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

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            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 (3)

              • 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.

              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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                Images

                No images available for this drug.
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                Patient Handout

                Patient Education
                aminosalicylic acid oral

                AMINOSALICYLIC ACID GRANULES - ORAL

                (a-MEE-noe-sal-i-SIL-ik AS-id)

                COMMON BRAND NAME(S): Paser

                USES: This medication is used in combination with other drugs to treat tuberculosis. The treatment of active tuberculosis infection requires taking several drugs in combination for 6 months or longer. This medication may be used as part of this combined drug treatment. Aminosalicylic acid is known as an antituberculosis antibiotic. It works by stopping or slowing the growth of bacteria.This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

                HOW TO USE: Do not take this medication if the packet is swollen or the granules have turned dark brown or purple instead of tan. This may be a sign that the medication has not been properly stored. See also Storage section.Take this medication by mouth, usually 2 to 3 times daily or as directed by your doctor. This medication needs to be taken with an acidic food to properly work in your body. Open the packet and sprinkle your dose onto an acidic food such as applesauce, yogurt, or juice (such as tomato, orange, grapefruit, grape, cranberry, apple juice, or punch). Do not mix in other foods. If the granules are mixed in juice, stir to suspend the granules and drink all of the mixture right away. The granules will not dissolve in the prepared mixture. Do not crush or chew the granules before or while swallowing. Do not prepare a supply in advance. Ask your doctor or pharmacist if you have any questions about how to take this medication.Dosage is based on your medical condition, age, and response to treatment.For the best effect, take this antibiotic at evenly spaced times. To help you remember, take this medication at the same time every day.Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.Tell your doctor if your condition does not improve or if it worsens.

                SIDE EFFECTS: Upset stomach, nausea, vomiting, or diarrhea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.You may notice the empty granule coatings in your stool. This is harmless.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if any of these rare but serious side effects occur: black/bloody stools, vomit that contains blood or looks like coffee grounds.Rarely, aminosalicylic acid may cause serious (possibly fatal) liver damage, usually within the first 3 months after starting treatment. Stop taking this medication and seek immediate medical attention if you develop: rash followed by a fever, dark urine, persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin.A very serious allergic reaction to this drug is rare. Stop taking this medication and seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

                PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain enzyme problem (glucose-6-phosphate-dehydrogenase deficiency-G6PD), kidney disease, liver problems, stomach ulcer.Aminosalicylic acid may cause live bacterial vaccines (such as typhoid vaccine) to not work as well. Do not have any immunizations/vaccinations while using this medication unless your doctor tells you to.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This drug passes into breast milk and the effect on a nursing infant is unknown. Consult your doctor before breast-feeding.

                DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.This medication may decrease the amount of substances (such as vitamin B12) in your body. Your doctor may recommend that you take a nutritional supplement while taking this drug. Ask your doctor for details.This medication may interfere with certain laboratory tests (including albumin, urine tests for ketones/bilirubin), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

                OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

                NOTES: Do not share this medication with others.This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor tells you to.Laboratory and/or medical tests (such as sputum exam/culture) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

                MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

                STORAGE: Store in a refrigerator or freezer below 59 degrees F (15 degrees C) away from moisture. Brief storage at room temperature is permitted. Keep away from heat. Do not store in the bathroom. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your medication.

                Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

                IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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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.