Camoxtin/Camoxtin ES

Dry powder: Off-white to light yellow powder.
Reconstituted suspension: Off-white to light yellow suspension with pineapple odor.
Camoxtin: Each 5 ml contains Amoxicillin trihydrate eq. to Amoxicillin 400 mg, Clavulanate potassium eq. to Clavulanic acid 57 mg.
Camoxtin ES: Each 5 ml contains Amoxicillin trihydrate eq. to Amoxicillin 600 mg, Clavulanate potassium eq. to Clavulanic acid 42.9 mg.

Pharmacology: Pharmacodynamics: CAMOXTIN contains amoxicillin trihydrate which is broad-spectrum antibiotic, and clavulanic acid which inhibits beta-lactamase from gram positive and gram negative bacteria and enhances broad-spectrum bactericidal of amoxicillin. CAMOXTIN is active in vitro against organisms susceptible to amoxicillin including many beta-lactamase-producing organisms that are resistant to amoxicillin as follows.
Gram positive: Aerobes: Staphylococcus aureus, S. epidermidis, Streptococcus pneumoniae, Enterococcus faecalis (formerly Streptococcus faecalis), Streptococcus viridans, Streptococcus pyogenes, Listeria monocytogenes.
Anaerobes: Clostridium sp., Peptococcus sp., Peptostreptococcus sp.
Gram negative: Aerobes: Neisseria meningitidis, Neisseria gonorrhoeae, Haemophillus influenzae, H. parainfluenzae, H. ducreyi, Moraxella catarrhalis (formerly Branhamella catarrhalis), Escherichia coli, Proteus mirabilis, Salmonella sp., Shigella sp., Citrobacter diversus, K. pneumoniae, P. mirabilis, Proteus vulgaris, Enterobacter sp., Klebsiella sp., Bordetella pertussis, Pasteurella multocida.
Anaerobes: L. pneumophila, L. micdadei, L. bozemanii, Prevotella melaninogenica (formerly Bacteroides melaninogenicus), P. oralis (formerly B. oralis) including Bacteroides fragilis group.
Mycobacterium: Mycobacterium tuberculosis, M. fortuitum.
Pharmacokinetics: Absorption: Amoxicillin trihydrate and clavulanate potassium are both generally stable in the presence of acidic gastric secretions and are well absorbed following oral administration of amoxicillin and clavulanate potassium. Peak serum concentrations of amoxicillin and of clavulanate are generally attained within 1-2.5 hours following oral administration.
Distribution: Amoxicillin and clavulanic acid are both distributed into the lungs, pleural fluid, and peritoneal fluid.
Low concentrations of each drug are attained in sputum, saliva, cerebrospinal fluid (CSF). Amoxicillin and clavulanic acid readily cross the placenta, and are distributed into milk in low concentration.
Elimination: This medicine is excreted unchanged in urine within 6-8 hours. Amoxicillin has an elimination half-life of 1-1.3 hours and clavulanic acid has an elimination half-life of 0.78-1.2 hours.

CAMOXTIN/CAMOXTIN ES, for twice daily oral dosing, is indicated for short term treatment of bacterial infections at the following sites when amoxicillin resistant beta-lactamase producing strains are suspected as the cause. In other situations, amoxicillin alone should be considered.
Upper respiratory tract infections (including ENT) e.g. recurrent tonsillitis, sinusitis, otitis media.
Lower respiratory tract infections e.g. acute exacerbations of chronic bronchitis, lobar and bronchopneumonia.
Urinary tract infections e.g. cystitis, urethritis, pyelonephritis.
Skin and soft tissue infections e.g. cellulitis, animal bites.
Camoxtin: Dental infections e.g. severe dental abscess with spreading cellulitis. Mixed infections caused by amoxicillin-susceptible organisms in conjunction with this medicine susceptible beta-lactamase producing organisms may be treated with CAMOXTIN. These infections should not require the addition of another antibiotic resistant to beta-lactamases.

Recommended Dose: Camoxtin: The usual recommended daily dosage is: 25/3.6 mg/kg/day in mild to moderate infections (upper respiratory tract infections e.g. recurrent tonsillitis, lower respiratory infections and skin and soft tissue infections).
45/6.4 mg/kg/day for the treatment of more serious infections (upper respiratory tract infections e.g. otitis media and sinusitis, lower respiratory tract infections e.g. bronchopneumonia and urinary tract infections).
The tables as follows give guidance for children. (See Table 1.)

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Children aged 2 months to 2 years: Children under 2 years should be dosed according to body weight. (See Table 2.)

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There is insufficient experience for dosage recommendations for children under 2 months old.
Camoxtin ES: Pediatric patients 3 months and older: The recommended dose for CAMOXTIN ES is 90/6.4 mg/kg/day in 2 divided doses at 12-hour intervals for 10 days. (See Table 3.)

