Amro Capsules

AMRO formulations are indicated for the treatment of mild to moderately severe infections caused by susceptible organisms:

• Upper Respiratory tract infections such as sinusitis, otitis media, tonsillitis
• Lower respiratory tract infections such as bronchitis, lobar and bronchopneumonia
• Gastro-intestinal infections such as typhoid fever
• Other infections including Borreliosis (Lyme disease)
• In the following infections, amoxycillin therapy should be initiated only if there is microbiological evidence that the causative organism is sensitive to amoxicillin:
• Skin and soft tissue infections
• Urinary tract infections: cystitis, urethritis, pyelonephritis, bacteriuria in pregnancy
• u201cAs part of combination therapy in established Helicobacter pylori infection, associated with duodenal ulceration.u201d
• Prophylaxis of endocarditis

The total daily dose as below is administered in divided doses. The most common regimen is 8 hourly.

ORAL ADMINISTRATION

Treatment should be continued for 48 to 72 hours beyond the time that a clinical response has been obtained. It is recommended that at least 10 days treatment be given for any infection caused by beta-haemolytic streptococci to prevent the occurrence of acute rheumatic fever or glomerulonephritis.

The absorption of AMRO is not affected significantly when taken with food.

Adults and children over 40 kg

• Total daily dosage of 750 mg to 3 g administered in divided doses
• Maximum recommended dose: 6 g/day in divided doses
• Respiratory tract infections: 500 mg administered 8 hourly.
• Lyme disease: 4 g/day in isolated erythema chronicum migrans and 6 g/day in the case of generalised manifestations, both for a minimum of 12 days
• Gonorrhoea: 3 g with 1 g probenecid
• Eradication of Helicobacter pylori: 750 mg-1 g in combination treatment given 12 hourly for the eradication of established H pylori infection associated with duodenal ulceration for seven days.

Children under 40 kg:

• 20 - 50 mg/kg/day in divided doses
• Maximum recommended dose: 150 mg/kg/day in divided doses
• Lyme disease: 25 - 50 mg/kg/day in isolated erythema chronicum migrans and 100 mg/kg/day in the case of generalised manifestations, both for a minimum of 12 days

Elderly

No adjustment needed: as for adults unless there is evidence of severe renal impairment (see below)

Renal impairment

• Glomerular filtration rate >30 mI/min: No adjustment needed
• Glomerular filtration rate 10-30 ml/min: Maximum 500 mg 12 hourly
• Glomerular filtration rate <10 mI/mm: Maximum 500 mg daily.
• In patients receiving peritoneal dialysis: Maximum 500 mg daily

PROPHYLAXIS OF ENDOCARDITIS

Prophylaxis with alternative antibiotics should be considered if the patient has received penicillin within the previous month or is allergic to penicillin.

For dental, oral or upper respiratory tract procedures:

• Prophylaxis for patients undergoing dental extraction, scaling or surgery involving gingival tissues, tonsillectomy, adenoidectomy, bronchoscopy with a rigid bronchoscope and surgical procedures that involve respiratory mucosa.

For patients NOT having a general anaesthetic:

• Adults: 2 g orally, 1 hour before the procedure
• Children: 50 mg/kg, 1 hour before the procedure
• Childrenu2019s dose not to exceed the adult dose

Hypersensitivity to penicillins or to cephalosporin. Cross-sensitivity between penicillins and cephalosporin is well documented.

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. Before initiating therapy with AMRO, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity, who have experienced severe reactions when treated with cephalosporin. If an allergic reaction occurs, AMRO should be discontinued and the appropriate therapy instituted. Serious anaphylactic reactions may require immediate emergency treatment with adrenaline. Oxygen, intravenous steroids and airway management, including intubation may also be required.

AMRO should be avoided if infectious mononucleosis is suspected since the occurrence of a morbilliform rash has been associated with this condition following the use of amoxycillin. Prolonged use may result in overgrowth of non-susceptible organisms. Pseudomembranous enterocolitis has been reported. Prolongation of prothrombin time has been reported rarely in patients receiving AMRO. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently. Periodic assessment of organ function, including renal, hepatic and haematopoietic functions, is advisable during prolonged therapy. Transient hepatitis and cholestatic jaundice has been reported. AMRO should be used with caution in patients with evidence of hepatic dysfunction.

