Amoxicillin 250 & 500 Portfolio Capsules

Infections caused by susceptible non-penicillinase-producing organisms including:

• Respiratory tract infections (upper and lower): sinusitis, pharyngitis, epiglottitis, acute and chronic bronchitis and acute typical pneumonia.
• Otitis media;
• Urinary tract infections;
• Uncomplicated gonococcal infections;
• Meningitis (sensitivity tests must be performed);
• Gastrointestinal infections including salmonella and typhoid;
• Uncomplicated gastro-enteritis and enteric fever;
• Miscellaneous: Skin and soft tissue infections, bacteraemia and as adjunct in the treatment of sepsis caused by gram-negative bacteria.

Posology

Adults and children over 12 years

• AMOXICILLIN PORTFOLIO 250 mg every 8 hours (three times a day).
• Severe infections: AMOXICILLIN PORTFOLIO 500 mg every 8 hours (three times a day).
• Gonorrhoea: 3 g amoxicillin (e.g. six AMOXICILLIN 500 PORTFOLIO capsules) as a single dose usually combined with 1 g probenecid.
• In the treatment of beta-haemolytic streptococcal infections, a therapeutic dose should be administered for at least 10 days.

Method of administration

AMOXICILLIN PORTFOLIO is for oral use. Swallow with water without opening capsule. Absorption of AMOXICILLIN PORTFOLIO is unimpaired by food.

• Hypersensitivity to amoxicillin, to any of the penicillins or to any of the excipients (see section 6.1).
• History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam medicine (e.g. a cephalosporin, carbapenem or monobactam).
• AMOXICILLIN PORTFOLIO should not be given to patients with infectious mononucleosis, since they are especially susceptible to amoxycillin-induced skin rashes, patients with lymphatic leukaemia and patients with hyperuricaemia being treated with allopurinol, may be at increased risk of developing skin rashes.

Hypersensitivity reactions

Before initiating therapy with AMOXICILLIN PORTFOLIO, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam medicines (see sections 4.3 and 4.8). Serious and occasionally fatal hypersensitivity reactions (including anaphylactoid and severe cutaneous adverse reactions) have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and in atopic individuals. If an allergic reaction occurs, AMOXICILLIN PORTFOLIO therapy must be discontinued and appropriate alternative therapy instituted.

Non-susceptible microorganisms

AMOXICILLIN PORTFOLIO 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 AMOXICILLIN PORTFOLIO (see section 5.1). This particularly applies when considering the treatment of patients with urinary tract infections and severe infections of the ear, nose and throat.

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).

Renal impairment

In patients with renal impairment, the dose should be adjusted according to the degree of impairment (see section 4.2).

Skin reactions

The occurrence at the treatment initiation of a feverish generalised erythema associated with pustula may be a symptom of acute generalised exanthemous pustulosis (AGEP, see section 4.8). This reaction requires AMOXICILLIN PORTFOLIO discontinuation and contraindicates any subsequent administration.

Jarisch-Herxheimer reaction

The Jarisch-Herxheimer reaction has been reported following amoxicillin treatment of syphilis (see section 4.8). Caution should be used when treating syphilis with AMOXICILLIN PORTFOLIO. 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 colitis has been reported with nearly all antibacterial medicines and may range in severity from mild to life threatening (see section 4.8). Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during, or subsequent to, the administration of any antibiotics. Should antibiotic-associated colitis occur, AMOXICILLIN PORTFOLIO should immediately be discontinued, a medical practitioner consulted, and an appropriate therapy initiated. Anti-peristaltic medicines are contraindicated in this situation.

Prolonged therapy

Periodic assessment of organ system functions; including renal, hepatic and hematopoietic function is advisable during prolonged therapy. Elevated liver enzymes and changes in blood counts have been reported (see section 4.8).

Anticoagulants

Prolongation of prothrombin time has been reported in patients receiving amoxicillin. Appropriate monitoring should be undertaken when anticoagulants are prescribed concomitantly. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation (see section 4.5 and 4.8).

Crystalluria

In patients with reduced urine output, crystalluria has been observed, predominantly with parenteral therapy. During the administration of high doses of AMOXICILLIN PORTFOLIO, it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxicillin crystalluria. In patients with bladder catheters, a regular check of patency should be maintained (see section 4.8 and 4.9).

Interference with diagnostic tests

Elevated serum and urinary levels of amoxicillin are likely to affect certain laboratory tests. Due to the high urinary concentrations of amoxicillin, false positive readings are common with chemical methods. It is recommended that when testing for the presence of glucose in urine during AMOXICILLIN PORTFOLIO treatment, enzymatic glucose oxidase methods should be used. The presence of amoxicillin may distort assay results for estriol in pregnant women.

