Cledomox Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Indications/Uses Dosage/Direction for Use Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Per 375 mg FC tab Amoxicillin 250 mg, clavulanic acid 125 mg. Per 625 mg FC tab Amoxicillin 500 mg, clavulanic acid 125 mg. Per 1,000 mg FC tab Amoxicillin 875 mg, clavulanic acid 125 mg. Per 5 mL powd for oral susp Amoxicillin 125 mg, clavulanic acid 31.25 mg

Indications/Uses

Lower resp tract infections, otitis media, & sinusitis caused by β-lactamase-producing strains of H. influenzae & M. catarrhalis. Skin & skin structure infections caused by β-lactamase-producing strains of S. aureus, E. coli, & Klebsiella spp. UTIs caused by β-lactamase-producing strains of E. coli, Klebsiella spp, & Enterobacter spp.

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Dosage/Direction for Use

Recommended duration of therapy: 14 days (10 days for acute otitis media). FC tab Adult, & childn weighing ≥40 kg 375 mg every 8 hr or 625 mg every 12 hr. More severe infection & resp tract infection 625 mg every 8 hr or 1,000 mg every 12 hr. Patient w/ GFR 10-30 mL/min 375 mg or 625 mg every 12 hr depending on severity of infection, <10 mL/min 375 mg or 625 mg every 24 hr depending on severity of infection. Hemodialysis patient 375 mg or 625 mg every 24 hr, & additional dose during & at the end of dialysis. Powd for oral susp Patient ≥3 mth Otitis media, sinusitis, lower resp tract infection, & more severe infection 40 mg/kg/day based on amoxicillin component (divided every 8 hr). Less severe infection 20 mg/kg/day based on amoxicillin component (divided every 8 hr). Neonate & infant <3 mth 30 mg/kg/day based on amoxicillin component (divided every 12 hr).

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Administration

May be taken with or without food: May be given w/o regard to meals. Best taken at the start of meals for better absorption & to reduce GI discomfort.

Contraindications

History of allergic reactions to any penicillin. Previous history of cholestatic jaundice or hepatic dysfunction associated w/ Cledomox.

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Special Precautions

Discontinue treatment if any allergic reactions occur after administration. Patients w/ lymphatic leukaemia are susceptible to amoxicillin-induced skin rashes. Reports of pseudomembranous colitis. Change in LFTs. Onset of signs & symptoms of hepatic dysfunction may occur during or several wk after treatment discontinuation. Increased risk of neonatal necrotising enterocolitis if administered during pregnancy. Caution when administering to a nursing mother.

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Use In Pregnancy & Lactation

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Adverse Reactions

GI disorders (including diarrhea, nausea, vomiting), hepatitis & cholestatic jaundice, skin & SC tissue disorders, erythema multiforme, SJS, TEN, exfoliative dermatitis, tooth discoloration.

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Storage

View Cledomox storage conditions for details to ensure optimal shelf-life.

Description

View Cledomox description for details of the chemical structure and excipients (inactive components).

MIMS Class

Penicillins

ATC Classification

J01CR02 - amoxicillin and beta-lactamase inhibitor ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.

Regulatory Classification

Presentation/Packing

Form

Cledomox FC tab 1,000 mg

Packing/Price

10 × 10's

Form

Cledomox FC tab 375 mg

Packing/Price

10 × 10's

Form

Cledomox FC tab 625 mg

Packing/Price

10 × 10's

Form

Cledomox powd for oral susp 156.25 mg/5 mL

Packing/Price

((60 mL)) 1's

Cledomox

amoxicillin + clavulanic acid

Manufacturer:

Medopharm

Distributor:

Controlled Medications