Label: PHOSPHO-TRIN 250 NEUTRAL- sodium phosphate, dibasic, anhydrous, potassium phosphate, monobasic, and sodium phosphate, monobasic, monohydrate tablet

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 dose until this effect subsides or, if necessary, discontinue the use of the 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 levels 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

Careful monitoring of renal function and serum calcium, phosphorus, potassium, and 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 alkaloid; or corticosteroids, especially mineralocorticoids 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 medication or potassium-sparing diuretics may cause hyperkalemia. Patients should have serum potassium level determinations at periodic intervals.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long term or reproduction studies in animals or humans have been performed with Phospho-Trin™ 250 Neutral to evaluate its carcinogenic, mutagenic, or impairment of fertility potential.

Pregnancy

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.

Pediatric Use

See DOSAGE AND ADMINISTRATION.

Adults

One or two tablets, four times daily;

Pediatric patients over 4 years of age

One tablet four times daily.

Pediatric Patients under 4 years of age

Use only as directed by physician.

STORAGE

Keep tightly closed. Store upright at 20 to 25°C (68 to 77°F). Excursions permitted 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children. Dispense in tight, light-resistant containers with child resistant closures.