Pharmaceutical Form

Granupas (Enterogranulate 4 g)

Gastro-resistant granules. The granules are small off-white / light brown with a diameter of about 1.5 mm.

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Indications

Granupas is indicated for use as part of a suitable combination regimen for multidrug-resistant tuberculosis. Used in adults and children from 28 days and older, when an effective treatment regimen can not otherwise be compiled due to resistance or tolerability. Account should be taken of official guidance on the appropriate use of antibacterial agents.

 

Product Information

Granupase: gastro-resistant formulation of para-aminosalicylic acid.

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• Streptomycin and pas were the first effective antibiotic treatment for TB introduced in the 1950s. (1)

• Pas proved to be very effective in reducing the development of resistance to companions. (5)

• The current profile of MDR-TB shows little resistance to passports unlike many other second-line drugs. (3.6)

• Granupase is a gastro-resistant form that is better tolerated than previous formulations (9% versus 58% incidence of gastrointestinal side effects. (1.7)

 

References

1. British Medical Research Council

Treatment of tuberculosis with streptomycin and para-aminosalicylic acid. BMJ 1950; (11): 1073-85

2. Ambrosio L et al

New anti-tuberculosis drugs and regimens: 2015 update. ERJ Open Res 2015; 1: 00010–2015

3. Gunther G et al

Multidrug-Resistant Tuberculosis in Europe, 2010–2011. Emerging Infectious Diseases 2015; 21 (3) 409-16

4. Lange C et al

Limited Benefit of the New Shorter Multidrug-Resistant Tuberculosis Regimen in Europe. American Journal of Respiratory and Critical Care Medicine 2016; 194 (8) 1029-31

5. Donald P and Diacon A

Para-aminosalicylic acid: the return of an old friend. Lancet Infect Dis 2015; 3: 1091-9

6. Ahuja et al

Multidrug Resistant Pulmonary Tuberculosis Treatment Regimens and Patient Outcomes: An Individual Patient Data Meta-analysis of 9,153 Patients. PLOS Medicine 2012; 9 (8) | e1001300

7. Kibleur Y and Veziris N

French Nationwide Cohort Temporary Utilization Authorization Survey of GranuPAS ® in MDR-TB Patients. Chemotherapy 2014; 60: 174-9

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Article Number

034602

 

ATC Code

J04AA02