Indo Amoxycillin 250 mg/500 mg Capsules

INDO AMOXYCILLIN formulation is 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 tract infections such as typhoid fever.
• Other infections including Borreliosis (Lyme disease).
• In the following infections, amoxicillin 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 ulcerationu201d.
• Prophylaxis of endocarditis.
• Gonorrhoea

Posology

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

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 u2013 1 g in combination treatment given 12 hourly for the eradication of established H pylori infection associated with duodenal ulceration for 7 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 ml/min: No adjustment needed. Glomerular filtration rate 10-30 ml/min: Maximum 500 mg every 12 hours. Glomerular filtration rate < 10 ml/min: 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.

Method of administration

For oral use. The absorption of INDO AMOXYCILLIN is not affected significantly when taken with food. INDO AMOXYCILLIN may, therefore, be taken with meals.

• Hypersensitivity to penicillins or to cephalosporins or to any of the excipients listed in see section 6.1.
• Amoxicillin as contained in INDO AMOXYCILLIN is penicillin and should not be given to patients with a history of hypersensitivity to u03b2-lactam antibiotics (e.g. carbapenem or monobactam). Potential cross allergy to other beta-lactams such as cephalosporins should be taken into account.

Hypersensitivity reactions:

• Serious and occasional fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy.
• Hypersensitivity reactions can also progress to Kounis syndrome, a serious allergic reaction that can result in myocardial infarction (see section 4.8).
• Before initiating therapy with INDO AMOXYCILLIN, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens (see sections 4.3). 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, INDO AMOXYCILLIN 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.
• Drug-induced enterocolitis syndrome (DIES) has been reported mainly in children receiving amoxicillin/clavulanate (see section 4.8). DIES is an allergic reaction with the leading symptom of protracted vomiting (1-4 hours after intake of amoxicillin) in the absence of allergic skin or respiratory symptoms. Further symptoms could comprise abdominal pain, diarrhoea, hypotension or leucocytosis with neutrophilia. There have been severe cases including progression to shock.

Non-susceptible microorganisms:

• The use of INDO AMOXYCILLIN may lead to the selection of resistant strains of organisms and sensitivity testing should, therefore, be carried out whenever possible, to demonstrate the appropriateness of therapy.
• INDO AMOXYCILLIN is not suitable for the treatment of some types of infection unless the pathogen is already documented and known to be susceptible or there is a very high likelihood that the pathogen would be suitable for treatment with INDO AMOXYCILLIN. This particularly applies when considering the treatment of patients with urinary tract infections and severe infections of the ear, nose and throat.
• Since INDO AMOXYCILLIN contains amoxycillin, an aminopenicillin, it is not the treatment of choice in patients presenting with sore throat or pharyngitis because of the possibility that the underlying cause in infectious mononucleosis, in the presence of which there is a high incidence of rash if amoxycillin is used (see sub-header u2018Skin reactionsu2019).
• There is insufficient evidence at present to show that INDO AMOXYCILLIN penetrates into the cerebrospinal fluid in therapeutic quantities and it should, therefore, not be used in the treatment of cerebrospinal infections.

Convulsions:

Convulsions may occur in patients with impaired renal function or in those receiving high doses or in patients with predisposing factors (e.g. history of seizures, treated epilepsy or meningeal disorders (see section 4.8).

Impaired renal function:

In patients with moderate or severe renal impairment, INDO AMOXYCILLIN dosage should be adjusted (see section 4.2).

Skin reactions:

INDO AMOXYCILLIN 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 amoxicillin. The occurrence at the treatment initiation of a feverish generalised erythema associated with pustula may be a symptom of acute generalised exanthemous pustulosis (AEGP). This reaction requires INDO AMOXYCILLIN discontinuation and contraindicates any subsequent administration.

Lymphatic leukaemia:

INDO AMOXYCILLIN should be given with caution to patients with lymphatic leukaemia since they are especially susceptible to amoxycillin induced skin rashes.

Jarisch-Herxheimer reaction:

Caution is needed when administering amoxicillin to patients with syphilis, as the Jarisch-Herxheimer reaction may occur in these patients. The Jarisch-Herxheimer reaction has been reported following amoxicillin treatment of Lyme disease (see section 4.8). It results directly from the bactericidal activity of amoxicillin on the causative bacteria of Lyme disease, the spirochaete Borrelia burgdorferi. Patients should be reassured that this is a common and usually self-limiting consequence of antibiotic treatment of Lyme disease.

Overgrowth of non-susceptible microorganisms:

• Prolonged use may result in overgrowth of non-susceptible organisms.
• Antibiotic associated Pseudomembranous enterocolitis has been reported. The severity of the colitis may range from mild to life threatening. It is important to consider this diagnosis in patients who develop diarrhoea or colitis in association with INDO AMOXYCILLIN use (this may occur up to several weeks after cessation of INDO AMOXYCILLIN therapy). If prolonged or significant diarrhoea occurs or the patient experiences abdominal cramps, treatment with INDO AMOXYCILLIN should be discontinued immediately.
• Anti-peristaltic medicines are contraindicated in this situation.

