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Drug overview for PASER (aminosalicylic acid):
Generic name: AMINOSALICYLIC ACID (a-MEE-noe-sal-i-SIL-ik AS-id)
Drug class: Aminosalicylic Acid
Therapeutic class: Anti-Infective Agents
Aminosalicylic acid, a structural analog of aminobenzoic acid, is a synthetic antituberculosis agent.
No enhanced Uses information available for this drug.
Generic name: AMINOSALICYLIC ACID (a-MEE-noe-sal-i-SIL-ik AS-id)
Drug class: Aminosalicylic Acid
Therapeutic class: Anti-Infective Agents
Aminosalicylic acid, a structural analog of aminobenzoic acid, is a synthetic antituberculosis agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for PASER (aminosalicylic acid) have been approved by the FDA:
Indications:
Active tuberculosis
Pulmonary tuberculosis
Professional Synonyms:
Active TB
Acute tuberculosis
Pulmonary TB
Indications:
Active tuberculosis
Pulmonary tuberculosis
Professional Synonyms:
Active TB
Acute tuberculosis
Pulmonary TB
The following dosing information is available for PASER (aminosalicylic acid):
No enhanced Dosing information available for this drug.
Aminosalicylic acid is administered orally. Although aminosalicylic acid has been administered IV, a parenteral dosage form of the drug is not commercially available in the US. Commercially available aminosalicylic acid granules (Paser(R)) have an acid-resistant coating that dissolves promptly (within 1 minute) at neutral pH such as that found in the small intestine or in neutral foods.
Therefore, the granules should be administered in an acidic food or drink having a pH less than 5, such as applesauce, yogurt, or fruit juice. The manufacturer states that the following juices have been tested and are suitable for administration of the granules: orange, apple, tomato, grapefruit, grape, cranberry, ''fruit punch.'' When administered in fruit juice, the granules sink but can be resuspended by swirling.
Paser(R) granules mixed with an acidic food should be swallowed without chewing. The manufacturer states that the acid-resistant coating will last at least 2 hours in these acidic foods or drinks. Patients in whom stomach acid has been neutralized by concurrent administration of antacids do not need to administer Paser(R) granules in an acidic food or drink.
Therefore, the granules should be administered in an acidic food or drink having a pH less than 5, such as applesauce, yogurt, or fruit juice. The manufacturer states that the following juices have been tested and are suitable for administration of the granules: orange, apple, tomato, grapefruit, grape, cranberry, ''fruit punch.'' When administered in fruit juice, the granules sink but can be resuspended by swirling.
Paser(R) granules mixed with an acidic food should be swallowed without chewing. The manufacturer states that the acid-resistant coating will last at least 2 hours in these acidic foods or drinks. Patients in whom stomach acid has been neutralized by concurrent administration of antacids do not need to administer Paser(R) granules in an acidic food or drink.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| PASER GRANULES 4 GM PACKET | Maintenance | Adults take 1 packet (4 gram) mixed with applesauce, yogurt, or fruit juice by oral route 3 times per day |
No generic dosing information available.
The following drug interaction information is available for PASER (aminosalicylic acid):
There are 0 contraindications.
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Fecal Microbiota Spores/Antibiotics SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Fecal microbiota spores is a suspension of live bacterial spores, which may be compromised by concurrent use of antibiotics.(1) CLINICAL EFFECTS: Antibiotics may decrease the effectiveness of fecal microbiota spores.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Antibiotics should not be used concurrently with fecal microbiota spores. Antibacterial treatment should be completed for 2 to 4 days before initiating treatment with fecal microbiota spores.(1) DISCUSSION: Antibiotics may compromise the effectiveness of fecal microbiota spores. |
VOWST |
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Azathioprine; Mercaptopurine/Aminosalicylate Derivatives SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: The exact mechanism is not known. Aminosalicylic acid and its derivatives (balsalazide, mesalamine, olsalazine, sulfasalazine) may inhibit azathioprine or mercaptopurine inactivation via the thiopurine methyltransferase (TPMT) pathway. Aminosalicylates, azathioprine and mercaptopurine are all associated risk for neutropenia, thrombocytopenia, and anemia and so these risks could be additive. CLINICAL EFFECTS: Concurrent use of azathioprine or mercaptopurine with aminosalicylates may increase the risk for anemia, neutropenia, or thrombocytopenia. PREDISPOSING FACTORS: Patients with reduced or absent thiopurine S-methyltransferase (TPMT) or nucleotide diphosphatase (NUDT15) activity are at higher risk of accumulating thiopurine metabolites and severe myelosuppression. Approximately 0.3 % of patients of European, Latino, or African descent have mutations of the TPMT gene resulting in