DENVAR 400 MG

Description

Indications

Denvar 400 mg Capsule contains Cefixime, a third-generation cephalosporin antibiotic with strong bactericidal activity against Gram-positive and Gram-negative microorganisms. It is prescribed for treating the following infections caused by susceptible organisms:

1. Upper Respiratory Tract Infections (URTI):

   • Otitis media and other URTIs where resistance to commonly used antibiotics or treatment failure may pose significant risks.

2. Lower Respiratory Tract Infections (LRTI):

   • Bronchitis and other bacterial infections of the respiratory tract.

3. Urinary Tract Infections (UTI):

   • Conditions like cystitis, cystourethritis, and pyelonephritis.

Denvar is effective against organisms such as Streptococcus pneumoniae, Streptococcus pyogenes, Escherichia coli, Proteus mirabilis, Klebsiella spp., Haemophilus influenzae (both beta-lactamase positive and negative), Moraxella catarrhalis (both beta-lactamase positive and negative), and Enterobacter spp.

Pharmacology

Cefixime inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs). This interference prevents cell wall formation, leading to bacterial death. Cefixime is highly resistant to beta-lactamase enzymes, making it effective against many organisms resistant to penicillins. Its bioavailability is approximately 40%-50%, unaffected by food intake.

Dosage & Administration

1. Adults and Children Over 10 Years:

   • 200-400 mg daily based on infection severity, either as a single dose or divided into two doses.

2. Elderly:

   • Same dosage as adults, with renal function assessment for dose adjustment in severe renal impairment.

3. Children:

   • 8 mg/kg/day, administered as a single dose or in two divided doses.

   • Age-Specific Doses (Suspension):

     • 6 months to 1 year: 3.75 ml daily.

     • 1-4 years: 5 ml daily.

     • 5-10 years: 10 ml daily.

   • In typhoid: 5 mg/kg twice daily for 10-14 days.

4. Renal Impairment:

   • Patients with creatinine clearance <20 ml/min: Maximum dose of 200 mg once daily.

Administration Instructions

• Take with or without food.

• Course duration: 7-14 days depending on infection severity.

Interactions

• Anticoagulants: May prolong prothrombin time; caution with anticoagulant therapy.

• Other Medications: No significant interactions noted with acetaminophen or contraceptive medications.

Contraindications

• Hypersensitivity to cephalosporins or any component of the formulation.

Side Effects

1. Common:

   • Diarrhea, nausea, abdominal pain, vomiting, dyspepsia, flatulence.

2. Rare:

   • Pseudomembranous colitis, hypersensitivity reactions (rash, pruritus, urticaria), headache, dizziness.

3. Hematological:

   • Thrombocytopenia, leukopenia, eosinophilia.

4. Others:

   • Mild, transient changes in liver and renal function tests, genital pruritus, vaginitis.

Pregnancy & Lactation

• Limited studies in pregnant women. Use only if clearly necessary.

• Not known if excreted in human milk; exercise caution in breastfeeding mothers.

Precautions & Warnings

• Use cautiously in patients with a history of drug allergies or penicillin hypersensitivity (due to possible cross-reactivity).

• Monitor for signs of pseudomembranous colitis and discontinue if severe diarrhea occurs.

• Exercise caution in renal impairment; dose adjustments may be necessary.

Overdose Management

• Symptoms: Gastrointestinal disturbances, including nausea and diarrhea.

• Treatment: Gastric lavage if necessary; symptomatic treatment for side effects. Denvar is not removed significantly by dialysis.

Therapeutic Class

• Third-generation cephalosporins.

Storage Conditions

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

Quick Tips for Patients

• Complete the full course even if symptoms improve early.

• Take with food to reduce stomach upset.

• Notify your doctor if side effects like severe diarrhea or rash occur.

• Avoid alcohol during treatment to minimize side effects.