Camoxtin/Camoxtin ES Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Warnings Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing Local Product Insert

Concise Prescribing Info

Contents

Co-amoxiclav (amoxicillin & clavulanic acid). Per Camoxtin 457 mg/5 mL susp Amoxicillin 400 mg, clavulanic acid 57 mg. Per Camoxtin ES 642.9 mg/5 mL susp Amoxicillin 600 mg, clavulanic acid 42.9 mg

Indications/Uses

Short term treatment of bacterial infections eg, URTI including ENT (eg, recurrent tonsillitis, sinusitis, otitis media), lower resp tract infections (eg, acute exacerbations of chronic bronchitis, lobar & bronchopneumonia), UTI (eg, cystitis, urethritis, pyelonephritis), skin & soft tissue infections (eg, cellulitis, animal bites). Camoxtin Dental infections eg, severe dental abscess w/ spreading cellulitis. Mixed infections caused by amoxicillin-susceptible organisms.

Click to view Camoxtin/Camoxtin ES detailed prescribing information

Dosage/Direction for Use

Camoxtin Mild to moderate infections [URTI (eg, recurrent tonsillitis), lower resp infections, skin & soft tissue infections] 25/3.6 mg/kg daily. Childn 7-12 yr weighing 22-40 kg 5 mL bid, 2-6 yr weighing 13-21 kg 2.5 mL bid, 2 mth to 2 yr weighing 15 kg 2.3 mL bid, 14 kg 2.2 mL bid, 13 kg 2 mL bid, 12 kg 1.9 mL bid, 11 kg 1.7 mL bid, 10 kg 1.6 mL bid, 9 kg 1.4 mL bid, 8 kg 1.3 mL bid, 7 kg 1.1 mL bid, 6 kg 0.9 mL bid, 5 kg 0.8 mL bid, 4 kg 0.6 mL bid, 3 kg 0.5 mL bid, 2 kg 0.3 mL bid. More serious infections [URTI (eg, otitis media & sinusitis), lower resp tract infections (eg, bronchopneumonia) & UTI] 45/6.4 mg/kg daily. Childn 7-12 yr weighing 22-40 kg 10 mL bid, 2-6 yr weighing 13-21 kg 5 mL bid, 2 mth to 2 yr weighing 15 kg 4.2 mL bid, 14 kg 3.9 mL bid, 13 kg 3.7 mL bid, 12 kg 3.4 mL bid, 11 kg 3.1 mL bid, 10 kg 2.8 mL bid, 9 kg 2.5 mL bid, 8 kg 2.3 mL bid, 7 kg 2 mL bid, 6 kg 1.7 mL bid, 5 kg 1.4 mL bid, 4 kg 1.1 mL bid, 3 kg 0.8 mL bid, 2 kg 0.6 mL bid. Max duration: 14 days. Camoxtin ES Ped patient ≥3 yr 90/6.4 mg/kg daily in 2 divided doses at 12 hr intervals for 10 days, weighing 36 kg 13.5 mL bid, 32 kg 12 mL bid, 28 kg 10.5 mL bid, 24 kg 9 mL bid, 20 kg 7.5 mL bid, 16 kg 6 mL bid, 12 kg 4.5 mL bid, 8 kg 3 mL bid. Max duration: 14 days.

Click to view Camoxtin/Camoxtin ES detailed prescribing information

Overdosage

View Camoxtin/Camoxtin ES overdosage for action to be taken in the event of an overdose.

Administration

Should be taken with food: Take at the start of meal to minimize potential GI intolerance. Shake well before use.

Contraindications

History of hypersensitivity to β-lactams eg, penicillins & cephalosporins; co-amoxiclav-associated jaundice/hepatic dysfunction.

Click to view Camoxtin/Camoxtin ES detailed prescribing information

Warnings

For additional cautionary notes to warn of the potential risk of using the medicine... Click to view Camoxtin/Camoxtin ES detailed prescribing information

Special Precautions

Not to be used in patients w/ hypersensitivity. Hypersensitivity reactions. Discontinue treatment if erythema rash, irritation or edema; rash or flu-like symptoms; SJS; prolonged or significant diarrhea or abdominal cramps occur. Avoid use in suspected infectious mononucleosis. Overgrowth of non-susceptible organisms w/ prolonged use. Pseudomembranous colitis; cholestatic jaundice. Abnormal prolongation of prothrombin time in concomitant use w/ anticoagulants. Changes in LFTs. Crystalluria in patients w/ reduced urine output. Patients who develop diarrhea during or after antibiotic use; w/ phenylketonuria. Maintain adequate fluid intake & urinary output during high-dose therapy. Hepatic dysfunction. Not recommended in renal impairment. Avoid use during pregnancy especially during 1st trimester. Increased risk of necrotizing enterocolitis in neonates. Camoxtin Not recommended in infants w/ immature kidney function; childn <2 mth; w/ GFR <30 mL/min. Camoxtin ES Ped patients weighing >40 kg. Childn <3 mth. Adults.

Click to view Camoxtin/Camoxtin ES detailed prescribing information

Use In Pregnancy & Lactation

Click to view Camoxtin/Camoxtin ES detailed prescribing information

Adverse Reactions

Diaper & skin rash, urticaria; abdominal distress, diarrhea, loose stool, nausea, vomiting; vaginitis; candidiasis, vag mycosis.

Click to view Camoxtin/Camoxtin ES detailed prescribing information

Drug Interactions

Lower oestrogen reabsorption. Reduced efficacy of combined OC. Reduced pre-dose conc of mycophenolate mofetil active metabolite mycophenolic acid. Amoxicillin: Decreased renal tubular secretion w/ probenecid. Increased allergic reactions w/ allopurinol. Increased INR w/ acenocoumarol or warfarin.

Click to view Camoxtin/Camoxtin ES detailed prescribing information

Storage

View Camoxtin/Camoxtin ES storage conditions for details to ensure optimal shelf-life.

Description

View Camoxtin/Camoxtin ES description for details of the chemical structure and excipients (inactive components).

Action

View Camoxtin/Camoxtin ES mechanism of action for pharmacodynamics and pharmacokinetics details.

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.

Thai FDA Category

Presentation/Packing

Form

Camoxtin ES powd for oral susp 642.9 mg/5 mL

Packing/Price

70 mL x 1's

Form

Camoxtin powd for oral susp 457 mg/5 mL

Packing/Price

70 mL x 1's

Camoxtin/Camoxtin ES

amoxicillin + clavulanic acid

Manufacturer:

MacroPhar

Distributor:

MacroPhar Lab

Marketer:

MacroPhar Lab