Cefaclor

KEFLOR CD can be taken with or without food. However, absorption is enhanced when KEFLOR CD is administered with food (see Section 5.2 PHARMACOKINETIC PROPERTIES). The tablets should not be cut, crushed or chewed. The usual adult dosage is 375 mg twice daily. For lower urinary tract infections, 500 mg once daily may be given. For pneumonia and acute bacterial sinusitis, the recommended dosage is 750 mg twice daily. For acute bacterial sinusitis, KEFLOR CD should be taken for 10 days. In the treatment of infections caused by S. pyogenes (group A streptococci), a therapeutic dosage of KEFLOR CD should be administered for at least 10 days. For patients with markedly impaired renal function - see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR

KEFLOR CD is contraindicated in patients with known allergy to the cephalosporin group of antibiotics or who have previously experienced a major allergy to penicillin (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE) or any of the

As with antibiotic therapy in general, administration of KEFLOR CD should be continued for a minimum of 48 to 72 hours after the patient becomes asymptomatic or after evidence of bacterial eradication has been obtained. A minimum of ten days of treatment is recommended in infections caused by group A beta-haemolytic streptococci in order to guard against the risk of rheumatic fever or glomerulonephritis. Prolonged use of KEFLOR CD may result in the overgrowth of non-susceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken. Severe cutaneous adverse reactions Severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP) have been reported in patients taking beta-lactam antibiotics. When SCAR is suspected, KEFLOR CD should be …

Anticoagulants, coumarin- or indandione-derivative, or Heparin or Thrombolytic agents Because all cephalosporins can inhibit vitamin K synthesis by suppressing gut flora, prophylactic vitamin K therapy is recommended when any of these medications is used for prolonged periods in malnourished or seriously ill patients. Platelet aggregation inhibitors Hypoprothrombinemia induced by large doses of salicylates and/or cephalosporins, and the gastrointestinal ulcerative or haemorrhagic potential of nonsteroidal anti-inflammatory drugs (NSAIDs), salicylates, or sulfinpyrazone may increase the risk of haemorrhage. Antacids The extent of absorption of sustained release cefaclor is diminished if magnesium- or aluminium hydroxide-containing antacids are taken within 1 hour of administration Probenecid Probenecid decreases renal tubular secretion of those cephalosporins excreted by this mechanism, resulting in increased and prolonged cephalosporin serum concentrations, prolonged elimination …

The majority of adverse reactions observed in clinical trials of sustained release cefaclor were mild and transient. Drug related adverse reactions requiring discontinuation of therapy occurred in 1.7% of patients. The following adverse reactions have been reported following the use of sustained release cefaclor in clinical trials. Incidence rates were less than 1%, except as otherwise noted. Gastrointestinal Disorders Diarrhoea (3.4%), nausea (2.5%), vomiting and dyspepsia. Immune System Disorders Rash, urticaria or pruritus occurred in approximately 1.7% of patients. One serum-sickness-like reaction (0.03%) was reported among the 3,272 patients treated with sustained release cefaclor during the controlled clinical trials. Blood and Lymphatic System Disorders Eosinophilia. Infections and Infestations Vaginal moniliasis (2.5%) and vaginitis (1.7%). Acute Bacterial Sinusitis: Adverse experiences reported among patients with acute bacterial sinusitis treated with sustained …

Signs and Symptoms The toxic symptoms following an overdose of KEFLOR CD may include nausea, vomiting, epigastric distress and diarrhoea. The severity of the epigastric distress and the diarrhoea are dose related. If other symptoms are present, it is probable that they are secondary to an underlying disease state, an allergic reaction, or the effects of other intoxication. Treatment In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs and unusual drug kinetics in your patient. Protect the patient's airway and support ventilation and perfusion. Meticulously monitor and maintain, within acceptable limits, the patient's vital signs, blood gases, serum electrolytes, etc. Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal. Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Safeguard the patient's airway when employing charcoal. Forced diuresis, …

Effects on Fertility Adequate and well-controlled studies in humans have not been done. However, studies in animals have not shown that cefaclor causes impaired fertility. Use in Pregnancy (Category B1) The oral administration of high dose cefaclor (500 mg/kg) in pregnant rats and mice has resulted in a slight increase of minor skeletal malformations. Safety of this product for use during pregnancy has not been established. Cefaclor should not be used in women of child bearing potential unless, in the judgement of the treating clinician, its use is considered essential to the welfare of the patient and the expected benefits outweigh potential risks. Labour and Delivery KEFLOR CD has not been studied for use during labour and delivery. Treatment should be given only if clearly needed. Use in Lactation No studies have been done with KEFLOR CD. Small amounts of cefaclor have been detected in mother's milk following administration of single 500 mg doses of cefaclor. Average levels were …