Clavimox 457 mg/5 ml oral suspension 75 ml
Pharco Pharmaceuticals Inc.
Pharco Pharmaceuticals Inc.
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.