Nalidixic Acid

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:

• Acute and chronic urinary tract infections due to gram-negative organisms other than Pseudomonas spp.

Contraindications

Tablets

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy (first trimester)
• Renal impairment
• Hepatic impairment
• Central nervous system damage
• Patients subject to convulsions
• Respiratory insufficiency
• Children younger than 1 month

Suspension

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to other quinolones
• History of convulsive diseases
• Pregnancy
• Breastfeeding
• Porphyria

Cautions

• Pregnancy (second and third trimester) (tab)
• Breastfeeding (tab)
• Renal impairment (sus)
• Hepatic impairment (sus)
• Elderly
• Exposure to sunlight
• Prepubertal patients
• Epilepsy
• Severe cerebral arteriosclerosis
• Glucose-6-phosphate dehydrogenase deficiency

Forms avail. in SA and covered in this monograph: tab, sus

Infections caused by: Gram negative organisms (excluding Pseudomonas spp.)

• Acute infections: Oral (tab, sus): 4g/day in 4 divided doses (total daily dose 4g); Treatment duration: At least 7 days 
• Chronic infections: Oral (tab, sus): 0.5g, 4 times a day (total daily dose 2g)

Bacteria resistant to nalidixic acid may emerge within a few days of commencing treatment. Therefore, cultures and bacterial sensitivity tests should be repeated if the clinical response is unsatisfactory or if a relapse occurs

Chronic cases may require longer treatment

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

Infections caused by: Gram negative organisms (excluding Pseudomonas spp.)

General dosing range

• Younger than 3 months: Not recommended for use
• Older than 3 months: Acute infections: Oral (sus): 50-55mg/kg/day, in 4 equally divided doses
• Older than 3 months: Chronic infections: Oral (sus): 30mg/kg/day, in 4 equally divided doses

Bacteria resistant to nalidixic acid may emerge within a few days of commencing treatment. Therefore, cultures and bacterial sensitivity tests should be repeated if the clinical response is unsatisfactory or if a relapse occurs

Chronic cases may require longer treatment

Pregnancy

• Contraindicated in the first trimester of pregnancy (tab)
• Contraindicated (sus)

Breastfeeding

• Caution; no information available (tab)
• Contraindicated (sus)

Renal Impairment

• Contraindicated (tab)
• Caution; no dose adjustment recommended (sus)

Hepatic Impairment

• Contraindicated (tab)
• Caution; no dose adjustment recommended (sus)

Elderly

• Caution; no dose adjustment recommended

Porphyria Information

• Not yet classified (NC)
• Suspension: Contraindicated

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache
• Drowsiness 
• Malaise
• Asthenia

Gastrointestinal Disorders

• Nausea and vomiting
• Abdominal pain
• Diarrhoea
• Gastrointestinal bleeding

Hepatobiliary Disorders

• Cholestasis

Musculoskeletal Disorders

• Muscular weakness
• Myalgia 
• Arthralgia

Skin and Subcutaneous Tissue Disorders

• Pruritis
• Urticaria
• Rashes
• Photosensitivity

Immune, Blood and Lymphatic System Disorders

• Allergic reaction
• Eosinophilia
• Fever
• Thrombocytopenia
• Leukopenia
• Haemolytic anaemia

Sensory Disorders

• Vertigo
• Visual disturbances

• Oxolinic acid
• Chloramphenicol
• Tetracycline
• Nitrofurantoin
• Oral anticoagulants
• Warfarin
• Bishydroxycoumarin
• Probenecid
• Melphalan
• Sodium bicarbonate
• Sodium citrate

• Renal function
• Hepatic function
• Full blood count

Nalidixic acid has bacterial activity against infections caused by Gram negative organisms. It is bactericidal and its effective over the entire urinary pH range. It appears to act by inhibiting deoxyribo-nucleic acid synthesis.

Spectrum of activity: Gram negative organisms (excluding Pseudomonas spp.)

Tablet 500mg

• Puromylon (Pharmacare)

Suspension (per 5ml) 250mg

• Adco-Winlomylon (Adcock)