Megamox 228.5 mg / 5 ml suspension, 70 ml

Available at Pharmaegy Pharmacy. Use as directed by your doctor.

Megamox Amoxicillin +Clavulanic Acid 228.5 mg/ 5 ml Broad spectrum Antibiotic Powder for oral suspension (After Reconstitution 70 ml) Composition: Megamox 228 mg Suspension: Each 5 ml contains: Amoxicillin 200 mg Clavulanic Acid 28.5 mg Description: MEGAMOX is an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Indications and Usage: To reduce the development of drug-resistant bacteria and maintain the effectiveness of MEGAMOX (amoxicillin/clavulanate potassium) and other antibacterial drugs, MEGAMOX should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. MEGAMOX is a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated for the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below: -Lower Respiratory Tract Infections caused by beta-lactamase-producing isolates of Haemophilus influenzae and Moraxella catarrhalis. -Acute Bacterial Otitis Media caused by beta-lactamase-producing isolates of H. influenzae and M. catarrhalis. -Sinusitis caused by beta-lactamase-producing isolates of H. influenzae and M. catarrhalis. -Skin and Skin Structure Infections caused by beta-lactamase-producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species. -Urinary Tract Infections caused by beta-lactamase-producing isolates of E. coli, Klebsiella species, and Enterobacter species. Limitations of Use: When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, MEGAMOX should not be used. Dosage and Administration: MEGAMOX may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when MEGAMOX is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, MEGAMOX should be taken at the start of a meal. -Adults Adults who have difficulty swallowing may be given the 125 mg/5 mL or 250 mg/5 mL suspension in place of the 500-mg tablet. The 200 mg/5 mL or 400 mg/5 mL suspension may be used in place of the 875-mg tablet. -Pediatric Patients: Based on the amoxicillin component, MEGAMOX should be dosed as follows: Neonates and Infants Aged <12 weeks (<3 months): The recommended dose is 30 mg/kg/day, divided every 12 hours. Limited experience with the 200 mg/5 mL formulation in this age group. Use of the 125 mg/5 mL oral suspension is recommended. Patients Aged 12 weeks (3 months) and Older: See dosing regimens in the table below. The every 12-hour regimen is recommended as it is associated with significantly less diarrhea. However, the every 12-hour suspension (200 mg/5 mL and 400 mg/5 mL) contains aspartame and should not be used by phenylketonurics. Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older: Otitis media, sinusitis, lower respiratory tract infections, and more severe infections: 45 mg/kg/day every 12 hours or 40 mg/kg/day every 8 hours Less severe infections: 25 mg/kg/day every 12 hours or 20 mg/kg/day every 8 hours Duration of therapy studied and recommended for acute otitis media is 10 days. Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations. Patients with Renal Impairment: GFR <30 mL/min: Do not receive the 875 mg dose. GFR 10-30 mL/min: 500 mg or 250 mg every 12 hours. GFR <10 mL/min: 500 mg or 250 mg every 24 hours. During Dialysis: Additional dose during and at the end of dialysis. Directions for Mixing Oral Suspension: Tap bottle until all powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution and shake well. Contraindications: Serious Hypersensitivity Reactions: MEGAMOX is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin, clavulanate, or other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins). Cholestatic Jaundice/Hepatic Dysfunction: Contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with MEGAMOX. Warnings and Precautions: Hypersensitivity Reactions: Serious and occasionally fatal hypersensitivity reactions (anaphylactic reactions) may occur. Discontinue MEGAMOX immediately and initiate appropriate therapy. Hepatic Dysfunction: Hepatic toxicity (e.g., hepatitis, cholestatic jaundice) has been reported. Hepatic function should be monitored in patients with hepatic impairment. Clostridium difficile Associated Diarrhea (CDAD): May range from mild diarrhea to fatal colitis. Discontinue MEGAMOX if CDAD occurs. Skin Rash in Patients with Mononucleosis: High percentage of patients with mononucleosis develop an erythematous rash. Do not administer MEGAMOX to these patients. Potential for Microbial Overgrowth: Consider the possibility of superinfections. Discontinue MEGAMOX if superinfection occurs. Adverse Reactions: Gastrointestinal: Indigestion, gastritis, stomatitis, glossitis, black "hairy" tongue, mucocutaneous candidiasis, enterocolitis, hemorrhagic/pseudomembranous colitis. Hypersensitivity Reactions: Pruritus, angioedema, serum sickness-like reactions, erythema multiforme, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis. Liver: Hepatic dysfunction, increases in serum transaminases, serum bilirubin, alkaline phosphatase. Renal: Interstitial nephritis, hematuria, crystalluria. Hemic and Lymphatic Systems: Anemia, hemolytic anemia, thrombocytopenia, eosinophilia, leukopenia, agranulocytosis. Central Nervous System: Agitation, anxiety, confusion, convulsions, dizziness, insomnia, hyperactivity. Miscellaneous: Tooth discoloration in pediatric patients. Pregnancy: Should only be used during pregnancy if clearly needed. Nursing Mothers: Caution should be exercised when administering MEGAMOX to nursing women. Storage: Store at a temperature not exceeding 30°C, in a dry place. Use within 7 days after reconstitution when stored at temperatures between 2-8°C. Packaging: Carton box containing a 70 ml bottle of suspension after reconstitution and an inner leaflet.