steady Aminohippurate Sodium Dosage Form: injection, solution Overview Side Effects Professional Reviews Q & A More Aminohippurate Sodium PAH INJECTION Aminohippurate Sodium Description Aminohippurate Sodium 1 is an agent to measure effective renal plasma flow (ERPF). It is the sodium salt of para-aminohippuric acid, commonly abbreviated PAH . It is water soluble, lipid-insoluble, and has a pKa of 3.83. The empirical formula of the anhydrous salt is C 9 H 9 N 2 NaO 3 and its structural formula is: It is provided as a sterile, non-preserved 20 percent aqueous solution for injection, with a pH of 6.7 to 7.6. Each 10 mL contains: Aminohippurate Sodium 2 g. Inactive ingredients: Sodium hydroxide to adjust pH, water for injection, q.s. 1 Formerly referred to as Sodium para-Aminohippurate. Slideshow Binge Eating Disorder: Beyond Overeating Aminohippurate Sodium - Clinical Pharmacology PAH is filtered by the glomeruli and is actively secreted by the proximal tubules. At low plasma concentrations (1.0 to 2.0 mg/100 mL), an average of 90 percent of PAH is cleared by the kidneys from the renal blood stream in a single circulation. It is ideally suited for measurement of ERPF since it has a high clearance, is essentially nontoxic at the plasma concentrations reached with recommended doses, and its analytical determination is relatively simple and accurate. PAH is also used to measure the functional capacity of the renal tubular secretory mechanism or transport maximum (Tm PAH ). This is accomplished by elevating the plasma concentration to levels (40-60 mg/100 mL) sufficient to saturate the maximal capacity of the tubular cells to secrete PAH. Inulin clearance is generally measured during Tm PAH determinations since glomerular filtration rate (GFR) must be known before calculations of secretory Tm measurements can be done (see DOSAGE AND ADMINISTRATION, Calculations ). Indications and Usage for Aminohippurate Sodium Estimation of effective renal plasma flow. Measurement of the functional capacity of the renal tubular secretory mechanism. Contraindications Hypersensitivity to this product or to its components. Precautions General Intravenous solutions must be given with caution to patients with low cardiac reserve, since a rapid increase in plasma volume can precipitate congestive heart failure. For measurement of ERPF, small doses of PAH are used. However, in research procedures to measure Tm PAH , high plasma levels are required to saturate the capacity of the tubular cells. During these procedures, the intravenous administration of PAH solutions should be carried out slowly and with caution. The patient should be continuously observed for any adverse reactions. Use caution when injecting this product into latex-sensitive individuals, since the vial stopper contains dry natural latex rubber that may cause allergic reactions. Drug Interactions Renal clearance measurements of PAH cannot be made with any significant accuracy in patients receiving sulfonamides, procaine, or thiazolesulfone. These compounds interfere with chemical color development essential to the analytical procedures. Probenecid depresses tubular secretion of certain weak acids such as PAH. Therefore, patients receiving probenecid will have erroneously low ERPF and Tm PAH values. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been done to evaluate any effects upon fertility or carcinogenic potential of PAH. Pregnancy Pregnancy Category C Animal reproduction studies have not been done with PAH. It is also not known whether PAH can cause fetal harm when given to a pregnant woman or can affect reproduction capacity. PAH should be given to a pregnant woman only if clearly needed. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when PAH is administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Clinical studies of PAH did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Adverse Reactions Hypersensitivity reactions including anaphylaxis, angioedema, urticaria, vasomotor disturbances, flushing, tingling, nausea, vomiting, and cramps may occur. Patients may have a sensation of warmth or the desire to defecate or urinate during or shortly following initiation of infusion. OVERDOSE The intravenous LD 50 in female mice is 7.22 g/kg. Aminohippurate Sodium Dosage and Administration For intravenous use only Clearance measurements using single injection techniques are generally inaccurate, particularly in the measurement of ERPF. For this reason, intravenous infusions at fixed rates are used to sustain the plasma PAH concentration at the desired level. To measure ERPF, the concentration of PAH in the plasma should be maintained at 2 mg per 100 mL, which can be achieved with a priming dose of 6 to 10 mg/kg and an infusion dose of 10 to 24 mg/min. As a research procedure for the measurement of Tm PAH , the plasma level of PAH must be sufficient to saturate the capacity of the tubular secretory cells. Concentrations from 40 to 60 mg per 100 mL are usually necessary. Technical details of these tests may be found in Smith 1 ; Wesson 2 ; Bauer 3 ; Pitts 4 ; and Schnurr 5 . Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use, whenever solution and container permit. NOTE: The normal color range for this product is a colorless to yellow/brown solution. The efficacy is not affected by color changes within this range. Calculations Effective Renal Plasma Flow (ERPF) The clearance of PAH, which is extracted almost completely from the plasma during its passage through the renal circulation, constitutes a measure of ERPF. Hence: ERPF = U PAH V/P PAH Where U PAH = concentration of PAH (mg/mL) in the urine V = rate of urine excretion (mL/min), and P PAH = plasma concentration of PAH (mg/mL). Example: U PAH = 8.0 mg/mL V = 1.5 mL/min P PAH = 0.02 mg/mL ERPF = 8.0 x 1.5/0.02 = 600 mL/min Based on PAH clearance studies, the normal values for ERPF are: men 675 150 mL/min women 595 125 mL/min Maximum Tubular Secretory (Tm PAH ) Mechanism The quantity of PAH secreted by the tubules (Tm PAH ) is given by the difference between the total rate of excretion (U PAH V) and the quantity filtered by the glomeruli (GFR x P PAH ). Hence: Tm PAH = U PAH V (GFR x P PAH x 0.83) The factor, 0.83, corrects for that portion of PAH which is bound to plasma protein and hence is unfilterable. Example: U PAH = 9.55 mg/mL V = 16.68 mL/min GFR = 120 mL/min P PAH = 0.60 mg/mL Then Tm PAH = 9.55 x 16.68 (120 x 0.60 x 0.83) = 100 mg/min. Average normal values of Tm PAH are 80-90 mg/min. The value of the expression U PAH V, used in calculations of ERPF and Tm PAH , may be found by determining the amount of PAH in a measured volume of urine excreted within a specific period of time. These calculations are based on a body surface area of 1.73 m 2 . Corrections for variations in surface area are made by multiplying the values obtained for ERPF and Tm PAH by 1.73/A, where A is the subject surface area. How is Aminohippurate Sodium Supplied No. 95 Aminohippurate Sodium, 20 percent sterile solution for intravenous injection, is supplied as follows: NDC 0006-3395-11 in 10 mL vials. Storage Store at 25 C (77 F); excursions permitted to 15-30 C (59-86 F) [see USP Controlled Room Temperature]. REFERENCES Smith, H.W.: Lectures on the kidney, University Extension Division, University of Kansas, Lawrence, Kansas, 1943. Wesson, L.G., Jr.: "Physiology of the Human Kidney," New York, Grune & Stratton, 1969, pp. 632-655. Bauer, J.D.; Ackermann, P.G.; Toro, G.: "Brays Clinical Laboratory Methods," ed. 7, St. Louis, Mosby, 1968. Pitts, R.F.: "Physiology of the Kidney and Body Fluids," ed. 2, Chicago, Year Book Medical Publishers, 1968. Schnurr, E.; Lahme, W.; Kuppers, H.: Measurement of renal clearance of inulin and PAH in the steady state without urine collection; Clinical Nephrology, 13 (1): (26-29), 1980. Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA Issued January 2011 Printed in USA 9051026 Copyright 1983 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved This is a representative sample of the packaging. Please see How Supplied section for a complete list of available packaging. PRINCIPAL DISPLAY PANEL - Carton - 10 mL Single Dose Vial NDC 0006-3395-11 SINGLE DOSE VIAL 10 mL INJECTION Aminohippurate Sodium 2 g in 10 mL (20% solution) FOR INTRAVENOUS USE ONLY TO DETERMINE KIDNEY FUNCTION Rx only Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC. Whitehouse Station, NJ 08889, USA Aminohippurate Sodium PAH Aminohippurate Sodium injection, solution Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0006-3395 Route of Administration INTRAVENOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Aminohippurate Sodium (AMINOHIPPURIC ACID) Aminohippurate Sodium 2 g in 10 mL Inactive Ingredients Ingredient Name Strength SODIUM HYDROXIDE WATER Product Characteristics Color YELLOW, BROWN (colorless to yellow/brown) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description 1 NDC:0006-3395-11 1 VIAL, SINGLE-DOSE (VIAL) in 1 CARTON 1 10 mL in 1 VIAL, SINGLE-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA005619 12/30/1944 Labeler - Merck Sharp & Dohme Corp. (001317064) Establishment Name Address ID/FEI Operations Merck Sharp & Dohme Corp. 002387926 MANUFACTURE Revised: 01/2011 Merck Sharp & Dohme Corp. 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