Allopathy
Prescription Required
DCGI (Drugs Controller General of India)
Schedule H
Prothionamide is an Antitubercular agent belonging to nicotinamide derivative
Prothionamide is used in the Treatment of Tuberculosis.
Prothionamide is Readily absorbed form the GI tract (oral); peak plasma concentrations after 2 hr and get Widely distributed into body fluids and CSF which gets Converted to sulfoxide (active) and other metabolites and get excreted via urine (<1% as unchanged).
The Onset of action of Prothionamide is within 30-60 min.
The Duration of action of Prothionamide was within 12-16 hr.
The Tmax of Prothionamide was achieved within 1 hr.
Prothionamide shows common side effects like Nausea and Vomiting, Stomach pain, Diarrhoea, Dizziness, Headache, Skin Rash, Double vision, Loss of appetite, Confusion
Prothionamide is available in the form of Tablets.
Prothionamide is available in India, Germany, China, Italy, USA
Prothionamide inhibits peptide synthesis. It is active against mycobacteria species. Bacteriostatic against M. tuberculosis. Also active against atypical mycobacteria e.g. M. kansasii and some strains of M. avium complex, and M. leprae.
Prothionamide is used in the Treatment of Tuberculosis.
Protionamide 250mg Tablets may be taken with or without food. Intake with food or at bedtime may improve gastrointestinal tolerability
Prothionamide is approved for use in the following clinical indications
- Tuberculosis: This medicine is a second line agent used in a combination with other medicines for the treatment of active tuberculosis, a chronic bacterial infection caused by Mycobacterium tuberculosis.
Prothionamide is available in various strengths as 250 mg
- Dosage Adjustment in Hepatic impairment Patient
Mild to moderate impairment: There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.
Prothionamide is contraindicated in patients with known allergy to the drug.
Prothionamide is also contraindicated in pregnant and lactating women and in patients who have severe renal disease and porphyria.
- Driving or Operating machinery
This medicine may cause dizziness or drowsiness in some patients. It is advised that you do not perform any activities that require high mental alertness like driving a vehicle or operating machinery if you experience any of these symptoms during treatment with this medicine.
- Liver function impairment
This medicine should be used with extreme caution in patients suffering from mild to moderate liver diseases or patients at risk of liver diseases due to the increased risk of severe adverse effects. Close monitoring of liver function tests is necessary while receiving this medicine. Appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition. This medicine is not recommended for use in patients with severe liver diseases.
- Kidney function Impairment
This medicine should be used with caution in patients suffering from kidney diseases due to the increased risk of severe adverse effects. Close monitoring of kidney function tests is necessary while receiving this medicine. Appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition.
- Drug resistance
Usage of this medicine without sufficient proof or suspicion of a mycobacterial infection should be avoided. Irrational dosing might fail in providing the benefits and even cause toxicity. It may also increase the risk of development of bacteria that are drug resistant.
Alcohol Warning
Prothionamide may cause liver problems, and using it with substantial quantities of ethanol may increase that risk.
Food Warning
Absorption is not affected by administration with a high-fat meal or yogurt.
- Common Adverse effects
Psychotic disturbances, mental depression, anxiety, drowsiness, dizziness, restlessness, headache, peripheral neuritis, paraesthesia, seizures, tremors, pellagra-like syndrome, hallucination
- Less Common Adverse effects:
Nausea, vomiting, diarrhea, abdominal pain, excessive salivation, metallic taste, stomatitis, anorexia, wt loss., Olfactory disturbances. Hepatic: Hepatitis, transient increase in serum bilirubin
- Rare Adverse effects
Diplopia, optic neuritis, blurred vision. Dermatologic: Rash, photosensitivity, purpura, acne, dermatitis, alopecia.
Prothionamide could cause adverse effects when given along with
• Cycloserine (increased risk of neurotoxicity).
• Isoniazid (increased serum concentrations).
• P-aminosalicylic acid (increased risk of hypothyroidism).
• Rifampicin and thioacetazone (increased risk of hepatotoxicity).
The common side effects of Prothionamide include the following Psychotic disturbances, mental depression, anxiety, drowsiness, dizziness, restlessness, headache, peripheral neuritis, paraesthesia, seizures, tremors, pellagra-like syndrome, hallucination.
Pharmacodynamic
Prothionamide inhibits peptide synthesis. It is active against mycobacteria species. Bacteriostatic against M. tuberculosis. Also active against atypical mycobacteria e.g. M. kansasii and some strains of M. avium complex, and M. leprae.
Pharmacokinetics
- Absorption: Readily absorbed form the GI tract (oral); peak plasma concentrations after 2 hr.
- Distribution: Widely distributed into body fluids and CSF.
- Metabolism: Converted to sulfoxide (active) and other metabolites.
- Excretion: Via urine (<1% as unchanged).
- https://pubmed.ncbi.nlm.nih.gov/1091001/
- https://clinicaltrials.gov/ct2/show/NCT01422915
- https://clinicaltrials.gov/ct2/show/NCT02263547
- https://www.medicines.org.uk/emc/product/128/smpc.
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1364710/
- https://reference.medscape.com/drug/colestid-Prothionamide -342452
- https://go.drugbank.com/drugs/DB00375
- https://www.sciencedirect.com/topics/medicine-and-dentistry/Prothionamide
- https://europepmc.org/article/med/6988203
