SUBCLAV Pediatric Suspension

SUBCLAV Pediatric Suspension
(Co-Amoxiclav 400 mg / 57 mg per 5 mL)
(Amoxicillin + Clavulanic Acid)
Generic Name:
Amoxicillin + Clavulanic Acid
Therapeutic Group:
Antibacterial
Drug Category:
Beta-lactam Antibiotic Combination (Aminopenicillin + Beta-lactamase Inhibitor)
Content / Composition:
After reconstitution, each 5 mL contains:
Amoxicillin (as trihydrate) ………… 400 mg
Clavulanic Acid (as potassium clavulanate) ………… 57 mg
Excipients ………………………………… q.s.
Indications:
SUBCLAV Suspension is indicated for pediatric treatment of infections caused by beta-lactamase producing organisms:
Upper respiratory tract infections (sinusitis, tonsillitis)
Lower respiratory tract infections (bronchitis, pneumonia)
Otitis media
Urinary tract infections (UTIs)
Skin & soft tissue infections
Dental infections
Dosage:
Children (≥ 3 months):
Based on amoxicillin component:
25–45 mg/kg/day divided every 12 hours
Severe infections:
Up to 45 mg/kg/day (in 2 divided doses)
Important:
Use dosing syringe for accuracy
Do not exceed recommended clavulanate exposure
Contraindications:
Hypersensitivity to penicillins or beta-lactam antibiotics
History of cholestatic jaundice or hepatic dysfunction associated with co-amoxiclav
Administration:
For oral use only
Reconstitute with clean water up to mark
Shake well before each use
Administer at the start of meals (improves tolerance)
Complete full course
Drug Interactions:
Allopurinol → increased risk of rash
Anticoagulants → prolonged bleeding time
Methotrexate → increased toxicity
Probenecid → increases amoxicillin levels
Compatibility / Clinical Benefits:
Broad-spectrum coverage including resistant bacteria
Effective against beta-lactamase producing organisms
Pediatric-friendly formulation
Improved clinical outcomes in resistant infections
Twice daily dosing improves compliance
Stability / Storage:
Store dry powder below 25°C
After reconstitution:
Refrigeration preferred (2–8°C)
Use within 7–10 days
Keep tightly closed
Do not freeze
Precautions:
Use with caution in hepatic impairment
Monitor liver function in prolonged use
Risk of antibiotic-associated diarrhea
Use cautiously in renal impairment
Avoid unnecessary prolonged therapy
Side Effects:
Common:
Diarrhea
Nausea
Vomiting
Uncommon:
Rash
Oral candidiasis
Serious (Rare):
Hepatic dysfunction
Anaphylaxis
Stevens-Johnson Syndrome
Pseudomembranous colitis
Clinical Advantages:
SUBCLAV provides:
Enhanced antibacterial spectrum
Effective against resistant infections
Combination therapy in single formulation
Improved pediatric compliance
Packaging:
60 mL bottle (after reconstitution)
Measuring cup + oral syringe included