Megamox 457 mg/5 ml Suspension 70 ml

Megamox 457 mg/5 ml Suspension 70 ml

Composition:

Each 5 ml of reconstituted suspension contains:
Amoxicillin (as trihydrate) 400 mg and Clavulanic Acid (as potassium clavulanate) 57 mg.
Excipients include suspension stabilizers, sweetening agents, and flavorings.

Product Description:

Megamox is a broad-spectrum antibacterial combination comprising amoxicillin, a beta-lactam antibiotic, and clavulanic acid, a competitive beta-lactamase inhibitor.
Amoxicillin exerts bactericidal activity by inhibiting bacterial cell wall peptidoglycan synthesis.
Clavulanic acid inactivates a wide range of beta-lactamase enzymes (Types II, III, IV, and V) produced by resistant microorganisms, thereby protecting amoxicillin from enzymatic degradation and restoring its activity against beta-lactamase-producing Gram-positive and Gram-negative aerobic and anaerobic bacteria.

Indications for Use:

• Upper respiratory tract and ENT infections (recurrent or chronic tonsillitis, sinusitis, otitis media).
• Lower respiratory tract infections (acute bronchitis, acute exacerbation of chronic bronchitis, community-acquired pneumonia, pleural empyema, lung abscess).
• Urinary tract and pelvic infections (pyelonephritis, pyelitis, cystitis, urethritis, endometritis, salpingo-oophoritis, septic abortion).
• Skin and soft tissue infections (erysipelas, impetigo, secondarily infected dermatoses, abscesses, cellulitis, wound infections).
• Bone and joint infections (osteomyelitis).
• Postoperative surgical site infections.

Method of Administration and Dosage:

• The medication is intended for oral administration.
• To minimize gastrointestinal intolerance, the suspension should be administered at the start of a meal.
• To prepare 70 ml of suspension, add 62 ml of cooled boiled water to the bottle containing the powder and shake vigorously until a uniform suspension is formed. 
• Shake the bottle well before each use.
• Dosing is calculated based on age, body weight, and severity of infection:
  Pediatric patients under 12 years (or weighing <40 kg): 20 mg/kg/day to 40 mg/kg/day ( amoxicillin component) divided into 2 or 3 doses.
  Adults and pediatric patients over 12 years (weighing ≥40 kg): 250 mg to 500 mg 2 to 3 times daily or 875 mg twice daily (using appropriate dosage formulations).

Contraindications:

• Known hypersensitivity to amoxicillin, clavulanic acid, other penicillins, or any of the excipients in the formulation.
• History of severe immediate hypersensitivity reactions (anaphylaxis) to other beta-lactam agents (cephalosporins, carbapenems, monobactams).
• History of amoxicillin/clavulanate-associated cholestatic jaundice or hepatic dysfunction.
• Severe renal impairment (creatinine clearance <30 ml/min).

Precautions:

• Megamox should not be administered if infectious mononucleosis is suspected due to the high incidence of morbilliform skin rash associated with amoxicillin use in these patients.
• Periodic evaluation of organ system functions, including renal, hepatic, and hematopoietic function, is recommended during prolonged therapy. 
• Cross-reactivity may occur in patients with penicillin hypersensitivity when treated with cephalosporins. 
• Prolonged use may result in fungal superinfections (e.g., Candida species). 
• False-positive urinary glucose test results may occur with non-enzymatic copper reduction methods (such as Benedict's or Fehling's reagents); glucose oxidase methods are recommended.

Adverse Reactions / Side Effects:

• Gastrointestinal Disorders: common — nausea, vomiting, diarrhea; uncommon — dyspepsia, abdominal pain, stomatitis, glossitis, moderate elevations in serum transaminases; rarely — cholestatic jaundice, hepatitis.
• Blood and Lymphatic System Disorders: reversible prolongation of bleeding and prothrombin times, thrombocytopenia, leukopenia, eosinophilia; rarely — agranulocytosis, hemolytic anemia.
• Nervous System Disorders: dizziness, headache, hyperactivity, anxiety, behavioral changes, convulsions (particularly in patients with renal impairment or at high doses).
• Renal and Urinary Disorders: interstitial nephritis, crystalluria, hematuria.
• Skin and Subcutaneous Tissue Disorders: urticaria, maculopapular rash, pruritus, erythema multiforme; rarely — Stevens-Johnson syndrome, toxic epidermal necrolysis.
• General Disorders: mucosal candidiasis, development of resistant superinfections.

Pregnancy and Lactation:

Megamox should be used during pregnancy (especially in the first trimester) and breastfeeding only if the expected therapeutic benefit to the mother outweighs the potential risk to the fetus or infant.
Trace amounts of amoxicillin and clavulanic acid are excreted in human breast milk.

Storage Conditions:

• Store the dry powder at a temperature not exceeding 30 °C in a dry place.
• Following reconstitution, store the oral suspension refrigerated between 2 °C and 8 °C and use within 7 to 10 days. 
• Do not freeze. 
• Keep out of reach of children.

Packaging:

The cardboard box contains a bottle with dry powder for reconstitution to 70 ml oral suspension, a measuring device (dosing cup or oral syringe), and a medical instruction insert.