ALLERGY STATEMENT

This product has been manufactured in a facility that also manufactures products containing tree nuts, peanuts, fish, egg, wheat, milk, soy and shellfish. Individuals with allergies to these substances should use discretion.

General

This product contains potassium and sodium and should be used with caution if clinical management of these elements is desired. Some individuals may experience a mild laxative effect during the first few days of phosphate therapy; lower 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 patients receiving digitalis); severe adrenal insufficiency (Addison's disease); acute dehydration; severe renal insufficiency; renal function impairment or chronic renal disease; extensive tissue breakdown (such as with 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. 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 because they may prevent the absorption of phosphate.

Laboratory Tests

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 antihypertensive drugs or corticosteroids 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 Virt-Phos 250 Neutral to evaluate its carcinogenic, mutagenic, or impairment of fertility potential.

Pregnancy and Lactation

Animal reproduction studies have not been conducted with Virt-Phos 250 Neutral. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. This product should be given to a pregnant woman only if clearly needed.

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 DIRECTIONS FOR USE.

SIDE EFFECTS

Gastrointestinal upset (diarrhea, nausea, stomach pain, or vomiting) may occur with phosphate therapy. Bone and joint pain and possibly osteomalacia could occur.

Adverse effects due to sodium or potassium may be observed: headache; dizziness; mental confusion; seizures; weakness or heaviness of legs; unusual tiredness or weakness; 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 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 licensed healthcare practitioner.