Cefotil 500

Indications

This product is recommended for addressing infections triggered by susceptible bacteria, such as:

• Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.
• Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis (beta-lactamase producing strains), or Streptococcus pyogenes.
• Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non beta-lactamase producing strains).
• Lower respiratory tract infections including pneumoniae, caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase-producing strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, and E. coli.
• Acute bacterial exacerbation of chronic bronchitis and Secondary bacterial infections of Acute bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains), or Haemophilus parainfluenzae (beta-lactamase negative strains).
• Skin and skin-structure infections caused by Staphylococcus aureus (including beta-lactamase producing strains) or Streptococcus pyogenes.
• Urinary tract infections caused by E.coli or Klebsiella pneumoniae.
• Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).
• Gonorrhoea caused by penicillinase-producing and non-penicillinase producing strains of Neisseria gonorrhoeae.
• Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi.

Pharmacology

This product, a potent antibacterial agent, demonstrates broad-spectrum bactericidal activity against various common pathogens, including β-lactamase producing strains. It exhibits robust stability to bacterial β-lactamase, thus effectively combating many ampicillin-resistant and amoxicillin-resistant strains.

Dosage

For tablets or suspension, dosages recommended for adolescents and adults (13 years and older) vary depending on the infection type. For instance:

• Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days.
• Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days.
• Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days.
• Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days.
• Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days.
• Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days.
• Uncomplicated Gonorrhoea: 1000 mg Single dose.
• Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days.
• MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days.
• Early Lyme disease: 500 mg b.i.d. for 20 days.

For pediatric patients (3 months to 12 years), dosages are adjusted accordingly based on body weight and the specific infection being treated.

Administration

It is advised to use freshly reconstituted solutions for optimal efficacy. However, solutions maintain potency for at least 24 hours at room temperature or 48 hours at 5°C.

Interaction

No potentially hazardous interactions have been reported with this product.

Contraindications

This product is contraindicated in patients with known allergy to Cephalosporins.

Side Effects

Adverse effects have occurred infrequently and have been generally mild and transient in nature. Effects reported include rashes and gastrointestinal disturbances. As with other antibiotics, prolonged use may result in the overgrowth of non-susceptible organisms, e.g., Candida.

Pregnancy & Lactation

The US FDA pregnancy category is B. However, there are no adequate and well-controlled studies in pregnant women. Thus, caution should be exercised when this product is administered during pregnancy. It has been shown to be excreted in human milk, so caution should also be exercised when administered to nursing women.

Precautions & Warnings

This product should be given with care to patients receiving concurrent treatment with potent diuretics and those with a history of colitis. While cross reactions with penicillin hypersensitivity have been reported, they are not likely to be problematic at recommended dose levels.

Therapeutic Class

This product belongs to the second generation Cephalosporins.

Reconstitution

For intramuscular or intravenous injections, proper reconstitution guidelines should be followed to ensure efficacy.

Storage Conditions

Store this product in a cool, dry place (below 30°C), away from light and moisture, and keep it out of the reach of children.