Rx Item-Amino Salicylic Acid 100GM Powder by Fagron Pharma USA

PASER- aminosalicylic acid granule, delayed release
Jacobus Pharmaceutical Company, Inc.
PASER granules are 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 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 sugar. The molecular formula is C7 H7 NO3 with molecular weight of 153.14. With heat p-aminosalicylic acid is decarboxylated to produce CO2 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.

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 few minutes at neutral pH. The inert ingredients are:
colloidal silicon dioxide
dibutyl sebacate
hydroxypropyl methyl cellulose
methacrylic acid copolymer
microcrystalline cellulose
talc
The packets contain grams of aminosalicylic acid for oral administration three times 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 hours. Swirling the juice in the glass will help resuspend the granules if they sink.

CLINICAL 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.
INDICATIONS AND USAGE
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 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.
DOSAGE AND ADMINISTRATION
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 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.
HOW SUPPLIED
Carton of 30 PASER packets (NDC 49938-107-04).
Each packet contains four grams aminosalicylic acid.
PASER granules are supplied in packets containing grams of aminosalicylic acid for administration three times day by suspension in an acidic drink or food with pH less than 5. Examples include apple sauce, yogurt, tomato or orange juice.
Distributors and Pharmacists: Store below 59?F (15?C) (in refrigerator or freezer).
Patients are urged to store PASER in 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.

Rx Item-Amino Salicylic Acid 100GM Powde
Item No. RX236253, 236253, NDC No.: 51552-1326-05, 51552-326-05, 5155232605, 51552132605, 1326-05, 132605 UPC No. 3-51552-13265-0, 351552-132650, 351552132650

Rx Item-Amino Salicylic Acid 100GM Powde
Item No. RX236253, 236253, NDC No.: 51552-1326-05, 51552-326-05, 5155232605, 51552132605, 1326-05, 132605 UPC No. 3-51552-13265-0, 351552-132650, 351552132650

Rx Item-Amino Salicylic Acid 100GM Powde
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