Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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)
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)
Warnings
Contraindications
Hypersensitivity
End-stage renal disease
Cautions
Monitor liver function; reports of drug-induced hepatitis with rapidly absorbed aminosalicylic acid preparations
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.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
Images
Patient Handout
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 as directed by your doctor, usually 2 to 3 times daily. 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 last or get worse, 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 you have any serious side effects, including: 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 get medical help right away if you develop: rash followed by a fever, nausea/vomiting that doesn't stop, dark urine, stomach/abdominal pain, yellowing eyes/skin.A very serious allergic reaction to this drug is rare. However, get medical help right away 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 well. Tell your health care professional that you are using aminosalicylic acid before having any immunizations/vaccinations.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: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines 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.
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.Lab and/or medical tests (such as sputum exam/culture) should be done while you are taking this medication. Keep all medical and lab appointments. 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 away from moisture. Brief storage at room temperature is permitted. Keep away from heat. Do not store in the bathroom. Keep all medications 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.
Information last revised December 2022. Copyright(c) 2023 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.
Formulary
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