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Drugs Celormed 500 have composition Cefaclor monohydrate 500mg, Indications treatment of infections Low, Upper respiratory-tract infections, Skin and soft tissue infections, Uncomplicated lower urinary-tract infections: cystitis

Scanax 500mg treatment of infections including anthrax, bone and joint infections, and throat infections

Rovamycine 3M intended for the treatment and prevention of certain infections:  ENT, bronchopulmonary

Composition:

Each capsule contains

Active ingredient: Cefaclor monohydrate equivalent to 500 mg anhydrous cefaclor.

Inactive ingredients: Pregelatinized starch, croscarmellose sodium, colloidal silicon dioxide, Com starch, magnesium stearate

Celormed 500 - Cefaclor monohydrate 500mg

Pharmacodynamics and Pharmacokinetics

Pharmacodynamics

Celormed 500 ( Cefaclor ) and oral antibiotic in the second-generation cephalosporins. The bactericidal action of cefaclor results from inhibition ot cell wall synthesis by binding to the penicillin-binding proteins (PBPs)

Celormed 500 has antimicrobial activity simitar to that of cefalexin but is reported to be more active against Gram-negative bacteria including Escherichia coll, Klebsiella pneumoniae, Neisseria gonorrhoeas . especially against Haemophilus influenzae. It is active against some beta-lactamase-producing strains of H. influenzae.

Celormed 500 is not active against Pseudomonas spp. or Acinobacter spp, methicillin-resistant Staphylococcus and most strains of Enterococcus.

Pharmacokinetics

Celormed 500 is well absorbed from the gastrointestinal tract. Following doses of 250 mg, 500 mg and 1 g to fasted subjects, average peak serum levels of approximately 7,13, and 23 micro grams/mL respectively were obtained within 30 to 60 minutes. The presence of food may delay the absorption of cefaclor, but the total amount absorbed is unchanged: the peak concentration achieved is 50 to 75% of that observed when die drug is administered to fasted subjects and is delayed by 45 to 60 minutes. A plasma half-life in normal subjects is 30 to 60 minutes. It may be slightly prolonged in patients with renal impairment. In these with complete absence of renal function, the plasma half-life is about 2.3 to 2.8 hours.

About 25% is bound to plasma proteins. Cefaclor appears to be widely distributed In the body; it crosses the placenta and low concentrations have been detected in breast milk.

Cefaclor is rapidly excreted by the kidneys: up to 85% of a dose appears unchanged in the urine within 8 hours, the greater portion being excreted within the first 2 hours. During this 8-hour period, peak unne concentrations following the 250 mg. 500 mg and 1 g doses were approximately 600,900 and 1 900 mg/l respectively. Some cefaclor is removed by haemodialysis. Probenecid delays excretion.

Indications

For the treatment of susceptible infections including:

– Upper respiratory-tract infections: acute otitis media, acute sinusitis, pharyngitis and tonsillitis.

– Lower respiratory-tract infections: Pneumonia, chronic bronchitis.

– Skin and soft tissue infections due to susceptible Staphylococcus aureus and Streptococcus pyogenes.

– Uncomplicated lower urinary-tract infections: cystitis.

Recommended dose and mode of administration

Dosage

Adufts: take 500 mg every 8 hours Do not take more than 4 g daily,

Reduce dose in patients with renal impairment.

The therapy should be continued for 5 to 10 days.

Mode of administration

Should be taken without food.

Contraindications

Patients with hypersensitivity to cephalosporins or any ingredient of this product.

Warnings and precautions

Do not use this product with any other product containing cefaclor.

Prolonged use of cefaclor may result in an overgrowth of bacteria that do not respond to the medication.

Check with your doctor before use if you have any the following:

history of hypersensitivity to penicillins, history of Gl disease especially pseudomembranous colitis, marked renal failure, infants under 1 month of age,

Use in pregnant and breast-feeding women: Animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. The amount of cefaclor distributed into breast milk is too small to be harmful to a breast-fed infant No adverse effects have been observed in breast-feeding infants whose mothers were receiving cefaclor. However, nursing mothers are advised to consult a physician before use.

Effects on the ability to drive or operate machinery: There are no data on the influence of cefaclor on the ability to drive and operate machinery.

Interactions with other medicine and other forms of interaction

The renal excretion of cefaclor is delayed by probenecid.

Co-administration with warfarin may increase prothrombin times.

Co-administration with aminoglycoside or furosemide may increase risk of nephrotoxicity.

Undesirable effects

The most frequently reported adverse effects include diarrhea, erythema, eoslnophilia.

Other side effects including vomiting, nausea, pruritus and urticaria, genital itching, vaginitis, candidiasis, neutropaenia occur occasionally.

There are rare cases such as fever, anaphylaxis, Stevens-Johnson syndrome, thrombocytopaenia, pseudomembranous colitis, interstitial nephritis.

Stop use and ask a doctor if. your symptoms do not improve or get worse within a few days, anaphylactoid reactions, pseudomembranous colitis or convulsion occur.

Inform your physician in case of any adverse reaction related to drug use.

Overdose and treatment

Symptoms:

The toxic symptoms following an overdose of cefaclor may include nausea, vomiting, epigastric distress, and diarrhea. The severity ot the epigastric distress and the diarrhea are dose related. It oth symptoms are present, it is probable that they are secondary to an allergic reaction; or the effects of other Intoxication; or an underlying disease state.

Treatment:

–  In managing overdosage, consider the possibility ot multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient.

– Unless 5 times the normal dose ot cefaclor has been ingested, gastrointestinal decontamination will not be necessary.

– Protect the patient s airway and support ventilation and perfusion.

– Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emesis or lavage; consider charcoal instead of or in addition ft gastric emptying. Safeguard the patient’s airway when employing gastric emptying or charcoal.

– Forced diuresis, peritoneal dialysis or hemodialysis have

Dosage forms and packaging available

Box of 2 blisters of 10 capsules.

Storage Store at the temperature not more than 300C, In a dry place, protect from light.

Specification: Manufacturer’s.

Shelf-life: 36 months from manufacturing date.

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