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Pronunciation:

(a mee noe sal i SIL ik AS id)

U.S. Brand Names:

Paser®

Synonyms:

Aminosalicylate Sodium; 4-Aminosalicylic Acid; Para-Aminosalicylate Sodium; PAS; Sodium PAS

Generic Available:

Canadian Brand Names:

Nemasol® Sodium

Use:

Adjunctive treatment of tuberculosis used in combination with other antitubercular agents

Use - Unlabeled/Investigational:

Crohn's disease

Pregnancy Risk Factor:

Pregnancy Implications:

Teratogenic effects have been reported in animals, however, adequate studies have not been done in humans. Use during pregnancy only if clearly needed.

Lactation:

Enters breast milk/not recommended

Contraindications:

Hypersensitivity to aminosalicylic acid or any component of the formulation

Warnings/Precautions:

Use with caution in patients with hepatic or renal dysfunction and patients with gastric ulcer.

Adverse Reactions:

Frequency not defined.

Cardiovascular: Pericarditis, vasculitis

Central nervous system: Encephalopathy, fever

Dermatologic: Skin eruptions

Endocrine & metabolic: Goiter (with or without myxedema), hypoglycemia

Gastrointestinal: Abdominal pain, diarrhea, nausea, vomiting

Hematologic: Agranulocytosis, anemia (hemolytic), leukopenia, thrombocytopenia

Hepatic: Hepatitis, jaundice

Ocular: Optic neuritis

Respiratory: Eosinophilic pneumonia

Overdosage/Toxicology:

Acute overdose results in crystalluria and renal failure, nausea, and vomiting. Alkalinization of urine with sodium bicarbonate and forced diuresis can prevent crystalluria and nephrotoxicity.

Drug Interactions:

Digoxin: Serum levels may be decreased by aminosalicylic acid.

Vitamin B12: Serum levels may be decreased by aminosalicylic acid.

Stability:

Prior to dispensing, store granules below 15°C (59°F). Once dispensed, packets may be stored at room temperature for short periods of time. Do not use if packet is swollen or if granules are dark brown or purple.

Mechanism of Action:

Aminosalicylic acid (PAS) is a highly specific bacteriostatic agent active against M. tuberculosis. Structurally related to para-aminobenzoic acid (PABA) and its mechanism of action is thought to be similar to the sulfonamides, a competitive antagonism with PABA; disrupts plate biosynthesis in sensitive organisms.

Pharmacodynamics/Kinetics:

Absorption: Readily, >90%

Protein binding: 50% to 60%

Metabolism: Hepatic (>50%) via acetylation

Half-life elimination: Reduced with renal impairment

Time to peak, serum: 6 hours

Excretion: Urine (>80% as unchanged drug and metabolites)

Dosage:

Oral:

Children: Tuberculosis: 200-300 mg/kg/day in 3-4 equally divided doses

Adults:

Tuberculosis: 150 mg/kg/day in 2-3 equally divided doses

Crohn's disease (unlabeled use): 1.5 g/day

Dosing adjustment in renal impairment:

Clcr 10-50 mL/minute: Administer 50% to 75% of dose

Clcr<10 mL/minute: Administer 50% of dose

Administer after hemodialysis: Administer 50% of dose

Continuous arteriovenous hemofiltration: Dose for Clcr<10 mL/minute

Administration:

Do not use granules if packet is swollen or if granules are discolored (ie, brown or purple). Granules may be sprinkled on applesauce or yogurt (do not chew) or suspended in tomato or orange juice.

Dietary Considerations:

May be taken with food.

Patient Education:

May be taken with food; may sprinkle on applesauce or yogurt, or suspend in tomato or orange juice. Do not use granules if discolored (brown or purple) or if packet is swollen; see pharmacist for new prescription. Do not stop taking without consulting prescriber. Report persistent sore throat, fever, unusual bleeding or bruising, persistent nausea or vomiting, or abdominal pain. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Breast-feeding is not recommended.

Dental Health: Effects on Dental Treatment:

NSAID formulations are known to reversibly decrease platelet aggregation via mechanisms different than observed with aspirin. The dentist should be aware of the potential of abnormal coagulation. Caution should also be exercised in the use of NSAIDs in patients already on anticoagulant therapy with drugs such as warfarin (Coumadin®).

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

None reported

Mental Health: Effects on Psychiatric Treatment:

May cause bone marrow suppression; use caution with clozapine and carbamazepine

Dosage Forms:

Granules: 4 g/packet (30s) [contains talc]

International Brand Names:

Mesacol® (BD, IN, TH); Nemasol® Sodium (CA); Pasalba® (AU); Pas Atlantic® (TH); Pas-Fatol N® (DE); PAS® (TR); Quadrasa® (FR, IT)

References

Davidson PT and Le HQ, "Drug Treatment of Tuberculosis - 1992,"Drugs, 1992, 43(5):651-73.

"Drugs for Tuberculosis,"Med Lett Drugs Ther, 1993, 35(908):99-101.

Iseman MD, "Treatment of Multidrug-Resistant Tuberculosis,"N Engl J Med, 1993, 329(11):784-91.

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