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Paser
Overview
What is Paser?
PASER granules are a delayed release granule preparation of aminosalicylic acid (p-aminosalicylic acid; 4-aminosalicylic acid) for use with other anti-tuberculosis drugs for the treatment of all forms of active tuberculosis due to susceptible strains of tubercle bacilli. The granules are designed for gradual release to avoid high peak levels not useful (and perhaps toxic) with bacteriostatic drugs. Aminosalicylic acid is rapidly degraded in acid media; the protective acid-resistant outer coating is rapidly dissolved in neutral media so a mildly acidic food such as orange, apple or tomato juice, yogurt or apple sauce should be used.
Aminosalicylic acid (p-aminosalicylic acid) is 4-Amino-2-hydroxybenzoic acid. PASER granules are the free base of aminosalicylic acid and do NOT contain sodium or a sugar. The molecular formula is CHNO with a molecular weight of 153.14. With heat p-aminosalicylic acid is decarboxylated to produce CO and m-aminophenol. If the airtight packets are swollen, storage has been improper. DO NOT USE if packets are swollen or the granules have lost their tan color and are dark brown or purple.
The structural formula is:
PASER granules are supplied as off-white tan colored granules with an average diameter of 1.5 mm and an average content of 60% aminosalicylic acid by weight. The acid resistant outer coating will be completely removed by a few minutes at a neutral pH. The inert ingredients are:
The packets contain 4 grams of aminosalicylic acid for oral administration three times a day by sprinkling on apple sauce or yogurt to be eaten without chewing. Suspension in an acidic fruit drink such as orange juice or tomato juice will protect the coating for at least 2 hours. Swirling the juice in the glass will help resuspend the granules if they sink.
What does Paser look like?
What are the available doses of Paser?
Sorry No records found.
What should I talk to my health care provider before I take Paser?
Sorry No records found
How should I use Paser?
PASER is indicated for the treatment of tuberculosis in combination with other active agents. It is most commonly used in patients with Multi-drug Resistant TB (MDR-TB) or in situations when therapy with isoniazid and rifampin is not possible due to a combination of resistance and/or intolerance. When PASER is added to the treatment regimen in patients proven or suspected drug resistance, it should be accompanied by at least one and preferably two other new agents to which the patient's organism is known or expected to be susceptible.
PASER granules should be administered with other drugs to which the organism is known or expected to be susceptible. It is most commonly administered to patients with Multi-drug Resistant TB (MDR-TB) or in other situations in which therapy with isoniazid or rifampin is not possible due to a combination of resistance and/or intolerance. The adult dosage of four grams (one packet) three times per day or correspondingly smaller doses in children should be given by sprinkling on apple sauce or yogurt or by swirling in the glass to suspend the granules in an acidic drink such as tomato or orange juice.
DO NOT USE if packet is swollen or the granules have lost their tan color, turning dark brown or purple.
What interacts with Paser?
Sorry No Records found
What are the warnings of Paser?
Sorry No Records found
What are the precautions of Paser?
Sorry No Records found
What are the side effects of Paser?
Sorry No records found
What should I look out for while using Paser?
Hypersensitivity to any component of this medication.
Severe renal disease.
Patients with severe renal disease will accumulate aminosalicylic acid and its acetyl metabolite but will continue to acetylate, thus leading exclusively to the inactive acetylated form; deacetylation, if any, is not significant.
The half life of free aminosalicylic acid in renal disease is 30.8 minutes in comparison to 26.4 minutes in normal volunteers. but the half life of the inactive metabolite is 309 minutes in uremic patients in comparison to 51 minutes in normal volunteers. Although aminosalicylic acid passes dialysis membranes, the frequency of dialysis usually is not comparable to the half-life of 50 minutes for the free acid. Patients with end stage renal disease should not receive aminosalicylic acid.
What might happen if I take too much Paser?
Overdosage has not been reported.
How should I store and handle Paser?
