Novaclav 1.2 IV Injection

✔️ Novaclav 1.2 IV Injection

IV Injection

Adults:

1.2 gm every 8 hours

For severe cases: every 6 hours

Surgical prophylaxis: 1.2 gm at induction; high-risk procedures may require 2–3 gm every 8 hours

Children:

0–3 months: 30 mg/kg every 8 hours (or every 12 hours for premature/perinatal infants)

3 months–12 years: 30 mg/kg every 8 hours; increase to every 6 hours if severe

Renal Impairment

Adults:

Mild (CrCl >30 ml/min): No adjustment

Moderate (CrCl 10–30 ml/min): 375 mg or 625 mg every 12 hours; IV 1.2 gm then 0.6 gm every 12 hours

Severe (CrCl <10 ml/min): 375 mg every 12 hours; IV 1.2 gm then 0.6 gm every 24 hours

Hemodialysis: An additional 0.6 gm dose during and after dialysis

Children: Adjust dose similarly based on renal function.

✔️ Administration | Amoxicillin + Clavulanic Acid IV forms:

Not suitable for intramuscular or subcutaneous use

Administer via slow IV push (2 minutes) or IV infusion (30 minutes)

Reconstituted solutions must be used within 20 minutes

✔️ Side Effect

Most reactions are mild and temporary. Reported effects include:

• Diarrhea, nausea, vomiting, indigestion
• Fungal overgrowth (candidiasis)

Rare: pseudomembranous colitis, hepatitis, cholestatic jaundice

• Skin reactions such as urticaria, erythematous rash

Very rare: Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis

• Hypersensitivity reactions, including angioedema, anaphylaxis

✔️ Drug Interaction

• May prolong bleeding time and prothrombin time
• Can reduce the effectiveness of oral contraceptives
• Concurrent allopurinol use increases the risk of skin rash
• No established data with other combination use

✔️ Contraindications

• History of allergy to penicillins or cephalosporins
• Previous cholestatic jaundice associated with Co-amoxiclav
• Hypersensitivity to any formulation component

✔️ Pregnancy & Lactation

• Animal data show no teratogenicity
• Limited human data suggest general safety, but use during pregnancy should be restricted unless essential
• Small amounts of Amoxicillin may appear in breast milk

✔️ Precautions & Warnings

• Use cautiously in patients on anticoagulants or with severe liver disease
• Dose adjustment needed in renal impairment
• Ensure adequate hydration to prevent crystalluria during high-dose therapy

✔️ Storage:

• Store below 25°C, protected from light and moisture
• Reconstituted suspension: refrigerate and use within 7 days
• Reconstituted injection: use within 20 minutes