SUBCLAV Pediatric Suspension

SUBCLAV Pediatric Suspension
(Co-Amoxiclav 312.5 mg per 5 mL)
(Amoxicillin 250 mg + Clavulanic Acid 62.5 mg equivalent formulation)
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) ………… 250 mg
Clavulanic Acid (as potassium clavulanate) ………… 62.5 mg
Excipients ………………………………… q.s.
Indications:
SUBCLAV Suspension is indicated in pediatric patients for infections caused by beta-lactamase producing bacteria:
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 Note:
Dose carefully to avoid excess clavulanate exposure
Always use calibrated measuring device
Contraindications:
Hypersensitivity to penicillins or beta-lactams
History of cholestatic jaundice or hepatic dysfunction due to co-amoxiclav
Administration:
For oral use only
Reconstitute with clean water up to indicated mark
Shake well before each use
Administer at the start of meals (reduces GI side effects)
Complete full course of therapy
Drug Interactions:
Allopurinol → increased risk of rash
Oral anticoagulants → prolonged bleeding
Methotrexate → increased toxicity
Probenecid → increases amoxicillin levels
Compatibility / Clinical Benefits:
Broad-spectrum antibacterial activity
Effective against resistant organisms
Optimized pediatric dosing strength
Better tolerability with food administration
Suitable for moderate to severe infections
Stability / Storage:
Store dry powder below 25°C
After reconstitution:
Preferably refrigerate (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 therapy
Risk of antibiotic-associated diarrhea
Use carefully in renal impairment
Avoid unnecessary prolonged use
Side Effects:
Common:
Diarrhea
Nausea
Vomiting
Uncommon:
Skin rash
Oral candidiasis
Serious (Rare):
Hepatic dysfunction
Anaphylaxis
Stevens-Johnson Syndrome
Pseudomembranous colitis
Clinical Advantages:
SUBCLAV 312.5 mg/5 mL offers:
Balanced combination strength for pediatrics
Effective treatment of resistant infections
Improved dosing accuracy
High compliance due to palatable flavor
Packaging:
60 mL bottle (after reconstitution)
Measuring cup + oral syringe included