Cefixime Trihydrate (Cefim) 20mg/ml Granules for Suspension (Oral Drops) 15ml

Cefixime Trihydrate (Cefim) 20mg/ml Granules for Suspension (Oral Drops) 15ml

Product Description:

Cefim contains Cefixime Trihydrate, a third-generation oral cephalosporin antibiotic, available as granules for suspension that can be prepared into oral drops. It is formulated to treat a variety of bacterial infections. Cefixime works by inhibiting the synthesis of the bacterial cell wall, resulting in bacterial cell death. The Cefim oral drop formulation is especially useful for pediatric patients or individuals who have difficulty swallowing tablets.

Each 15ml bottle of Cefim suspension provides 20mg/ml of Cefixime.

Indications:

Cefim is indicated for the treatment of various bacterial infections caused by susceptible microorganisms, including:

1. Respiratory Tract Infections:

   • Acute Otitis Media (middle ear infection).

   • Pharyngitis (inflammation of the throat).

   • Tonsillitis (inflammation of the tonsils).

   • Acute Sinusitis (infection of the sinuses).

   • Bronchitis (acute exacerbations).

   • Pneumonia (community-acquired).

2. Urinary Tract Infections:

   • Cystitis (bladder infection).

   • Pyelonephritis (kidney infection).

3. Gonorrhea:

   • Treatment of uncomplicated gonorrhea in both males and females.

4. Pharyngitis/Tonsillitis:

   • Caused by Streptococcus pyogenes.

5. Enteric Infections:

   • Typhoid fever (caused by Salmonella typhi).

6. Other Infections:

   • Infections of the skin and soft tissue caused by susceptible organisms.

Dosage and Administration:

The dosage of Cefim will depend on the age of the patient, the type of infection, and the severity. The recommended dosages are as follows:

• Adults:

  • For most infections: 400mg once daily or 200mg twice daily.

  • For Gonorrhea: A single dose of 400mg.

• Children:

  • Infants and children (over 6 months): The typical dose is 8mg/kg/day given once daily or divided into two doses.

    • For simple infections (e.g., ear or throat infections): 4mg/kg/day, administered as a single dose.

    • For more severe infections: 8mg/kg/day, either as a single dose or divided into two doses.

• Neonates: Not recommended for neonates due to lack of safety data.

Administration:

• Shake the bottle well before each use.

• Administer the prepared oral suspension or drops directly to the patient, preferably with food or milk to reduce potential gastrointestinal discomfort.

Side Effects:

Although Cefim (Cefixime) is generally well-tolerated, side effects can occur. The common and serious side effects may include:

1. Gastrointestinal Effects:

   • Diarrhea (common).

   • Nausea and vomiting.

   • Abdominal pain or discomfort.

   • Dyspepsia (indigestion).

   • Flatulence (gas).

2. Hematologic Effects:

   • Leukopenia (reduced white blood cell count).

   • Thrombocytopenia (low platelet count).

   • Eosinophilia (elevated eosinophil count).

3. Allergic Reactions:

   • Rash, urticaria (hives), and pruritus (itching).

   • Anaphylaxis (rare, severe allergic reaction).

4. Renal Effects:

   • Elevated serum creatinine (in cases of renal impairment).

5. Hepatic Effects:

   • Transient elevations in liver enzymes (AST, ALT).

   • Jaundice (yellowing of the skin or eyes).

6. Superinfections:

   • Clostridium difficile-associated diarrhea (due to prolonged use or use in immunocompromised patients).

7. CNS Effects (rare):

   • Headache.

   • Dizziness or confusion.

Contraindications:

Cefim should be used with caution or avoided in certain patient populations:

1. Hypersensitivity to Cephalosporins:

   • Cefim is contraindicated in patients with a known allergy to Cefixime or other cephalosporin antibiotics.

   • Caution is required for those with a history of penicillin allergy, as cross-reactivity between cephalosporins and penicillins is possible.

2. Severe Renal Impairment:

   • In patients with severe renal impairment (creatinine clearance <30 mL/min), dose adjustment is required to avoid potential toxicity.

3. Neonates:

   • Cefixime is not recommended for neonates (infants less than 2 months old) due to insufficient safety data.

Precautions:

1. Use in Pregnancy:

   • Pregnancy Category B: Cefim is generally considered safe for use during pregnancy, but it should be used only if clearly needed. Always consult a healthcare provider before use.

2. Breastfeeding:

   • Cefixime is excreted in breast milk in small amounts. If breastfeeding, the potential risks and benefits should be considered. Generally, it is considered safe for breastfeeding mothers.

3. Renal Function:

   • Cefim should be used with caution in patients with renal impairment. The dose may need to be reduced depending on the level of renal dysfunction.

4. Superinfections:

   • Prolonged use of Cefim may result in the development of superinfections, particularly with organisms such as Clostridium difficile. If symptoms of superinfection occur, discontinue use and provide appropriate treatment.

5. Monitoring:

   • During prolonged therapy, renal and hepatic function should be monitored. Regular blood tests are advised to monitor for adverse effects such as blood dyscrasias or liver damage.

Conclusion:

Cefim (Cefixime) is an effective antibiotic used to treat a wide variety of bacterial infections, particularly those in the respiratory and urinary tracts. It is suitable for use in both adults and children, with a formulation that provides flexibility for pediatric patients in the form of oral drops. As with any antibiotic, it should be used as directed to avoid antibiotic resistance and to ensure the best outcomes for the patient.