little to no TPMT activity (homozygous deficiency), and approximately 10 % have intermediate TPMT activity (heterozygous deficiency). NUDT15 deficiency is not seen in patients of African descent and is seen in less than 1 % of patients of European descent. Approximately 1 % of patients of East Asian descent, 0.5 % of patients of central/south Asian descent, and 2 % of patients of Latino descent have homozygous NUDT15 deficiency. About 17 % of patients of East Asian descent, 13 % of patients of central/south Asian descent, and 8 % of patients of Latino descent have heterozygous NUDT15 deficiency. Added risk for myelosuppression would be expected in patients who also receive allopurinol or other agents which block xanthine oxidase (XO), the other major inactivation pathway for azathioprine and mercaptopurine. PATIENT MANAGEMENT: Use the lowest possible dose of each drug and monitor closely for myelosuppression. DISCUSSION: Manufacturer prescribing information states that concurrent use of aminosalicylates with azathioprine or mercaptopurine has been reported to cause bone marrow suppression. In a prospective study, 22 inflammatory bowel disease (IBD) patients on concurrent 5-aminosalicylate with (2 g daily and later increased to 4 g daily) with azathioprine had increased levels of 6-thioguanine (6-TGN) metabolites. One patient had signs of myelosuppression.(3) A prospective study in 183 IBD patients on concurrent 5-aminosalicylic acid and thiopurines found no significant interaction between thiopurines and 5-aminosalicylic acid.(4) A retrospective study in 199 IBD patients reported an increased rate of adverse events in the dual 5-aminosalicylates and azathioprine dual therapy group compared (48%) to the monotherapy azathioprine group (30%)(chi = 6.4, p = 0.05). Discontinuation of azathioprine because of adverse events was higher in the dual therapy group (52% vs. 24%).(5) In a prospective study, 16 Crohn's disease patients on a stable dose of azathioprine with sulfasalazine or mesalamine discontinued the aminosalicylate after 3 months, which resulted in an average decrease 0f 10% in 6-TGN levels. Myelosuppression may be related to increased levels of 6-TGN.(6) In a 8 week non-randomized parallel group drug interaction study, 34 patients with Crohn's disease receiving azathioprine or 6-mercaptopurine with mesalamine (4 g/day), or sulfasalazine (4 g/day), or balsalazide (6.75 g/day) had a high frequency of leukopenia (20-55%) and significant increases in whole blood 6-TGN levels.(7) A 16 year-old Crohn's disease patient on concurrent 6-mercaptopurine (75 mg) and olsalazine (1000 mg) developed leukopenia (WBC count 1.7 x 10*9/L, ANC 1.309 x 10*9/L, hemoglobulin 113 gm/L, platelet count 550 x 10*9/L) and required a dose reduction for 6-mercaptopurine. Another episode occurred later on after increasing her dose of olsalazine and 6-mercaptopurine which resulted in discontinuation of olsalazine.(8) An in vitro study showed that sulfasalazine and other aminosalicylate derivatives were able to inhibit recombinant human TPMT.(9) In a prospective study, 17 IBD patients on stable mercaptopurine and mesalamine therapy had a 23% reduction in 6-TGN levels after discontinuing mercaptopurine.(10) |
AZASAN, AZATHIOPRINE, AZATHIOPRINE SODIUM, IMURAN, MERCAPTOPURINE, PURIXAN |
The following contraindication information is available for PASER (aminosalicylic acid):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 4 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Aspirin exacerbated respiratory disease |
| Glucose-6-phosphate dehydrogenase (g6Pd) deficiency |
| Hemoglobin H disease |
| Hemolytic anemia from pyruvate kinase and g6PD deficiencies |
There are 3 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Gastrointestinal ulcer |
| Peptic ulcer |
| Vitamin b12 deficiency |
There are 6 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Acidosis |
| Crystalluria |
| Disease of liver |
| Goiter |
| Hypokalemia |
| Kidney disease with reduction in glomerular filtration rate (GFr) |
The following adverse reaction information is available for PASER (aminosalicylic acid):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 14 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Drug fever Eosinophilia Leukopenia Pruritus of skin |
Crystalluria Goiter Hemolytic anemia Hepatitis Infectious mononucleosis Jaundice Malaise Myxedema Skin rash |
| Rare/Very Rare |
|---|
|
Glucose-6-phosphate dehydrogenase (g6Pd) deficiency anemia |
There are 0 less severe adverse reactions.
The following precautions are available for PASER (aminosalicylic acid):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Safe use of aminosalicylic acid during pregnancy has not been established and the drug should be used during pregnancy only when clearly needed. The American Thoracic Society (ATS), US Centers for Disease Control and Prevention (CDC), and Infectious Diseases Society of America (IDSA) state that, although aminosalicylic acid has been used safely during pregnancy, the drug should be used in pregnant women only when there are no alternatives for the treatment of multidrug-resistant tuberculosis. Aminosalicylic acid is distributed into milk.