Probenecid

Probenecid decreases the renal tubular secretion of amoxicillin. Concomitant use of probenecid may result in increased and prolonged blood levels of amoxicillin.

Allopurinol

Concurrent use of allopurinol during treatment with AMOXICILLIN PORTFOLIO can increase the likelihood of allergic skin reactions.

Tetracyclines

Tetracyclines and other bacteriostatic medicines may interfere with the bactericidal effects of AMOXICILLIN PORTFOLIO.

Oral anticoagulants

Oral anticoagulants and penicillin antibiotics have been widely used in practice without reports of interaction. However, in the literature there are cases of increased international normalised ratio (INR) in patients maintained on acenocoumarol or warfarin and prescribed a course of AMOXICILLIN PORTFOLIO. If co-administration is necessary, the prothrombin time or international normalised ratio should be carefully monitored with the addition or withdrawal of AMOXICILLIN PORTFOLIO. Moreover, adjustments in the dose of oral anticoagulants may be necessary (see sections 4.4 and 4.8).

Methotrexate

Penicillins may reduce the excretion of methotrexate causing a potential increase in toxicity.

Oral contraceptives

AMOXICILLIN PORTFOLIO may decrease the efficacy of oestrogen-containing oral contraceptives. AMOXICILLIN PORTFOLIO may affect the absorption of other medicines, due to its effect on the gastrointestinal flora.

Pregnancy

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Limited data on the use of AMOXICILLIN PORTFOLIO during pregnancy in humans do not indicate an increased risk of congenital malformations.

Breastfeeding

Amoxicillin is excreted into breast milk in small quantities with the possible risk of sensitisation. Consequently, diarrhoea and fungus infection of the mucous membranes are possible in the breastfed infant, so that breastfeeding might have to be discontinued.

Fertility

There are no data on the effects of amoxicillin on fertility in humans. Reproductive studies in animals have shown no effects on fertility.

AMOXICILLIN PORTFOLIO may be associated with allergic reactions, dizziness, and convulsions. Therefore, patients must be cautious when driving or using machines and should be advised not to drive or operate machinery if they experience these symptoms (see section 4.8).

a. Summary of the safety profile

The most frequently reported adverse drug reactions (ADRs) are diarrhoea, nausea and skin rash.

b. Tabulated summary of adverse reactions

The ADRs derived from clinical studies and post-marketing surveillance with amoxicillin, presented by MedDRA System Organ Class are listed below.

MedDRA system organ class

Frequency

Adverse reactions

Infections and infestations

Less frequent

Mucocutaneous candidiasis

Blood and lymphatic system disorders

Less frequent

Reversible leukopenia (including severe neutropenia or agranulocytosis), reversible thrombocytopenia and haemolytic anaemia, prolongation of bleeding time and prothrombin time (see section 4.4).

Immune system disorders

Less frequent

Severe allergic reactions, including angioedema, anaphylaxis, serum sickness and hypersensitivity vasculitis (see section 4.4).

Frequency unknown

Jarisch-Herxheimer reaction (see section 4.4)

Nervous system disorders

Less frequent

Hyperkinesia, dizziness and convulsions (see section 4.4)

Gastrointestinal disorders

Frequent

Diarrhoea, nausea

Less frequent

Vomiting, antibiotic associated colitis (including pseudomembraneous colitis and haemorrhagic colitis see section 4.4), black hairy tongue

Hepato-biliary disorders

Less frequent

Hepatitis and cholestatic jaundice, a moderate rise in AST and/or ALT

Skin and subcutaneous tissue disorders

Frequent

Skin rash

Less frequent

Urticaria, pruritus, skin reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis, acute generalised exanthematous pustulosis (AGEP) (see section 4.4), drug reaction with eosinophilia and systemic symptoms (DRESS)

Renal and urinary disorders

Less frequent

Interstitial nephritis, crystalluria (see sections 4.4 and 4.9)

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications:

https://www.sahpra.org.za/Publications/Index/8

Symptoms

Gastrointestinal symptoms (such as nausea, vomiting and diarrhoea) and disturbance of the fluid and electrolyte balances may be evident. Amoxicillin crystalluria, in some cases leading to renal failure, has been observed. Convulsions may occur in patients with impaired renal function or in those receiving high doses (see sections 4.4 and 4.8).

Treatment

Gastrointestinal symptoms may be treated symptomatically, with attention to the water/electrolyte balance. AMOXICILLIN PORTFOLIO can be removed from the circulation by haemodialysis (see section 4.2).