Megamox ES 642.9 mg/5 ml suspension 100 ml
Hikma Pharmaceuticals
Hikma Pharmaceuticals
Composition
Amoxicillin 600 mg/5 ml (as trihydrate)
Clavulanic acid 42.9 mg/5 ml (as potassium salt)
Description
Megamox ES is a combination antibiotic containing amoxicillin, a penicillin-class antibacterial, and clavulanic acid, a beta-lactamase inhibitor. This formulation is designed to treat infections caused by susceptible bacteria and reduce the development of drug-resistant strains. It is supplied as a powder for oral suspension and must be reconstituted before use.
Indications
Megamox ES is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media caused by:
-Streptococcus pneumoniae (penicillin MICs ≤ 2 mcg/ml)
-Haemophilus influenzae (including beta-lactamase-producing strains)
-Moraxella catarrhalis (including beta-lactamase-producing strains)
Dosage and Administration
Pediatric patients (3 months and older)
90 mg/kg/day of amoxicillin component divided every 12 hours for 10 days.
(This provides 6.4 mg/kg/day of clavulanic acid.)
8kg- 3.0 ml twice daily
12kg- 4.5 ml twice daily
16kg- 6.0 ml twice daily
20kg- 7.5 ml twice daily
24kg- 9.0 ml twice daily
28kg-10.5 ml twice daily
32kg-12.0 ml twice daily
36kg-13.5 ml twice daily
Pediatric patients > 40 kg and Adults
Experience is not available. Adults should not substitute Megamox ES for tablet formulations.
Patients with hepatic impairment
Use with caution and monitor hepatic function regularly.
Preparation of Suspension
Tap bottle to loosen powder.
Add approximately 2/3 of the total water for reconstitution, shake vigorously.
Add the remaining water up to the marked line, shake vigorously again.
Each 5 ml after reconstitution contains: 600 mg amoxicillin + 42.9 mg clavulanic acid.
Important: Shake well before each use.
Administration
Take at the start of a meal to minimize gastrointestinal discomfort and enhance clavulanic acid absorption.
Contraindications
-History of serious hypersensitivity reactions (e.g., anaphylaxis, Stevens-Johnson syndrome) to amoxicillin, clavulanate, penicillins, or cephalosporins.
-History of cholestatic jaundice or hepatic dysfunction associated with amoxicillin/clavulanic acid use.
Warnings and Precautions
-Monitor for signs of hypersensitivity reactions. Discontinue if allergic reactions occur.
-Use with caution in patients with hepatic impairment.
Side Effects
Side effects associated with Megamox ES may include
-Serious hypersensitivity reactions, including
Anaphylaxis, Stevens-Johnson syndrome
-Jaundice (especially cholestatic jaundice)
-Hepatic dysfunction
-If signs of an allergic reaction (rash, itching, facial swelling, or difficulty breathing) or symptoms of liver dysfunction (yellowing of the skin or eyes, dark urine) occur, the use of the medication should be discontinued immediately, and medical attention should be sought.
Storage Conditions
Store reconstituted suspension in a refrigerator (2–8°C).
Discard after 10 days.
Packaging
A carton contains one bottle of powder for reconstitution to 100 ml suspension and a package insert.