Clavimox 1 g 16 tablets

Clavimox 1 g 16 tablets

Composition:

Active Ingredients:
Amoxicillin anhydrous 875 mg and Clavulanic acid 125 mg per film-coated tablet.
Excipients:
Microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, and film-coating components (hypromellose, titanium dioxide, macrogol).

Product Description:

• Combined broad-spectrum antibacterial agent with bactericidal activity.
• Amoxicillin is a semisynthetic aminopenicillin that inhibits the synthesis of bacterial cell wall peptidoglycan during active multiplication. 
• Clavulanic acid is a beta-lactamase inhibitor that inactivates a wide range of beta-lactamase enzymes produced by penicillin- and cephalosporin-resistant bacteria, thereby protecting amoxicillin from enzymatic degradation and extending its antibacterial spectrum.
• The combination is active against Gram-positive and Gram-negative organisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes, Enterococcus faecalis, Haemophilus influenzae, Moraxella catarrhalis, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Neisseria gonorrhoeae, Bacteroides species (including Bacteroides fragilis), Clostridium species, and Peptostreptococcus species.

Indications for Use:

• Treatment of bacterial infections caused by amoxicillin/clavulanic acid-sensitive microorganisms:
• Upper respiratory tract infections (including acute bacterial sinusitis, tonsillitis, and otitis media).
• Lower respiratory tract infections (including acute exacerbations of chronic bronchitis, community-acquired pneumonia).
• Genitourinary tract infections (including pyelonephritis, cystitis, and urethritis).
• Skin and soft tissue infections (including cellulitis, animal bites, and severe dental abscesses with spreading cellulitis).
• Bone and joint infections (including osteomyelitis).

Method of Administration and Dosage:

• Administered orally.
  Swallow the tablet whole with water at the start of a meal to minimize potential gastrointestinal intolerance.
• Adults and adolescents weighing 40 kg or more: 1 tablet (875 mg/125 mg) twice daily (every 12 hours).
• Treatment duration: Typically ranges from 5 to 14 days depending on infection severity.
• Treatment should not exceed 14 days without clinical review.

Contraindications:

Known hypersensitivity to amoxicillin, clavulanic acid, penicillins, or any excipients.
History of severe immediate hypersensitivity reaction (e.g., anaphylaxis) to another beta-lactam agent (e.g., cephalosporin, carbapenem, or monobactam).
History of jaundice or hepatic impairment associated with amoxicillin/clavulanic acid.

Precautions:

• Before initiating therapy, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins or cephalosporins.
• Use with caution in patients with evidence of hepatic dysfunction or renal impairment (dosage adjustment required in severe renal failure).
• Prolonged use may occasionally result in overgrowth of non-susceptible organisms or Clostridioides difficile-associated diarrhea.
• Hepatic function, renal function, and hematological parameters should be monitored periodically during prolonged therapy.

Adverse Reactions / Side Effects:

• Gastrointestinal System: Diarrhea, nausea, vomiting, abdominal discomfort, and candidiasis (mucocutaneous).
• Hepatic System: Moderate elevation of AST/ALT, cholestatic jaundice, and hepatitis (more common in elderly males or prolonged treatment).
• Allergic Reactions: Skin rash, pruritus, urticaria; rarely, erythema multiforme, Stevens-Johnson syndrome, anaphylaxis, and angioedema.
• Hematopoietic System: Rare instances of reversible leukopenia, neutropenia, and thrombocytopenia.
• Nervous System: Dizziness, headache, and rarely, convulsions (at high doses or in impaired renal function).

Pregnancy and Lactation:

Use during pregnancy (especially in the first trimester) should be avoided unless considered essential by the physician.
Both amoxicillin and clavulanic acid are excreted in human milk in small trace amounts; use during lactation requires caution and medical evaluation.

Storage Conditions:

Store at a temperature not exceeding 30 °C in a dry place protected from light.
Keep out of reach of children.

Packaging:

Cardboard box containing 16 film-coated tablets in blisters.