Medicinal Products

PASTE 4 g

Generic drug of the therapeutic class: Infectiology - Parasitology
active ingredients: para-aminosalicylic acid
laboratory: Lucane Pharma

Gastro-resistant granulate
Sachets of 4 g
All forms

Indication

PASER is indicated, in adults, in combination with several other bactericidal or bacteriostatic antibiotic drugs known to be active on Mycobacterium tuberculosis in the treatment of multidrug-resistant tuberculosis (MDR-TB or XDR-TB) according to the results of the antibiogram. or when the use of isoniazid and rifampicin is impossible for reasons of cross-resistance or intolerance.

Dosage PASTER 4 g Granulose gastro-resistant Bags of 4 g

Dosage: Adults: 4 g (one sachet), three times a day.

Method of administration: the PASER granules have a gastroresistant coating which makes it possible to avoid the degradation of the active ingredient in the stomach.

PASER granules can either be mixed with an acidic food (applesauce, yoghurt) or suspended in an acidic beverage (tomato juice, orange juice) and swallowed immediately after the suspension, in order to avoid the deterioration of the gastro-resistant coating

Against indications

- Hypersensitivity to the active substance or to any of the excipients.

- Severe renal insufficiency.

Adverse effects Paser

There are few data on adverse events with PASER. In clinical studies conducted in the United States, the most commonly reported adverse reactions were gastrointestinal: gastrointestinal discomfort, bloating, nausea, diarrhea.

The following side effects have been reported when using different formulations of non-gastroresistant para-aminosalicylic acid (various para-aminosalicylic acid salts, free para-aminosalicylic acid):

The reported side effects are listed below by device and frequency.

Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100, <1/10), and uncommon (≥ 1/1000, <1/100). Within each frequency group, adverse effects are presented in descending order of severity.

Blood and lymphatic system disorders

Rare :

Hemolytic anemia in patients with G6PD deficiency

Metabolic disorders and the endocrine system

Rare :

Goiter, hypothyroidism

Gastrointestinal disorders

Very common :

Nausea, vomiting, diarrhea, gastrointestinal pain.

Renal and urinary disorders

Rare :

crystalluria

General disorders

Fever Hypersensitivity Reactions

Skin and subcutaneous tissue disorders

Uncommon

Skin rash, itching, Pruritus

Blood and lymphatic system disorders

Uncommon

Hypereosinophilia, leukopenia, lymphadenopathy, agranulocytosis, thrombocytopenia, reduction of prothrombin

Hepatobiliary disorders

Uncommon:

Hepatosplenomegaly, jaundice, hepatitis

infections

Uncommon:

Infectious mononucleosis syndrome

Autoimmune or inflammatory diseases

Uncommon:

Vasculitis, Loeffler syndrome, pericarditis encephalitis optic neuritis

Metabolic disorders

Uncommon:

hypoglycemia

Malabsorption syndrome may occur in patients treated with para-aminosalicylic acid. The complete malabsorption syndrome includes steatorrhea, decreased cholesterol, D-xylose, and plasma iron levels. The absorption of triglycerides is always preserved.

A decrease in thyroxine synthesis of 40% was reported in one study, with no interference with iodine uptake, one hour after sodium para-aminosalicylate administration. The possible development of a goiter can be prevented by the administration of thyroxine.

Laboratory test.

Para-aminosalicylic acid may interfere with serum albumin, ASAT, and urinary qualitative analysis of bilirubin, urobilinogen or porphobilinogen.

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