Probenecid decreases the renal tubular secretion of AMRO. Concurrent use with AMRO may result in increased and prolonged blood concentrations of AMRO. AMRO may reduce the efficacy of oral contraceptives and patients should be warned accordingly.

The concomitant administration of allopurinol and ampicillin substantially increases the incidence of skin rashes in patients receiving both agents as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricaemia present in these patients. Tetracyclines and other bacteriostatic drugs may interfere with the bactericidal effects of AMRO.

Interaction with Laboratory tests: It is recommended that when testing for the presence of glucose in urine during AMRO treatment, enzymatic glucose oxidase methods should be used. Due to the high urinary concentrations of AMRO, false positive readings are common with chemical methods.

Use in pregnancy: The safety of AMRO in pregnancy has not been established.

Use in lactation: AMRO is distributed into breast milk. Although significant problems in humans have not been documented, the use of AMRO by nursing mothers may lead to sensitisation, diarrhoea, candidiasis and skin rash in the infant.

Side effects

Gastrointestinal disorders:

• Frequent: Diarrhoea, nausea, vomiting, indigestion, abdominal pain, abnormal taste.
• Frequency unknown: Gastritis, stomatitis, glossitis, black u2018hairyu2019 tongue, enterocolitis, mucocutaneous candidiasis and antibiotic-associated colitis (including pseudomembranous colitis and haemorrhagic colitis). If gastro-intestinal reactions are evident, they may be reduced by taking AMRO at the start of a meal. Superficial tooth discolouration has been reported especially with the suspension and chewable tablet formulations. It can usually be removed by brushing.

Skin and subcutaneous tissue disorders:

• Frequent: Skin rashes, urticaria and erythema multiforme, pruritus, serum sickness-like syndrome.
• Less frequent: Stevens-Johnson syndrome, hypersensitivity vasculitis and bullous exfoliative dermatitis and toxic epidermal necrolysis. Whenever such reactions occur, AMRO should be discontinued.

Serious and occasional fatal hypersensitivity (anaphylactic) reactions and angioneurotic oedema can occur with oral penicillin (see Warnings).

Nervous system disorders:

• Frequent: Headache, dizziness.
• Less frequent: Reversible hyperactivity and convulsions. Convulsions may occur with impaired renal function or in those receiving high doses.

Reproductive system and breast disorders:

• Frequent: Vaginitis

Endocrine disorders:

• Frequent: Tiredness and hot flushes.

Renal and urinary disorders:

• Less frequent: Interstitial nephritis, crystalluria.

Hepato-biliary disorders:

• Less frequent: Hepatitis and cholestatic jaundice have been reported. The events may be severe, and occur predominantly in adult or elderly patients. Signs and symptoms usually occur during or shortly after treatment, but in some cases may not become apparent until several weeks after treatment has ceased. The hepatic effects are usually reversible. However, in extremely rare circumstances, death has been reported. These have almost always been cases associated with serious underlying disease or concomitant medication.

Investigations:

• Frequency unknown: A moderate raise in Aspartate transaminase (AST) and/or Alanine transaminase (ALT) has been noted in patients treated with AMRO, but the significance of these findings is unknown.

Blood and the lymphatic system disorders:

• Frequency unknown: Haemolytic anaemia, reversible thrombocytopenia, thrombocytopenic purpura, eosinophilia, reversible leucopenia and agranulocytosis have been reported. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.
• Less frequent: A slight thrombocytosis was noted in less than 1% of the patients treated with AMRO. Prolongation of bleeding time and prothrombin time have also been reported less frequently. Appropriate monitoring should be undertaken when anticoagulants are prescribed concomitantly.

Overdosage with AMRO is usually asymptomatic. However, gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and symptoms of water and electrolyte imbalance should be treated symptomatically. Adequate fluid intake and urinary output must be maintained to minimize the possibility of crystalluria. AMRO may be removed from the circulation by haemodialysis.