CALAMOX Tablet

Indications:

Calamox is indicated for the treatment of common bacterial infections where antibiotic therapy is indicated, including upper respiratory tract infections e.g., sinusitis, tonsillitis, otitis media. Lower Respiratory Tract Infections e.g. acute and chronic bronchitis, Lobar and bronchopneumonia, empyema, lung abcess. Skin and Soft tissue Infections e.g., boils, abscesses, cellulitis, wound infections, intra-abdominal sepsis. Genito-Urinary Tract infection e.g., cystitis, urethritis, pyelonephritis. Septic puerperal sepsis, pelvic infections, chancroid, gonorrhoea. Other infection e.g., osteomyelitis, septicaemia, peritonitis, post-operative infections. Calamox is also indicated for prophylaxis against cardiac, renal, biliary tract and joint replacement surgery.

Dosage and administrations:

Usual dosage for the treatment of infections

Adults and children over 12 years:

Mild-Moderate infections. One Calamox 625 mg tablet two times a day.

Severe infections: One Calamox 625 mg tablet three times a day OR One Calamox 1G tablet two times a day. Therapy can be started parenterally and continued with an oral preparation.

CHILDREN: The usual recommended daily dosage is 25 mg/kg/day in divived doses every eight hours. The table below gives the guidance for children.

Under 1 year: 25 mg/kg/day for example a 7.5 kg child would require 2 ml Calamox 156.25 mg syrup three times a day.

1-6 years (10-18 kg): 5 ml Calamox 156.25 mg suspension three a day.

Over 6 years (18-40 kg): 5 ml Calamox 312.5 mg DS suspension three times a day.

In more severe infections the dosage may be increased up to 50 mg/kg/day in divided doses every eight hours. Each 25 mg Calamox provides 20 mg amoxycillin and 5 mg Clavulanic acid.

DOSAGE IN RENAL IMPAIRMENT: In mild renal impairment (Creatinine clearance > 30 ml/min) no change in dosage is required.

In moderate renal impairment (creatinine clearence 10-30 ml/min) one 625 mg tablet 12 hourly.

Dosage in hepatic impairment.

Dose with caution: monitor hepatic function at regular intervals

Each Calamox 625 mg, 1G tablet contains 0.63 mmol (25mg) of potassium.

Calamox is contra-indicated in patients with hypersensitivity to penicillin antibiotics.

Side-effects, as with amoxycillin are uncommon and mainly of mild and transitory nature. Diarrhoea, pseudomembraneous colitis, indigestion, nausea, vomiting and candidasis have been reported. Urticaria and Erythematous rashes sometimes occur but their incidence has been particularly low in clinical trials. An urticarial rash suggest penicillin hypersensitivity and treatment should be discontinued. Erythematous rash are frequently mild and transient but may be severe when associated with infection mononucleosis. In which case treatment should be discontinued. Rare cases of erythema multiforme, Stevens-Johnson syndrome and occasional case of exfoliative dermatitis have been reported. Serious and occasionally fatal hypersensitivity reactions (anaphylactic) reaction and angioneurotic edema have been reported in patients on penicillin therapy.

Hepatitis and Cholestatic jaundice have been reported.

USE IN PREGNANCY AND LACTATION:

Animal studies have shown no teratogenic effects with the combination of antibiotics in Calamox. The product has been used in human pregnancy in a limited number of cases, with no untoward effect, however use in pregnancy is not recommended unless considered essential by the physician. As with all drugs Calamox therapy should be avoided If at all possible, specially during first trimester. During lactation, trace quantities of penicillin's can be detected in breast milk.

Change in liver function tests have been observed in some patients receiving Calamox. The clinical significance of these changes is uncertain but Calamox should be used with care in patients with evidence of severe hepatic dysfunction. In patient with moderate or severe renal impairment Calamox dosage should be adjusted as recommended.