Para-aminosalicylic acid (PAS) and sodium salt of PAS

Therapeutic action

– Antibacterial with bacteriostatic activity

Presentation

– Para-aminosalicylic acid (PAS): delayed-release granules, 4 g sachet (PASER® Jacobus)
– Para-aminosalicylate sodium (sodium salt of PAS or PAS-sodium):
• Powder for oral solution, 5.52 g sachet (PAS-Na® Olainfarm)
• 60% w/w delayed-release granules, 9.2 g sachet or 100 g jar (MONOPAS® Macleods)

One 4 g sachet of PAS (PASER® Jacobus) = one 5.52 g sachet of PAS-sodium (PAS-Na® Olainfarm) = one 9.2 g sachet of PAS sodium 60 % w/w (MONOPAS® Macleods).

Dosage (expressed in PAS)

– Child under 30 kg: 200 to 300 mg/kg/day in 2 to 3 divided doses (max. 8 g daily)
– Child over 30 kg and adult: 8 g once daily if tolerated or in 2 divided doses (max. 12 g daily)
– Patient with severe renal impairment: 8 g/day in 2 divided doses

For paediatric dosing: PAS (Jacobus) comes with a dosage scoop graduated in milligrams; PAS sodium (Macleods) with a measuring spoon graduated in grams.

Weight
(kg)

Daily dose
(in mg of PAS)

PASER®
Jacobus (mg)

PAS-Na®
Olainfarm (sachet)

MONOPAS 9.2 g®
Mcleods (g)

5

1000-1500

500 mg x 2

1.5 g x 2

6

1200-1800

750 mg x 2

1.5 g x 2

7

1400-2100

750 mg x 2

2 g x 2

8

1600-2400

1000 mg x 2

2 g x 2

9

1800-2700

1000 mg x 2

3 g x 2

10

2000-3000

1000 mg x 2

3 g x 2

11

2200-3300

1500 mg x 2

3 g x 2

12

2400-3600

1500 mg x 2

3 g x 2

13

2600-3900

1500 mg x 2

3 g x 2

14

2800-4200

1500 mg x 2

4 g x 2

15

3000-4500

2000 mg x 2

4 g x 2

16

3200-4800

2000 mg x 2

4 g x 2

17

3400-5100

2000 mg x 2

4 g x 2

18

3600-5400

2000 mg x 2

4 g x 2

19

3800-5700

2500 mg x 2

6 g x 2

20

4000-6000

2500 mg x 2

6 g x 2

21

4200-6300

2500 mg x 2

6 g x 2

22

4400-6600

2500 mg x 2

6 g x 2

23

4600-6900

3000 mg x 2

6 g x 2

24

4800-7200

3000 mg x 2

6 g x 2

25

5000-7500

3000 mg x 2

8 g x 2

26

5200-7800

3000 mg x 2

8 g x 2

27

5400-8000

3500 mg x 2

8 g x 2

28

5600-8000

3500 mg x 2

8 g x 2

29

5800-8000

3500 mg x 2

8 g x 2


30-70

8 g

2 sachets

2 sachets

2 sachets

> 70

8-12 g

2-3 sachets

2-3 sachets

2-3 sachets

Contra-indications, adverse effects, precautions

– Avoid or administer with caution to patients with hepatic or renal impairment or gastric ulcer.
– May cause:
• frequent gastrointestinal disturbances (nausea, vomiting, gastritis, diarrhoea);
• rarely: hypothyroidism, hepatitis, blood disorders, hypersensitivity reactions.
– For the management of adverse effects, see Appendix 10.
– Monitor combination with ethionamide/prothionamide (increased risk of hypothyroidism and gastrointestinal disturbances).
Pregnancy: safety is not established, no known teratogenicity.
Breast-feeding: no contra-indication

Monitoring

– Symptomatic monitoring, liver and thyroid function

Patient instructions

– Take the granules mixed with acidic juices (apple or orange).
– Do not chew the granules.
– Do not use if the sachet is swollen or if granules are dark brown or purple.
– Shells of the granules may appear in the stool.

Remarks

– To increase tolerance, start with a low dose (4 g/day in 2 divided doses) then, increase the dose over 1 to 2 weeks to achieve the target dose.
– PAS and PAS-sodium may come in various strengths or proportions. As daily dosages are expressed in PAS, always check the content of PAS in the product: 1 g of PAS is equivalent to 1.38 g of PAS-sodium (e.g. one 9.2 g sachet of MONOPAS® 60% w/w contains 600 mg of PAS-sodium equivalent to approximately 435 mg of PAS per 1 g of granules).
Storage:
PAS: below 15°C; may be stored at 40°C for 8 weeks maximum;
PAS-sodium: below 25°C -  -