Ceporex 1 g 8 tablets

Ceporex 1 g 8 tablets

Composition:

Each tablet contains: Cephalexin monohydrate — equivalent to 1 g of cephalexin.

Product Description:

• Cephalexin is a first-generation beta-lactam cephalosporin antibiotic.
• Mechanism of Action: Disrupts bacterial cell wall synthesis, exerting a bactericidal effect (leading to microbial cell death).
• Spectrum of Activity: Effective against Staphylococcus aureus (including penicillinase-producing strains), Streptococcus pneumoniae, Streptococcus pyogenes, Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae.
• Pharmacokinetics: Well absorbed after oral administration, achieves therapeutic concentrations in tissues and urine, and is excreted primarily by the kidneys.

Indications for Use:

• Upper Respiratory Tract Infections: Tonsillitis, pharyngitis, sinusitis.
• Lower Respiratory Tract Infections: Bronchitis, pneumonia.
• Urinary Tract Infections: Cystitis, urethritis, pyelonephritis.
• Skin and Soft Tissue Infections: Furunculosis, impetigo, abscesses.
• Bone and Joint Infections.
• Prophylaxis of Bacterial Infections: Prior to surgical procedures (when indicated).

Method of Administration and Dosage:

• Method of Administration: Oral use, regardless of meals, taken with water.
• Usual Adult Dosage: 250–1000 mg every 6–12 hours, depending on the severity of the infection.
• Ceporex 1 g: Usually 1 tablet every 12 hours (2 times daily).
• Maximum Daily Dose: Up to 4 g/day.
• Duration of Treatment: Typically 7 to 14 days.
• Special Dosage Instructions: Dose adjustment is required in patients with impaired renal function.

Contraindications:

Hypersensitivity to cephalexin, other cephalosporins, or any of the excipients.
History of severe immediate-type allergic reactions to other beta-lactam antibiotics (e.g., penicillins).

Precautions:

• Allergic Reactions: Administer with caution to patients prone to allergic reactions and those with penicillin hypersensitivity (risk of cross-reactivity).
• Renal Impairment: Dose modification and monitoring of renal function are necessary in severe renal impairment.
• Prolonged Use: May result in the overgrowth of non-susceptible organisms and fungal superinfections.
• Laboratory Tests: False-positive results may occur in urine glucose tests using reducing substances (e.g., Benedict's or Fehling's solution) and in the direct Coombs' test.

Adverse Reactions / Side Effects:

• Gastrointestinal Tract: Nausea, vomiting, diarrhea, dyspepsia, abdominal pain; rarely, pseudomembranous colitis.
• Allergic Reactions: Skin rash, urticaria, pruritus; rarely, angioedema, anaphylaxis.
• Hematologic System: Reversible leukopenia, neutropenia, eosinophilia, thrombocytopenia.
• Nervous System: Headache, dizziness.
• Hepatic and Renal Systems: Transient increase in liver enzyme levels; rarely, interstitial nephritis.

Pregnancy and Lactation:

Pregnancy:
Use only if the expected benefit to the mother outweighs the potential risk to the fetus (as prescribed by a physician).
Lactation:
Cephalexin is excreted in human milk.
Discontinuation of breastfeeding or cautious administration under medical supervision should be considered during treatment.

Storage Conditions:

Store below 25°C–30°C in the original package to protect from light and moisture.
Keep out of reach of children.

Packaging:

1 g tablets.
8 tablets per pack (in a blister).