No enhanced Lactation information available for this drug.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for PASER (aminosalicylic acid):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for PASER (aminosalicylic acid)'s list of indications:
| Active tuberculosis | |
| A15 | Respiratory tuberculosis |
| A15.0 | Tuberculosis of lung |
| A15.4 | Tuberculosis of intrathoracic lymph nodes |
| A15.5 | Tuberculosis of larynx, trachea and bronchus |
| A15.6 | Tuberculous pleurisy |
| A15.7 | Primary respiratory tuberculosis |
| A15.8 | Other respiratory tuberculosis |
| A15.9 | Respiratory tuberculosis unspecified |
| A17 | Tuberculosis of nervous system |
| A17.0 | Tuberculous meningitis |
| A17.1 | Meningeal tuberculoma |
| A17.8 | Other tuberculosis of nervous system |
| A17.81 | Tuberculoma of brain and spinal cord |
| A17.82 | Tuberculous meningoencephalitis |
| A17.83 | Tuberculous neuritis |
| A17.89 | Other tuberculosis of nervous system |
| A17.9 | Tuberculosis of nervous system, unspecified |
| A18 | Tuberculosis of other organs |
| A18.0 | Tuberculosis of bones and joints |
| A18.01 | Tuberculosis of spine |
| A18.02 | Tuberculous arthritis of other joints |
| A18.03 | Tuberculosis of other bones |
| A18.09 | Other musculoskeletal tuberculosis |
| A18.1 | Tuberculosis of genitourinary system |
| A18.10 | Tuberculosis of genitourinary system, unspecified |
| A18.11 | Tuberculosis of kidney and ureter |
| A18.12 | Tuberculosis of bladder |
| A18.13 | Tuberculosis of other urinary organs |
| A18.14 | Tuberculosis of prostate |
| A18.15 | Tuberculosis of other male genital organs |
| A18.16 | Tuberculosis of cervix |
| A18.17 | Tuberculous female pelvic inflammatory disease |
| A18.18 | Tuberculosis of other female genital organs |
| A18.2 | Tuberculous peripheral lymphadenopathy |
| A18.3 | Tuberculosis of intestines, peritoneum and mesenteric glands |
| A18.31 | Tuberculous peritonitis |
| A18.32 | Tuberculous enteritis |
| A18.39 | Retroperitoneal tuberculosis |
| A18.4 | Tuberculosis of skin and subcutaneous tissue |
| A18.5 | Tuberculosis of eye |
| A18.50 | Tuberculosis of eye, unspecified |
| A18.51 | Tuberculous episcleritis |
| A18.52 | Tuberculous keratitis |
| A18.53 | Tuberculous chorioretinitis |
| A18.54 | Tuberculous iridocyclitis |
| A18.59 | Other tuberculosis of eye |
| A18.6 | Tuberculosis of (inner) (middle) ear |
| A18.7 | Tuberculosis of adrenal glands |
| A18.8 | Tuberculosis of other specified organs |
| A18.81 | Tuberculosis of thyroid gland |
| A18.82 | Tuberculosis of other endocrine glands |
| A18.83 | Tuberculosis of digestive tract organs, not elsewhere classified |
| A18.84 | Tuberculosis of heart |
| A18.85 | Tuberculosis of spleen |
| A18.89 | Tuberculosis of other sites |
| A19 | Miliary tuberculosis |
| A19.0 | Acute miliary tuberculosis of a single specified site |
| A19.1 | Acute miliary tuberculosis of multiple sites |
| A19.2 | Acute miliary tuberculosis, unspecified |
| A19.8 | Other miliary tuberculosis |
| A19.9 | Miliary tuberculosis, unspecified |
| O98.0 | Tuberculosis complicating pregnancy, childbirth and the puerperium |
| O98.01 | Tuberculosis complicating pregnancy |
| O98.011 | Tuberculosis complicating pregnancy, first trimester |
| O98.012 | Tuberculosis complicating pregnancy, second trimester |
| O98.013 | Tuberculosis complicating pregnancy, third trimester |
| O98.019 | Tuberculosis complicating pregnancy, unspecified trimester |
| O98.02 | Tuberculosis complicating childbirth |
| O98.03 | Tuberculosis complicating the puerperium |
| P37.0 | Congenital tuberculosis |
| Pulmonary tuberculosis | |
| A15 | Respiratory tuberculosis |
| A15.0 | Tuberculosis of lung |
| A15.7 | Primary respiratory tuberculosis |
| A15.8 | Other respiratory tuberculosis |
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