Ampicillin/ Cloxacillin

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 organisms where a mixed infections is present and includes penicillin-resistant staphylococci

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Ampicillin
Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Hypersensitivity to beta-lactam antibiotics

Cautions

• Breastfeeding
• Severe renal impairment
• Infectious mononucleosis
• Acute/chronic leukaemia of lymphoid origin
• Prolonged use

Cloxacillin
Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• History of penicillin allergy 
• Hypersensitivity to cephalosporins
• Neonates born to mothers sensitive to penicillin 
• Intrathecal administration
• Ophthalmic use

Cautions

• Renal impairment
• Neonatal jaundice
• Seizure disorders

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

Infections caused by: Most Gram-positive aerobic organisms (including methicillin-sensitive Staphylococcus spp.); Some Gram-negative aerobic organisms (including Neisseria spp.); Some anaerobic organisms (including Peptostreptococcus and Clostridium spp.)

Ampicillin/ Cloxacillin
250/250 (mg)

• Oral (cap): 1-2 cap, 6hrly

250/250 (mg)
500/500 (mg) 

• IV/IM: 250/250mg - 500/500mg, 4-6hrly

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See additional prescribing points for administration directions

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

Infections caused by: Most Gram-positive aerobic organisms (including methicillin-sensitive Staphylococcus spp.); Some Gram-negative aerobic organisms (including Neisseria spp.); Some anaerobic organisms (including Peptostreptococcus and Clostridium spp.)

Ampicillin/ Cloxacillin
125/125 (mg/5ml)

• Younger than 2 years: Oral (sus): 5ml, 6hrly
• Between 2-10 years: Oral (sus): 5-10ml, 6hrly
• Older than 10 years: See adult dosage

125/125 (mg)
250/250 (mg)

• Less than 1 month: IV/IM: Not established for use
• Between 1 month - 2 years: IV/IM: 125/125mg, 4-6hrly
• Between 2-10 years: IV/IM: 125/125mg - 250/250mg, 4-6hrly
• Older than 10 years: IV/IM: See adult dosage

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See additional prescribing points for administration directions

Recommendations for this combination product as per highest risk category when comparing individual active ingredients

Pregnancy

• Safe (Ampicillin, Cloxacillin)
  Refer to single agent monograph for Ampicillin
  Refer to single agent monograph for Cloxacillin

Breastfeeding

• Caution (Ampicillin)
  Refer to single agent monograph for Ampicillin
  Refer to single agent monograph for Cloxacillin

Renal Impairment

• Caution; dose adjustment recommended (Ampicillin)
  Refer to single agent monograph for Ampicillin
  Refer to single agent monograph for Cloxacillin

Hepatic Impairment

• No dose adjustment recommended (Ampicillin, Cloxacillin)
  Refer to single agent monograph for Ampicillin
  Refer to single agent monograph for Cloxacillin

Elderly

• No dose adjustment recommended (Ampicillin, Cloxacillin)
  Refer to single agent monograph for Ampicillin
  Refer to single agent monograph for Cloxacillin

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warnings

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Ampicillin
Gastrointestinal Disorders

• Nausea and vomiting
• Diarrhoea
• Pseudomembraneous colitis
• Haemorrhagic colitis

Hepatobiliary Disorders

• Hepatitis
• Cholestatic jaundice
• Increased transaminase levels

Genitourinary Disorders

• Interstitial nephritis

Skin and Subcutaneous Tissue Disorders

• Rash
• Pruritis
• Urticaria
• Purpura
• Erythema multiforme
• Stevens-Johnson syndrome
• Toxic epidermal necrolysis

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions
• Anaphylaxis
• Transient leucopenia
• Transient thrombocytopenia
• Haemolytic anaemia
• Prolonged bleeding time
• Prolonged prothrombin

Cloxacillin
Central Nervous System Disorders

• Seizures
• Central nervous system toxicity

Cardiovascular Disorders

• Vasculitis
• Phlebitis
• Thrombophlebitis

Gastrointestinal Disorders

• Nausea
• Transient diarrhoea
• Sore mouth and tongue
• Hairy black tongue
• Heartburn
• Pruritis ani
• Pseudomembranous colitis

Hepatobiliary Disorders

• Increased hepatic enzyme values
• Hepatitis
• Cholestatic jaundice

Genitourinary Disorders

• Interstitial nephritis

Musculoskeletal Disorders

• Swollen joints

Skin and Subcutaneous Tissue Disorders

• Rash
• Urticaria
• Exfoliative dermatitis
• Angioneurotic oedema
• Pain with IM injection
• Erythema multiforme type rash
• Jarisch-Herxheimer reaction

Immune, Blood and Lymphatic System Disorders

• Overgrowth of non-susceptible organisms
• Leukopenia
• Defective platelet function
• Haemolytic anaemia
• Prolonged bleeding time
• Eosinophilia
• Hypersensitivity reactions
• Fever

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Ampicillin

• Bacteriostatic antibiotics
• Oral contraceptives
• Probenecid
• Allopurinol

Cloxacillin

• Aminoglycosides
• Bacteriostatic antibiotics
• Tetracycline antibiotics
• Erythromycin

None routine. Specific cases may require

• Renal function
• Hepatic function
• Full blood count

Administration directions

• IM: Reconstitute with 1.5ml water; Shake vigorously
• IV bolus: Reconstitute with 10ml sterile water; Inject slowly
• IV infusion: Dissolve in 0.9% sodium chloride, 5% dextrose, or Ringer's lactate; Give as rapid infusion over 30 minutes

Ampicillin
Ampicillin binds to specific penicillin-binding proteins located inside the cell wall. This results in inhibition of the final stage of cell wall biosynthesis leading to lysis of the bacterial cell by cell wall autolytic enzymes that become active when cell wall synthesis is arrested.

Cloxacillin
Cloxacillin is a bactericidal antibiotic. It acts by binding to specific penicillin-binding proteins located inside the cell wall. This results in inhibition of the final stage of cell wall biosynthesis leading to lysis of the bacterial cell by cell wall autolytic enzymes that become active when cell wall synthesis is arrested. Cloxacillin is active against penicillinase-producing organisms.

Spectrum of activity: Most Gram-positive aerobic organisms (including methicillin-sensitive Staphylococcus spp.); Some Gram-negative aerobic organisms (including Neisseria spp.); Some anaerobic organisms (including Peptostreptococcus and Clostridium spp.)

COMBINATION PREPARATIONS

Ampicillin/ Cloxacillin

Capsule 250/250mg

• Apen 500 (Xixia)
• Cloxam (Pharmacare)
• Megamox 500 (Pharmacare)

Suspension (per 5ml) 125/125mg

• Apen S (Xixia)
• Megamox S (Pharmacare)

Suspension (per 5ml) 250/250mg

• Ampiclox 500 (Pharmacare)

Injection (per vial) 125/125mg

• Ampoxin 250 (Unichem SA) - Discontinued (13/12/19)

Injection (per vial) 250/250mg

• Ampoxin 500 (Unichem SA)

Injection (per vial) 500/500mg

• Ampoxin 1000 (Unichem SA)