Anticoagulants:

Prolongation of prothrombin time has been reported rarely in patients receiving INDO AMOXYCILLIN. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently.

Prolonged therapy:

Periodic assessment of organ function, including renal, hepatic and haematopoietic functions, is advisable during prolonged therapy.

• The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, the agent should be discontinued and/or appropriate therapy instituted.
• Allopurinol: INDO AMOXYCILLIN should preferably not be used in patients treated with allopurinol since they are especially susceptible to ampicillin-induced skin rashes (see section 4.5).

Due to amoxicillinu2019s effect on intestinal flora, the absorption of other medicines may be affected.

• Probenecid: Probenecid decreases the renal tubular secretion of INDO AMOXYCILLIN. Concurrent use with INDO AMOXYCILLIN may result in increased and prolonged blood concentrations of INDO AMOXYCILLIN.
• Oral hormonal contraceptives: INDO AMOXYCILLIN may reduce the efficacy of oral contraceptives and patients should be warned accordingly.
• Allopurinol: 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 (see section 4.4). It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricaemia present in these patients.
• Digoxin: The absorption of concurrently administered digoxin may be increased during treatment with INDO AMOXYCILLIN.
• Anticoagulants: Concomitant administration of INDO AMOXYCILLIN and anticoagulants e.g. coumarin may prolong the bleeding time. A dose adjustment of anticoagulants may be necessary (see section 4.4). If coadministration is necessary, the prothrombin time or internationally normalised ratio should be carefully monitored with the addition or withdrawal of INDO AMOXYCILLIN.
• Tetracyclines: Tetracyclines and other bacteriostatic medicines may interfere with the bactericidal effects of INDO AMOXYCILLIN.
• Methotrexate: Interaction between INDO AMOXYCILLIN and methotrexate leading to methotrexate toxicity has been reported. Serum methotrexate levels should be closely monitored in patients who receive INDO AMOXYCILLIN and methotrexate simultaneously (see section 4.4). INDO AMOXYCILLIN decreases the renal clearance of methotrexate, probably by competition at the common tubular secretion system.
• Other forms of interactions: Forced diuresis leads to a reduction in blood concentrations by increased elimination of INDO AMOXYCILLIN. INDO AMOXYCILLIN may interfere with protein testing when colorimetric methods are used.

Women of childbearing potential/ Contraception in males and females: INDO AMOXYCILLIN may reduce the efficacy of oral contraceptives and patients should be warned accordingly (see section 4.5).

Pregnancy: The safety of INDO AMOXYCILLIN in pregnancy has not been established.

Breastfeeding: INDO AMOXYCILLIN is distributed into breast milk and should be used with caution when administered to lactating women. Although significant problems in humans have not been documented, the use of INDO AMOXYCILLIN by lactating women may lead to sensitisation, diarrhoea, candidiasis and skin rash in the infant.

INDO AMOXYCILLIN may cause allergic reactions, dizziness or convulsions and may thus have an effect on mental and/or physical abilities to perform or execute tasks or activities requiring mental alertness, judgment and/or sound coordination and vision (see section 4.8).

Summary of the safety profile: The most frequently reported adverse side effects are diarrhoea, nausea, vomiting, indigestion, abdominal pain, skin rashes, urticaria and erythema multiforme, vaginitis, abnormal taste, headache, dizziness, tiredness and hot flushes.

Tabulated summary of adverse reactions:

If gastrointestinal disorders are evident, they may be reduced by taking INDO AMOXYCILLIN at the start of a meal.

Whenever such skin and subcutaneous tissue disorders occur, INDO AMOXYCILLIN should be discontinued.

Haematological effects are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. A slight thrombocytosis was noted in less than 1% of patients treated with INDO AMOXYCILLIN.

The hepatobiliary disorders 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.

A moderate rise in Aspartate Transaminase (AST) or SGOT and/or Alanine Tranfersae transaminase (ALT) or SGPT has been noted in patients treated with INDO AMOXYCILLIN, but the significance of these findings is unknown.

In overdose, side effects can be precipitated and/or be of increased severity (see section 4.8).

Symptoms: Oral administration can cause gastro-intestinal symptoms such as transient diarrhoea, nausea and colic which are dose-related and a result of local irritation and not toxicity.

Treatment:

• If encountered, gastro-intestinal symptoms and disturbances of the fluid and electrolyte balance may be evident.
• They may be treated symptomatically and supportive with attention to the water/electrolyte balance.
• In the absence of an adequate fluid intake and urinary output, crystalluria, in some cases leading to renal failure, is a possibility.
• Amoxicillin may be removed from the circulation by haemodialysis.