Cilex

Treatment of the following infections when caused by susceptible strains of the designated microorganisms: Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis.

Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes.

Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis and joint infections.

Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis and Klebsiella pneumoniae.

Dental Infections: Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cilex and other antibacterial drugs, Cilex should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Cilex suspension or capsule is administered orally. The adult dosage ranges from 1-6 g daily in divided doses.

Adults: Usual Dose: 1-2 g daily given in divided doses at 6-, 8- or 12-hourly intervals.

For streptococcal pharyngitis or tonsillitis, mild, uncomplicated urinary tract infections and skin and soft tissue infections, 500 mg may be administered every 12 hrs.

For more severe infections or those caused by less susceptible organisms, larger doses may be needed.

If daily doses of Cilex require >4 g, parenteral cephalosporins in appropriate doses should be prescribed.

Suspension: Children: Usual Dose: 25-50 mg/kg body weight in divided doses (to be taken every 6 hrs).

125-mg/5 mL Suspension: Children 40 kg body weight: 2-4 tsp; 20 kg: 1-2 tsp; 10 kg: ½-1 tsp.

250-mg/5 mL Suspension: Children 40 kg body weight: 1-2 tsp; 20 kg: ½-1 tsp; 10 kg: ¼-½ tsp.

For streptococcal pharyngitis in children >1 year, mild, uncomplicated urinary tract infections and skin and soft tissue infections, the total daily dose may be divided, administered and taken every 12 hrs.

125-mg/5 mL Suspension: Children 40 kg body weight: 4-8 tsp; 20 kg: 2-4 tsp; 10 kg: 1-2 tsp.

250-mg/5 mL Suspension: Children 40 kg body weight: 2-4 tsp; 20 kg: 1-2 tsp; 10 kg: ½-1 tsp.

(5 mL is equivalent to 1 tsp.)

Shake the suspension well before use.

In severe infections, the dosage may be doubled.

In the therapy of otitis media, 75-100 mg/kg/day in 4 divided doses is needed.

In the treatment of β-hemolytic streptococcal infections, the therapeutic dosage of Cilex should be administered for a minimum of 10 days.

Note: Cilex may be taken on a full or empty stomach. Compliance with the full course of therapy especially in streptococcal infections is highly recommended.

Cilex is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

Cephalexin is used to treat bacterial infections including upper respiratory infections, ear infections, skin infections, and urinary tract infections.

Bacteriostatic Antibiotics: As cephalosporins like Cilex are only active against proliferating microorganisms, Cilex should not be combined with bacteriostatic antibiotics.

Uricosuric Drugs: Concomitant use of uricosuric drugs (eg, probenecid) suppresses renal drug elimination. As a result, Cilex plasma levels are increased and sustained for longer periods.

Metformin: A potential interaction between Cilex and metformin may result in an accumulation of metformin and could result in fatal lactic acidosis.

Increased Risk of Nephrotoxicity: If associated with highly potent diuretics (ethacrynic acid, furosemide) or other potentially nephrotoxic antibiotics (aminoglycosides, polymyxin, colistin), cephalosporins may show higher nephrotoxicity.

Oral Anticoagulants:

Typhoid Vaccine: Cilex, like other antibiotics with antibacterial activity against Salmonella typhi organisms, may interfere with the immunological response to the live typhoid vaccine. The appropriate period of time should elapse between the administration of the last dose of the antibiotic and the live typhoid vaccine.

Oral Contraceptives:

Incompatibilities: No incompatibilities have been reported.

Adverse effects of Cilex include gastrointestinal disturbances eg, nausea, vomiting, diarrhea and abdominal discomfort. The most common of these effects is diarrhea, but this is rarely severe enough to warrant cessation of therapy. Transient hepatitis and cholestatic jaundice have rarely been reported.

Allergic reactions have been reported eg, rash, urticaria, angioedema and rarely erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis (exanthematic necrolysis).

Other adverse effects eg, genital and anal pruritus, genital candidiasis, vaginitis and vaginal discharge, dizziness, fatigue, headache, agitation, confusion, hallucinations, arthralgia, arthritis and joint disorders have been reported.

As with other cephalosporins, interstitial nephritis has rarely been reported.

Eosinophilia, neutropenia, thrombocytopenia and slight elevations in aspartate aminotransferase and alanine aminotransferase have been reported.

As with other broad-spectrum antibiotics prolonged use may result in the overgrowth of non-susceptible organisms eg, candida. This may present a vulvo-vaginitis.

There is a possibility of development of pseudomembranous colitis and it is therefore important to consider its diagnosis in patients who develop diarrhea while taking Cilex. It may range in severity from mild to life-threatening with mild case usually responding to cessation of therapy. Appropriate measures should be taken with moderate to severe cases.

Each film-coated tablet contains Cefalexin monohydrate BP equivalent to anhydrous Cilex 375- and 750 mg, respectively.

It also contains the following excipients: Hyproellose, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, purified talc, colloidal anhydrous silica, opadry and macrogol 400.

Cilex is an extended release oral formulation of Cilex designed to be effective on twice daily dosing. Cilex is a semisynthetic cephalosporin antibiotic. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cilex has themolecular formula C₁₆H₁₇N₃O₄SH₂O and the molecular weight is 365.41.

The nucleus of Cilex is related to that of other cephalosporin antibiotics. The compound is a zwitterion; ie, the molecule contains both a basic and an acidic group. The isoelectric point of Cilex in water is approximately 4.5-5. The crystalline form of Cilex which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cilex has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3- position.