Para-Aminosalicylic Acid

Registered South African indications:

• Tuberculosis

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Severe renal disease
• Severe hepatic disease

Cautions

• Pregnancy
• Breastfeeding
• Mild to moderate renal impairment
• Mild to moderate hepatic impairment
• History of gastric ulcer

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

Tuberculosis (additional agents required)
- Multi-drug resistant tuberculosis
- Situation when therapy with isoniazid and rifampicin is not possible

• Oral (gra): 4g, 8hrly

Should be administered with at least 1 new agent to which the patient's organism is susceptible

Administer by sprinkling on apple sauce or yoghurt, or swirling granules in acidic drink e.g. orange/tomato juice

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

Tuberculosis (additional agents required)
- Multi-drug resistant tuberculosis
- Situation when therapy with isoniazid and rifampicin is not possible

• Oral (gra): 200-300mg/kg/day, in 2-4 divided doses; Max: 10g/24hrs

Decisions related to dose adjustment/discontinuing TB regimen must be discussed in advance with Pulmonologists/Infectious Disease specialists, and cases must be dealt with individually

Pregnancy

• FDA Pregnancy Category C

Breastfeeding

• Caution; no information available

Renal Impairment

• Mild to moderate: Caution; no dose adjustment recommended
• Severe: Contraindicated

Hepatic Impairment

• Mild to moderate: Caution; no dose adjustment recommended
• Severe: Contraindicated
  Severe hepatic disease is a relative contraindication

Elderly

• No dose adjustment recommended

Drugs in Sport

•  Permitted - No warning

Central Nervous System Disorders

• Neurological disease

Cardiovascular Disorders

• Pericarditis
• Vasculitis

Respiratory Disorders

• Eosinophilic pneumonitis

Gastrointestinal Disorders

• Abdominal pain
• Diarrhea
• Nausea and vomiting

Hepatobiliary Disorders

• Hepatitis
• Jaundice

Endocrine and Metabolic Disorders

• Goiter 
• Hypoglycemia
• Hypothyroidism

Skin and Subcutaneous Tissue Disorders

• Skin rash

Immune, Blood and Lymphatic System Disorders

• Agranulocytosis
• Haemolytic anemia
• Leukopenia
• Thrombocytopenia
• Fever

Sensory Disorders

• Optic neuritis

• Carbonic anhydrase inhibitors
• Dexketoprofen
• Ginkgo biloba
• Herbs 
• Hyaluronidase
• Influenza virus vaccine
• Methotrexate
• Non-steroidal anti-inflammatory drugs
• Pralatrexate
• Sulfinpyrazone
• Varicella virus-containing vaccines
• Vitamin K antagonists

• Hepatic function
• Thyroid function

Para-aminosalicylic acid is a bacteriostatic against Mycobacterium tuberculosis. It inhibits the onset of bacterial resistance to streptomycin and isoniazid. The mechanism of action has been postulated to be inhibition of folic acid synthesis and/or inhibition of synthesis of the cell wall component, mycobactin, thus reducing iron uptake by M. tuberculosis.

Granules (per sachet) 4g

• Paser (Equity) originator