Clavamox 125/31 Powder For Suspension
Amoxicillin + Clavulanic Acid (Clavulanate)
125 mg + 31.25 mg/5 ml
G. A. Company Ltd.
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Indications
Clavamox 125/31 Powder For Suspension is used for:
Lower respiratory tract infections, Acute bacterial otitis media, Sinusitis, Skin and skin structure infections, Urinary tract infections
Adult Dose
Adults:
Adult patients greater than 40 kg: 500 or 875 mg every 12 hours or 250 or 500 mg every 8 hours, based on the amoxicillin component.
Lower Respiratory Tract Infection
Beta-lactamase?producing strains of Haemophilus influenzae and Moraxella catarrhalis
Mild to moderate: 500/125 mg PO q12hr or 250/125 mg PO q8hr for 10 days
Severe: 875/125 mg PO q12hr or 500/125 mg PO q8hr or 2000 mg (2 extended-release tabs) PO q12hr for 7-10 days
Chronic Obstructive Pulmonary Disease
500 mg PO q8hr
Acute Bacterial Sinusitis
Beta-lactamase?producing strains of H influenzae and M catarrhalis
2000 mg (2 extended-release tablets) PO q12hr for 10 days
Animal/Human Bite Wounds
875 mg PO q12hr or 500 mg PO q8hr for 3-5 days
Erysipelas
875 mg PO q12hr or 500 mg PO q8hr for 7-10 days
Pyelonephritis
Beta-lactamase?producing strains of Escherichia coli, Klebsiella spp, and Enterobacter spp
875 mg PO q12hr or 500 mg PO q8hr
Skin Abscess
Beta-lactamase?producing strains of Staphylococcus aureus, E coli, and Klebsiella spp
875 mg PO q12hr
Diabetic Foot
Mild to moderate, localized cellulitis
2000 mg (2 extended-release tablets) PO q12hr for 7-14 days
Group A Streptococci, Chronic Carrier
40 mg/kg/day PO divided q8hr for 10 days; not to exceed 2000 mg/day
Child Dose
Children:
Pediatric Patients greater than 40 kg: 500 or 875 mg every 12 hours or 250 or 500 mg every 8 hours, based on the amoxicillin component.
Pediatric patients aged 12 weeks (3 months) and older: 25 to 45 mg/kg/day every 12 hours or 20 to 40 mg/kg/day every 8 hours, up to the adult dose.
Neonates and infants less than 12 weeks of age: 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Use of the 125 mg/5 mL oral suspension is recommended.
Children: 125/31.25-, 250/62.5-mg/5-mL susp: 20–40 mg amoxicillin component/kg/day (max 1,500 mg/day) q8h
200/28.5-, 400/57-mg/5-mL susp: 25-45 mg amoxicillin component/kg/day (max 1,750 mg/day) q12h
Children of 6-12 years: 2 teaspoonful Powder for Suspension every 8 hours.
Children of 1-6 years: 1 teaspoonful Powder for Suspension every 8 hours.
Children below 1 year: 25 mg/kg/day in divided doses every 8 hours.
Children over 12 years: IV Injection: 1.2 g every 6-8 hours,
Children up to 3 months: 30 mg/kg every 8 hours (every 12 hours in the perinatal period and in premature infants);
Child 3 months-12 years, 30 mg/kg every 6-8 hours.
Renal Dose
Renal impairment
CrCl <30 mL/min: Do not use 875/125 mg tablet or extended-release tablets
CrCl 10-30 mL/min: 250-500/125 mg PO q12hr
CrCl <10 mL/min: 250-500/125 mg PO q24hr
Hemodialysis: 250-500/125 mg PO q24hr; administer additional dose both during and at end of dialysis
Administration
Take with meals to avoid GI upset
Take suspension at start of meal to enhance absorption
Reconstitution: Powd for inj: Dissolve amoxicillin/clavulanic acid 500/100 mg in 10 mL solvent and 1,000/200 mg in 20 mL solvent. May further dilute to infusion soln containing either water for inj or NaCl 0.9%.