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There is no experience in pediatric patients weighing >40 kg, or in adults.
There are no clinical data in children under 3 months of age.
CAMOXTIN ES does not contain the same amount of clavulanate as any of other CAMOXTIN suspension. Therefore, CAMOXTIN 457 should not be substituted for CAMOXTIN ES, as they are not interchangeable.
Renal impairment: Camoxtin: For children with GFR of >30 ml/min no adjustment in dosage is required.
Not recommended in children with GFR of <30 ml/min.
Camoxtin ES: Not recommended in children with renal impairment.
Infants with immature kidney function: Camoxtin: Not recommended in infants with immature kidney function.
Hepatic impairment: Use with caution. Use contraindicated in patients with a history of amoxicillin and clavulanic acid associated hepatic dysfunction.
Mode of Administration: Oral administration.
Administer at the start of meal to minimize potential gastrointestinal intolerance. The absorption is optimized when taken at the start of a meal.
Duration of the therapy should be appropriate to the indication and should not exceed 14 days without review.
Therapy can be started parenterally and continued with an oral preparation.
Instructions for Use/Handling: At time of dispensing, the dry powder should be reconstituted to form an oral suspension, as detailed as follows.
Check cap seal if intact before use.
Invert and shake bottle to loosen powder.
Fill the bottle with water to just below the mark on bottle label. Close the cap, invert and shake well, then top up with water to the mark. Close the cap, invert and shake again.
Allow to stand for 5 minutes to ensure full dispersion.
Shake well before taking each dose.

Overdose and Treatment: Gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident. Gastrointestinal symptoms may be treated symptomatically with attention to the water/electrolyte balance. Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see Warnings and Precautions). This medicine can be removed from the circulation by haemodialysis.

Contraindicated in patients with a history of hypersensitivity to beta-lactams, e.g. penicillins and cephalosporins.
Contraindicated in patients with a previous history of amoxicillin/clavulanic acid associated jaundice/hepatic dysfunction.

Thai FDA mandatory warning: Do not use in patients with known hypersensitivity to this medicine.
This medicine may cause a serious hypersensitivity reaction which can be fatal.
If erythema rash, irritation or edema occurs, discontinue this medicine and consult a physician.
In case of rash or flu-like symptoms, discontinue this medicine and promptly consult a physician.
In case the following symptoms occur e.g. fever, rash, vesicles, exfoliation of skin and other mucous membrane such as in the mouth, throat, nose, reproductive organ and conjunctivitis, discontinue this medicine and consult a physician since this may be Stevens-Johnson syndrome.

Before initiating therapy with this medicine, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens.
Avoid this medicine if infectious mononucleosis is suspected since the occurrence of a morbilliform rash has been associated with this condition following the use of amoxicillin.
Prolonged use may also occasionally result in overgrowth of non-susceptible organisms.
Pseudomembranous colitis has been reported with the use of antibiotics and may range in severity form mild to life-threatening. Therefore, it is important to consider its diagnosis in patients who develop diarrhea during or after antibiotic use. If prolonged or significant diarrhea occurs or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient investigated further.
Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently and adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation. Abnormal prolongation of prothrombin time has been reported rarely in patients receiving this medicine and oral anticoagulants.
Should be used with caution in patients with evidence of hepatic dysfunction. Changes in liver function tests have been observed in some patients receiving this medicine.
Cholestatic jaundice, which may be severe, but is usually reversible, has been reported rarely. Signs and symptoms may not become apparent for up to six weeks after treatment has ceased.
Not recommended in patients with renal impairment.
In patients with reduced urine output, crystalluria has been observed very rarely, predominantly with parenteral therapy. During the administration of high doses of amoxicillin, it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxicillin crystalluria.
This product contains aspartame, therefore care should be taken in patients with phenylketonuria.

Pregnancy: Reproduction studies in animals (mice and rats) with oral and parenteral administrations have shown no teratogenic effects. Premature rupture of the foetal membrane (pPROM) was reported that prophylactic treatment with amoxicillin plus clavulanic acid may be associated with an increased risk of necrotizing enterocolitis in neonates. Avoid using in pregnancy, (especially during the first trimester - for Camoxtin), unless considered essential by the physician.
Lactation: This medicine may be administered during the period of lactation. With the exception of the risk of sensitization, associated with the excretion of trace quantities in the breast milk, there are no detrimental effects for the infant.

Dermatologic: Diaper rash, skin rash, urticaria.
Gastrointestinal: Abdominal distress, diarrhea, loose stool, nausea, vomiting.
Genitourinary: Vaginitis.
Infection: Candidiasis, vaginal rnycosis.
Rare but important or life-threatening: Cholestatic jaundice, flatulence, headache, hepatic insufficiency, hepatitis. Increased liver enzymes, increased serum alkaline phosphatase, prolonged prothrombin time, thrombocythemia, vasculitis (hypersensitivity).

Concomitant use with probenecid is not recommended. Probenecid decreases the renal tubular secretion of amoxicillin, concomitant using may result in increased and prolonged blood levels of amoxicillin but not clavulanic acid.
Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions.
This medicine may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.
There are rare cases of increased international normalised ratio in patients maintained on acenocoumarol or warfarin and prescribed a course of amoxicillin. If co-administration is necessary, the prothrombin time or international normalised ratio should be carefully monitored with addition or withdrawal of this medicine.
In patients receiving mycophenolate mofetil, reduction in pre-dose concentration of the active metabolite mycophenolic acid of approximately 50% has been reported following commencement of oral administration of this medicine. The change in pre-dose level may not accurately represent changes in overall mycophenolic acid exposure.

Keep in tight containers and store in a dry place below 30°C.
Once reconstituted, store in a refrigerator and use within 7 days for Camoxtin and 10 days for Camoxtin ES.

Penicillins

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

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