antibiotics beta-lactamic agents, particularly in patients with insufficiency of the kidneys, can result in encephalopathy (loss of consciousness, abnormal movements and convulsions).

In rare cases, after the bolus infusion may occur arrhythmias.

local Reactions: irritation, inflammation, and pain at the site of application.

As with other antibiotics, prolonged use of Claforan may result in overgrowth of organisms not susceptible.

During the treatment for infections caused by spirochetes, can occur reactions Herxheimer, characterized by occurrence or worsening of general symptoms such as: fever, chills, headache and joint pain.

The occurrence of one or more of the following symptoms have been reported after several weeks treatment of borreliosis: skin rash, pruritus, fever, leucopenia, increase in liver enzymes, difficulty in breathing, joint discomfort.

To some extent these manifestations are consistent with the symptoms of the disease for which the patient is being treated.

For administration IM: when administered in a solvent containing lidocaine, can occur reactions systemic especially: in cases of intravenous injections inadvertent; in cases of injections applied in places highly vascularized, and in the event of overdose.

since some of these symptoms (for example: pseudomembranous colitis, anaphylaxis, and some changes of the elements blood) can, under certain circumstances, be life threatening, it is essential that the patient report to a physician any severe reaction.

Contraindications

When should I not use?

Claforan is contraindicated in cases of allergy to cephalosporins and penicillins.

In case of doubt, it is essential that the doctor be present during the first administration, to treat any possible anaphylactic reaction.

it Is possible the occurrence of reaction of cross-sensitivity in patients allergic to penicillins or to other antibiotics beta-lactamic agents.

For pharmaceutical forms containing lidocaine as the diluent:

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  • the known history of allergies to lidocaine or other local anaesthetics of the type amide;
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  • obstruction heart is not paced;
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  • severe heart failure;
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  • iv administration;

This medicine is against-indicated in the pediatric age group below 30 months of age.

Warnings and Precautions

what should I know before using?

The treatment with this product should be individual and not adaptable to another person.

although the symptoms presented are equal to his, she may have a type of infection different, so the medication will not have the expected action, which can cause damage to your health.

In the prescription of cephalosporins, it is necessary to the patient preliminary with regard to predisposition to allergies, and particularly with respect to allergy to antibiotics beta-lactamic agents.

in Case of an allergic reaction, the treatment should be stopped.

As can occur allergy cross between penicillins and cephalosporins in 5 to 10% of the cases, the use of Claforan should be performed with extreme caution in patients sensitive to penicillin; careful monitoring is mandatory in the first administration.

allergic Reactions (anaphylaxis) occurring with these two families of antibiotics can be serious or even fatal.

Diarrhea, particularly severe or persame, occurring during treatment or in the initial weeks after treatment with several, but especially with broad-spectrum antibiotics, may be symptomatic of disease associated with the Clostridium difficile at its most severe, pseudomembranous colitis.

This diagnosis is rare, but condition possibly fatal, is confirmed by endoscopy and/or histology.

The diagnosis that is most effective for the disease associated with the Clostridium difficile is the investigation of the pathogen and its citotoxinas in the stool.

In a suspected diagnosis of pseudomembranous colitis, cefotaxime should be discontinued immediately and therapy with an antibiotic appropriate specific and should be initiated without delay (example: vancomycin or metronidazole).

The disease associated with the Clostridium difficile can be favored by stasis fecal matter.

Also the other antibiotics, the prolonged use of Claforan may result in overgrowth of organisms not susceptible.

it Is essential to evaluation the type of the condition of the patient.

If superinfection during therapy, appropriate measures should be taken.

the function of The kidneys should be monitored in patients treated concomitantly with aminoglycosides.

For treatments with a duration of more than ten days must be held a monitoring of the elements in the blood; in case of neutropenia, the use of Claforan should be stopped.

there is No evidence that cefotaxime decrease the ability to drive and operate machinery.

always Check the expiration date located on the packaging of the product and check out the name for there mistakes.

do Not use Claforan if there are signs of tampering or damage of the package.

Claforan in pregnancy and lactation: this medicine should not be used by pregnant women without medical or dental surgeon.

As cefotaxime is excreted in the milk, mothers who are breastfeeding should discontinue treatment with Claforan.

there are No warnings and special recommendations about the proper use of this medicine by elderly patients.

In cases of insufficiency of the kidneys, the dose should be modified according to the clearance of creatinine is calculated, if necessary, based on serum creatinine.

The sodium content of cefotaxime sodium should be taken into account (reaching 48.2 mg/g) in patients requiring restriction of sodium.

Drug Interactions

Administration concomitant or subsequent drug potentially nephrotoxic (such as aminoglycosides) requires a close monitoring of kidney function since there is a risk of increased creatinine, thus reducing your kidney function.

Claforan may not be administered in the same syringe with other antibiotics or in the same solution for infusion; this applies to all of the aminoglycosides.

By inhibiting the excretion of the kidneys, the concomitant administration of probenecid increases the concentration of cefotaxime in serum and prolongs its duration of action.

there is No data available about the interaction between food and Claforan.

Patients in the use of Claforan may present false-positive results in the Coombs test.

The same can occur with determinations of non-enzymatic of glicosúria.

Therefore the glucose in the urine should be determined by enzymatic methods during treatment with Claforan.

Overdose

what to do if someone use a larger amount than is recommended?

as Well as to other antibiotics beta-lactamic agents, there is a risk of the occurrence of the encephalopathy is reversible, in cases of administration of high doses of Claforan. There is no specific antidote.

treatment is symptomatic and must be accompanied by the support measures of the overall status.

at The first signs of anaphylactic shock (sweating, nausea, cyanosis) immediately discontinue the administration, but leave the cannula venous in location or provide a cannulation of the vein.

in Addition to the usual measures of emergency, to place the patient in a horizontal position with the legs elevated and the airway clear.

immediately Apply epinephrine intravenously (dilute 1 mL of the commercial presentation 1:1000 to 10 mL).

At the beginning, inject slowly 1 mL of this solution (equivalent to 0.1 mg) of epinephrine while monitoring pulse and blood pressure (see heart rhythm disorders).

The administration can be repeated.

The following, when necessary, restore the circulating volume with plasma expanders intravenously, such as albumin human solution balanced electrolyte, poligelina, etc.

then, apply glucocorticoids intravenously, for example, 250 to 1000 mg of methylprednisolone.

This administration can be repeated.

Other therapeutic measures, such as: artificial respiration, inhalation of oxygen, administration of anti-histaminic agents can be employed at the physician’s discretion.

The recommended dosages are for an adult of normal weight.

In children, the dose reduction should be made in relation to the body weight.

what should I do when I forget to use this medicine?

If there is forgetfulness of the administration of a dose, this should be done as soon as possible, however, if it is almost time of the next application, you should expect this time, always in compliance with the range determined by the dosage.

Never should be administered two doses at the same time.