Contra Indications
History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to Amoxicillin + Clavulanic Acid or to other beta‑lactams (e.g.,
penicillins or cephalosporins).
History of cholestatic jaundice/hepatic dysfunction associated with Amoxicillin + Clavulanic Acid.
Precautions
Serious (including fatal) hypersensitivity reactions: Discontinue Amoxicillin + Clavulanic Acid if a reaction occurs.
Severe Cutaneous Adverse Reactions (SCAR): Monitor closely. Discontinue if rash progresses.
Drug-induced enterocolitis syndrome (DIES) has been reported with use of amoxicillin, a component of Amoxicillin + Clavulanic Acid. If this occurs, discontinue Amoxicillin + Clavulanic Acid and institute appropriate therapy.
Hepatic dysfunction and cholestatic jaundice: Discontinue if signs/symptoms of hepatitis occur. Monitor liver function tests in patients with hepatic impairment.
Clostridioides difficile-associated diarrhea (CDAD): Evaluate patients if diarrhea occurs.
Patients with mononucleosis who receive Amoxicillin + Clavulanic Acid develop skin rash.
Avoid Amoxicillin + Clavulanic Acid use in these patients.
Overgrowth: The possibility of superinfections with fungal or bacterial pathogens should be considered during therapy.
Pregnancy-Lactation
Pregnancy
Reproduction studies in animals (mice and rats at doses up to 10 times the human dose) with orally and parenterally administered drugs have shown no teratogenic effects; in a single study in women with preterm, premature rupture of the fetal membrane (pPROM), it was reported that prophylactic treatment with this drug may be associated with an increased risk of necrotizing enterocolitis in neonates; as with all medications, use should be avoided in pregnancy, unless considered essential by the physician
Lactation
Ampicillin-class antibiotics are excreted in human milk; therefore caution should be exercised when the drug is administered to a nursing mother; however, the drug may be administered during the period of lactation; with the exception of risk of sensitization, associated with excretion of trace quantities in breast milk, there are no known detrimental effects for the breastfed infant
Interactions
Co‑administration with probenecid is not recommended.
Concomitant use of Amoxicillin + Clavulanic Acid and oral anticoagulants may increase the prolongation of prothrombin time.
Co-administration with allopurinol increases the risk of rash.
Amoxicillin + Clavulanic Acid may reduce the efficacy of oral contraceptives
Contraindicated (0)
Serious - Use Alternative (2)
pexidartinib
pretomanid
Adverse Effects
Side effects of Amoxicillin + Clavulanic Acid (Clavulanate) :
>10%
Diarrhea (3-34%; varies upon dose and regimen)
1-10%
Diaper rash (3.5%),Mycosis (3.3%),Nausea (2-3%),Rash (1-3%),Vomiting (1-2.2%),Loose stool (1.6%),Candidiasis (1.4%),Vaginitis (1%)
<1%
Hypersensitivity reactions,Anaphylaxis,Anemia,Thrombocytopenia,Leukopenia,Agranulocytosis,Hepatoxicity,AST/ALT elevation,Pseudomembranous colitis,Serum sickness,Abdominal discomfort,Cholestatic jaundice,Flatulence
Potentially Fatal: Anaphylactic reaction with CV collapse esp with parenteral use.
Mechanism of Action
Clavulanic acid has a high affinity for and binds to certain beta-lactamases that generally inactivate amoxicillin by hydrolyzing its ?-lactam ring. Combining clavulanate potassium with amoxicillin extends the antibacterial spectrum of amoxicillin to include many bacteria normally resistant to amoxicillin and other penicillins and cephalosporins.
Note
Clavamox 125/31 125 mg + 31.25 mg/5 ml Powder For Suspension manufactured by G. A. Company Ltd.. Its generic name is Amoxicillin + Clavulanic Acid (Clavulanate). Clavamox 125/31 is availble in Bangladesh.
Farmaco BD drug index information on Clavamox 125/31 Powder For Suspension is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.