The package insert of the medicine Ceclor bd

the package insert of the medicine Ceclor bd. Therapeutic class of Bactericidal. Active principles Cefaclor.

what For?

Ceclor ® BD is indicated for the treatment of the following infections caused by strains of microorganisms susceptible to this antibiotic:
Acute bronchitis and acute exacerbations of chronic bronchitis: caused by S. pneumoniae, H. influenzae (including strains producing betalactamase), H. parainfluenzae, M. catarrhalis (including strains producing betalactamase), and S. aureus.
Pharyngitis and tonsillitis caused by S. pyogenes (strep group A). (Penicillin is the drug usual choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Ceclor ® BD is generally effective in the eradication of streptococci from the oropharynx; however, they still are not available, substantial data establishing the efficacy of Ceclor ® BD in the prevention of rheumatic fever).
Pneumonia caused by S. pneumoniae, H. influenzae (including strains producing betalactamase) and M. catarrhalis (including strains producing betalactamase).
Sinusitis caused by S. pneumoniae (only the strains sensitive to penicillin), H. influenzae (including strains producing betalactamase), and M. catarrhalis (including strains producing betalactamase).
Infections are not complicated of the lower urinary tract, including cystitis and bacteriúria asymptomatic, caused by E. coli, K. pneumoniae, P. mirabilis and S. saprophyticus. Infections of the skin and skin structures caused by S. pyogenes (strep group A), S. aureus (including strains producing betalactamase) and S. epidermidis (including strains producing betalactamase). Research should be undertaken bacteriological to determine the micro-organisms that cause and their sensitivity to cefaclor. Therapy may be started while awaiting the results of these studies. Once these results are available, antimicrobial therapy should be adjusted accordingly.

Contraindications

When should I not use?

Ceclor® BD is contraindicated to patients allergic to the penicillins, other antibiotics beta-lactamic agents, and the cephalosporins.

Dosage

How to use?

Ceclor ® BD can be administered orally independent of meals. However, the absorption increases when the Ceclor® BD is administered with food (see Clinical Pharmacology).
Adult:
The coated tablets should not be broken, crushed or chewed. The recommended dose for pharyngitis, tonsillitis (tonsillitis) infections of skin and soft tissue, and infections of the lower urinary tract is 500 mg once a day. The recommended dose for bronchitis is 500 mg two times a day. For pneumonia and sinusitis, the recommended dose is 750 mg twice a day. In the treatment of infections caused by S. pyogenes (strep group A), the therapeutic dose of Ceclor® BD-coated tablets of 500 mg should be administered twice a day for at least 10 days.
Elderly patients: it is Not necessary dose adjustment in elderly patients with normal renal function.
Children: dosage the USUAL recommended daily is 20 mg/kg/day in divided doses every 12 hours. For bronchitis and pneumonia, the dosage is 20mg/kg/day in doses administered 2 times a day. For the treatment of otitis media and pharyngitis, the total dosage daily may be divided and administered every 12 hours.
Presentation: oral Suspension 375 mg/5 ml
CECLOR LIQUID: 20 mg/kg/day (Pharyngitis)
18.75 mg (WEIGHT): 2.5 ml,2 times a day.

CECLOR LIQUID: 20 mg/kg/day (Otitis media)
9,40 mg (Weight): 2.5 ml, 2 times a day.
18.75 mg (Weight): 5 ml, 2 times a day.

Instructions for Use
1. Before you use the medicine for the first time, shake VIGOROUSLY the vial until all the powder deposited at the bottom of the bottle is ressuspendido. Re-shake the bottle every time you use the product.
2. Remove the lid from the bottle of Ceclor ® BD and attach the nozzle adapter (supplied with the syringe) in the mouth of the bottle. Press until it is perfectly adjusted.
3. Attach the syringe dosing at the nozzle adapter that was placed in the mouth of the vial, turn the vial upside down and pull the plunger of the syringe until
reach the amount (dose) prescribed by your doctor.
4. Administer the dose contained in the syringe until it reaches the amount (dose) prescribed by the doctor.
5. Close the bottle well
6. Wash several times the syringe with water, cleaning it well so that it can be used again. Place the lid on the syringe and store it in a clean place, along with the bottle of Ceclor® BD.

Side Effects

What are the evils that can cause me?

gastrointestinal Symptoms – jaundice cholestatic, diarrhoea, tests abnormal liver function, nausea, pseudomembranous colitis, and vomiting.

Hematopoietic – as has been reported with other antibiotics beta-lactamic agents has occurred, rarely, hemolytic anemia, agranulocytosis, thrombocytopenia, eosinophilia and neutropenia, reversible possible clinical significance.
Renal – slight elevations in nitrogen uréico (BUN) or serum creatinine (less than 1500) or urinálises abnormal (less than 1200) and interstitial nephritis.
Skin and appendages – erythema multiforme, reactions similar to serum sickness, hypersensitivity reactions, pruritus, rash, urticaria, syndrome, StevensJohnson, toxic epidermal necrolysis.
Other – angioedema, arthralgia, arthritis, fever, f -. Cases of reactions similar to serum sickness occur rarely and usually consist of skin rash type rash, or erythema multiforme and a disorder joint such as arthritis or arthralgia. Differ from classic serum sickness in that because they are
infrequently associated lymphadenopathy and renal. Has not been identified, no pattern of association with concurrent medications or taken previously. The symptoms usually begin about 7 days after the start of treatment and last for one to two weeks. Occasionally, you may be required hospitalization for supportive therapy. Full recovery is expected in.

