Amro 250 mg/500 mg Capsules

AMRO are used 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 amoxycillin: Skin and soft tissue infections, Urinary tract infections: cystitis, urethritis, pyelonephritis, bacteriuria in pregnancy
• “As part of combination therapy in established Helicobacter pylori infection, associated with duodenal ulceration.”
• Prophylaxis of endocarditis

Do not take AMRO:

• If you are hypersensitive (allergic) to penicillins or to cephalosporins, or any of the other ingredients of AMRO. Cross-sensitivity between penicillins and cephalosporins is well documented.

Take special care with AMRO:

• Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. Before initiating therapy with AMRO, carefully 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 cephalosporins.
• If an allergic reaction occurs, AMRO should be discontinued and the appropriate therapy instituted. Serious anaphylactic reactions may require immediate emergency treatment.
• 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 AURO-AMOXYCILLIN CAPSULES. Appropriate monitoring should be undertaken when anticoagulants are used concurrently.
• Periodic assessment of organ function, including renal (kidney), hepatic (liver) and haematopoietic functions (blood), is advisable during prolonged therapy.
• Transient hepatitis and cholestatic jaundice has been reported. AMRO should be used with caution in patients with evidence of liver dysfunction.
• When high doses are administered, adequate fluid intake and urinary output must be maintained.
• AMRO should be given with caution to patients with lymphatic leukaemia since they are especially susceptible to amoxycillin induced skin rashes.
• Impaired liver function: Changes in liver function tests have been observed in some patients receiving AMRO. It should be used with care in patients with evidence of severe liver dysfunction.
• Impaired kidney function: In patients with moderate or severe kidney impairment AMRO dosage should be adjusted. Please consult your doctor, pharmacist or other healthcare professional, for advice.

Pregnancy and Breast-feeding:

• Use in pregnancy: The safety of AMRO in pregnancy has not been established.
• Use in lactation: AMRO is distributed into breast milk. The use of AMRO by nursing mothers may lead to sensitisation, diarrhoea, candidiasis and skin rash in the infant. If you are pregnant or breast feeding your baby while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice.

Taking other medicines with AMRO:

• AMRO interacts with probenecid, allopurinol, ampicillin and Tetracyclines. AMRO may reduce the efficacy of oral contraceptives and patients should be warned accordingly.
• If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of AMRO with these medicines may cause undesirable interactions. Please consult your doctor, pharmacist or other healthcare professional, for advice.

Always take AMRO exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. If you have the impression that the effect of AMRO is too strong or too weak, talk to your doctor or pharmacist.

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. AMRO may be taken with or without food.

Adults and children over 40 kg

Total daily dosage if 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/mm: No adjustment needed. Glomerular filtration rate 10 — 30 m/min: Maximum 500 mg 12 hourly. Glomerular filtration rate <110 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 a 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 procedure 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. Children’s dose not to exceed the adults dose.

If you take more AMRO than you should:

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 minimise the possibility of crystalluria. AMRO may be removed from the circulation by haemodialysis. In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control center. If you forget to take AMRO: Do not take a double dose to make up for forgotten individual doses.

AMRO can have side effects.

Gastrointestinal disorders:

Frequent: Diarrhoea, nausea, vomiting, indigestion, abdominal pain, abnormal taste. Frequency unknown: Gastritis, stomatitis, glossitis, black ‘hairy’ tongue, enterocolitis, mucocutaneous candidiasis and antibiotic-associated colitis (including pseudmembranous 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 has 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. Not all side effects reported for this medicine are included in this leaflet. Should your general health worsen while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice.

Keep all medicines out of the reach and sight of children. Store in a cool, dry place below 25 °C. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).