KADCYLA (ado-trastuzumab emtansine) is supplied as:Carton of 30 PASER packets (NDC 49938-107-04). Each packet contains four grams aminosalicylic acid. PASER granules are supplied in packets containing 4 grams of aminosalicylic acid for administration three times a day by suspension in an acidic drink or food with a pH less than 5. Examples include apple sauce, yogurt, tomato or orange juice. Distributors and Pharmacists: Store below 59°F (15°C) (in a refrigerator or freezer). Patients are urged to store PASER in a refrigerator or freezer. PASER packets may be stored at room temperature for short periods of time. AVOID EXCESSIVE HEAT. DO NOT USE if packet is swollen or the granules have lost their tan color, turning dark brown or purple. JACOBUS PHARMACEUTICAL CO. INC.P.O. Box 5290Princeton, NJ 08540 2A JULY, 1996 Carton of 30 PASER packets (NDC 49938-107-04). Each packet contains four grams aminosalicylic acid. PASER granules are supplied in packets containing 4 grams of aminosalicylic acid for administration three times a day by suspension in an acidic drink or food with a pH less than 5. Examples include apple sauce, yogurt, tomato or orange juice. Distributors and Pharmacists: Store below 59°F (15°C) (in a refrigerator or freezer). Patients are urged to store PASER in a refrigerator or freezer. PASER packets may be stored at room temperature for short periods of time. AVOID EXCESSIVE HEAT. DO NOT USE if packet is swollen or the granules have lost their tan color, turning dark brown or purple. JACOBUS PHARMACEUTICAL CO. INC.P.O. Box 5290Princeton, NJ 08540 2A JULY, 1996 Carton of 30 PASER packets (NDC 49938-107-04). Each packet contains four grams aminosalicylic acid. PASER granules are supplied in packets containing 4 grams of aminosalicylic acid for administration three times a day by suspension in an acidic drink or food with a pH less than 5. Examples include apple sauce, yogurt, tomato or orange juice. Distributors and Pharmacists: Store below 59°F (15°C) (in a refrigerator or freezer). Patients are urged to store PASER in a refrigerator or freezer. PASER packets may be stored at room temperature for short periods of time. AVOID EXCESSIVE HEAT. DO NOT USE if packet is swollen or the granules have lost their tan color, turning dark brown or purple. JACOBUS PHARMACEUTICAL CO. INC.P.O. Box 5290Princeton, NJ 08540 2A JULY, 1996 Carton of 30 PASER packets (NDC 49938-107-04). Each packet contains four grams aminosalicylic acid. PASER granules are supplied in packets containing 4 grams of aminosalicylic acid for administration three times a day by suspension in an acidic drink or food with a pH less than 5. Examples include apple sauce, yogurt, tomato or orange juice. Distributors and Pharmacists: Store below 59°F (15°C) (in a refrigerator or freezer). Patients are urged to store PASER in a refrigerator or freezer. PASER packets may be stored at room temperature for short periods of time. AVOID EXCESSIVE HEAT. DO NOT USE if packet is swollen or the granules have lost their tan color, turning dark brown or purple. JACOBUS PHARMACEUTICAL CO. INC.P.O. Box 5290Princeton, NJ 08540 2A JULY, 1996 Carton of 30 PASER packets (NDC 49938-107-04). Each packet contains four grams aminosalicylic acid. PASER granules are supplied in packets containing 4 grams of aminosalicylic acid for administration three times a day by suspension in an acidic drink or food with a pH less than 5. Examples include apple sauce, yogurt, tomato or orange juice. Distributors and Pharmacists: Store below 59°F (15°C) (in a refrigerator or freezer). Patients are urged to store PASER in a refrigerator or freezer. PASER packets may be stored at room temperature for short periods of time. AVOID EXCESSIVE HEAT. DO NOT USE if packet is swollen or the granules have lost their tan color, turning dark brown or purple. JACOBUS PHARMACEUTICAL CO. INC.P.O. Box 5290Princeton, NJ 08540 2A JULY, 1996 Carton of 30 PASER packets (NDC 49938-107-04). Each packet contains four grams aminosalicylic acid. PASER granules are supplied in packets containing 4 grams of aminosalicylic acid for administration three times a day by suspension in an acidic drink or food with a pH less than 5. Examples include apple sauce, yogurt, tomato or orange juice. Distributors and Pharmacists: Store below 59°F (15°C) (in a refrigerator or freezer). Patients are urged to store PASER in a refrigerator or freezer. PASER packets may be stored at room temperature for short periods of time. AVOID EXCESSIVE HEAT. DO NOT USE if packet is swollen or the granules have lost their tan color, turning dark brown or purple. JACOBUS PHARMACEUTICAL CO. INC.P.O. Box 5290Princeton, NJ 08540 2A JULY, 1996 Carton of 30 PASER packets (NDC 49938-107-04). Each packet contains four grams aminosalicylic acid. PASER granules are supplied in packets containing 4 grams of aminosalicylic acid for administration three times a day by suspension in an acidic drink or food with a pH less than 5. Examples include apple sauce, yogurt, tomato or orange juice. Distributors and Pharmacists: Store below 59°F (15°C) (in a refrigerator or freezer). Patients are urged