Warnings and Precautions

what should I know before using?

WARNINGS
Before you start therapy with cefaclor, a check should be made carefully to determine if the patient had earlier reactions of hypersensitivity to cefaclor, cephalosporins, penicillins or other drugs. If this product is to be administered to penicillin-allergic patients, care should be taken with hypersensitivity cross, including anaphylaxis between antibiotics beta-lactamic agents.
Antibiotics should be administered with caution to any patient who has demonstrated some form of allergy, particularly to drugs. It was reported pseudomembranous colitis with almost all broad-spectrum antibiotics (including macrolides, penicillins, semi-synthetic, and cephalosporins); therefore, it is important to consider this diagnosis in patients who developed diarrhea associated with the use of antibiotics. Such colitis may range in severity from mild to life threatening. Mild cases of pseudomembranous colitis usually respond only with discontinuation of the drug. In cases of moderate to severe should be taken appropriate measures.
Precautions:
The prolonged use of cefaclor may result in the proliferation of resistant microorganisms. It is essential to careful observation of the patient. If a superinfection during the treatment, you should take appropriate measures. Have reported Coombs test direct positive during the treatment with antibiotics cefalosporínicos. It must be recognized that a Coombs test positive can be due to the drug, that is, in studies of haematology or in the evidence of compatibility of blood for transfusion, when tests are performed “minor” of antiglobulina or in tests of Coombs and newborns whose mothers received antibiotics cefalosporínicos before delivery. The cefaclor should be administered with caution in the presence of severe renal insufficiency, since the half-life of cefaclor in patients anúricos is 2.3 to 2.8 hours, and there is no need to make adjustments of doses in patients with renal failure, moderate or serious. Clinical experience with cefaclor under such conditions is limited; therefore, it must be done careful clinical observation and laboratory. However, in cases of severe renal insufficiency, it is recommended reduction of the doses if the patient is using higher doses of cefaclor or together with agents, nephrotoxic. Antibiotics, including cephalosporins, should be prescribed with caution to patients with a history of disease of the gi-tract, particularly colitis. Antibiotics, including cefaclor, should be administered cautiously to any patient who has demonstrated some form of allergy particularly to drugs.
CARCINOGENESIS, MUTAGÊNESE AND DAMAGE TO the FERTILITY – there are no data in the literature of studies made to determine the potential for carcinogenicity or mutagenicity. The reproduction studies have not revealed evidence of harm to fertility.
USE IN PREGNANCY AND BREASTFEEDING – THE security of cefaclor for use in pregnant women has not been established. The evaluation of experimental studies in animals have not indicated direct or indirect effects of corruption with regard to the development of the embryo or fetus, the course of gestation and development of the peri-and post-natal. As there are no studies adequate and well controlled in pregnant women and because the reproduction studies in animals do not always predict the response in humans, this drug should be used during pregnancy only if really needed. No studies have been conducted with cefaclor in lactating women. However, there have been detected small amounts of cefaclor in breast milk following administration of single doses of 500 mg. The average levels were 0.18; 0,20; 0,21 and 0.16 mg/ml after 2, 3, 4 and 5 hours, respectively. Were detected traces of the drug after one hour. As is known, the effect of cefaclor in infants, Ceclor ® BD should be administered with caution to nursing women.

Overdose

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

Signs and Symptoms – The symptoms toxic after an overdose of cefaclor may include nausea, vomiting, with epigastric pain and diarrhea. The severity of with epigastric pain and diarrhea are dose related. If there are no other symptoms it is likely that these are secondary to a disease, concomitant, an allergic reaction or the effects of other intoxication.
Treatment – To treat an overdosage, consider the possibility of superdoses multiple drugs, interaction between drugs and of the kinetics pharmacokinetics uncommon of medication in the patient. Will not be required decontamination of the gi-tract, the less that has been ingested, a dose five times the maximum recommended dose. Protect the airway of the patient and to maintain ventilation and perfusion. Meticulously monitor and maintain, within acceptable limits, the patient’s vital signs, gases in blood, serum electrolytes, etc. The absorption of drugs by the gastrointestinal tract may be decreased by administering activated charcoal, which in many cases is more effective than the êmese or gastric lavage. Consider activated charcoal instead of or in addition to gastric emptying. Repeated Doses of activated charcoal may hasten elimination of some drugs that have been absorbed. Protect the way
air from the patient when to promote gastric emptying, or using activated carbon. Diuresis forced, peritoneal dialysis, hemodialysis, or hemoperfusão with activated charcoal have not been established as methods beneficial in cases of overdosage with ceclor.