PASER

What Is PASER ?

PASER granules are a delayed release granule preparation of aminosalicylic acid (p-aminosalicylic acid/4-aminosalicylic acid).

What are the uses of this medicine?

• This medicine is used with other anti-tuberculosis drugs for the treatment of all forms of active tuberculosis due to susceptible strains of tubercle bacilli.
• It is most commonly used in patients with Multi-drug Resistant TB (MDR-TB) or in situations when therapy with isoniazid and rifampin is not possible due to a combination of resistance and/or intolerance.

How does this medicine work?

Aminosalicylic acid is bacteriostatic against Mycobacterium tuberculosis. The mechanism of action has been postulated to be inhibition of folic acid synthesis (but without potentiation with antifolic compounds) and/or inhibition of synthesis of the cell wall component, mycobactin, thus reducing iron uptake by M. tuberculosis.

Who Should Not Use this medicine ?

This medicine cannot be used in:

• Hypersensitivity to any component of this medication
• In Patients with severe renal disease

Is this medicine FDA approved?

• It is on the World Health Organization's List of Essential Medicines, the safest and most effective medicines needed in a health system.
• As of 2005, a course of treatment for tuberculosis costs about US$2,700.

How should this medicine be used?

• PASER granules should be administered with other drugs to which the organism is known or expected to be susceptible.
• The adult dosage of four grams (one packet) three times per day or correspondingly smaller doses in children should be given by sprinkling on apple sauce or yogurt or by swirling in the glass to suspend the granules in an acidic drink such as tomato or orange juice.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• PASER granules are supplied in packets containing 4 grams of aminosalicylic acid for administration three times a day by suspension in an acidic drink or food with a pH less than 5. Examples include apple sauce, yogurt, tomato or orange juice.

What side effects can this medication cause?

Common possible side effects of this medicine include:

• gastrointestinal intolerance manifested by nausea, vomiting, diarrhea, and abdominal pain.
• Hypersensitivity reactions: Fever, skin eruptions of various types, including exfoliative dermatitis, infectious mononucleosis-like, or lymphoma-like syndrome, leucopenia, agranulocytosis, thrombocytopenia, Coombs' positive hemolytic anemia, jaundice, hepatitis, pericarditis, hypoglycemia, optic neuritis, encephalopathy, Leoffler's syndrome, vasculitis and a reduction in prothrombin.
• Crystalluria may be prevented by the maintenance of urine at a neutral or an alkaline pH.

What special precautions should I follow?

• All drugs should be stopped at the first sign suggesting a hypersensitivity reaction.
• The patient should be advised that the first signs of hypersensitivity include a rash, often followed by fever, and much less frequently, GI disturbances of anorexia, nausea or diarrhea.
• Patients should be advised that the skeleton of the granules may be seen in the stool.
• The coating to protect the PASER granules dissolves promptly under neutral conditions; the granules therefore should be administered by sprinkling on acidic foods such as apple sauce or yogurt or by suspension in a fruit drink .
• Patients should be advised to store PASER in a refrigerator or freezer.
• PASER packets may be stored at room temperature for short periods of time.
• Patients should be advised NOT to use if the packets are swollen or the granules have lost their tan color and are dark brown or purple.

What to do in case of emergency/overdose?

• Overdosage has not been reported.

Can this medicine be used in pregnancy?

• Because there are no adequate and well controlled studies of aminosalicylic acid in humans, PASER granules should be given to a pregnant woman only if clearly needed.

What should I know about storage and disposal of this medication?

• Store below 59°F (15°C) (in a refrigerator or freezer).
• Patients are urged to store PASER in a refrigerator or freezer. PASER packets may be stored at room temperature for short periods of time.

• Dailymed label info on PASER
• FDA PASER

PASER Resources
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