Cefotil 500 mg

Description

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Indications
This medication is primarily used for the treatment of infections caused by bacteria that are sensitive to Cefuroxime. Some specific conditions it treats include:

• Pharyngitis/Tonsillitis caused by Streptococcus pyogenes
• Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis (including beta-lactamase producing strains), or Streptococcus pyogenes

Note: Always follow the advice of a registered medical professional before taking this medication.

Pharmacology
Cefuroxime is a well-established antibacterial agent with a broad spectrum of bactericidal activity. It effectively targets a wide range of common pathogens, including those that produce beta-lactamase enzymes. The drug is known for its stability against bacterial beta-lactamase, making it effective against strains resistant to ampicillin and amoxicillin.

Dosage

Tablet or Suspension Form:

For Adolescents and Adults (13 years and older):

• Pharyngitis/Tonsillitis: 250 mg twice daily for 5–10 days
• Acute Bacterial Maxillary Sinusitis: 250 mg twice daily for 10 days
• Acute Bacterial Exacerbation of Chronic Bronchitis: 250–500 mg twice daily for 10 days
• Secondary Bacterial Infections of Acute Bronchitis: 250–500 mg twice daily for 5–10 days
• Uncomplicated Skin and Skin Structure Infections: 250–500 mg twice daily for 10 days
• Uncomplicated Urinary Tract Infections: 250 mg twice daily for 7–10 days
• Uncomplicated Gonorrhoea: 1000 mg as a single dose
• Community-Acquired Pneumonia: 250–500 mg twice daily for 5–10 days
• MDR Typhoid Fever: 500 mg twice daily for 10–14 days
• Early Lyme Disease: 500 mg twice daily for 20 days

For Paediatric Patients (3 months to 12 years):

• Pharyngitis/Tonsillitis: 20 mg/kg/day, twice daily for 5–10 days
• Acute Otitis Media: 30 mg/kg/day, twice daily for 10 days
• Acute Bacterial Maxillary Sinusitis: 30 mg/kg/day, twice daily for 10 days
• Impetigo: 30 mg/kg/day, twice daily for 10 days

Parenteral Form (Injection):

For Adults:

• General Dosage: 750 mg three times daily via IM or IV injection. For severe infections, the dose can be increased to 1.5 gm three times daily via IV injection. In some cases, the frequency may be increased to four times daily, allowing for total daily doses of 3 to 6 gms.
• Gonorrhoea: 1.5 gm as a single dose (administered as two 750 mg injections in different sites, e.g., each buttock)
• Meningitis: 3 gm IV injection three times daily
• Pneumonia: 1.5 gm IV injection twice daily for 2–3 days, followed by 500 mg orally twice daily for 7–10 days
• Acute Exacerbation of Chronic Bronchitis: 750 mg twice daily (IM or IV injection) for 2–3 days, followed by 500 mg twice daily orally for 5–10 days

For Children (above 3 months of age):

• General Dosage: 30–100 mg/kg/day given in 3 or 4 divided doses, with 60 mg/kg/day being suitable for most infections
• Meningitis: 200–240 mg/kg/day via IV injection in 3 or 4 divided doses, reduced to 100 mg/kg/day after 3 days or as clinically appropriate

For Neonates:

• General Dosage: 30–100 mg/kg/day via IV injection in 2 or 3 divided doses, reduced as clinically indicated

For Surgical Prophylaxis:

• 1.5 gm IV injection at the induction of anesthesia, with up to 3 additional doses of 750 mg every 8 hours for high-risk procedures

Administration
The freshly reconstituted solution should be used. If necessary, the solution maintains its potency for at least 24 hours at room temperature or 48 hours at 5°C.

Interactions
No known hazardous drug interactions have been reported with Cefuroxime.

Contraindications
Cefuroxime should not be used in patients with a known allergy to cephalosporins.

Side Effects
Although rare, some adverse effects may occur with the use of Cefuroxime. These include skin rashes and gastrointestinal disturbances. Prolonged use may result in the overgrowth of non-susceptible organisms, such as Candida.

Pregnancy and Lactation
Cefuroxime belongs to FDA pregnancy category B. While no adequate, well-controlled studies have been conducted in pregnant women, the drug should only be used during pregnancy if clearly needed. Cefuroxime is known to be excreted in human breast milk, so caution is advised when administered to nursing mothers.

Precautions and Warnings
Cefuroxime should be used with caution in patients receiving potent diuretics or those with a history of colitis. Although cephalosporin antibiotics are generally safe for patients with penicillin allergies, cross-reactions have been reported, though the risk is minimal at recommended dosages.

Therapeutic Class
Second-generation Cephalosporins

Reconstitution

• For 750 mg Intramuscular Injection: Add 3 mL of water for injection to the vial and shake gently.
• For 750 mg Intravenous Injection: Add 8 mL of water for injection to the vial and shake gently. The solution should be administered slowly into a vein over 3 to 5 minutes.
• For 1.5 gm Intravenous Injection: Add 16 mL of water for injection to the vial and shake gently. The solution should be administered slowly into a vein over 3 to 5 minutes.

Storage Conditions
Store in a cool, dry place, below 30°C, away from light and moisture. Keep out of reach of children.