Betamox S/SF Capsules & Suspension

BETAMOX u00ae is indicated for the treatment of infections caused by susceptible, non-penicillinase-producing organisms including:

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

The average adult dose for BETAMOX u00ae is 750 mg to 1,5 g per day.

General dosages

• Adults: 250 mg (1 X 250 mg capsule or 5 ml of 250 mg/5 ml suspension) three times a day.
• Children 2 to 10 years: 125 mg (5 ml of 125 mg/5 ml suspension) three times a day.
• Children 6 months to 2 years: 125 mg (5 ml of 125 mg/5 ml suspension) three times a day.
• Infants 0 to 6 months: 62,5 mg (2,5 ml of 125 mg/5 ml suspension) three times a day.

To reconstitute 75 ml suspension, add 44 ml of water, invert the bottle and shake well until all the powder is dispersed.

To reconstitute 100 ml suspension, add 57 ml of water, invert the bottle and shake well until all the powder is dispersed.

Specific dosages

• Gastrointestinal tract infections: Adults: 1 to 2 g daily for 4 to 5 days.
• Acute typhoid fever: Adults: 4 g daily for 14 days. Children: 100 mg/kg daily for 21 days.
• Gonorrhoea: Adults: 2 to 3 g stat.

• Hypersensitivity to penicillins (e.g. amoxycillin) or to another beta-lactam agent (e.g. cephalosporin, carbapenem or monobactam), or to any of the excipients listed in section 6.1.
• Patients with infectious mononucleosis since they are especially susceptible to amoxycillin induced skin rashes.
• Patients with lymphatic leukaemia.
• Patients with hyperuricaemia being treated with allopurinol may also be at an increased risk of developing skin rashes.

Hypersensitivity reactions

Before initiating therapy with any penicillin, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other beta-lactam agents (see section 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 persons with a history of hypersensitivity to beta-lactam antibiotics and in atopic individuals. Hypersensitivity reactions can also progress to Kounis syndrome, a serious allergic reaction that can result in myocardial infarction (see section 4.8). If an allergic reaction occurs, amoxycillin therapy must be discontinued and appropriate alternative therapy instituted.

Non-susceptible microorganisms

BETAMOX u00ae 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 BETAMOX u00ae. 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.

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 BETAMOX u00ae discontinuation and contraindicates any subsequent administration. BETAMOX u00ae 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.

Jarisch-Herxheimer reaction

BETAMOX u00ae should be used with caution in patients with syphilis, as the Jarisch-Herxheimer reaction may occur (see section 4.8).

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 agents 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, BETAMOX u00ae should immediately be discontinued, a doctor consulted and an appropriate therapy initiated. Anti-peristaltic medicinal products 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 (see section 4.8).

Anticoagulants

Prolongation of prothrombin time has been reported rarely in patients receiving amoxycillin. 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 sections 4.5 and 4.8).

Crystalluria

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

Interference with diagnostic tests

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

Excipients

BETAMOX u00ae suspension contains sucrose which may have an effect on the glycaemic control of patients with diabetes mellitus and may be harmful to the teeth when intended for chronic use, e.g. for two weeks or more. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take BETAMOX u00ae suspension.

Probenecid

Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of BETAMOX u00ae. Concomitant use of probenecid may result in increased and prolonged blood levels of BETAMOX u00ae.

Allopurinol

Concurrent administration of allopurinol during treatment with BETAMOX u00ae can increase the likelihood of allergic skin reactions.

Tetracyclines

Tetracyclines and other bacteriostatic medicines may interfere with the bactericidal effects of BETAMOX u00ae.

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 amoxycillin. If co-administration is necessary, the prothrombin time or international normalised ratio should be carefully monitored with the addition or withdrawal of BETAMOX u00ae. 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

BETAMOX u00ae may decrease the efficacy of oestrogen-containing oral contraceptives.

Other

BETAMOX u00ae may affect the absorption of other medicines, due to its effect on the gastrointestinal flora.

Pregnancy

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

Breastfeeding

Amoxycillin 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 breastfeeding might have to be discontinued.

Fertility

There are no reported data on the effects of amoxycillin on fertility in humans. Reported reproductive studies in animals have shown no effects on fertility.

BETAMOX u00ae may cause an allergic reaction, dizziness or convulsions, which may influence the ability to drive and use machines (see section 4.8).

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

Body System Frequent Less Frequent Frequency Unknown

Infections and infestations Mucocutaneous candidiasis

Blood and lymphatic system disorders Reversible leucopenia (including severe neutropenia and agranulocytosis) Reversible thrombocytopenia Haemolytic anaemia Prolongation of bleeding time and prothrombin time (see section 4.4)

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)

Nervous system disorders Hyperkinesia Dizziness Convulsions (see section 4.4)

Gastrointestinal disorders Diarrhoea Nausea Vomiting Antibiotic-associated colitis (including pseudomembranous colitis and haemorrhagic colitis see section 4.4) Black hairy tongue Superficial tooth discolouration

Hepatobiliary disorders Hepatitis Cholestatic jaundice A moderate rise in AST and/or ALT

Skin and subcutaneous tissue disorders Skin rash Urticaria Pruritus 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) Linear IgA disease

Renal and urinary tract disorders Interstitial nephritis Crystalluria (see section 4.4)

Cardiac disorders Kounis syndrome

# For suspensions: Superficial tooth discolouration has been reported in children. Good oral hygiene may help to prevent tooth discolouration as it can usually be removed by brushing.

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 u20186.04 Adverse Drug Reaction Reporting formu2019, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/index/8

See section 4.4 and 4.8.

Treatment is symptomatic and supportive. Should a serious anaphylactic reaction occur, BETAMOX u00ae should be discontinued and the patient treated with adrenalin, corticosteroids and antihistamines.