Each light peach caplet contains 258 mg phosphorous, 49.4 mg potassium and 262.4 mg sodium derived from sodium phosphate monobasic anhydrous, dipotassium phosphate anhydrous, and disodium phosphate anhydrous.
URO-KP-NEUTRAL® increases urinary phosphate and pyrophosphate. As a phosphorus supplement, each caplet supplies 25% of the U. S. Recommended Daily Allowance (U. S. RDA) of phosphorus for adults.
This product is contraindicated in patients with infected phosphate stones, in patients with severely impaired renal function (less than 30% of normal) and in the presence of hyperphosphatemia.
General: This product contains potassium and sodium and should be used with caution if regulation of these elements is desired. Occasionally, some individuals may experience a mild laxative effect during the first few days of phosphate therapy. If laxation persists to an unpleasant degree, reduce the daily dosage until this effect subsides or, if necessary, discontinue the use of this product.
Caution should be exercised when prescribing this product in the following conditions: Cardiac disease (particularly in digitalized patients); severe adrenal insufficiency (Addison's disease); acute dehydration; severe renal insufficiency; renal function impairment or chronic renal disease; extensive tissue breakdown (such as severe burns); myotonia congenita; cardiac failure; cirrhosis of the liver or severe hepatic disease; peripheral or pulmonary edema; hypernatremia; hypertension; toxemia of pregnancy; hypoparathyroidism; and acute pancreatitis. Rickets may benefit from phosphate therapy, but caution should be exercised. High serum phosphate may increase the incidence of extraskeletal calcification.
Information for Patients: Patients with kidney stones may pass old stones when phosphate therapy is started and should be warned of this possibility. Patients should be advised to avoid the use of antacids containing aluminum, magnesium or calcium which may prevent the absorption of phosphate.
Laboratory Tests: Careful monitoring of renal function and serum electrolytes (calcium, phosphorus, potassium, sodium) may be required at periodic intervals during phosphate therapy. Other tests may be warranted in some patients, depending on conditions.
Drug Interactions: The use of antacids containing magnesium, aluminum or calcium in conjunction with phosphate preparations may bind the phosphate and prevent its absorption. Concurrent use of antihypertensives, especially diazoxide, guanethidine, hydralazine, methyldopa, or rauwolfia alkaloids; or corticosteroids, especially mineralcorticoids or corticotropin, with sodium phosphate may result in hypernatremia. Calcium-containing preparations and/or vitamin D may antagonize the effects of phosphates in the treatment of hypercalcemia. Potassium-containing medications or potassium-sparing diuretics may cause hyperkalemia. Patients should have serum potassium level determinations at periodic intervals.
Carcinogenesis, Mutagenesis, Impairment of Fertility: There have been no studies in animals or humans to evalute the carcinogenesis, mutagenesis, or impairment of fertility for this product.
Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with this product. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product 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 this product is administered to a nursing woman.
Gastrointestinal upset (diarrhea, nausea, stomach pain, and vomiting) may occur with phosphate therapy. Also, bone and joint pain (possible phosphate-induced osteomalacia) could occur. The following adverse effects may be observed (primarily from sodium or potassium): headaches; dizziness; mental confusion; seizures; weakness or heaviness of legs; unusual tiredness or weakness; muscle cramps; numbness, tingling, pain, or weakness of hands or feet; numbness or tingling around lips; fast or irregular heartbeat; shortness of breath or troubled breathing; swelling of feet or lower legs; unusual weight gain; low urine output; unusual thirst.
Adults: One or two tablets four times a day with a full glass of water.
Light peach, film coated caplet with the Star logo and number 109 debossed on each caplet. Bottles of 100 caplets (NDC 0076-0109-03).
Federal law prohibits dispensing without a prescription.
Star Pharmaceuticals, Inc.