Clavimox 457 mg/5 ml oral suspension 75 ml

Clavimox 457 mg/5 ml oral suspension 75 ml

Composition:
Each 5 ml of reconstituted suspension contains:
- Amoxicillin trihydrate equivalent to 400 mg of amoxicillin anhydrous
- Potassium clavulanate equivalent to 57 mg of clavulanic acid.
Inactive ingredients:
Xanthan gum, Hydroxypropyl methylcellulose, Aspartame, Succinic acid, Colloidal silicon dioxide, Sodium benzoate, Saccharin sodium, Strawberry flavor, Mannitol.
Description:
Clavimox is a broad-spectrum antibiotic combining amoxicillin, a semisynthetic penicillin with bactericidal activity, and clavulanic acid, a beta-lactamase inhibitor that extends the antibacterial spectrum of amoxicillin.
The product is supplied as a powder for oral suspension, to be reconstituted before use.
It is effective against various bacterial infections caused by beta-lactamase-producing strains resistant to amoxicillin alone.
Indications for Use:
Clavimox is indicated for the treatment of:
- Acute bacterial sinusitis
- Acute otitis media
- Acute exacerbations of chronic bronchitis
- Community-acquired pneumonia
- Cystitis and pyelonephritis
- Skin and soft tissue infections (including cellulitis, animal bites, severe dental abscess)
- Bone and joint infections (e.g., osteomyelitis).
Dosage and Method of Administration:
For oral use only.
Administer at the start of a meal to minimize gastrointestinal discomfort and enhance absorption.
Reconstitute the powder with water up to the indicated mark, shake well before each use.
Adults and children ≥ 40 kg:
- 5 ml twice daily (equivalent to 400 mg amoxicillin / 57 mg clavulanic acid per 5 ml).
- For severe infections, the dose may be increased to 5 ml three times daily.
Children < 40 kg:
- 25 mg/3.6 mg to 45 mg/6.4 mg per kg per day in two divided doses.
- For certain infections (e.g., otitis media, sinusitis), up to 70 mg/10 mg per kg per day in two divided doses may be used.
- Duration of therapy depends on infection severity and patient response but should not exceed 14 days without reassessment.
Contraindications:
- Hypersensitivity to amoxicillin, clavulanic acid, other penicillins, or any excipient.
- History of severe immediate hypersensitivity (e.g., anaphylaxis) to beta-lactam antibiotics.
- Previous hepatic dysfunction or jaundice associated with amoxicillin/clavulanic acid.
Precautions:
- Before starting therapy, enquire about previous allergic reactions to penicillins or cephalosporins.
- Discontinue immediately if an allergic reaction occurs.
- Use with caution in patients with hepatic impairment - monitor liver function during prolonged therapy.
- Caution is required in renal impairment; dose adjustment may be necessary.
- Prolonged use may cause overgrowth of non-susceptible organisms or antibiotic-associated colitis - discontinue if diarrhea occurs.
- Avoid in patients with suspected infectious mononucleosis, as it may cause rash.
- Maintain adequate hydration to prevent crystalluria.
- Clavimox contains aspartame (source of phenylalanine) and should be used cautiously in patients with phenylketonuria.
Side Effects:
- Gastrointestinal: Nausea, vomiting, diarrhea (common); antibiotic-associated colitis (rare).
- Hepatic: Elevation of liver enzymes, hepatitis, cholestatic jaundice (uncommon to rare).
- Skin reactions: Rash, pruritus, urticaria (uncommon); erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, or AGEP (very rare).
- Blood and lymphatic system: Reversible leucopenia, thrombocytopenia (rare).
- Immune system: Hypersensitivity reactions including angioedema, anaphylaxis (rare).
- Other: Dizziness, headache, reversible hyperactivity (uncommon).
Pregnancy and Breastfeeding:
- Animal studies and limited human data do not indicate teratogenic risk.
However, use during pregnancy should be limited to cases when clearly necessary.
- Both active substances are excreted in breast milk; diarrhea or candidiasis may occur in infants.
Use during breastfeeding only after medical evaluation of benefits and risks.
Storage Conditions:
Store the dry powder below 30°C in a dry place.
After reconstitution, keep refrigerated (2-8°C) and use within 7 days.
Shake well before each use.
Keep out of reach of children.
Packaging:
Carton box containing a 75 ml bottle with powder for oral suspension, a measuring cup, and a leaflet.