to store PASER in a refrigerator or freezer. PASER packets may be stored at room temperature for short periods of time. AVOID EXCESSIVE HEAT. DO NOT USE if packet is swollen or the granules have lost their tan color, turning dark brown or purple. JACOBUS PHARMACEUTICAL CO. INC.P.O. Box 5290Princeton, NJ 08540 2A JULY, 1996 Carton of 30 PASER packets (NDC 49938-107-04). Each packet contains four grams aminosalicylic acid. PASER granules are supplied in packets containing 4 grams of aminosalicylic acid for administration three times a day by suspension in an acidic drink or food with a pH less than 5. Examples include apple sauce, yogurt, tomato or orange juice. Distributors and Pharmacists: Store below 59°F (15°C) (in a refrigerator or freezer). Patients are urged to store PASER in a refrigerator or freezer. PASER packets may be stored at room temperature for short periods of time. AVOID EXCESSIVE HEAT. DO NOT USE if packet is swollen or the granules have lost their tan color, turning dark brown or purple. JACOBUS PHARMACEUTICAL CO. INC.P.O. Box 5290Princeton, NJ 08540 2A JULY, 1996
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Mechanism of Action: Aminosalicylic acid is bacteriostatic against Mycobacterium tuberculosis. It inhibits the onset of bacterial resistance to streptomycin and isoniazid. The mechanism of action has been 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.
Non-Clinical Toxicology
Hypersensitivity to any component of this medication.Severe renal disease.
Patients with severe renal disease will accumulate aminosalicylic acid and its acetyl metabolite but will continue to acetylate, thus leading exclusively to the inactive acetylated form; deacetylation, if any, is not significant.
The half life of free aminosalicylic acid in renal disease is 30.8 minutes in comparison to 26.4 minutes in normal volunteers. but the half life of the inactive metabolite is 309 minutes in uremic patients in comparison to 51 minutes in normal volunteers. Although aminosalicylic acid passes dialysis membranes, the frequency of dialysis usually is not comparable to the half-life of 50 minutes for the free acid. Patients with end stage renal disease should not receive aminosalicylic acid.
Aminosalicylic acid at a dosage of 12 grams in a rapidly available form has been reported to produce a 20 percent reduction in the acetylation of isoniazid, especially in patients who are rapid acetylators; INH serum levels, half lives and excretions in fast acetylators still remain half of the levels seen in slow acetylators with or without p-aminosalicylic acid. The effect is dose related and, while it has not been studied with the current delayed release preparation, the lower serum levels with this preparation will result in a reduced effect on the acetylation of INH.
Aminosalicylic acid has previously been reported to block the absorption of rifampin. A subsequent report has shown that this blockade was due to an excipient not included in PASER granules. Oral administration of a solution containing both aminosalicylic acid and rifampin showed full absorption of each product.
As a result of competition, Vitamin B absorption has been reduced 55% by 5 grams of aminosalicylic acid with clinically significant erythrocyte abnormalities developing after depletion; patients on therapy of more than one month should be considered for maintenance B.
A malabsorption syndrome can develop in patients on aminosalicylic acid but is usually not complete. The complete syndrome includes steatorrhea, an abnormal small bowel pattern on x-ray, villus atrophy, depressed cholesterol, reduced D-xylose and iron absorption. Triglyceride absorption always is normal.
In one literature report 8 hours after the last dosage of aminosalicylic acid at 2 gm qid serum digoxin levels were reduced 40% in two of ten patients but not changed in the remaining eight.
All drugs should be stopped at the first sign suggesting a hypersensitivity reaction. They may be restarted one at a time in very small but gradually increasing doses to determine whether the manifestations are drug-induced and, if so, which drug is responsible.
Desensitization has been accomplished successfully in 15 of 17 patients starting with 10 mg aminosalicylic acid given as a single dose. The dosage is doubled every 2 days until reaching a total of 1 gram after which the dosage is divided to follow the regular schedule of administration. If a mild temperature rise or skin reaction develops, the increment is to be dropped back one level or the progression held for one cycle. Reactions are rare after a total dosage of 1.5 grams.
Patients with hepatic disease may not tolerate aminosalicylic acid as well as normal patients, even though the metabolism in patients with hepatic disease has been reported to be comparable to that in normal volunteers.
The most common side effect is gastrointestinal 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 may be prevented by the maintenance of urine at a neutral or an alkaline pH.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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