aminosalicylic acid (Rx)

Brand and Other Names:Paser
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

oral granules, delayed-release

  • 4g/packet

Tuberculosis

Indicated for treatment of TB in combination with other active agents; most commonly used in regimens for multi-drug resistant TB or when intolerance to other antitubercular agents occurs

4 g PO TID

Mix granules in acidic liquid or sprinkle on acidic food (see Administration)

Ulcerative Colitis (Orphan)

Treatment of mild-to-moderate ulcerative colitis in patients intolerant to sulfasalazine

Orphan indication sponsor

  • Beeken, Warren M.D.; University Of Vermont, Given C-317; Burlington, VT 05405

Renal & Hepatic Impairment

Hepatic impairment: Caution advised

Renal impairment

  • CrCl 10-50 mL/min: Decrease dose by 25-50%
  • CrCl <10 mL/min: Decrease dose by 50%
  • Hemodialysis: Administer 50% of dose after dialysis

Administration

Mix granules in acidic liquid or sprinkle on food (ie, pH <5) such as, apple sauce, yogurt, tomato or orange juice

Granules are protected by an enteric coating absorption does not commence until they leave the stomach; the soft skeletons of the granules remain and may be seen in the stool

Patients who have neutralized gastric acid with antacids will not need to protect the acid resistant coating with an acidic food since no acid is present to spoil the drug

Store granules before use in refrigerator or freezer (ie, below 59°F [15°C]); may store at room temperature for show periods of time

Avoid excessive heat; do not use if packet becomes swollen or granules have lost tan color and have turned dark brown or purple

Dosage Forms & Strengths

oral granules, delayed-release

  • 4g/packet

Tuberculosis

Indicated for treatment of TB in combination with other active agents; most commonly used in regimens for multi-drug resistant TB or when intolerance to other antitubercular agents occurs

200-300 mg/kg/day PO divided in 2-4 equal doses; not to exceed 10 g/day

Mix granules in acidic liquid or sprinkle on acidic food (see Administration)

Crohn Disease (Orphan)

Treatment of acute flares in pediatric patients with ileocecal Crohn disease

Orphan indication sponsor

  • Jacobus Pharmaceutical Co., Inc. 37 Cleveland Lane Princeton, NJ 08540

Renal & Hepatic Impairment

Hepatic impairment: Caution advised

Renal impairment

  • CrCl 10-50 mL/min: Decrease dose by 25-50%
  • CrCl <10 mL/min: Decrease dose by 50%
  • Hemodialysis: Administer 50% of dose after dialysis

Administration

Mix granules in acidic liquid or sprinkle on food (ie, pH <5) such as, apple sauce, yogurt, tomato or orange juice

Granules are protected by an enteric coating absorption does not commence until they leave the stomach; the soft skeletons of the granules remain and may be seen in the stool

Patients who have neutralized gastric acid with antacids will not need to protect the acid resistant coating with an acidic food since no acid is present to spoil the drug

Store granules before use in refrigerator or freezer (ie, below 59°F [15°C]); may store at room temperature for show periods of time

Avoid excessive heat; do not use if packet becomes swollen or granules have lost tan color and have turned dark brown or purple

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Interactions

Interaction Checker

and aminosalicylic acid

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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             activity indicator 

            Contraindicated (1)

            • dichlorphenamide

              dichlorphenamide increases levels of aminosalicylic acid by unknown mechanism. Contraindicated. Coadministration of dichlorphenamide with high-dose aspirin may increase salicylate levels. Anorexia, tachypnea, lethargy, and coma reported.

            Serious - Use Alternative (0)

              Monitor Closely (4)

              • benazepril

                aminosalicylic acid decreases effects of benazepril by pharmacodynamic antagonism. Use Caution/Monitor. Salicylates may also increase nephrotoxic effects of ACE inhibitors.

              • dapsone topical

                aminosalicylic acid increases toxicity of dapsone topical by altering metabolism. Modify Therapy/Monitor Closely. May induce methemoglobinemia.

              • voclosporin

                voclosporin, aminosalicylic acid. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Coadministration with drugs associated with nephrotoxicity may increase the risk for acute and/or chronic nephrotoxicity.

              • warfarin

                aminosalicylic acid increases effects of warfarin by anticoagulation. Use Caution/Monitor.

              Minor (0)

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                Adverse Effects

                Frequency Not Defined

                GI 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 (prevent by maintaining urine at neutral or alkaline pH)

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                Warnings

                Contraindications

                Hypersensitivity

                End-stage renal disease

                Cautions

                Monitor liver function; reports of drug-induced hepatitis with rapidly absorbed aminosalicylic acid preparations

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                Pregnancy & Lactation

                Pregnancy Category: C

                Lactation: Distributed in human breast milk; caution advised

                Pregnancy Categories

                A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                NA: Information not available.

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                Pharmacology

                Mechanism of Action

                Bacteriostatic against Mycobacterium tuberculosis; inhibits onset of bacterial resistance to streptomycin and isoniazid

                Mechanism of action 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

                Absorption

                Peak Plasma Time: Initial time 2 hr (range 45 min to 24 hr); median time 6 hr (range 1.5-24 hr

                Peak Plasma Concentration: Initial 2 mcg/mL (ASA); mean 20 mcg/mL

                Distribution

                Protein Bound: 50-60%

                Penetration into CSF with inflamed meninges

                Metabolism

                Metabolized by acetylation

                After 2 hr in simulated gastric fluid, 10% of unprotected aminosalicylic acid is decarboxylated to form meta-aminophenol, a known hepatotoxin

                Elimination

                Excretion: Urine 80%, with 50% in acetylated form

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                Patient Handout

                A Patient Handout is not currently available for this monograph.
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                Formulary

                FormularyPatient Discounts

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                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.