Amoxicillin/ Flucloxacillin

These indications are based on manufacturer information for both originator and generic products. For product specific registered indications, please refer to product specific manufacturer information

Registered South African indications:

• Susceptible bacterial infections of mixed origin where penicillin-resistant staphylococci may be implicated

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Hypersensitivity to other penicillins
• Neonates

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Mononucleosis
• Lymphatic leukaemia
• Patients with hyperuricemia on allopurinol therapy
• Prolonged use
• High doses
• Syphilis co-infection

For additional pharmacological effects not accounted for by the action of the combination product 

Refer to the single agent monograph for Amoxicillin
Refer to the single agent monograph for Flucloxacillin

Forms avail. in SA and covered in this monograph: cap

Infections caused by: Some Gram-positive and Gram-negative organisms

South African manufacturer recommendations

Amoxicillin/ Flucloxacillin
250/250 (mg)

• Oral (cap): 1 cap, 8hrly

Take 1hr before meals and in a fasting state for maximal absorption

Paed. forms avail. in SA and covered in this monograph: sus

Infections caused by: Some Gram-positive and Gram-negative organisms

South African manufacturer recommendations

Amoxicillin/ Flucloxacillin
125/125 (mg/5ml)

• Neonates: Contraindicated
• Younger than 2 years: Oral (sus): 125mg (2.5ml), 8hrly
• Between 2-12 years: Oral (sus): 250mg (5ml), 8hrly
• Older than 12 years: See adult dosage

No specific recommendations are provided for children >12 years. Refer to the adult dosage for guidance

In severe infections, these dosages may be increased

Take 1hr before meals and in a fasting state for maximal absorption

Pregnancy

• Caution
• Safety in pregnancy has not been established

Breastfeeding

• Caution
• Safety in breastfeeding has not been established

Renal Impairment

• Caution; no information available

Hepatic Impairment

• Caution; no information available

Elderly

• Caution; no information available

Drugs in Sport

• Permitted - No warnings

For additional recommendations based on the individual active ingredients

Refer to the single agent monograph for Amoxicillin
Refer to the single agent monograph for Flucloxacillin

Gastrointestinal Disorders

• Diarrhoea
• Nausea and vomiting
• Pseudomembranous colitis

Hepatobiliary Disorders

• Cholestatic hepatitis

Skin and Subcutaneous Tissue Disorders

• Skin rashes
  - Urticarial
  - Maculopapular

Immune, Blood and Lymphatic System Disorders

• Allergic reactions
• Anaphylactic shock with collapse and sometimes death
• Angioedema
• Bronchospasm
• Supra-infections with non-susceptible organisms
• Jarisch-Herxheimer's reaction

For additional pharmacological effects not accounted for by the action of the combination product 

Refer to the single agent monograph for Amoxicillin
Refer to the single agent monograph for Flucloxacillin

• Allopurinol
• Oestrogen-containing oral contraceptives

For additional pharmacological effects not accounted for by the action of the combination product 

Refer to the single agent monograph for Amoxicillin
Refer to the single agent monograph for Flucloxacillin

None routine. Specific cases may require

• Renal function
• Full blood count
• Sensitivity testing

For additional monitoring parameters not accounted for the combination product 

Refer to the single agent monograph for Amoxicillin
Refer to the single agent monograph for Flucloxacillin

Amoxicillin/ Flucloxacillin exhibits in vitro and in vivo bactericidal activity against some Gram-positive and Gram-negative bacteria. In vitro sensitivity does not necessarily imply in vivo efficacy.

Spectrum of activity: Some Gram-positive and Gram-negative organisms

COMBINATION PREPARATIONS

Amoxicillin/ Flucloxacillin

Capsule 250/250mg

• Macropen 500 (Xixia)
• Megapen 500 (Pharmacare)

Suspension (per 5ml) 125/125mg

• Macropen S (Xixia)
• Megapen S (Pharmacare)