Medical Description
Antibiotic, belongs to the penicillin group used in the treatment of bacterial rhinosinusitis, pneumonia, otitis media, prophylaxis or treatment against bite wound infection, diabetic foot infection, odontogenic infection and urinary tract infection.
Indication & Usage
-Adult dosing: IV: 1 g every 8 hours or 2 g every 8 to 12 hours.
-Pediatric dosing: IV dosing: 5:1 formulation: Infants <3 months or weighing <4 kg: IV: 25 mg amoxicillin/kg/dose every 12 hours, infants ≥3 months weighing ≥4 kg, children, and adolescents: IV: 25 mg amoxicillin/kg/dose every 8 hours; maximum dose: 1,000 mg amoxicillin/dose. Or 10:1 formulation: Infants <3 months or weighing <4 kg: IV: 50 mg amoxicillin/kg/dose every 12 hours, while in case of infants ≥3 months, children, and adolescents weighing 4 to <40 kg: 50 mg amoxicillin/kg/dose every 8 hours; maximum dose: 2,000 mg amoxicillin/dose, while in case of children and adolescents weighing ≥40 kg: 2,000 mg amoxicillin every 8 to 12 hours.
-Used in the treatment of:
1-Acute bacterial rhinosinusitis.
2-Pneumonia.
3-Urinary tract infection.
4-Peritonsillar cellulitis or abscess.
5-Acute otitis media.
6-Odontogenic infection.
7-Intra-abdominal infection.
8-Diabetic foot infection.
9-Chronic obstructive pulmonary disease.
10-Prophylaxis or treatment of bite wound infection (animal or human bite) for adults.
Active Ingredients
AmoxicillinClavulanic Acid
Dosage & Administration
-Administer by slow IV injection over 3 to 4 minutes (1 g dose only) or as an infusion over 30 to 40 minutes.
-Administer around-the-clock.
Side Effects
-Antibiotic-associated diarrhea (AAD), nausea, and vomiting, Clostridioides difficile infection (CDI), drug-induced liver injury, urticaria, angioedema and anaphylaxis.
-Diaper rash, skin rash, urticaria, nausea, vomiting, vaginitis, candidiasis, vaginal mycosis, abdominal distress, flatulence, thrombocythemia and headache.
Safety Advice
-Should not be given to patients suffering from hypersensitivity to amoxicillin, clavulanic acid and other beta-lactam antibacterial drugs.
-Use is contraindicated in patients with a history of amoxicillin and clavulanate-associated hepatic dysfunction.
-In case of renal impairment: If the creatinine clearance is 10 to <30 mL/minute: Dose when needed: 250 to 500 mg every 12 hours, If the creatinine clearance is <10 mL/minute: 250 to 500 mg every 12 to 24 hours.
-Prolonged use may result in fungal or bacterial superinfection.
-In case of over dose be ready to tell or show what was taken, how much and when it happened, and seek immediate medical attention. For additional information call us on 16676. Always tell your physician your detailed medical history.
Storage
Store at room temperature.
Drug Interactions
-Allopurinol: May enhance the potential for allergic or hypersensitivity reactions to Amoxicillin.
-Aminoglycosides: Penicillins may decrease the serum concentration of Aminoglycosides.
-Acemetacin: May increase the serum concentration of Penicillins.
-BCG Vaccine: Antibiotics may diminish the therapeutic effect of BCG Vaccine.
-Methotrexate: Penicillins may increase the serum concentration of Methotrexate.
-Mycophenolate: Penicillins may decrease serum concentrations of the active metabolite(s) of Mycophenolate.
-Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate.
-Tetracyclines: May diminish the therapeutic effect of Penicillins.
-Vitamin K Antagonists (eg, warfarin): Penicillins may enhance the anticoagulant effect of Vitamin K Antagonists.
Pregnancy & Lactation
-Both amoxicillin and clavulanic acid cross the placenta. An increased risk of necrotizing enterocolitis in neonates or bowel disorders in children may be associated with amoxicillin/clavulanate when exposure occurs near delivery, as a class, penicillin antibiotics are widely used in pregnant women. Based on available data, penicillin antibiotics are generally considered compatible for use during pregnancy, Amoxicillin/clavulanate is considered compatible for the of treatment airway diseases in pregnant women. Use should be avoided in women at risk for preterm delivery.
-Amoxicillin is present in breast milk following administration amoxicillin/clavulanate. The relative infant dose (RID) of amoxicillin following administration of amoxicillin/clavulanate is 0.02% to 0.07%. In general, breastfeeding is considered acceptable when the RID is <10%, amoxicillin/clavulanate is considered compatible with breastfeeding when used in usual recommended doses.
-Ask your physician before taking any medication during pregnancy or lactation.