Stellacelen 250 mg/500 mg 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: 250 mg of amoxycillin three times a day; 500 mg of amoxycillin may be required in some severe infections. In gonorrhoea the usual dose is the equivalent of 3 g given as a single dose, usually combined with 1 g probenecid.

Method of administration

For oral use.

• Hypersensitivity to amoxicillin or to any of the excipients of STELLACELEN listed in section 6.1.
• Patients known to be sensitive to penicillins or cephalosporins.
• 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 STELLACELEN, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam medicines. 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, STELLACELEN therapy must be discontinued, and appropriate alternative therapy instituted.

Non-susceptible microorganisms

Amoxicillin 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. 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).

Renal impairment

In patients with renal impairment, the dose should be adjusted according to the degree of impairment.

Skin reactions

The occurrence at the treatment initiation of a feverish generalised erythema associated with pustules may be a symptom of acute generalised exanthemous pustulosis (AGEP). This reaction requires STELLACELEN discontinuation and contra-indicates any subsequent administration. STELLACELEN 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.

Jarisch-Herxheimer reaction

The Jarisch-Herxheimer reaction has been seen following amoxicillin treatment of Lyme disease. 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 occasionally 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. 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, STELLACELEN 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 haematopoietic function is advisable during prolonged therapy. Elevated liver enzymes and changes in blood counts have been reported.

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.

Crystalluria

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

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 treatment, enzymatic glucose oxidase methods should be used. The presence of amoxicillin may distort assay results for oestriol in pregnant women.

Probenecid

Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of amoxicillin. Concomitant use of probenecid may result in increased and prolonged blood levels of amoxicillin.

Allopurinol

Concurrent administration of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions.

Tetracyclines

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

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 in patients maintained on acenocoumarol or warfarin and prescribed a course of amoxicillin. If co-administration is necessary, the prothrombin time or international normalised ratio should be carefully monitored with the addition or withdrawal of amoxicillin. Moreover, adjustments in the dose of oral anticoagulants may be necessary.

Methotrexate

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

Oral contraceptives

Amoxicillin may decrease the efficacy of oestrogen-containing oral contraceptives.

Pregnancy

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Limited data on the use of amoxicillin during pregnancy in humans do not indicate an increased risk of congenital malformations. STELLACELEN may be used with caution in pregnancy.

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 breast-fed infant, so that breast-feeding might have to be discontinued. STELLACELEN should be used with caution during breastfeeding.

Fertility

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

No studies on the effects of the ability to drive and use machines have been performed. However, undesirable effects may occur (e.g. allergic reactions, dizziness, convulsions), which may influence the ability to drive and use machines.

a) Summary of the safety profile

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

b) Tabulated list of adverse reactions

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

System Organ Class

Frequency

Frequent

Less Frequent

Not known

Infections and infestations

mucocutaneous candidiasis

Blood and lymphatic system disorders

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

pancytopenia

Immune system disorders

severe allergic reactions, including angioneurotic oedema, anaphylaxis, serum sickness and hypersensitivity vasculitis (see section 4.4)

Jarisch-Herxheimer reaction (see section 4.4)

Psychiatric disorders

auditory and visual hallucinations

Nervous system disorders

hyperkinesia, dizziness and convulsions (see section 4.4).

Gastrointestinal disorders

diarrhoea and nausea*

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

Hepatobiliary disorders

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

Skin and subcutaneous tissue disorders

skin rash*

urticaria and pruritus*

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

Renal and urinary disorders

interstitial nephritis, crystalluria (see sections 4.4 and 4.9 Overdose)

* The incidence of these AEs was reportedly derived from clinical studies involving a total of approximately 6000 adults and paediatric patients taking amoxicillin.

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. Healthcare professionals are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reaction Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8

Signs and symptoms of overdose

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.

Treatment of intoxication

Treatment is symptomatic and supportive. Amoxicillin can be removed from the circulation by haemodialysis.